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Trial record 1 of 1 for:    The WATCH Study: Wellness Achieved Through Changing Habits
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Wellness Achieved Through Changing Habits (The WATCH Study)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03284788
Recruitment Status : Completed
First Posted : September 15, 2017
Last Update Posted : April 22, 2021
Sponsor:
Collaborators:
StayWell
National Heart, Lung, and Blood Institute (NHLBI)
WellCare Health Plans, Inc.
Information provided by (Responsible Party):
University of Florida

Study Description
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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.

Condition or disease Intervention/treatment Phase
Weight Loss Obesity Overweight Behavioral: ABT Weight Loss Intervention Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Wellness Achieved Through Changing Habits (The WATCH Study)
Actual Study Start Date : August 8, 2018
Actual Primary Completion Date : July 30, 2020
Actual Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in participant recruitment rate [ Time Frame: Baseline; Week 8 ]
    The recruitment strategy will be deemed "feasible" if approximately 15 participants are recruited within 8 weeks.

  2. Change in participant attrition rate [ 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.

  3. Change in number of enrollees [ Time Frame: Baseline; Week 1 ]
    The study will be deemed "acceptable" if at least 80% of enrolled participants decide to participate in the intervention.

  4. Change in number of sessions completed by those who completed the intervention [ Time Frame: Week 1; Week 24 ]
    The study will be deemed "acceptable" if at least 70% of intervention completers attend all sessions.


Secondary Outcome Measures :
  1. Change in BMI Z-score [ Time Frame: Baseline; Month 6 ]
    Measurement of relative weight at pre- and post-treatment adjusted for participant age and sex


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03284788


Locations
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United States, Florida
HealthStreet and University of Florida
Gainesville, Florida, United States, 32608
Sponsors and Collaborators
University of Florida
StayWell
National Heart, Lung, and Blood Institute (NHLBI)
WellCare Health Plans, Inc.
Investigators
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Principal Investigator: Michelle I Cardel, PhD, MS, RD University of Florida
More Information
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03284788    
Other Study ID Numbers: IRB201701609-N
K01HL141535 ( U.S. NIH Grant/Contract )
PA-16-190 ( Other Grant/Funding Number: National Institute of Health )
First Posted: September 15, 2017    Key Record Dates
Last Update Posted: April 22, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Florida:
acceptance-based therapy
adolescents
weight
 weight loss
obesity
overweight
Additional relevant MeSH terms:
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Overweight
Weight Loss
Overnutrition
 Nutrition Disorders
Body Weight
Body Weight Changes