Wellness Achieved Through Changing Habits (The WATCH Study)

NCT03284788 | Completed Results

• 3 other identifiers: IRB201701609-NK01HL141535PA-16-190
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Weight Loss; Obesity; Overweight

Keywords

acceptance-based therapy; adolescents; weight; weight loss; obesity; overweight

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Change in BMI Z-score

  Baseline; Month 6

Study Arms (1)

ABT Weight Loss Intervention

EXPERIMENTAL

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

Interventions

ABT Weight Loss Intervention BEHAVIORAL

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.

ABT Weight Loss Intervention

Eligibility Criteria

• Age: 14 Years - 19 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Adolescent girls between ages 14-19 with overweight or obesity above the 85th percentile for sex and age as determined by CDC growth charts

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• StayWell: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• WellCare Health Plans, Inc.: collaborator

Study Sites (1)

HealthStreet and University of Florida

Gainesville, Florida, 32608, United States

Location

MeSH Terms

Conditions

Weight Loss; Obesity; Overweight; Body Weight

Condition Hierarchy (Ancestors)

Body Weight Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Dr. Michelle Cardel, Adjunct Professor
• Organization: University of Florida

mcardel@ufl.edu

352-273-8811

Study Officials

• Michelle I Cardel, PhD, MS, RD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2017
• First Posted: September 15, 2017
• Study Start: August 8, 2018
• Primary Completion: July 30, 2020
• Study Completion: October 1, 2020
• Last Updated: October 5, 2023
• Results First Posted: October 5, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)