Bright 1 Bodies Weight Management Program

NCT02768987 | Completed DMC

• 1 other identifier: 1605017843
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

exercise; physical activity; behavior modification; coping skills; self management; glycemic control; overweight; obesity; body composition; adherence

Outcome Measures

Primary Outcomes (2)

• Change from baseline body mass index (BMI) over 24 weeks

  Baseline, 12 weeks, 24 weeks

• Change from baseline in daily physical activity energy expenditure over 24 weeks

  Baseline, 12 weeks, 24 weeks

Secondary Outcomes (15)

• Change from baseline in Progressive Aerobic Cardiovascular Endurance Run score over 24 weeks

  Baseline, 12 weeks, 24 weeks

• Change from baseline in blood pressure over 24 weeks

  Baseline, 12 weeks, 24 weeks

• Change from baseline daily insulin usage over 24 weeks

  Baseline, 12 weeks, 24 weeks

• Change from baseline lipid profile over 12 weeks

  Baseline, 12 weeks

• Change from baseline adipocytokines over 12 weeks

  Baseline, 12 weeks

Study Arms (2)

Overweight

EXPERIMENTAL

Sedentary adolescents with T1D and overweight

Behavioral: Bright 1 Bodies

Normal Weight

EXPERIMENTAL

Sedentary adolescents with T1D and normal weight

Behavioral: Bright 1 Bodies

Interventions

Bright 1 Bodies BEHAVIORAL

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

Normal Weight; Overweight

Eligibility Criteria

• Age: 11 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patient of the Yale-New Haven Hospital (YNHH) Pediatrics Long Wharf or Trumbull Diabetes Clinic
• Diagnosed with T1D
• 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

Sponsors & Collaborators

• Yale University: lead
• University of the West of Scotland: collaborator
• Texas A&M University: collaborator

Study Sites (1)

Yale Children's Diabetes Program

New Haven, Connecticut, 06511, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Motor Activity; Overweight; Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Behavior; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Garrett I Ash, PhD, CSCS

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2016
• First Posted: May 11, 2016
• Study Start: July 1, 2016
• Primary Completion: October 31, 2017
• Study Completion: November 8, 2017
• Last Updated: May 30, 2018

Record last verified: 2018-05

Locations

US (1)