Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2025-12-25 @ 8:49 PM
Study NCT ID:
NCT04797169
Status:
COMPLETED
Last Update Posted:
2025-08-11
First Post:
2021-03-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Noom Health for Weight Management
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tom.hildebrandt@mssm.edu', 'phone': '(212) 659-8673', 'title': 'Thomas B Hildebrandt, Psy.D.', 'organization': 'Icahn School of Medicine at Mount Sinai'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '30 months', 'eventGroups': [{'id': 'EG000', 'title': 'Noom Health', 'description': 'In Noom Health, participants encouraged to use the Noom app multiple times a day to log eating episodes, physical activity and weight. They will also have the ability to interact with coaches to receive advice and feedback specific to weight loss.', 'otherNumAtRisk': 302, 'deathsNumAtRisk': 302, 'otherNumAffected': 43, 'seriousNumAtRisk': 302, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Noom Digital Health', 'description': 'In Noom Digital Health, participants used a simplified version to log eating episodes and weight. Both conditions will receive the same weight loss advice content.', 'otherNumAtRisk': 298, 'deathsNumAtRisk': 298, 'otherNumAffected': 42, 'seriousNumAtRisk': 298, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Colitis - unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 302, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Food poisoning - unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 302, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 298, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stomach cramps - unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 302, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Allergic reaction - unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 302, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 298, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dental problem - unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 302, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Unknown health problem - unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 302, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 298, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Viral/bacterial Illness - unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 302, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 298, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Car accident - unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 302, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injury - unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 302, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 298, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fibromyalgia - unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 302, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 298, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Multiple Sclerosis - unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 302, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain/muscular issue - unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 302, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 298, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cancer - unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 302, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 298, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Breastfeeding - unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 302, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pregnancy - unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 302, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 298, 'numAffected': 10}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anxiety - unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 302, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 298, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Depression - unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 302, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Swelling - unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 302, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 298, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Surgery - unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 302, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 298, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Migraine - unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 302, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Breastfeeding supply lowered', 'stats': [{'groupId': 'EG000', 'numAtRisk': 302, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numAffected': 2}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fainted during exercise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 302, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 298, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Weight From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Noom Health', 'description': 'In Noom Health, participants encouraged to use the Noom app multiple times a day to log eating episodes, physical activity and weight. They will also have the ability to interact with coaches to receive advice and feedback specific to weight loss.'}, {'id': 'OG001', 'title': 'Noom Digital Health', 'description': 'In Noom Digital Health, participants used a simplified version to log eating episodes and weight. Both conditions will receive the same weight loss advice content.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '210.1', 'spread': '42.1', 'groupId': 'OG000'}, {'value': '211.7', 'spread': '44.7', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '199.4', 'spread': '41.4', 'groupId': 'OG000'}, {'value': '204.6', 'spread': '45.8', 'groupId': 'OG001'}]}]}, {'title': '30 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '197.2', 'spread': '43.1', 'groupId': 'OG000'}, {'value': '201.6', 'spread': '43.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 months and 30 Months', 'description': "Weight at 6 months and 30 months as compared to baseline. Weight will be documented using staff-led Zoom calls and taken with the participant's home scale.", 'unitOfMeasure': 'lbs', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Results available for participants who had study visit and provided data.'}, {'type': 'SECONDARY', 'title': 'Change in Caloric Intake Using the Automated Self-Administered Recall System (ASA24) From Baseline to 30 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Noom Health', 'description': 'In Noom Health, participants encouraged to use the Noom app multiple times a day to log eating episodes, physical activity and weight. They will also have the ability to interact with coaches to receive advice and feedback specific to weight loss.'}, {'id': 'OG001', 'title': 'Noom Digital Health', 'description': 'In Noom Digital Health, participants used a simplified version to log eating episodes and weight. Both conditions will receive the same weight loss advice content.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2186.6', 'spread': '957.3', 'groupId': 'OG000'}, {'value': '2118.2', 'spread': '908.1', 'groupId': 'OG001'}]}]}, {'title': '30 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1681.7', 'spread': '906.9', 'groupId': 'OG000'}, {'value': '1578.5', 'spread': '784.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 30 Months', 'description': 'Caloric intake at 30 months as compared to baseline. Caloric intake will be measured using the ASA24 dietary recall system.', 'unitOfMeasure': 'calories', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Results available for participants who had study visit and provided data.'}, {'type': 'SECONDARY', 'title': 'Change in Dietary Behavior Using the Eating Disorder Examination Questionnaire (EDE-Q) From Baseline to 30 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Noom Health', 'description': 'In Noom Health, participants encouraged to use the Noom app multiple times a day to log eating episodes, physical activity and weight. They will also have the ability to interact with coaches to receive advice and feedback specific to weight loss.'}, {'id': 'OG001', 'title': 'Noom Digital Health', 'description': 'In Noom Digital Health, participants used a simplified version to log eating episodes and weight. Both conditions will receive the same weight loss advice content.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.5', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': '30 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.7', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '1.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 30 Months', 'description': 'EDE-Q global score at 30 months as compared to baseline. Dietary restraint, eating, shape, and weight concerns are measured with the EDE-Q. These subscales are summed and then divided by the total number of subscales (4) to create a global score. Scores range from 0 to 52 with higher scores indicating higher severity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Results available for participants who had study visit and provided data.'}, {'type': 'SECONDARY', 'title': 'Change in Physical Activity Using the International Physical Activity Questionnaire (IPAQ) From Baseline to 30 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Noom Health', 'description': 'In Noom Health, participants encouraged to use the Noom app multiple times a day to log eating episodes, physical activity and weight. They will also have the ability to interact with coaches to receive advice and feedback specific to weight loss.'}, {'id': 'OG001', 'title': 'Noom Digital Health', 'description': 'In Noom Digital Health, participants used a simplified version to log eating episodes and weight. Both conditions will receive the same weight loss advice content.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2328.1', 'spread': '1638.2', 'groupId': 'OG000'}, {'value': '2249.0', 'spread': '1577.6', 'groupId': 'OG001'}]}]}, {'title': '30 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1919.6', 'spread': '1463.0', 'groupId': 'OG000'}, {'value': '1973.9', 'spread': '1748.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 30 Months', 'description': 'Physical activity at 30 months as compared to baseline. The IPAQ includes 27 items and determines a MET value for time spent in an average week completing different levels of activity including vigorous or moderate physical activity, walking, and sitting. One MET is the energy spent sitting at rest.', 'unitOfMeasure': 'Met Value', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Results available for participants who had study visit and provided data.'}, {'type': 'SECONDARY', 'title': 'Change in Depression Using the Depression Anxiety Stress Scales (DASS) From Baseline to 30 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Noom Health', 'description': 'In Noom Health, participants encouraged to use the Noom app multiple times a day to log eating episodes, physical activity and weight. They will also have the ability to interact with coaches to receive advice and feedback specific to weight loss.'}, {'id': 'OG001', 'title': 'Noom Digital Health', 'description': 'In Noom Digital Health, participants used a simplified version to log eating episodes and weight. Both conditions will receive the same weight loss advice content.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.5', 'spread': '5.4', 'groupId': 'OG000'}, {'value': '5.0', 'spread': '5.9', 'groupId': 'OG001'}]}]}, {'title': '30 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.9', 'spread': '7.2', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '6.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 30 Months', 'description': 'Depression subscale score at 30 months as compared to baseline. DASS is a 42-item self-report scale of negative emotional states with subscales of depression, anxiety, and stress. Each subscale is scored 0-42, with total score from 0-126. Higher scores indicate more severe psychological distress.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Results available for participants who had study visit and provided data.'}, {'type': 'SECONDARY', 'title': 'Change in Anxiety Using the Depression Anxiety Stress Scales (DASS) From Baseline to 30 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Noom Health', 'description': 'In Noom Health, participants encouraged to use the Noom app multiple times a day to log eating episodes, physical activity and weight. They will also have the ability to interact with coaches to receive advice and feedback specific to weight loss.'}, {'id': 'OG001', 'title': 'Noom Digital Health', 'description': 'In Noom Digital Health, participants used a simplified version to log eating episodes and weight. Both conditions will receive the same weight loss advice content.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.8', 'spread': '3.9', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '3.8', 'groupId': 'OG001'}]}]}, {'title': '30 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.4', 'spread': '4.8', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '4.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 30 Months', 'description': 'Anxiety subscale score at 30 months as compared to baseline. DASS is a 42-item self-report scale of negative emotional states with subscales of depression, anxiety, and stress. Each subscale is scored 0-42, with total score from 0-126. Higher scores indicate more severe psychological distress.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Results available for participants who had study visit and provided data.'}, {'type': 'SECONDARY', 'title': 'Change in Stress Using the Depression Anxiety Stress Scales (DASS) From Baseline to 30 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Noom Health', 'description': 'In Noom Health, participants encouraged to use the Noom app multiple times a day to log eating episodes, physical activity and weight. They will also have the ability to interact with coaches to receive advice and feedback specific to weight loss.'}, {'id': 'OG001', 'title': 'Noom Digital Health', 'description': 'In Noom Digital Health, participants used a simplified version to log eating episodes and weight. Both conditions will receive the same weight loss advice content.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.8', 'spread': '6.8', 'groupId': 'OG000'}, {'value': '8.6', 'spread': '7.4', 'groupId': 'OG001'}]}]}, {'title': '30 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.4', 'spread': '7.3', 'groupId': 'OG000'}, {'value': '6.7', 'spread': '8.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 30 Months', 'description': 'Stress subscale score at 30 months as compared to baseline. DASS a 42-item self-report scale of negative emotional states with subscales of depression, anxiety, and stress. Each subscale is scored 0-42, with total score from 0-126. Higher scores indicate more severe psychological distress.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Results available for participants who had study visit and provided data.'}, {'type': 'SECONDARY', 'title': 'Change in Sleep Impairment Using the PROMIS Sleep Related Impairment Survey From Baseline to 30 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Noom Health', 'description': 'In Noom Health, participants encouraged to use the Noom app multiple times a day to log eating episodes, physical activity and weight. They will also have the ability to interact with coaches to receive advice and feedback specific to weight loss.'}, {'id': 'OG001', 'title': 'Noom Digital Health', 'description': 'In Noom Digital Health, participants used a simplified version to log eating episodes and weight. Both conditions will receive the same weight loss advice content.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35.7', 'spread': '11.7', 'groupId': 'OG000'}, {'value': '37.5', 'spread': '11.8', 'groupId': 'OG001'}]}]}, {'title': '30 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31.6', 'spread': '11.6', 'groupId': 'OG000'}, {'value': '33.9', 'spread': '12.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 30 Months', 'description': 'Sleep impairment at 30 months as compared to baseline. The PROMIS Sleep Related Impairment v.1.0 is a 16-item self-report measure of perceived functioning during waking hours in relation to tiredness and trouble sleeping. A raw score is calculated by summing all individual items and is translated into a T-score with standard error (SE). A T-score of 50 indicates normal impairment compared to the general population, scores above 50 indicate more impairment.', 'unitOfMeasure': 't-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Results available for participants who had study visit and provided data.'}, {'type': 'SECONDARY', 'title': 'Change in Physical Composite Score (PCS) Using the Short-Form-36 (SF-36) From Baseline to 30 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Noom Health', 'description': 'In Noom Health, participants encouraged to use the Noom app multiple times a day to log eating episodes, physical activity and weight. They will also have the ability to interact with coaches to receive advice and feedback specific to weight loss.'}, {'id': 'OG001', 'title': 'Noom Digital Health', 'description': 'In Noom Digital Health, participants used a simplified version to log eating episodes and weight. Both conditions will receive the same weight loss advice content.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43.1', 'spread': '10.2', 'groupId': 'OG000'}, {'value': '42.3', 'spread': '10.3', 'groupId': 'OG001'}]}]}, {'title': '30 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45.9', 'spread': '10.1', 'groupId': 'OG000'}, {'value': '44.8', 'spread': '11.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 30 Months', 'description': 'PCS at 30 months as compared to baseline. The SF-36 is a 36-item self-report health-related quality of life assessment of physical functioning, limitations, energy, emotional well-being, social functioning, pain and general health. Scores range from 17.2- 66.7 with lower scores indicating worse quality of life related to physical health.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Results available for participants who had study visit and provided data.'}, {'type': 'SECONDARY', 'title': 'Change in Mental Composite Score (MCS) Using the Short-Form-36 (SF-36) From Baseline to 30 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Noom Health', 'description': 'In Noom Health, participants encouraged to use the Noom app multiple times a day to log eating episodes, physical activity and weight. They will also have the ability to interact with coaches to receive advice and feedback specific to weight loss.'}, {'id': 'OG001', 'title': 'Noom Digital Health', 'description': 'In Noom Digital Health, participants used a simplified version to log eating episodes and weight. Both conditions will receive the same weight loss advice content.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '53.4', 'spread': '7.2', 'groupId': 'OG000'}, {'value': '53.1', 'spread': '7.5', 'groupId': 'OG001'}]}]}, {'title': '30 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '53.5', 'spread': '7.6', 'groupId': 'OG000'}, {'value': '54.9', 'spread': '7.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 30 Months', 'description': 'MCS at 30 months as compared to baseline. The SF-36 is a 36-item self-report health-related quality of life assessment of physical functioning, limitations, energy, emotional well-being, social functioning, pain and general health. Scores range from 12.7-64.2 with lower scores indicating worse quality of life related to mental health.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Results available for participants who had study visit and provided data.'}, {'type': 'SECONDARY', 'title': 'Change in Self-Efficacy for Healthy Eating Using the Diet Self-Efficacy Scale (DIET-SE) From Baseline to 30 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Noom Health', 'description': 'In Noom Health, participants encouraged to use the Noom app multiple times a day to log eating episodes, physical activity and weight. They will also have the ability to interact with coaches to receive advice and feedback specific to weight loss.'}, {'id': 'OG001', 'title': 'Noom Digital Health', 'description': 'In Noom Digital Health, participants used a simplified version to log eating episodes and weight. Both conditions will receive the same weight loss advice content.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.3', 'spread': '9.6', 'groupId': 'OG000'}, {'value': '16.4', 'spread': '9.5', 'groupId': 'OG001'}]}]}, {'title': '30 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.0', 'spread': '11.4', 'groupId': 'OG000'}, {'value': '21.7', 'spread': '12.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 30 Months', 'description': 'Self-efficacy at 30 months as compared to baseline. The DIET-SE is an 11-item self-report assessment of healthy eating with scales specific to temptations, social/internal factors, and negative emotional related to resistance. The score ranges from 0 - 40 with higher scores indicating more self-efficacy.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Results available for participants who had study visit and provided data.'}, {'type': 'SECONDARY', 'title': 'Adherence to Intervention Measured Using a Percentage of the Total Number of Available App Features Used at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Noom Health', 'description': 'In Noom Health, participants encouraged to use the Noom app multiple times a day to log eating episodes, physical activity and weight. They will also have the ability to interact with coaches to receive advice and feedback specific to weight loss.'}, {'id': 'OG001', 'title': 'Noom Digital Health', 'description': 'In Noom Digital Health, participants used a simplified version to log eating episodes and weight. Both conditions will receive the same weight loss advice content.'}], 'classes': [{'categories': [{'measurements': [{'value': '38.4', 'spread': '24.2', 'groupId': 'OG000'}, {'value': '17.9', 'spread': '15.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 Months', 'description': 'The percent of available features on the app, expected verses completed at 6 months', 'unitOfMeasure': 'percentage of available features on app', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With 12-Month Completion Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Noom Health', 'description': 'In Noom Health, participants encouraged to use the Noom app multiple times a day to log eating episodes, physical activity and weight. They will also have the ability to interact with coaches to receive advice and feedback specific to weight loss.'}, {'id': 'OG001', 'title': 'Noom Digital Health', 'description': 'In Noom Digital Health, participants used a simplified version to log eating episodes and weight. Both conditions will receive the same weight loss advice content.'}], 'classes': [{'categories': [{'measurements': [{'value': '220', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 Months', 'description': 'Attrition at 12 months as compared to number randomized at baseline documented using completion status', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent of Successful Technological Fixes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Noom Health', 'description': 'In Noom Health, participants encouraged to use the Noom app multiple times a day to log eating episodes, physical activity and weight. They will also have the ability to interact with coaches to receive advice and feedback specific to weight loss.'}, {'id': 'OG001', 'title': 'Noom Digital Health', 'description': 'In Noom Digital Health, participants used a simplified version to log eating episodes and weight. Both conditions will receive the same weight loss advice content.'}], 'classes': [{'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 12 Months', 'description': 'App compatibility will be examined by calculating the percent of successful technological fixes at 12 months as compared to baseline. The type of technological problems encountered by participants while using the app and any fixes needed will be categorized.', 'unitOfMeasure': 'percent of successful tech fixes', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in CDC NCHS National Health Interview Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Noom Health', 'description': 'In Noom Health, participants encouraged to use the Noom app multiple times a day to log eating episodes, physical activity and weight. They will also have the ability to interact with coaches to receive advice and feedback specific to weight loss.'}, {'id': 'OG001', 'title': 'Noom Digital Health', 'description': 'In Noom Digital Health, participants used a simplified version to log eating episodes and weight. Both conditions will receive the same weight loss advice content.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.8', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '3.6', 'groupId': 'OG001'}]}]}, {'title': '30 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.9', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '3.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 30 Months', 'description': 'Changes in health status from baseline to 30-months as measured by questions from the CDC NCHS National Health Interview Survey. Using an adapted version of the CDC NCHS National Health Interview Survey, the survey includes 4 questions about healthcare utilization. Items identify type of healthcare sought and frequency. The frequency of provider visits will be calculated to determine healthcare utilization. A frequency score of zero indicates no healthcare utilized. There is no upper limit for the frequency.', 'unitOfMeasure': 'visits/months', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Results available for participants who had study visit and provided data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Noom Health', 'description': 'In Noom Health, participants encouraged to use the Noom app multiple times a day to log eating episodes, physical activity and weight. They will also have the ability to interact with coaches to receive advice and feedback specific to weight loss.'}, {'id': 'FG001', 'title': 'Noom Digital Health', 'description': 'In Noom Digital Health, participants used a simplified version to log eating episodes and weight. Both conditions will receive the same weight loss advice content.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '302'}, {'groupId': 'FG001', 'numSubjects': '298'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '190'}, {'groupId': 'FG001', 'numSubjects': '193'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '112'}, {'groupId': 'FG001', 'numSubjects': '105'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '84'}, {'groupId': 'FG001', 'numSubjects': '67'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '35'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'BG000'}, {'value': '298', 'groupId': 'BG001'}, {'value': '600', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Noom Health', 'description': 'In Noom Health, participants encouraged to use the Noom app multiple times a day to log eating episodes, physical activity and weight. They will also have the ability to interact with coaches to receive advice and feedback specific to weight loss.'}, {'id': 'BG001', 'title': 'Noom Digital Health', 'description': 'In Noom Digital Health, participants used a simplified version to log eating episodes and weight. Both conditions will receive the same weight loss advice content.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41', 'spread': '9', 'groupId': 'BG000'}, {'value': '42', 'spread': '9', 'groupId': 'BG001'}, {'value': '42', 'spread': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '251', 'groupId': 'BG000'}, {'value': '246', 'groupId': 'BG001'}, {'value': '497', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '277', 'groupId': 'BG000'}, {'value': '274', 'groupId': 'BG001'}, {'value': '551', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '260', 'groupId': 'BG000'}, {'value': '249', 'groupId': 'BG001'}, {'value': '509', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '210.1', 'spread': '42.1', 'groupId': 'BG000'}, {'value': '211.7', 'spread': '44.7', 'groupId': 'BG001'}, {'value': '210.9', 'spread': '43.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pounds', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': '24-hr Caloric Intake', 'classes': [{'categories': [{'measurements': [{'value': '2186.6', 'spread': '957.3', 'groupId': 'BG000'}, {'value': '2118.2', 'spread': '908.1', 'groupId': 'BG001'}, {'value': '2152.7', 'spread': '933.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Caloric Intake using the Automated Self-Administered Recall System (ASA24)', 'unitOfMeasure': 'calories', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'EDEQ Global', 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'spread': '0.9', 'groupId': 'BG000'}, {'value': '2.6', 'spread': '1.0', 'groupId': 'BG001'}, {'value': '2.5', 'spread': '1.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Dietary Behavior assessed by the Eating Disorder Examination Questionnaire (EDE-Q) global score. Dietary restraint, eating, shape, and weight concerns are measured with the EDE-Q. These subscales are summed and then divided by the total number of subscales (4) to create a global score. Scores range from 0 to 52 with higher scores indicating higher severity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Metabolic Equivalents (METS) Value measured by IPAQ', 'classes': [{'categories': [{'measurements': [{'value': '2328.1', 'spread': '1638.2', 'groupId': 'BG000'}, {'value': '2249.0', 'spread': '1577.6', 'groupId': 'BG001'}, {'value': '2288.8', 'spread': '1607.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Physical Activity using the International Physical Activity Questionnaire (IPAQ). The IPAQ includes 27 items and determines a MET value for time spent in an average week completing different levels of activity including vigorous or moderate physical activity, walking, and sitting. One MET is the energy spent sitting at rest.', 'unitOfMeasure': 'METS Value', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'The Depression Anxiety Stress Scales (DASS)', 'classes': [{'title': 'Depression', 'categories': [{'measurements': [{'value': '4.5', 'spread': '5.4', 'groupId': 'BG000'}, {'value': '5.0', 'spread': '5.9', 'groupId': 'BG001'}, {'value': '4.7', 'spread': '5.6', 'groupId': 'BG002'}]}]}, {'title': 'Anxiety', 'categories': [{'measurements': [{'value': '2.8', 'spread': '3.9', 'groupId': 'BG000'}, {'value': '3.1', 'spread': '3.8', 'groupId': 'BG001'}, {'value': '3.0', 'spread': '3.8', 'groupId': 'BG002'}]}]}, {'title': 'Stress', 'categories': [{'measurements': [{'value': '7.8', 'spread': '6.8', 'groupId': 'BG000'}, {'value': '8.6', 'spread': '7.4', 'groupId': 'BG001'}, {'value': '8.2', 'spread': '7.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'DASS a 42-item self-report scale of negative emotional states with subscales of depression, anxiety, and stress. Each subscale is scored 0-42, with total score from 0-126. Higher scores indicate more severe psychological distress.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sleep Impairment using the PROMIS Sleep Related Impairment Survey Sleep impairment', 'classes': [{'categories': [{'measurements': [{'value': '35.7', 'spread': '11.7', 'groupId': 'BG000'}, {'value': '37.5', 'spread': '11.8', 'groupId': 'BG001'}, {'value': '36.6', 'spread': '11.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Related Impairment v.1.0 is a 16-item self-report measure of perceived functioning during waking hours in relation to tiredness and trouble sleeping. A raw score is calculated by summing all individual items and is translated into a T-score with standard error (SE). A T-score of 50 indicates normal impairment compared to the general population, scores above 50 indicate more impairment.', 'unitOfMeasure': 't-score', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Short Form 36 (SF-36)', 'classes': [{'title': 'Physical Composite', 'categories': [{'measurements': [{'value': '43.1', 'spread': '10.2', 'groupId': 'BG000'}, {'value': '42.3', 'spread': '1.03', 'groupId': 'BG001'}, {'value': '42.7', 'spread': '10.3', 'groupId': 'BG002'}]}]}, {'title': 'Mental Composite', 'categories': [{'measurements': [{'value': '53.4', 'spread': '7.2', 'groupId': 'BG000'}, {'value': '53.1', 'spread': '7.5', 'groupId': 'BG001'}, {'value': '53.3', 'spread': '7.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Short-Form-36 (SF-36) is a 36-item self-report health-related quality of life assessment of physical functioning, limitations, energy, emotional well-being, social functioning, pain and general health.\n\nPhysical Composite Score (PCS) range from 17.2- 66.7 with lower scores indicating worse quality of life related to physical health.\n\nMental Composite Score (MCS) range from 12.7-64.2 with lower scores indicating worse quality of life related to mental health.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Self-Efficacy for Healthy Eating using the Diet Self-Efficacy Scale (DIET-SE)', 'classes': [{'categories': [{'measurements': [{'value': '16.3', 'spread': '9.6', 'groupId': 'BG000'}, {'value': '16.4', 'spread': '9.5', 'groupId': 'BG001'}, {'value': '16.4', 'spread': '9.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Self-Efficacy for Healthy Eating using the Diet Self-Efficacy Scale (DIET-SE) is an 11-item self-report assessment of healthy eating with scales specific to temptations, social/internal factors, and negative emotional related to resistance. The score ranges from 0 - 40 with higher scores indicating more self-efficacy.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'CDC NCHS National Health Interview Survey', 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'spread': '2.4', 'groupId': 'BG000'}, {'value': '1.7', 'spread': '3.6', 'groupId': 'BG001'}, {'value': '1.7', 'spread': '3.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Using an adapted version of the CDC National Center for Health Statistics (NCHS) National Health Interview Survey, the survey includes 4 questions about healthcare utilization. Items identify type of healthcare sought and frequency. The frequency of provider visits will be calculated to determine healthcare utilization. A frequency score of zero indicates no healthcare utilized. There is no upper limit for the frequency.', 'unitOfMeasure': 'visits/months', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-09-01', 'size': 554223, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-05-19T13:58', 'hasProtocol': True}, {'date': '2023-09-26', 'size': 363304, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-04-21T18:23', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomized to one of two conditions in a parallel design including a 12-month intervention. Participants will be openly-enrolled over the course of 12-months until the recruitment goal of 600, 300 in each group, is reached.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 600}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-05-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-23', 'studyFirstSubmitDate': '2021-03-10', 'resultsFirstSubmitDate': '2025-05-02', 'studyFirstSubmitQcDate': '2021-03-10', 'lastUpdatePostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-07-23', 'studyFirstPostDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Weight From Baseline', 'timeFrame': 'Baseline, 6 months and 30 Months', 'description': "Weight at 6 months and 30 months as compared to baseline. Weight will be documented using staff-led Zoom calls and taken with the participant's home scale."}], 'secondaryOutcomes': [{'measure': 'Change in Caloric Intake Using the Automated Self-Administered Recall System (ASA24) From Baseline to 30 Months', 'timeFrame': 'Baseline and 30 Months', 'description': 'Caloric intake at 30 months as compared to baseline. Caloric intake will be measured using the ASA24 dietary recall system.'}, {'measure': 'Change in Dietary Behavior Using the Eating Disorder Examination Questionnaire (EDE-Q) From Baseline to 30 Months', 'timeFrame': 'Baseline and 30 Months', 'description': 'EDE-Q global score at 30 months as compared to baseline. Dietary restraint, eating, shape, and weight concerns are measured with the EDE-Q. These subscales are summed and then divided by the total number of subscales (4) to create a global score. Scores range from 0 to 52 with higher scores indicating higher severity.'}, {'measure': 'Change in Physical Activity Using the International Physical Activity Questionnaire (IPAQ) From Baseline to 30 Months', 'timeFrame': 'Baseline and 30 Months', 'description': 'Physical activity at 30 months as compared to baseline. The IPAQ includes 27 items and determines a MET value for time spent in an average week completing different levels of activity including vigorous or moderate physical activity, walking, and sitting. One MET is the energy spent sitting at rest.'}, {'measure': 'Change in Depression Using the Depression Anxiety Stress Scales (DASS) From Baseline to 30 Months', 'timeFrame': 'Baseline and 30 Months', 'description': 'Depression subscale score at 30 months as compared to baseline. DASS is a 42-item self-report scale of negative emotional states with subscales of depression, anxiety, and stress. Each subscale is scored 0-42, with total score from 0-126. Higher scores indicate more severe psychological distress.'}, {'measure': 'Change in Anxiety Using the Depression Anxiety Stress Scales (DASS) From Baseline to 30 Months', 'timeFrame': 'Baseline and 30 Months', 'description': 'Anxiety subscale score at 30 months as compared to baseline. DASS is a 42-item self-report scale of negative emotional states with subscales of depression, anxiety, and stress. Each subscale is scored 0-42, with total score from 0-126. Higher scores indicate more severe psychological distress.'}, {'measure': 'Change in Stress Using the Depression Anxiety Stress Scales (DASS) From Baseline to 30 Months', 'timeFrame': 'Baseline and 30 Months', 'description': 'Stress subscale score at 30 months as compared to baseline. DASS a 42-item self-report scale of negative emotional states with subscales of depression, anxiety, and stress. Each subscale is scored 0-42, with total score from 0-126. Higher scores indicate more severe psychological distress.'}, {'measure': 'Change in Sleep Impairment Using the PROMIS Sleep Related Impairment Survey From Baseline to 30 Months', 'timeFrame': 'Baseline and 30 Months', 'description': 'Sleep impairment at 30 months as compared to baseline. The PROMIS Sleep Related Impairment v.1.0 is a 16-item self-report measure of perceived functioning during waking hours in relation to tiredness and trouble sleeping. A raw score is calculated by summing all individual items and is translated into a T-score with standard error (SE). A T-score of 50 indicates normal impairment compared to the general population, scores above 50 indicate more impairment.'}, {'measure': 'Change in Physical Composite Score (PCS) Using the Short-Form-36 (SF-36) From Baseline to 30 Months', 'timeFrame': 'Baseline and 30 Months', 'description': 'PCS at 30 months as compared to baseline. The SF-36 is a 36-item self-report health-related quality of life assessment of physical functioning, limitations, energy, emotional well-being, social functioning, pain and general health. Scores range from 17.2- 66.7 with lower scores indicating worse quality of life related to physical health.'}, {'measure': 'Change in Mental Composite Score (MCS) Using the Short-Form-36 (SF-36) From Baseline to 30 Months', 'timeFrame': 'Baseline and 30 Months', 'description': 'MCS at 30 months as compared to baseline. The SF-36 is a 36-item self-report health-related quality of life assessment of physical functioning, limitations, energy, emotional well-being, social functioning, pain and general health. Scores range from 12.7-64.2 with lower scores indicating worse quality of life related to mental health.'}, {'measure': 'Change in Self-Efficacy for Healthy Eating Using the Diet Self-Efficacy Scale (DIET-SE) From Baseline to 30 Months', 'timeFrame': 'Baseline and 30 Months', 'description': 'Self-efficacy at 30 months as compared to baseline. The DIET-SE is an 11-item self-report assessment of healthy eating with scales specific to temptations, social/internal factors, and negative emotional related to resistance. The score ranges from 0 - 40 with higher scores indicating more self-efficacy.'}, {'measure': 'Adherence to Intervention Measured Using a Percentage of the Total Number of Available App Features Used at 6 Months', 'timeFrame': '6 Months', 'description': 'The percent of available features on the app, expected verses completed at 6 months'}, {'measure': 'Number of Participants With 12-Month Completion Status', 'timeFrame': '12 Months', 'description': 'Attrition at 12 months as compared to number randomized at baseline documented using completion status'}, {'measure': 'Percent of Successful Technological Fixes', 'timeFrame': 'Baseline and 12 Months', 'description': 'App compatibility will be examined by calculating the percent of successful technological fixes at 12 months as compared to baseline. The type of technological problems encountered by participants while using the app and any fixes needed will be categorized.'}, {'measure': 'Change in CDC NCHS National Health Interview Survey', 'timeFrame': 'Baseline and 30 Months', 'description': 'Changes in health status from baseline to 30-months as measured by questions from the CDC NCHS National Health Interview Survey. Using an adapted version of the CDC NCHS National Health Interview Survey, the survey includes 4 questions about healthcare utilization. Items identify type of healthcare sought and frequency. The frequency of provider visits will be calculated to determine healthcare utilization. A frequency score of zero indicates no healthcare utilized. There is no upper limit for the frequency.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Weight Loss', 'Mobile App', 'Digital Health', 'Weight Loss Maintenance', 'Weight Loss Suppression', 'Obesity'], 'conditions': ['Weight Loss', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '35969439', 'type': 'DERIVED', 'citation': 'Sysko R, Bibeau J, Boyar A, Costello K, Michaelides A, Mitchell ES, Susanin A, Hildebrandt T. A 2.5-Year Weight Management Program Using Noom Health: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 Aug 12;11(8):e37541. doi: 10.2196/37541.'}]}, 'descriptionModule': {'briefSummary': 'The goals of the study are to use the Noom mobile app to help individuals with weight loss and weight loss maintenance. This project will test the comparative efficacy of Noom Health vs. Noom Digital Health for weight loss, quality of life, psychosocial functioning, and self-reported health status. It is expected that use of Noom Health will show post-intervention success relative to Noom Digital Health as well as long-term success with weight loss maintenance. Data is expected to show that participants who are older, have less support, have more health conditions, and with more psychosocial problems will benefit more from Noom Health. It is also expected that confidence in the ability to lose weight will produce more successful results in Noom Health vs. Noom Digital Health.', 'detailedDescription': 'A total of 600 subjects will be enrolled in a randomized-controlled trial comparing the Noom app (Noom Health) to a digital control (Noom Digital Health) with 6 months of intervention and 6 months active maintenance in both groups. Measures will include demographics, psychosocial measures, height/weight, waist circumference, weight loss history/practices, health care practices/utilization, and quality of life.\n\nParticipants will complete informed consent and interviews via a HIPAA-compliant videoconference (Zoom) and other questionnaires via a REDCap interface. All participants will complete screening/baseline procedures to determine eligibility and initial information. Subsequently, they will be randomized to one of the groups for a 6-month intervention and 6- month maintenance period (12 months total).\n\nIn Noom Health, participants will be encouraged to use the app multiple times per day to log eating episodes, physical activity and weight. Coaches will also interact with participants directly through the app. In Noom Digital Health, participants will use a simplified version to log eating episodes and weight. Both conditions will receive the same weight loss advice content.\n\nDuring the intervention, participants will complete monthly satisfaction surveys. Additionally, follow-up measures will be conducted at 7 time points (Screening/Baseline, 1 month, 4 months, 6 months, 12 months, 18 months, 24 months, and 30 months).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must be interested in the Noom app\n* BMI \\> 27 kg/m2\n* Ages of 18 and 60 at entry to the study\n* Speak English\n\nExclusion Criteria:\n\n* Contraindication to smartphone use (e.g., seizures from prior smartphone use, do not own a smartphone)\n* Acute suicide risk\n* Pregnant or planning to become pregnant during the study\n* Current Noom use'}, 'identificationModule': {'nctId': 'NCT04797169', 'briefTitle': 'Noom Health for Weight Management', 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': 'Noom Health for Weight Management', 'orgStudyIdInfo': {'id': 'GCO 20-2224'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Noom Health', 'interventionNames': ['Behavioral: Noom Health']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Noom Digital Health', 'interventionNames': ['Behavioral: Noom Digital Health']}], 'interventions': [{'name': 'Noom Health', 'type': 'BEHAVIORAL', 'description': 'In Noom Health, participants will be encouraged to use the Noom app multiple times a day to log eating episodes, physical activity and weight. They will also have the ability to interact with coaches to receive advice and feedback specific to weight loss.', 'armGroupLabels': ['Noom Health']}, {'name': 'Noom Digital Health', 'type': 'BEHAVIORAL', 'description': 'In Noom Digital Health, participants will use a simplified version to log eating episodes and weight. Both conditions will receive the same weight loss advice content.', 'armGroupLabels': ['Noom Digital Health']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10028', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Department of Psychiatry, Eating and Weight Disorders Program', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Thomas Hildebrandt, PsyD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}, 'collaborators': [{'name': 'Noom Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor and Chief of the Division of Eating & Weight Disorders', 'investigatorFullName': 'Tom Hildebrandt', 'investigatorAffiliation': 'Icahn School of Medicine at Mount Sinai'}}}}