Wellness Achieved Through Changing Habits (The WATCH Study)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Florida
- Enrollment
- 17
- Locations
- 2
- Primary Endpoint
- Percentage of Participants Who Decide to Participate in the Intervention
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 14 Years to 19 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Percentage of Participants Who Decide to Participate in the Intervention
Time Frame: 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
Time Frame: 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.
Time Frame: 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.
Time Frame: 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 Outcomes
- Change in BMI Z-score(Baseline; Month 6)