Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2026-01-04 @ 3:55 PM
Study NCT ID:
NCT03824769
Status:
COMPLETED
Last Update Posted:
2023-12-11
First Post:
2019-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Physical Activity Choices Everyday
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'zeely.denmat@uconn.edu', 'phone': '860-455-3842', 'title': 'Zeely Denmat', 'organization': 'University of Connecticut'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were monitored for all participants enrolled in Phase I (including participants randomized to Phase II) from from the start of the program to the post-Phase I assessment (a total of 16 weeks). For participants randomized to Phase II, Adverse events data were additionally collected at the Phase II baseline, 2-month and 4-month assessment visits (a total of 32 weeks).', 'eventGroups': [{'id': 'EG000', 'title': 'Phase II (RCT): Behavioral Weight Loss Maintenance + Healthy Thinking', 'description': 'Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will be asked to read short passages related to nutrition and a healthy lifestyle through our study website twice a day for the duration of treatment.\n\nWeight Loss Maintenance + Healthy Thinking: Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will be asked to read short passages related to nutrition and a healthy lifestyle through our study website twice a day for the duration of treatment.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 9, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Phase II (RCT) Behavioral Weight Loss Maintenance Treatment + Future Thinking', 'description': 'Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will create descriptions of upcoming positive events and will be asked to read short passages through our study website at least twice a day for the duration of treatment.\n\nWeight Loss Maintenance Treatment + Future Thinking: Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will create descriptions of upcoming positive events and will be asked to read short passages through our study website at least twice a day for the duration of treatment.', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 7, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Phase I Only (Weight Loss Phase): 16 Weeks', 'description': 'This group consists of the participants who enrolled in Phase I (Weight Loss Phase) but were not randomized to Phase I because they dropped out or were not eligible for Phase II (Weight Maintenance Phase).', 'otherNumAtRisk': 108, 'deathsNumAtRisk': 108, 'otherNumAffected': 4, 'seriousNumAtRisk': 108, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Muscle or bone injury (e.g., broken bone, torn ligament, sprain)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 108, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 108, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gall bladder attack or surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'New diagnosis, started treatment, or hospitalized for depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stroke, ministroke (TIA), or other neurological problems', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 108, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Motor vehicle accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 108, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Weekly Moderate-Vigorous Physical Activity Minutes, Accelerometry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Weight Loss Maintenance + Healthy Thinking', 'description': 'Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will be asked to read short passages related to nutrition and a healthy lifestyle through our study website twice a day for the duration of treatment.\n\nWeight Loss Maintenance + Healthy Thinking: Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will be asked to read short passages related to nutrition and a healthy lifestyle through our study website twice a day for the duration of treatment.'}, {'id': 'OG001', 'title': 'Behavioral Weight Loss Maintenance Treatment + Future Thinking', 'description': 'Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will create descriptions of upcoming positive events and will be asked to read short passages through our study website at least twice a day for the duration of treatment.\n\nWeight Loss Maintenance Treatment + Future Thinking: Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will create descriptions of upcoming positive events and will be asked to read short passages through our study website at least twice a day for the duration of treatment.'}], 'classes': [{'title': 'Phase II baseline to 1-month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-21.4286', 'spread': '61.52851', 'groupId': 'OG000'}, {'value': '-53.9600', 'spread': '149.60712', 'groupId': 'OG001'}]}]}, {'title': 'Phase II baseline to 2-month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.6000', 'spread': '100.36900', 'groupId': 'OG000'}, {'value': '-38.6800', 'spread': '108.40846', 'groupId': 'OG001'}]}]}, {'title': 'Phase II baseline to 4-month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-12.7143', 'spread': '96.02403', 'groupId': 'OG000'}, {'value': '-65.7308', 'spread': '126.15627', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Phase II baseline to 1 month, 2 months and 4 months (end of treatment)', 'description': 'Change in weekly minutes of moderate to vigorous physical activity measured via a waist worn accelerometer during the Phase II maintenance program. At each assessment time point, participants were instructed to wear the accelerometer on their right waist during all waking hours for 7 days. Participants with a minimum of 600 min of valid daily wear time for at least 4 days were included in reported outcomes.', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The number of participants analyzed in this outcome measure generally reflects the number that completed accelerometry assessment procedures at each timepoint. At the 2 month assessment, one Healthy Thinking participant's data was excluded due to insufficient device wear time. All other missing participant data indicates that the participant did not complete this assessment procedure."}, {'type': 'PRIMARY', 'title': 'Delay Discounting (Adjusting Amount Task)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Weight Loss Maintenance + Healthy Thinking', 'description': 'Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will be asked to read short passages related to nutrition and a healthy lifestyle through our study website twice a day for the duration of treatment.\n\nWeight Loss Maintenance + Healthy Thinking: Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will be asked to read short passages related to nutrition and a healthy lifestyle through our study website twice a day for the duration of treatment.'}, {'id': 'OG001', 'title': 'Behavioral Weight Loss Maintenance Treatment + Future Thinking', 'description': 'Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will create descriptions of upcoming positive events and will be asked to read short passages through our study website at least twice a day for the duration of treatment.\n\nWeight Loss Maintenance Treatment + Future Thinking: Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will create descriptions of upcoming positive events and will be asked to read short passages through our study website at least twice a day for the duration of treatment.'}], 'classes': [{'title': 'Baseline to 1-month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.001280', 'spread': '0.003962', 'groupId': 'OG000'}, {'value': '0.107264', 'spread': '0.547971', 'groupId': 'OG001'}]}]}, {'title': 'Baseline to 2-month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.000165', 'spread': '0.003824', 'groupId': 'OG000'}, {'value': '0.108922', 'spread': '0.558786', 'groupId': 'OG001'}]}]}, {'title': 'Baseline to 4-month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.000071', 'spread': '0.003989', 'groupId': 'OG000'}, {'value': '0.101414', 'spread': '0.538400', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Phase II baseline to 1 month, 2 months and 4 months (end of treatment)', 'description': 'Change in delay discounting measured using the Adjusting Amount task during the Phase II maintenance program. Delay discounting refers to the decline in the present value of a reward with delay to its receipt. The Adjusting Amount task identifies an individual\'s discount rate, which reflects how much they devalue future rewards. In the task, participants are presented with a choice between a smaller, immediate (hypothetical) monetary reward and a larger, delayed (hypothetical) monetary reward. Then, using a titration procedure, the delayed reward amount is adjusted based on the participant\'s choices to find the point at which they are indifferent between the two options (i.e., discounting rate). The discount rate is represented by "k". A higher "k" value means a steeper discount rate, indicating a greater preference for immediate rewards and a higher devaluation of future rewards.', 'unitOfMeasure': 'k-value', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed in each group reflects the number of randomized participants that completed the delay discounting measure at each timepoint.'}, {'type': 'PRIMARY', 'title': 'Delay Discounting (Monetary Choice Questionnaire)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Weight Loss Maintenance + Healthy Thinking', 'description': 'Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will be asked to read short passages related to nutrition and a healthy lifestyle through our study website twice a day for the duration of treatment.\n\nWeight Loss Maintenance + Healthy Thinking: Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will be asked to read short passages related to nutrition and a healthy lifestyle through our study website twice a day for the duration of treatment.'}, {'id': 'OG001', 'title': 'Behavioral Weight Loss Maintenance Treatment + Future Thinking', 'description': 'Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will create descriptions of upcoming positive events and will be asked to read short passages through our study website at least twice a day for the duration of treatment.\n\nWeight Loss Maintenance Treatment + Future Thinking: Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will create descriptions of upcoming positive events and will be asked to read short passages through our study website at least twice a day for the duration of treatment.'}], 'classes': [{'title': 'Baseline to 2-months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.002863', 'spread': '0.029509', 'groupId': 'OG000'}, {'value': '-0.007161', 'spread': '0.017930', 'groupId': 'OG001'}]}]}, {'title': 'Baseline to 4-months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.001625', 'spread': '0.022689', 'groupId': 'OG000'}, {'value': '-0.004049', 'spread': '0.015750', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Phase II baseline to 2 months and 4 months (end of treatment)', 'description': 'Change in delay discounting measured using the Monetary Choice Questionnaire (MCQ) task during the Phase II maintenance program. Delay discounting refers to the decline in the present value of a reward with delay to its receipt. The MCQ identifies an individual\'s discount rate, which reflects how much they devalue future rewards. In the task, each question asks participants to make a choice between a smaller, immediate (hypothetical) monetary reward and a larger, delayed (hypothetical) reward. Unlike the Adjusting Amount task, each MCQ question includes different combinations of delay periods and reward amounts that are not influenced by previous responses (i.e., delay periods and reward amounts are static and the same for each participant). The discount rate is represented by "k". A higher "k" value means a steeper discount rate, indicating a greater preference for immediate rewards and a higher devaluation of future rewards.', 'unitOfMeasure': 'k-value', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed at each timepoint reflects the number of randomized participants who completed this measure.'}, {'type': 'SECONDARY', 'title': 'Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Weight Loss Maintenance + Healthy Thinking', 'description': 'Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will be asked to read short passages related to nutrition and a healthy lifestyle through our study website twice a day for the duration of treatment.\n\nWeight Loss Maintenance + Healthy Thinking: Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will be asked to read short passages related to nutrition and a healthy lifestyle through our study website twice a day for the duration of treatment.'}, {'id': 'OG001', 'title': 'Behavioral Weight Loss Maintenance Treatment + Future Thinking', 'description': 'Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will create descriptions of upcoming positive events and will be asked to read short passages through our study website at least twice a day for the duration of treatment.\n\nWeight Loss Maintenance Treatment + Future Thinking: Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will create descriptions of upcoming positive events and will be asked to read short passages through our study website at least twice a day for the duration of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.87', 'spread': '7.66', 'groupId': 'OG000'}, {'value': '-9.28', 'spread': '6.63', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 months', 'description': 'Weight change from end of Phase 1 weight loss program to end of Phase II maintenance program', 'unitOfMeasure': 'kilograms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Phase II (RCT): Behavioral Weight Loss Maintenance + Healthy Thinking', 'description': 'Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will be asked to read short passages related to nutrition and a healthy lifestyle through our study website twice a day for the duration of treatment.\n\nAll participants randomized to this treatment arm completed Phase I (Weight Loss Phase) and were eligible for Phase II (Weight Maintenance Phase).'}, {'id': 'FG001', 'title': 'Phase II (RCT): Behavioral Weight Loss Maintenance Treatment + Future Thinking', 'description': 'Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will create descriptions of upcoming positive events and will be asked to read short passages through our study website at least twice a day for the duration of treatment.\n\nWeight Loss Maintenance Treatment + Future Thinking: Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will create descriptions of upcoming positive events and will be asked to read short passages through our study website at least twice a day for the duration of treatment.'}, {'id': 'FG002', 'title': 'Phase I Only (Weight Loss Phase): 16 Weeks', 'description': 'This group consists of the participants who enrolled in Phase I (Weight Loss Phase) but were not randomized to Phase I because they dropped out or were not eligible for Phase II (Weight Maintenance Phase).'}], 'periods': [{'title': 'Phase I (Weight Loss): 16 Weeks', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '108'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'For this Phase, completion would include 1) participation in the entire 16-week program 2) completion of the post-Phase I assessment and 3) confirmed eligible for Phase II. All participants in this arm were eligible and randomized into the Phase II Weight Maintenance RCT.', 'groupId': 'FG000', 'numSubjects': '24'}, {'comment': 'For this Phase, completion would include 1) participation in the entire 16-week program 2) completion of the post-Phase I assessment and 3) confirmed eligible for Phase II. All participants in this arm were eligible and randomized into the Phase II Weight Maintenance RCT.', 'groupId': 'FG001', 'numSubjects': '28'}, {'comment': 'For this Phase, completion would include 1) participation in the entire 16-week program 2) completion of the post-Phase I assessment and 3) confirmed eligible for Phase II. Because participants in this group did not meet all 3 of these requirements and were not randomized, all are considered incomplete.', 'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '108'}]}]}, {'title': 'Phase II (Weight Maintenance): 4 Months', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'comment': 'Participants in this group were not eligible for Phase II; therefore, these milestones are not applicable.', 'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': '1 Month Assessment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'comment': 'Participants in this group were not eligible for Phase II; therefore, these milestones are not applicable.', 'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': '2 Month Assessment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'comment': 'Participants in this group were not eligible for Phase II; therefore, these milestones are not applicable.', 'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'comment': 'Participants in this group were not eligible for Phase II; therefore, these milestones are not applicable.', 'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Following enrollment, participants began Phase I, a 16-week weight loss program aiming to induce clinically significant weight loss (5% of starting body weight). After Phase I, eligibility to continue to Phase II (weight maintenance) was evaluated. Those who lost at least 5% of their body weight remained eligible. Given that Phase II was the primary focus of the study, primary outcome data were analyzed only from randomized, Phase II participants (eligible subset of Phase I participants).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}, {'value': '160', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Behavioral Weight Loss Maintenance + Healthy Thinking', 'description': 'Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will be asked to read short passages related to nutrition and a healthy lifestyle through our study website twice a day for the duration of treatment.\n\nWeight Loss Maintenance + Healthy Thinking: Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will be asked to read short passages related to nutrition and a healthy lifestyle through our study website twice a day for the duration of treatment.'}, {'id': 'BG001', 'title': 'Behavioral Weight Loss Maintenance Treatment + Future Thinking', 'description': 'Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will create descriptions of upcoming positive events and will be asked to read short passages through our study website at least twice a day for the duration of treatment.\n\nWeight Loss Maintenance Treatment + Future Thinking: Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will create descriptions of upcoming positive events and will be asked to read short passages through our study website at least twice a day for the duration of treatment.'}, {'id': 'BG002', 'title': 'Phase I Only (Weight Loss Phase): 16 Weeks', 'description': 'This group consists of the participants who enrolled in Phase I (Weight Loss Phase) but were not randomized to Phase I because they dropped out or were not eligible for Phase II (Weight Maintenance Phase).'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}, {'value': '160', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '45.83', 'spread': '10.26', 'groupId': 'BG000'}, {'value': '48.11', 'spread': '13.02', 'groupId': 'BG001'}, {'value': '46.80', 'spread': '12.03', 'groupId': 'BG002'}, {'value': '46.88', 'spread': '11.91', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}, {'value': '160', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}, {'value': '138', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}, {'value': '160', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}, {'value': '143', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaskan Native', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}, {'value': '160', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}, {'value': '160', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}, {'value': '160', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}]}]}, {'title': 'Native Hawaiian or other Pacific Islander', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}, {'value': '160', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'White', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}, {'value': '160', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}, {'value': '116', 'groupId': 'BG003'}]}]}, {'title': 'More than One Race', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}, {'value': '160', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}, {'value': '160', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Prefer not to answer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}, {'value': '160', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}, {'value': '160', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}, {'value': '160', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weekly Moderate-Vigorous Physical Activity Minutes, Accelerometry', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '194.29', 'spread': '119.595', 'groupId': 'BG000'}, {'value': '229.82', 'spread': '162.393', 'groupId': 'BG001'}, {'value': '213.42', 'spread': '143.985', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Weekly minutes of moderate to vigorous physical activity measured via a waist worn accelerometer during the Phase II baseline assessment. At Phase II baseline, participants were instructed to wear the accelerometer on their right waist during all waking hours for 7 days. Participants with a minimum of 600 min per day of valid daily wear time for at least 4 days were included in reported outcomes.', 'unitOfMeasure': 'minutes', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'This study specific measure was first collected at Phase II baseline and data were analyzed only from randomized Phase II participants.'}, {'title': 'Delay Discounting (Adjusting Amount Task)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0.002589348', 'spread': '0.003302', 'groupId': 'BG000'}, {'value': '0.021894643', 'spread': '0.108428', 'groupId': 'BG001'}, {'value': '0.012984507', 'spread': '0.079520', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline delay discounting measured using the Adjusting Amount task during the Phase II baseline assessment. Delay discounting refers to the decline in the present value of a reward with delay to its receipt. The Adjusting Amount task identifies an individual\'s discount rate, which reflects how much they devalue future rewards. Discount rate is represented by "k". A higher "k" value means a greater preference for immediate rewards and a higher devaluation of future rewards.', 'unitOfMeasure': 'k-value', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'This study specific measure was first collected at Phase II baseline and data were analyzed only from randomized Phase II participants.'}, {'title': 'Delay Discounting (Monetary Choice Questionnaire)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0.017834', 'spread': '0.019678', 'groupId': 'BG000'}, {'value': '0.025506', 'spread': '0.047832', 'groupId': 'BG001'}, {'value': '0.021965', 'spread': '0.037427', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline delay discounting measured using the Monetary Choice Questionnaire (MCQ) task during the Phase II baseline assessment. Delay discounting refers to the decline in the present value of a reward with delay to its receipt. The MCQ task identifies an individual\'s discount rate, which reflects how much they devalue future rewards. Discount rate is represented by "k". A higher "k" value means a greater preference for immediate rewards and a higher devaluation of future rewards.', 'unitOfMeasure': 'k-value', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'This study specific measure was first collected at Phase II baseline and data were analyzed only from randomized Phase II participants.'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '94.89', 'spread': '17.09', 'groupId': 'BG000'}, {'value': '92.00', 'spread': '16.38', 'groupId': 'BG001'}, {'value': '93.33', 'spread': '16.61', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'This study specific measure was first collected at Phase II baseline and data were analyzed only from randomized Phase II participants.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-06-30', 'size': 716232, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-09-12T11:57', 'hasProtocol': True}, {'date': '2020-08-03', 'size': 278786, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-09-12T11:58', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2021-05-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-08', 'studyFirstSubmitDate': '2019-01-29', 'resultsFirstSubmitDate': '2023-09-12', 'studyFirstSubmitQcDate': '2019-01-29', 'lastUpdatePostDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-12-08', 'studyFirstPostDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weekly Moderate-Vigorous Physical Activity Minutes, Accelerometry', 'timeFrame': 'Phase II baseline to 1 month, 2 months and 4 months (end of treatment)', 'description': 'Change in weekly minutes of moderate to vigorous physical activity measured via a waist worn accelerometer during the Phase II maintenance program. At each assessment time point, participants were instructed to wear the accelerometer on their right waist during all waking hours for 7 days. Participants with a minimum of 600 min of valid daily wear time for at least 4 days were included in reported outcomes.'}, {'measure': 'Delay Discounting (Adjusting Amount Task)', 'timeFrame': 'Phase II baseline to 1 month, 2 months and 4 months (end of treatment)', 'description': 'Change in delay discounting measured using the Adjusting Amount task during the Phase II maintenance program. Delay discounting refers to the decline in the present value of a reward with delay to its receipt. The Adjusting Amount task identifies an individual\'s discount rate, which reflects how much they devalue future rewards. In the task, participants are presented with a choice between a smaller, immediate (hypothetical) monetary reward and a larger, delayed (hypothetical) monetary reward. Then, using a titration procedure, the delayed reward amount is adjusted based on the participant\'s choices to find the point at which they are indifferent between the two options (i.e., discounting rate). The discount rate is represented by "k". A higher "k" value means a steeper discount rate, indicating a greater preference for immediate rewards and a higher devaluation of future rewards.'}, {'measure': 'Delay Discounting (Monetary Choice Questionnaire)', 'timeFrame': 'Phase II baseline to 2 months and 4 months (end of treatment)', 'description': 'Change in delay discounting measured using the Monetary Choice Questionnaire (MCQ) task during the Phase II maintenance program. Delay discounting refers to the decline in the present value of a reward with delay to its receipt. The MCQ identifies an individual\'s discount rate, which reflects how much they devalue future rewards. In the task, each question asks participants to make a choice between a smaller, immediate (hypothetical) monetary reward and a larger, delayed (hypothetical) reward. Unlike the Adjusting Amount task, each MCQ question includes different combinations of delay periods and reward amounts that are not influenced by previous responses (i.e., delay periods and reward amounts are static and the same for each participant). The discount rate is represented by "k". A higher "k" value means a steeper discount rate, indicating a greater preference for immediate rewards and a higher devaluation of future rewards.'}], 'secondaryOutcomes': [{'measure': 'Weight', 'timeFrame': '4 months', 'description': 'Weight change from end of Phase 1 weight loss program to end of Phase II maintenance program'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Weight Loss Maintenance'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '32833481', 'type': 'DERIVED', 'citation': "Leahey TM, Gorin AA, Wyckoff E, Denmat Z, O'Connor K, Field C, Dunton GF, Gunstad J, Huedo-Medina TB, Gilder C. Episodic future thinking, delay discounting, and exercise during weight loss maintenance: The PACE trial. Health Psychol. 2020 Sep;39(9):796-805. doi: 10.1037/hea0000860."}]}, 'descriptionModule': {'briefSummary': 'This study aims to test two strategies for weight loss maintenance. It involves two phases, a weight loss phase and a maintenance phase. During Phase I (the weight loss phase), participants will receive a 16-week, Web-based behavioral weight loss program that involves access to weekly weight loss information and weekly personalized feedback on diet, activity, and weight loss goals. Individuals who lose at least 5% of their initial body weight during this program, will be invited to participate in Phase II. During Phase II, two 4-month treatments for weight loss maintenance will be tested. At the beginning of Phase II, participants will be randomly assigned to one of the two maintenance programs: (1) a behavioral maintenance program that involves in-person group meetings plus daily exercises in which information about a healthy lifestyle is reviewed or (2) a behavioral maintenance program that involves in-person group meetings plus daily exercises in which descriptions of positive future events are reviewed. Throughout the study, participants will complete assessments that examine the effects of the interventions on delay discounting, physical activity, weight, and other important health and psychosocial outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age between 18-70\n* Body Mass Index between 30-50\n* English Speaking\n* Have a smartphone that can be used for study activities\n\nExclusion Criteria:\n\n* Report being unable to walk 2 blocks without stopping\n* Are currently participating in weight loss treatment, have a history of bariatric surgery, or lost ≥5% in the past 6-months\n* Are pregnant or plan to become pregnant within 1 year\n* Report a heart condition, chest pain during periods of rest or activity, or loss of consciousness on the Physical Activity Readiness Questionnaire\n* Report a medical condition that could jeopardize their safety in a weight control program with diet and exercise guidelines\n* History of or current traumatic brain injury, dementia or Alzheimer's disease; a history of Multiple Sclerosis, or other neurological disorders\n* Report conditions that, in the judgment of the PI, would render them unlikely to follow the protocol (e.g., relocation, dementia, unable to read and write in English)\n* Have no Internet access or unwilling to use personal smartphone for study."}, 'identificationModule': {'nctId': 'NCT03824769', 'acronym': 'PACE', 'briefTitle': 'Physical Activity Choices Everyday', 'organization': {'class': 'OTHER', 'fullName': 'University of Connecticut'}, 'officialTitle': 'Is Long-term Maintenance Worth the Wait? Using Real Time Data Capture to Examine Delayed Discounting as a Putative Target of Physical Activity Adherence in Weight Loss Maintenance Interventions', 'orgStudyIdInfo': {'id': 'H18-153'}, 'secondaryIdInfos': [{'id': 'R21NR018359', 'link': 'https://reporter.nih.gov/quickSearch/R21NR018359', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Behavioral Weight Loss Maintenance + Healthy Thinking', 'description': 'Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will be asked to read short passages related to nutrition and a healthy lifestyle through our study website twice a day for the duration of treatment.', 'interventionNames': ['Behavioral: Weight Loss Maintenance + Healthy Thinking']}, {'type': 'EXPERIMENTAL', 'label': 'Behavioral Weight Loss Maintenance Treatment + Future Thinking', 'description': 'Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will create descriptions of upcoming positive events and will be asked to read short passages through our study website at least twice a day for the duration of treatment.', 'interventionNames': ['Behavioral: Weight Loss Maintenance Treatment + Future Thinking']}], 'interventions': [{'name': 'Weight Loss Maintenance + Healthy Thinking', 'type': 'BEHAVIORAL', 'description': 'Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will be asked to read short passages related to nutrition and a healthy lifestyle through our study website twice a day for the duration of treatment.', 'armGroupLabels': ['Behavioral Weight Loss Maintenance + Healthy Thinking']}, {'name': 'Weight Loss Maintenance Treatment + Future Thinking', 'type': 'BEHAVIORAL', 'description': 'Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will create descriptions of upcoming positive events and will be asked to read short passages through our study website at least twice a day for the duration of treatment.', 'armGroupLabels': ['Behavioral Weight Loss Maintenance Treatment + Future Thinking']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06103', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'UConn Weight Management Research Laboratory', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}], 'overallOfficials': [{'name': 'Amy Gorin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Connecticut'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Connecticut', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Nursing Research (NINR)', 'class': 'NIH'}, {'name': 'University at Buffalo', 'class': 'OTHER'}, {'name': 'Kent State University', 'class': 'OTHER'}, {'name': 'University of Southern California', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Institute for Collaboration on Health, Intervention, and Policy Professor, Psychological Sciences', 'investigatorFullName': 'Amy Gorin', 'investigatorAffiliation': 'University of Connecticut'}}}}