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Bright 1 Bodies Weight Management Program

NCT02768987 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2018-05-30

No results posted yet for this study

Summary

Physical inactivity occurs among 65% to 95% of youth with type 1 diabetes (T1D) and based upon limited evidence may contribute to the rapidly growing incidence of overweight among this population. The purpose of the present study is to pilot test a 12-week intensive lifestyle program for adolescents with overweight and T1D utilizing group exercise classes adapted for this population, supplemented with coping skills training and diabetes self-management education to address problem solving behaviors that limit their physical activity and weight control. Our primary aim is to evaluate the changes in physical activity adherence, anthropometrics, and self-management behaviors following this program among sedentary adolescents with T1D and overweight (n=25, OW) compared with sedentary adolescents with T1D and normal weight (n=25, NW). We hypothesize that the OW group will achieve improve physical activity adherence and anthropometrics to the same or greater extent as the NW group and previous Bright Bodies cohorts, and that these changes will correlate with improved exercise-related problem solving. Our secondary aim is to evaluate changes in adipocytokines and epigenetic factors related to the etiology of overweight/obesity following our physical activity intervention. We hypothesize changes in these biomarkers will correlate with changes in anthropometry variables and partially explain any differences in response between the groups and individuals should those occur.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

BEHAVIORAL

Bright 1 Bodies

A 12-week intensive lifestyle program utilizing group exercise classes adapted for this population, supplemented with coping skills training and diabetes self-management education.

Sponsors & Collaborators

  • University of the West of Scotland

    collaborator OTHER

  • Texas A&M University

    collaborator OTHER

  • Yale University

    lead OTHER

Principal Investigators

  • Garrett I Ash, PhD, CSCS · Yale University

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
11 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2017-10-31
Completion
2017-11-08

Countries

  • United States

Study Locations

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02768987 on ClinicalTrials.gov