Adolescent Obesity Clinical Trial
— TRUSTOfficial title:
Pilot Study Evaluating the Effects of a Trust-Building Intervention on Adolescent Weight Self-Management Behaviors
NCT number | NCT03016247 |
Other study ID # | 09-16-49 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 15, 2018 |
Est. completion date | July 31, 2019 |
Verified date | November 2019 |
Source | University Hospitals Cleveland Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this pilot study is to evaluate the effect of the Trust-building weight Self-management Together (TRUST) intervention on weight self-management behaviors and neural processing in overweight/obese adolescents. Study aims include comparing the effects of the TRUST intervention with Enhanced Usual Care on BMI and quality of life in overweight/obese early adolescents and exploring differences in neural processing (DMT/TPN switching and reward activation).
Status | Completed |
Enrollment | 2 |
Est. completion date | July 31, 2019 |
Est. primary completion date | June 24, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 10 Years to 12 Years |
Eligibility |
Inclusion Criteria: - 10-12 year old Cleveland Metropolitan School District student - identified as overweight or obese (BMI >85th percentile for age/sex during school screenings) - able to read, speak, and understand the English language - able to complete a self-administered questionnaire Exclusion Criteria: - taking medications that alter appetite or weight - stage 2 hypertension or stage 1 hypertension with end organ damage - severe behavioral problems that preclude group participation (as reported by parent/guardian) - child involvement in another weight management program - pregnancy - family expectation to move from the region within 1 year |
Country | Name | City | State |
---|---|---|---|
United States | Case Western Reserve University | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
University Hospitals Cleveland Medical Center | Case Western Reserve University |
United States,
Heinberg LJ, Kutchman EM, Berger NA, Lawhun SA, Cuttler L, Seabrook RC, Horwitz SM. Parent involvement is associated with early success in obesity treatment. Clin Pediatr (Phila). 2010 May;49(5):457-65. doi: 10.1177/0009922809337531. Epub 2009 Jun 1. — View Citation
Jack AI, Dawson AJ, Begany KL, Leckie RL, Barry KP, Ciccia AH, Snyder AZ. fMRI reveals reciprocal inhibition between social and physical cognitive domains. Neuroimage. 2013 Feb 1;66:385-401. doi: 10.1016/j.neuroimage.2012.10.061. Epub 2012 Oct 27. — View Citation
Steinberg L. A Social Neuroscience Perspective on Adolescent Risk-Taking. Dev Rev. 2008 Mar;28(1):78-106. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Body Mass Index | Statistically significant change in BMI from baseline to 3 months and 6 months | 6 months | |
Secondary | Eating | Change in Nutrient Data Systems Report data | 6 months | |
Secondary | Physical Activity | Change in accelerometer data | 6 months | |
Secondary | Sleep | Change in PROMIS-Sleep 4 scale score and Pediatric Daytime Sleepiness Scale score | 6 months |
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