Wellness Achieved Through Changing Habits (The WATCH Study)

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight; Weight Loss
• Intervention / Treatment: Behavioral: ABT Weight Loss Intervention

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 Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32608
      • HealthStreet and University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: ABT Weight Loss Intervention; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); StayWell; WellCare Health Plans, Inc.
• Investigators: Principal Investigator: Michelle I Cardel, PhD, MS, RD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2018
• Primary Completion (Actual): July 30, 2020
• Study Completion (Actual): October 1, 2020

Study Registration Dates

• First Submitted: August 29, 2017
• First Submitted That Met QC Criteria: September 14, 2017
• First Posted (Actual): September 15, 2017

Study Record Updates

• Last Update Posted (Actual): October 5, 2023
• Last Update Submitted That Met QC Criteria: September 12, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: obesity; overweight; adolescents; weight loss; weight; acceptance-based therapy
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Body Weight Changes; Weight Loss; Overweight
• Other Study ID Numbers: IRB201701609-N; K01HL141535 (U.S. NIH Grant/Contract); PA-16-190 (Other Grant/Funding Number: NIH NHLBI)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No