Wellness Achieved Through Changing Habits (The WATCH Study)

Not Applicable

Completed

• Conditions: Obesity; Overweight; Weight Loss
• Interventions: Behavioral: ABT Weight Loss Intervention

• Registration Number: NCT03284788
• Lead Sponsor: University of Florida

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2017-08-29
• Study First Submitted QC: 2017-09-14
• Study First Posted: 2017-09-15
• Study Start: 2018-08-08
• Primary Completion: 2020-07-30
• Study Completion: 2020-10-01
• Results First Submitted: 2023-06-09
• Status Verified: 2023-09
• Results First Submitted QC: 2023-09-12
• Last Update Submitted: 2023-09-12
• Results First Posted: 2023-10-05
• Last Update Posted: 2023-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 17

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ABT Weight Loss Intervention	ABT Weight Loss Intervention	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Decide to Participate in the Intervention	Baseline; Week 1	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.
Number of Participants Recruited	Baseline; Week 8	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.
Percentage of Participants Who Did Not Complete the Intervention.	Baseline; Month 6	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.
Percentage of Participants Who Attend All Intervention Sessions.	Week 1; Week 24	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.

Secondary Outcome Measures

Name	Time	Method
Change in BMI Z-score	Baseline; Month 6	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.

Trial Locations

Locations (1)

HealthStreet and University of Florida; 🇺🇸 Gainesville, Florida, United States