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The goal of this clinical trial is to learn about cardiovascular disease risk among adolescent girls with overweight/obesity. The main questions this trial aims to answer are:
Participants in this trial will:
Researchers will compare the acceptance-based and health education intervention groups to see if the acceptance-based treatment will indeed be effective in improving participants' health outcomes.
Overweight/obesity (OW/OB) affects 14 million adolescents in the U.S. and disproportionately affects girls and racial/ethnic minorities while increasing their risk of cardiovascular disease (CVD) and type 2 diabetes. Adolescents demonstrate limited self-regulation skills, which are essential for adhering to diet and physical activity goals. Adolescents must contend with pervasive biological and environmental cues (e.g., cravings, labor-saving devices) that promote overeating and sedentary behavior. There is a critical need for interventions that teach self-regulation to enable adolescents to respond adaptively to these cues. Acceptance-based therapy (ABT) is an innovative approach that focuses on self-regulation skills, mindfulness, and increasing tolerance of uncomfortable internal experiences. There is strong evidence for ABT as an effective weight loss intervention for adults. The investigators conducted formative work using an adolescent-engaged approach to develop, implement, and feasibility test an ABT intervention for adolescent girls with OW/OB. The objective of this proposal is to test the efficacy of a novel ABT weight loss intervention tailored for adolescent girls with OW/OB.
This trial is the first to investigate ABT tailored for adolescent girls with OW/OB. The investigators will conduct a 6-month, randomized controlled trial comparing ABT with a health education comparison for 14- to 19-year-old adolescent girls with OW/OB, including ≥40% racial/ethnic minorities. To enhance scalability, interventions in both conditions will be delivered by bachelor's level paraprofessional weight loss coaches, treatment will occur in a hybrid of in-person and remote sessions, and the trial will take place in an outpatient community clinic. Assessments will be conducted at baseline, mid-treatment (month 3), post-treatment (month 6), 6-month follow-up (month 12), and 12-month follow-up (month 18), for a total study time of 18 months. The primary hypothesis is that adolescents randomized to ABT will exhibit significantly greater improvements in BMI z-score post-treatment compared to a health education comparison (HE). In the secondary aims, the investigators hypothesize that at post-treatment and 6- and 12-month follow-up, adolescents randomized to ABT will exhibit significantly greater improvements in their physiological, behavioral, and psychological risk factors compared to HE.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acceptance-based Treatment (ABT) | Experimental | ABT will consist of 18, 90-minute group sessions over 6 months. |
|
| Health Education (HE) Comparison | Sham Comparator | HE will include nine, 75-minute group health education sessions handouts over 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acceptance-based Treatment (ABT) | Behavioral | Participants will be provided with psycho-education, skill-builders, and other coaching to promote weight loss and healthy lifestyle changes. |
| Measure | Description | Time Frame |
|---|---|---|
| BMI z-score change | Compare ABT vs. HE on BMI z-score change at post-treatment (month 6). The investigators hypothesize a significantly greater decrease in BMI z-scores in the ABT relative to HE. | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Physiological - Adiposity | Compare change in percent body fat in ABT relative to HE | Month 6, month 12, month 18 |
| Physiological - Blood pressure | Compare change in diastolic and systolic blood pressure in ABT relative to HE |
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Inclusion Criteria:
Exclusion Criteria:
The participant must self-identify as female.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Manasse, PhD | Contact | 215-553-7157 | smm522@drexel.edu |
| Name | Affiliation | Role |
|---|---|---|
| Stephanie Manasse, PhD | Drexel University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Drexel University | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27272581 | Background | Ogden CL, Carroll MD, Lawman HG, Fryar CD, Kruszon-Moran D, Kit BK, Flegal KM. Trends in Obesity Prevalence Among Children and Adolescents in the United States, 1988-1994 Through 2013-2014. JAMA. 2016 Jun 7;315(21):2292-9. doi: 10.1001/jama.2016.6361. | |
| 36394498 | Background | Newsome FA, Cardel MI, Chi X, Lee AM, Miller D, Menon S, Janicke DM, Gurka MJ, Butryn ML, Manasse S. Wellness Achieved Through Changing Habits: A Randomized Controlled Trial of an Acceptance-Based Intervention for Adolescent Girls With Overweight or Obesity. Child Obes. 2023 Dec;19(8):525-534. doi: 10.1089/chi.2022.0116. Epub 2022 Nov 17. |
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De-identified data will be shared with the study Data Safety Monitoring Board (DSMB). Following study close-out, de-identified data and related data dictionaries will be available upon request.
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Data will be available upon request following the conclusion of the study.
For access, interested parties must contact the principal investigator.
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D006371 | Helium |
| ID | Term |
|---|---|
| D005741 | Noble Gases |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
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Participants will be randomized to either an acceptance-based treatment intervention or a health education comparison for the duration of the study.
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| Health Education (HE) Comparison | Behavioral | Participants will be provided with psych-education and resources to promote weight loss and healthy lifestyle changes. They will not be provided with directives. |
|
| Month 6, month 12, month 18 |
| Physiological - Blood lipids | Compare change in total blood lipid levels in ABT relative to HE. HDL, LDL, and total cholesterol will each be examined. | Month 6, month 12, month 18 |
| Health-related behaviors - dietary intake | Compare change in dietary intake in ABT relative to HE. Dietary intake will be measured with a VioScreen Food Frequency Questionnaire. | Month 6, month 12, month 18 |
| Health-related behaviors - physical activity | Compare change in physical activity in ABT relative to HE. Physical activity will be measured with a smart watch. | Month 6, month 12, month 18 |
| Psychological - Quality of life | Compare change in quality of life, in ABT relative to HE. Quality of life will be measured with the Quality of Life Inventory. | Month 6, month 12, month 18 |
| Psychological - Depression | Compare change in depression in ABT relative to HE at all time points. Depression will be measured using Beck's Depression Inventory-II. | Month 6, month 12, month 18 |
| Psychological - Disordered eating | Compare change in disordered eating in ABT relative to HE at all time points. Disordered eating will be measured using the Eating Disorder Examination Questionnaire. | Month 6, month 12, month 18 |
| Psychological - Psychological flexibility | Compare change in psychological flexibility in ABT relative to HE at all time points. Psychological flexibility will be measured using the Acceptance and Action Questionnaire II. | Month 6, month 12, month 18 |
| 39019153 | Derived | Manasse SM, Moussaoui JR, Lampe EW, Brown KL, Zhang F, Janicke DM, McCrea L, Cardel MI, Butryn ML. Evaluating an acceptance-based lifestyle modification program to address cardiovascular disease risk among adolescent girls with overweight and obesity: Protocol for a randomized controlled trial. Contemp Clin Trials. 2024 Sep;144:107634. doi: 10.1016/j.cct.2024.107634. Epub 2024 Jul 15. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |