Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2025-12-28 @ 12:08 AM
Study NCT ID:
NCT06034457
Status:
COMPLETED
Last Update Posted:
2025-12-19
First Post:
2023-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Testing the Effectiveness of WW Clinic GLP1
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': 'heinbel@ccf.org', 'phone': '216 445-1986', 'title': 'Dr. Leslie Heinberg, Vice Chair for Psychology, Department of Psychiatry and Psychology', 'organization': 'Cleveland Clinic'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Week 0 to Week 24', 'description': 'There were no adverse events during the collection of this observational survey study. Side effects related to GLP1s were gathered and reported by WW but there were no adverse events during the conduct of this observational study.', 'eventGroups': [{'id': 'EG000', 'title': 'Single Arm', 'description': 'WW GLP-1 behavioral program program + Sequence medical weight management prescribed semaglutide or tirzepatide.', 'otherNumAtRisk': 180, 'deathsNumAtRisk': 180, 'otherNumAffected': 0, 'seriousNumAtRisk': 180, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Weight in Pounds From Week 0 to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm', 'description': 'WW GLP-1 behavioral program program + Sequence medical weight management prescribed semaglutide or tirzepatide.'}], 'classes': [{'categories': [{'measurements': [{'value': '-27.41', 'spread': '14.86', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 to 24 weeks', 'description': 'Effect of WW GLP1 behavioral program + WW Clinic (formerly known as Sequence) on absolute change of weight loss at 24 weeks.', 'unitOfMeasure': 'pounds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Weight Loss Percentage Change From Week 0 to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm', 'description': 'WW GLP-1 behavioral program program + Sequence medical weight management prescribed semaglutide or tirzepatide.'}], 'classes': [{'title': 'Number of participants with >= 5% weight loss at 24 weeks', 'categories': [{'measurements': [{'value': '161', 'groupId': 'OG000'}]}]}, {'title': 'Number of participants with >= 10% weight loss at 24 weeks', 'categories': [{'measurements': [{'value': '121', 'groupId': 'OG000'}]}]}, {'title': 'Number of participants with >= 15% weight loss at 24 weeks', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}]}]}, {'title': 'Number of participants with >= 20% weight loss at 24 weeks', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 24 weeks', 'description': 'Effect of WW + WW Clinic (formerly known as Sequence) on weight loss and % reaching 5, 10, 15, 20 % body weight loss at 24 weeks.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Blood Pressure Changes (Systolic and Diastolic) in mmHg From Week 0 to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm', 'description': 'WW GLP-1 behavioral program program + Sequence medical weight management prescribed semaglutide or tirzepatide.'}], 'classes': [{'title': 'Change in diastolic blood pressure at 24 weeks', 'categories': [{'measurements': [{'value': '-5.66', 'spread': '13.29', 'groupId': 'OG000'}]}]}, {'title': 'Change in systolic blood pressure at 24 weeks', 'categories': [{'measurements': [{'value': '-11.17', 'spread': '14.96', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 to 24 weeks', 'description': 'Effect of WW + WW Clinic (formerly known as Sequence) on absolute change of blood pressure at 24 weeks', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Quality of Life Scores From Week 0 to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm', 'description': 'WW GLP-1 behavioral program program + Sequence medical weight management prescribed semaglutide or tirzepatide.'}], 'classes': [{'title': 'Physical Function', 'categories': [{'measurements': [{'value': '-20.13', 'spread': '17.79', 'groupId': 'OG000'}]}]}, {'title': 'Self-Esteem', 'categories': [{'measurements': [{'value': '-27.98', 'spread': '22.5', 'groupId': 'OG000'}]}]}, {'title': 'Sexual Life', 'categories': [{'measurements': [{'value': '-18.27', 'spread': '23.1', 'groupId': 'OG000'}]}]}, {'title': 'Public Distress', 'categories': [{'measurements': [{'value': '-11.44', 'spread': '17.99', 'groupId': 'OG000'}]}]}, {'title': 'Work', 'categories': [{'measurements': [{'value': '-12.08', 'spread': '19.81', 'groupId': 'OG000'}]}]}, {'title': 'Total Score', 'categories': [{'measurements': [{'value': '-19.19', 'spread': '13.42', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 to 24 weeks', 'description': 'Effect of WW + WW Clinic (formerly known as Sequence) on absolute change of Quality of Life (QOL) scores using "Impact of Weight on Quality of Life-Lite Scale" Scale Name + Description of scale: "Impact of Weight on Quality of Life-Lite (IWQOL-Lite) Is a validated, 31-item, self-report measure of obesity-specific quality of life in adults. There are five domains include physical function, self-esteem, sexual life, public distress and work.\n\nScale Ranges (min, max): 0-100 Description of scoring: Higher scores represent lower quality of life (i.e., greater impact of obesity on quality of life). Lower scores represent a better quality of life (i.e., less impact of obesity). A negative mean change indicates improvement in quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Changes in Well-being Scores From Week 0 to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm', 'description': 'WW GLP-1 behavioral program program + Sequence medical weight management prescribed semaglutide or tirzepatide.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.92', 'spread': '3.98', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 to 24 weeks', 'description': 'Effect of WW + WW Clinic (formerly known as Sequence) on absolute change of Well-being at 24 weeks using "WHO Well-Being Index 5" Scale Name + Description of scale: "Well-being Index 5 (WHO-5)" is a 5-item questionnaire that assesses subjective well-being through five statements about feeling cheerful, calm, active, interested and rested over the past two weeks.\n\nScale Ranges (min, max) 0-25 Description of scoring: Lower scores indicate worse overall well-being, higher scores indicate better overall well-being. A positive mean change indicates improvement in well-being.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Changes in Disordered Eating Scores From Week 0 to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm', 'description': 'WW GLP-1 behavioral program program + Sequence medical weight management prescribed semaglutide or tirzepatide.'}], 'classes': [{'title': 'Restraint Score', 'categories': [{'measurements': [{'value': '0.09', 'spread': '1.74', 'groupId': 'OG000'}]}]}, {'title': 'Eating Concerns Score', 'categories': [{'measurements': [{'value': '-0.75', 'spread': '1.28', 'groupId': 'OG000'}]}]}, {'title': 'Shape Concern Score', 'categories': [{'measurements': [{'value': '-1.04', 'spread': '1.07', 'groupId': 'OG000'}]}]}, {'title': 'Weight Concern Score', 'categories': [{'measurements': [{'value': '-0.76', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'Global Score', 'categories': [{'measurements': [{'value': '-0.61', 'spread': '0.95', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 to 24 weeks', 'description': 'Effect of WW + WW Clinic (formerly known as Sequence) on absolute change of Disordered Eating at 24 weeks using "Eating Disorder Examination-Questionnaire" Scale Name + Description of scale: "Eating Disorder Examination-Questionnaire (EDE-Q)" is a 28-item self-report questionnaire, adapted from the semi-structured interview, the Eating Disorder Examination (EDE). The questionnaire is designed to assess the range, frequency and severity of behaviors associated with a diagnosis of an eating disorder.\n\nScale Ranges (min, max): 0-6 Description of scoring: Lower scores indicate less problematic eating disordered behaviors and cognitions and higher scores indicate more problematic eating disordered behaviors and cognitions. A positive mean change indicates an increase in eating disordered symptoms. A negative mean change could indicate a decrease in eating disorder symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Changes in Strength Training Scores From Week 0 to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm', 'description': 'WW GLP-1 behavioral program program + Sequence medical weight management prescribed semaglutide or tirzepatide.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.48', 'spread': '1.37', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 to 24 weeks', 'description': 'Effect of WW + WW Clinic (formerly known as Sequence) on absolute change of Strength Training Behavior at 24 weeks using the "Strength Training Behavior Scale" Scale Name + Description of scale: "Stage of Change for Strength Training" Strength training is defined as all activities that serve to enhance muscle strength and endurance (free weights, body weight exercises, etc.) Regular resistance training is described as engaging in these activities at least two times per week.\n\nScale Ranges (min, max): 0-7 Description of scoring: Lower scores indicate less days strength training. Higher scores equal more days of strength training. A positive mean change indicates an increase in number of days of strength training.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Changes in Stress Scores From Week 0 to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm', 'description': 'WW GLP-1 behavioral program program + Sequence medical weight management prescribed semaglutide or tirzepatide.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.66', 'spread': '6.51', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 to 24 weeks', 'description': 'Effect of WW + WW Clinic (formerly known as Sequence) on absolute change of Stress at 24 weeks using the "Perceived Stress Scale" Scale Name + Description of scale: "Perceived Stress Scale, PSS-10" is a self-report scale that asks about feelings and thoughts related to stressful things during the last month.\n\nScale Ranges (min, max): 10-50 Description of scoring: Higher scores indicate more perceived stress and lower scores indicate less perceived stress. A negative mean change indicates improvement in perceived stress.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Changes in Emotional Eating Scores From Week 0 to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm', 'description': 'WW GLP-1 behavioral program program + Sequence medical weight management prescribed semaglutide or tirzepatide.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.99', 'spread': '4.79', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 to 24 weeks', 'description': 'Effect of WW + WW Clinic (formerly known as Sequence) on absolute change of Emotional Eating scores using the "Palatable Eating Motives Scale-Coping Subscale" Scale Name + Description of scale: "Palatable Eating Motives Scale - Coping Subscale (PEMs-Coping)" is a four-item coping subscale of the PEMs self-report that measures eating behavior as a method of coping with problems and negative feelings.\n\nScale Ranges (min, max): 4-20 Description of scoring: Lower scores indicate lower frequency of eating as a method of coping with problems and negative feelings. Higher scores indicate higher frequency of eating as a method of coping with problems and negative feelings. A negative mean score indicates a decrease in using eating to cope with problems and negative feelings.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Changes in UnHealthy Habits Strength Scores From Week 0 to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm', 'description': 'WW GLP-1 behavioral program program + Sequence medical weight management prescribed semaglutide or tirzepatide.'}], 'classes': [{'title': 'Sugary Foods', 'categories': [{'measurements': [{'value': '-1.64', 'spread': '1.86', 'groupId': 'OG000'}]}]}, {'title': 'Fried Foods', 'categories': [{'measurements': [{'value': '-1.13', 'spread': '1.81', 'groupId': 'OG000'}]}]}, {'title': 'Drinking', 'categories': [{'measurements': [{'value': '-0.83', 'spread': '1.66', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 to 24 weeks', 'description': 'Effect of WW + WW Clinic (formerly known as Sequence) on absolute change of Unhealthy Habits scores using "Self-Reported Behavioral Automaticity Index" Scale Name + Description of scale: "Self-Reported Behavioral Automaticity Index (SRBAI)-Unhealthy Habits Subscale" is a self-report measure to assess how automatic or habitual certain behaviors are, often used to understand unhealthy habits. Unhealthy habits included are eating sugary foods, fried foods and drinking sugary drinks.\n\nScale Ranges (min, max): 1-7 Description of scoring: Lower scores indicate less automatic or habitual unhealthy habits. Higher scores indicate more automatic or habitual unhealthy habits. A negative mean change indicates a decrease in automatic or habitual unhealthy behaviors.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Changes in Healthy Habits Strength Scores From Week 0 to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm', 'description': 'WW GLP-1 behavioral program program + Sequence medical weight management prescribed semaglutide or tirzepatide.'}], 'classes': [{'title': 'Portion', 'categories': [{'measurements': [{'value': '1.72', 'spread': '1.68', 'groupId': 'OG000'}]}]}, {'title': 'Tracking', 'categories': [{'measurements': [{'value': '0.55', 'spread': '1.86', 'groupId': 'OG000'}]}]}, {'title': 'Points', 'categories': [{'measurements': [{'value': '1.24', 'spread': '1.82', 'groupId': 'OG000'}]}]}, {'title': 'Vegetables', 'categories': [{'measurements': [{'value': '0.48', 'spread': '1.4', 'groupId': 'OG000'}]}]}, {'title': 'Weighing', 'categories': [{'measurements': [{'value': '1.29', 'spread': '2.01', 'groupId': 'OG000'}]}]}, {'title': 'Physically', 'categories': [{'measurements': [{'value': '1.02', 'spread': '1.57', 'groupId': 'OG000'}]}]}, {'title': 'Self-Talk', 'categories': [{'measurements': [{'value': '0.82', 'spread': '1.74', 'groupId': 'OG000'}]}]}, {'title': 'Healthy Food', 'categories': [{'measurements': [{'value': '0.97', 'spread': '1.79', 'groupId': 'OG000'}]}]}, {'title': 'Snacking', 'categories': [{'measurements': [{'value': '0.61', 'spread': '1.81', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 to 24 weeks', 'description': 'Effect of WW + WW Clinic (formerly known as Sequence) on absolute change of Habit Strength scores using the "Self-Reported Behavioral Automaticity Index for Healthy Habits" Scale Name + Description of scale: "Self-Reported Behavioral Automaticity Index (SRBAI) Healthy Habits Subscale" is a self-report measure to assess how automatic or habitual certain behaviors are, often used to understand healthy habits. Healthy habits included are portion control, food tracking, protein content, eating vegetables, weighing self, physical activity, positive self-talk after a setback, arranging kitchen so healthy foods are easy to access and meal planning.\n\nScale Ranges (min, max): 1-7 Description of scoring: Lower scores indicate less automatic or habitual healthy habits. Higher scores indicate more automatic or habitual healthy habits. A positive mean change indicates an increase in automatic or habitual healthy behaviors.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Changes in Weight Bias Internalization Scores From Week 0 to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm', 'description': 'WW GLP-1 behavioral program program + Sequence medical weight management prescribed semaglutide or tirzepatide.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.12', 'spread': '9.83', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 to 24 weeks', 'description': 'Effect of WW + WW Clinic (formerly known as Sequence) on absolute change of Weight Bias Internalization scores using "Weight Bias Internalization Scale" Scale Name + Description of scale: "Weight Bias Internalization Scale, WBIS-2F" is a 13-item measure developed to assess weight related self-stigma.\n\nScale Ranges (min, max): 13-91 Description of scoring: Lower scores indicate more weight related self-stigma, higher scores indicate less weight related self-stigma. A negative mean change indicates a decrease in weight related self-stigma.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Changes in Self-Compassion Scores From Week 0 to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm', 'description': 'WW GLP-1 behavioral program program + Sequence medical weight management prescribed semaglutide or tirzepatide.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.05', 'spread': '0.32', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 to 24 weeks', 'description': 'Effect of WW + WW Clinic (formerly known as Sequence) on absolute change of Self-Compassion scores using the "Self-Compassion Scale" Scale Name + Description of scale: "Self-Compassion Scale" is a self-report questionnaire that asks how someone typically acts towards themselves in difficult times.\n\nScale Ranges (min, max): 1-5 Description of scoring: Lower scores indicate that an individual might be more critical of themselves during difficult times. Higher scores might indicate someone who might be less critical on themselves during difficult times. A positive mean change indicates more self-compassion.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With GLP1 Side Effects From Week 0 to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm', 'description': 'WW GLP-1 behavioral program program + Sequence medical weight management prescribed semaglutide or tirzepatide.'}], 'classes': [{'title': 'Nausea', 'categories': [{'measurements': [{'value': '146', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}]}]}, {'title': 'Constipation', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}]}]}, {'title': 'Diarrhea', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}]}]}, {'title': 'Abdominal Pain', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Complete Lack of Appetite', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Injection Site Reaction', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Hair Loss', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 24 weeks', 'description': 'Number of Participants with GLP1 Side Effects from week 0 to week 24', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Changes in Restraint/Disinhibition Scores From Week 0 to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm', 'description': 'WW GLP-1 behavioral program program + Sequence medical weight management prescribed semaglutide or tirzepatide.'}], 'classes': [{'title': 'Restraint Score', 'categories': [{'measurements': [{'value': '2.42', 'spread': '4.03', 'groupId': 'OG000'}]}]}, {'title': 'Disinhibition Score', 'categories': [{'measurements': [{'value': '-3.72', 'spread': '3.49', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 to 24 weeks', 'description': 'Effect of WW + WW Clinic (formerly known as Sequence) on absolute change of Restraint/Disinhibition scores using the "Three Factor Eating Questionnaire" Scale Name + Description of scale: "Three Factor Eating Questionnaires, TFEQ". Is a self-report scale that measures three dimensions of eating behavior: cognitive restraint, disinhibition and hunger. The first two factors were included.\n\nScale Ranges (min, max): restraint 0-21, disinhibition 0-16 Description of scoring: Lower scores indicate less restraint. Higher scores indicate more restraint. A positive change indicates improvement in restraint. Lower scores indicate less disinhibition. Higher scores indicate more disinhibition. A negative mean change improvement in disinhibition.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Changes in Depression Symptom Scores From Week 0 to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm', 'description': 'WW GLP-1 behavioral program program + Sequence medical weight management prescribed semaglutide or tirzepatide.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.99', 'spread': '4.59', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 to 24 weeks', 'description': 'Effect of WW + WW Clinic (formerly known as Sequence) on absolute change of Depression symptoms using the "Patient Health Questionnaire-8"\n\nScale Name + Description of scale: "Patient Health Questionniare-8 item" is a self-report scale that rates depressive symptoms including questions about interest, enjoyment, sadness, sleep, appetite, energy, guilt, concentration.\n\nScale Ranges (min, max): 0-24\n\nDescription of scoring: Lower scores indicate fewer depressive symptoms, higher scores indicate more depressive symptoms. A negative mean change indicates an improvement in depressive symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Single Arm', 'description': 'WW GLP-1 behavioral program program + Sequence medical weight management prescribed semaglutide or tirzepatide.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '180'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '166'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Single Arm', 'description': 'WW GLP-1 behavioral program program + Sequence medical weight management prescribed semaglutide or tirzepatide.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.11', 'spread': '10.41', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}, {'title': 'Female', 'categories': [{'measurements': [{'value': '164', 'groupId': 'BG000'}]}]}, {'title': 'Intersex', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Prefer not to say', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '166', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '146', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-12-13', 'size': 294977, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-10-02T09:38', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2024-10-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-17', 'studyFirstSubmitDate': '2023-08-24', 'resultsFirstSubmitDate': '2025-10-02', 'studyFirstSubmitQcDate': '2023-09-05', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-12-17', 'studyFirstPostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-10-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Blood Pressure Changes (Systolic and Diastolic) in mmHg From Week 0 to Week 24', 'timeFrame': '0 to 24 weeks', 'description': 'Effect of WW + WW Clinic (formerly known as Sequence) on absolute change of blood pressure at 24 weeks'}, {'measure': 'Change in Quality of Life Scores From Week 0 to Week 24', 'timeFrame': '0 to 24 weeks', 'description': 'Effect of WW + WW Clinic (formerly known as Sequence) on absolute change of Quality of Life (QOL) scores using "Impact of Weight on Quality of Life-Lite Scale" Scale Name + Description of scale: "Impact of Weight on Quality of Life-Lite (IWQOL-Lite) Is a validated, 31-item, self-report measure of obesity-specific quality of life in adults. There are five domains include physical function, self-esteem, sexual life, public distress and work.\n\nScale Ranges (min, max): 0-100 Description of scoring: Higher scores represent lower quality of life (i.e., greater impact of obesity on quality of life). Lower scores represent a better quality of life (i.e., less impact of obesity). A negative mean change indicates improvement in quality of life.'}, {'measure': 'Changes in Well-being Scores From Week 0 to Week 24', 'timeFrame': '0 to 24 weeks', 'description': 'Effect of WW + WW Clinic (formerly known as Sequence) on absolute change of Well-being at 24 weeks using "WHO Well-Being Index 5" Scale Name + Description of scale: "Well-being Index 5 (WHO-5)" is a 5-item questionnaire that assesses subjective well-being through five statements about feeling cheerful, calm, active, interested and rested over the past two weeks.\n\nScale Ranges (min, max) 0-25 Description of scoring: Lower scores indicate worse overall well-being, higher scores indicate better overall well-being. A positive mean change indicates improvement in well-being.'}, {'measure': 'Changes in Disordered Eating Scores From Week 0 to Week 24', 'timeFrame': '0 to 24 weeks', 'description': 'Effect of WW + WW Clinic (formerly known as Sequence) on absolute change of Disordered Eating at 24 weeks using "Eating Disorder Examination-Questionnaire" Scale Name + Description of scale: "Eating Disorder Examination-Questionnaire (EDE-Q)" is a 28-item self-report questionnaire, adapted from the semi-structured interview, the Eating Disorder Examination (EDE). The questionnaire is designed to assess the range, frequency and severity of behaviors associated with a diagnosis of an eating disorder.\n\nScale Ranges (min, max): 0-6 Description of scoring: Lower scores indicate less problematic eating disordered behaviors and cognitions and higher scores indicate more problematic eating disordered behaviors and cognitions. A positive mean change indicates an increase in eating disordered symptoms. A negative mean change could indicate a decrease in eating disorder symptoms.'}, {'measure': 'Changes in Strength Training Scores From Week 0 to Week 24', 'timeFrame': '0 to 24 weeks', 'description': 'Effect of WW + WW Clinic (formerly known as Sequence) on absolute change of Strength Training Behavior at 24 weeks using the "Strength Training Behavior Scale" Scale Name + Description of scale: "Stage of Change for Strength Training" Strength training is defined as all activities that serve to enhance muscle strength and endurance (free weights, body weight exercises, etc.) Regular resistance training is described as engaging in these activities at least two times per week.\n\nScale Ranges (min, max): 0-7 Description of scoring: Lower scores indicate less days strength training. Higher scores equal more days of strength training. A positive mean change indicates an increase in number of days of strength training.'}, {'measure': 'Changes in Stress Scores From Week 0 to Week 24', 'timeFrame': '0 to 24 weeks', 'description': 'Effect of WW + WW Clinic (formerly known as Sequence) on absolute change of Stress at 24 weeks using the "Perceived Stress Scale" Scale Name + Description of scale: "Perceived Stress Scale, PSS-10" is a self-report scale that asks about feelings and thoughts related to stressful things during the last month.\n\nScale Ranges (min, max): 10-50 Description of scoring: Higher scores indicate more perceived stress and lower scores indicate less perceived stress. A negative mean change indicates improvement in perceived stress.'}, {'measure': 'Changes in Emotional Eating Scores From Week 0 to Week 24', 'timeFrame': '0 to 24 weeks', 'description': 'Effect of WW + WW Clinic (formerly known as Sequence) on absolute change of Emotional Eating scores using the "Palatable Eating Motives Scale-Coping Subscale" Scale Name + Description of scale: "Palatable Eating Motives Scale - Coping Subscale (PEMs-Coping)" is a four-item coping subscale of the PEMs self-report that measures eating behavior as a method of coping with problems and negative feelings.\n\nScale Ranges (min, max): 4-20 Description of scoring: Lower scores indicate lower frequency of eating as a method of coping with problems and negative feelings. Higher scores indicate higher frequency of eating as a method of coping with problems and negative feelings. A negative mean score indicates a decrease in using eating to cope with problems and negative feelings.'}, {'measure': 'Changes in UnHealthy Habits Strength Scores From Week 0 to Week 24', 'timeFrame': '0 to 24 weeks', 'description': 'Effect of WW + WW Clinic (formerly known as Sequence) on absolute change of Unhealthy Habits scores using "Self-Reported Behavioral Automaticity Index" Scale Name + Description of scale: "Self-Reported Behavioral Automaticity Index (SRBAI)-Unhealthy Habits Subscale" is a self-report measure to assess how automatic or habitual certain behaviors are, often used to understand unhealthy habits. Unhealthy habits included are eating sugary foods, fried foods and drinking sugary drinks.\n\nScale Ranges (min, max): 1-7 Description of scoring: Lower scores indicate less automatic or habitual unhealthy habits. Higher scores indicate more automatic or habitual unhealthy habits. A negative mean change indicates a decrease in automatic or habitual unhealthy behaviors.'}, {'measure': 'Changes in Healthy Habits Strength Scores From Week 0 to Week 24', 'timeFrame': '0 to 24 weeks', 'description': 'Effect of WW + WW Clinic (formerly known as Sequence) on absolute change of Habit Strength scores using the "Self-Reported Behavioral Automaticity Index for Healthy Habits" Scale Name + Description of scale: "Self-Reported Behavioral Automaticity Index (SRBAI) Healthy Habits Subscale" is a self-report measure to assess how automatic or habitual certain behaviors are, often used to understand healthy habits. Healthy habits included are portion control, food tracking, protein content, eating vegetables, weighing self, physical activity, positive self-talk after a setback, arranging kitchen so healthy foods are easy to access and meal planning.\n\nScale Ranges (min, max): 1-7 Description of scoring: Lower scores indicate less automatic or habitual healthy habits. Higher scores indicate more automatic or habitual healthy habits. A positive mean change indicates an increase in automatic or habitual healthy behaviors.'}, {'measure': 'Changes in Weight Bias Internalization Scores From Week 0 to Week 24', 'timeFrame': '0 to 24 weeks', 'description': 'Effect of WW + WW Clinic (formerly known as Sequence) on absolute change of Weight Bias Internalization scores using "Weight Bias Internalization Scale" Scale Name + Description of scale: "Weight Bias Internalization Scale, WBIS-2F" is a 13-item measure developed to assess weight related self-stigma.\n\nScale Ranges (min, max): 13-91 Description of scoring: Lower scores indicate more weight related self-stigma, higher scores indicate less weight related self-stigma. A negative mean change indicates a decrease in weight related self-stigma.'}, {'measure': 'Changes in Self-Compassion Scores From Week 0 to Week 24', 'timeFrame': '0 to 24 weeks', 'description': 'Effect of WW + WW Clinic (formerly known as Sequence) on absolute change of Self-Compassion scores using the "Self-Compassion Scale" Scale Name + Description of scale: "Self-Compassion Scale" is a self-report questionnaire that asks how someone typically acts towards themselves in difficult times.\n\nScale Ranges (min, max): 1-5 Description of scoring: Lower scores indicate that an individual might be more critical of themselves during difficult times. Higher scores might indicate someone who might be less critical on themselves during difficult times. A positive mean change indicates more self-compassion.'}, {'measure': 'Number of Participants With GLP1 Side Effects From Week 0 to Week 24', 'timeFrame': '0 to 24 weeks', 'description': 'Number of Participants with GLP1 Side Effects from week 0 to week 24'}, {'measure': 'Changes in Restraint/Disinhibition Scores From Week 0 to Week 24', 'timeFrame': '0 to 24 weeks', 'description': 'Effect of WW + WW Clinic (formerly known as Sequence) on absolute change of Restraint/Disinhibition scores using the "Three Factor Eating Questionnaire" Scale Name + Description of scale: "Three Factor Eating Questionnaires, TFEQ". Is a self-report scale that measures three dimensions of eating behavior: cognitive restraint, disinhibition and hunger. The first two factors were included.\n\nScale Ranges (min, max): restraint 0-21, disinhibition 0-16 Description of scoring: Lower scores indicate less restraint. Higher scores indicate more restraint. A positive change indicates improvement in restraint. Lower scores indicate less disinhibition. Higher scores indicate more disinhibition. A negative mean change improvement in disinhibition.'}, {'measure': 'Changes in Depression Symptom Scores From Week 0 to Week 24', 'timeFrame': '0 to 24 weeks', 'description': 'Effect of WW + WW Clinic (formerly known as Sequence) on absolute change of Depression symptoms using the "Patient Health Questionnaire-8"\n\nScale Name + Description of scale: "Patient Health Questionniare-8 item" is a self-report scale that rates depressive symptoms including questions about interest, enjoyment, sadness, sleep, appetite, energy, guilt, concentration.\n\nScale Ranges (min, max): 0-24\n\nDescription of scoring: Lower scores indicate fewer depressive symptoms, higher scores indicate more depressive symptoms. A negative mean change indicates an improvement in depressive symptoms.'}], 'primaryOutcomes': [{'measure': 'Change in Weight in Pounds From Week 0 to Week 24', 'timeFrame': '0 to 24 weeks', 'description': 'Effect of WW GLP1 behavioral program + WW Clinic (formerly known as Sequence) on absolute change of weight loss at 24 weeks.'}], 'secondaryOutcomes': [{'measure': 'Weight Loss Percentage Change From Week 0 to Week 24', 'timeFrame': '0 to 24 weeks', 'description': 'Effect of WW + WW Clinic (formerly known as Sequence) on weight loss and % reaching 5, 10, 15, 20 % body weight loss at 24 weeks.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Weight Loss', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '41253738', 'type': 'DERIVED', 'citation': 'Heinberg LJ, Lee AM, Foster GD, DiVita A, Allman M, Rotroff D, Dargham CB, Cardel MI. Effectiveness of Telemedicine Prescribing and a Long-Acting Obesity Medication Behavioral Program: A 24-Week Single-Arm Study. Obesity (Silver Spring). 2025 Nov 18. doi: 10.1002/oby.70056. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'The study objective is to evaluate the efficacy of the WeightWatchers (WW) GLP-1 behavioral program + WW Clinic (formerly known as Sequence medical weight management program) on weight loss and related outcomes. Participants will be invited to take part and answer surveys at 0, 12 and 24 weeks.', 'detailedDescription': 'This is a 24 week prospective single-arm efficacy outcomes study. Up to 180 adult participants who are currently enrolled in WW GLP-1 behavioral program program + WW Clinic (formerly known as Sequence medical weight management program) and already prescribed semaglutide or tirzepatide. The application of a comprehensive lifestyle-based intervention focused on dietary intake, physical activity, support and behavioral principles in conjunction with anti-obesity medication (AOM) is novel and may increase AOM efficacy while minimizing maintenance concerns. As obesity care can now be delivered virtually, it will also include an innovative strategy of virtual/remotely delivered medical care via Sequence and WW. Further, this study will examine multiple psychosocial domains associated with weight loss and weight loss related outcomes including physical activity, dietary behavior, disordered eating, depression symptoms, internalized weight bias and community, that have not been examined in AOM trials.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will consist of patients who are already enrolled in WW Clinic (formerly known as Sequence) and prescribed GLP-1 medications.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. 18 years or older\n2. BMI of \\>30 or BMI of \\>27 with one or more weight related medically qualifying condition (hypertension, dyslipidemia, sleep apnea, cardiovascular disease)\n3. Access to a smartphone or tablet that runs iOS/iPadOS 15.0 or later, or Android 7.0 or later\n4. A prescription for Wegovy, Mounjaro, or Zepbound\n\nExclusion criteria:\n\n1. Diabetes\n2. Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia type 2\n3. History of pancreatitis within 180 days\n4. Previous surgical obesity treatment\n5. Use of other anti-obesity medication in last 90 days\n6. Use of GLP-1 within the last 180 days\n7. Lost weight \\>11 lbs in the last 90 days\n8. Pregnant, breastfeeding, intends to become pregnant, of child-bearing potential and not using a highly effective contraceptive method'}, 'identificationModule': {'nctId': 'NCT06034457', 'acronym': 'WW Clinic', 'briefTitle': 'Testing the Effectiveness of WW Clinic GLP1', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': '24 Week External Single-arm Study Testing the Effectiveness of WW GLP1 Behavioral Program + Sequence Medical Weight Management on Weight Loss and Related Outcomes', 'orgStudyIdInfo': {'id': '23-814'}}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Amy DiVita', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The Cleveland Clinic'}, {'name': 'Matthew Allman', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The Cleveland Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'leslie heinberg', 'investigatorAffiliation': 'The Cleveland Clinic'}}}}