Wellness Achieved Through Changing Habits (The WATCH Study)

Study Overview
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Brief Summary
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The purpose of this pilot, feasibility study is to investigate the acceptability of an acceptance-based therapy healthy lifestyle intervention in adolescent girls with overweight/obesity.

Detailed Description
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Participants will attend 2 baseline clinic visits and adolescents will participate in an ABT healthy lifestyle intervention. The intervention will include 15 sessions over 6 months. A post-treatment visit will occur.

Official Title
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Wellness Achieved Through Changing Habits (The WATCH Study)

Conditions
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Weight Loss, Obesity, Overweight

Intervention / Treatment
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* Behavioral: ABT Weight Loss Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adolescent girls between ages 14-19 with overweight or obesity above the 85th percentile for sex and age as determined by CDC growth charts Exclusion Criteria: Known pregnancy or plans to become pregnant in the next 2 years Any condition prohibiting physical activity A diagnosis of cardiovascular disease or diabetes Have active cancer or cancer requiring treatment in the past 2 years Have active or chronic infections (e.g., HIV or TB) Have active kidney disease or lung disease An eating disorder or substance abuse disorder Having begun a course of or changed the dosage of any medications known to affect appetite or body composition within the previous 3 months Weight loss greater than or equal to 5% in the previous 6 months If they do not follow the study plan

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABT Weight Loss Intervention<br>Adolescent girls will attend healthy lifestyle sessions that include nutritional education and physical activity education and build skills in the areas of values clarification, mindfulness, self-regulation skills, acceptance of uncomfortable states, goal-setting, problem solving, and self-monitoring. | Behavioral: ABT Weight Loss Intervention<br>* This includes 15 sessions that are each 90 minutes in length. Intervention sessions will be weekly for the first 2 months, bi-weekly for the next 2 months, and monthly for the last 2 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Recruited | Number of teens who enrolled and completed both initial baseline visits. The recruitment strategy will be deemed 'feasible' if 15 participants are recruited within the 8 weeks. | Baseline; Week 8 | 
| Percentage of Participants Who Did Not Complete the Intervention. | The attrition strategy will be deemed feasible if there is less than 50% attrition at the end of the 6-month intervention. This percentage details attrition, or the percentage of participants who did not complete the intervention. | Baseline; Month 6 | 
| Percentage of Participants Who Decide to Participate in the Intervention | Of the participants who completed baseline visits, this percentage details what percentage of enrollees decided to participate in the intervention. The study will be deemed acceptable if at least 80% of enrolled participants decide to participate in the intervention. | Baseline; Week 1 | 
| Percentage of Participants Who Attend All Intervention Sessions. | This percentage details the percentage of those who attended all 15 intervention sessions among intervention completers (n=11). The study will be deemed 'acceptable' if at least 70% of intervention completers attend all sessions. | Week 1; Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in BMI Z-score | Body mass index (BMI) z-scores are measures of weight adjusted for the height, age, and sex of the child. BMI z-scores correspond with growth chart percentiles. These scores are calculated with an external reference rather than internal references. In this study, the Centers for Disease Control and Prevention SAS program was used to calculate scores based on 2000 CDC growth charts. Additionally, a clinically significant change in BMI z-score was defined as greater than or equal to -0.15 as this decrease has shown improvements in one or more cardiovascular disease risk factor. The central z-score value is 0, representing the population mean, and standard deviations below the mean indicate better outcomes. | Baseline; Month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acceptance-based therapy, adolescents, weight, weight loss, obesity, overweight