Bright 1 Bodies Weight Management Program

Completed · Not applicable

Conditions studied: Diabetes Mellitus, Type 1

In brief

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.

Key facts

Study ID

NCT02768987

Run by

Yale University

People needed

50

Starts

2016-07-01

Expected to finish

2017-11-08

Last updated by the study team

2018-05-30

Who can join

Age: 11 and older, up to 19. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient of the Yale-New Haven Hospital (YNHH) Pediatrics Long Wharf or Trumbull Diabetes Clinic
• Diagnosed with T1D
• 11 to 19 years old
• Sedentary (exercise less than twice per week over past two months)
• n=25 overweight (BMI > 85th percentile for age and sex according to Centers for Disease Control Growth Charts) and n=25 normal weight
• Family willing to commit the time and effort to a family-based lifestyle program.

You may not qualify if…

• Endocrinopathies other than type 1 diabetes; adequately treated hypothyroidism, as demonstrated by normal thyroid tests within previous six months, is allowed.
• Concurrent use of systemic (oral, parenteral) glucocorticoids or other medications known to contribute to obesity; inhaled steroids are allowed.
• Any use of pharmacological intervention for weight management, including prescription medication, over the counter medication, or herbal supplements.
• Chronic disease or physical disability that would influence treatment intervention or preclude participation in regular physical activity (e.g., chronic renal failure).
• Psychological conditions such as uncontrolled eating disorder, psychosis, personality disorders and other disorders that will interfere with the ability to maintain complete follow up and adherence to protocol.
• Any concurrent membership in a comprehensive weight management program.
• Inability or unwillingness of the parent to accompany the child to nutrition classes.
• Pregnancy

Where it is running

• Yale Children's Diabetes Program — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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