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
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Weight Loss Obesity Overweight||Behavioral: ABT Weight Loss Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
- 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.
- 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.
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||14 Years to 19 Years (Child, Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- Adolescent girls between ages 14-19 with overweight or obesity above the 85th percentile for sex and age as determined by CDC growth charts
- 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
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
|United States, Florida|
|HealthStreet and University of Florida|
|Gainesville, Florida, United States, 32608|
|Principal Investigator:||Michelle I Cardel, PhD, MS, RD||University of Florida|
|Responsible Party:||University of Florida|
|Other Study ID Numbers:||
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|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Body Weight Changes