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Wellness Achieved Through Changing Habits (The WATCH Study)

Primary Purpose

Weight Loss, Obesity, Overweight

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ABT Weight Loss Intervention
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weight Loss focused on measuring acceptance-based therapy, adolescents, weight, weight loss, obesity, overweight

Eligibility Criteria

14 Years - 19 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • HealthStreet and University of Florida

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ABT Weight Loss Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 29, 2017
Last Updated
September 12, 2023
Sponsor
University of Florida
Collaborators
StayWell, National Heart, Lung, and Blood Institute (NHLBI), WellCare Health Plans, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03284788
Brief Title
Wellness Achieved Through Changing Habits (The WATCH Study)
Official Title
Wellness Achieved Through Changing Habits (The WATCH Study)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
August 8, 2018 (Actual)
Primary Completion Date
July 30, 2020 (Actual)
Study Completion Date
October 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
StayWell, National Heart, Lung, and Blood Institute (NHLBI), WellCare Health Plans, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss, Obesity, Overweight
Keywords
acceptance-based therapy, adolescents, weight, weight loss, obesity, overweight

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ABT Weight Loss Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
ABT Weight Loss Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants Recruited
Description
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.
Time Frame
Baseline; Week 8
Title
Percentage of Participants Who Did Not Complete the Intervention.
Description
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.
Time Frame
Baseline; Month 6
Title
Percentage of Participants Who Decide to Participate in the Intervention
Description
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.
Time Frame
Baseline; Week 1
Title
Percentage of Participants Who Attend All Intervention Sessions.
Description
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.
Time Frame
Week 1; Week 24
Secondary Outcome Measure Information:
Title
Change in BMI Z-score
Description
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.
Time Frame
Baseline; Month 6

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle I Cardel, PhD, MS, RD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
HealthStreet and University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Wellness Achieved Through Changing Habits (The WATCH Study)

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