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Bright 1 Bodies Weight Management Program (B1B)

Primary Purpose

Diabetes Mellitus, Type 1

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bright 1 Bodies
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes Mellitus, Type 1 focused on measuring exercise, physical activity, behavior modification, coping skills, self management, glycemic control, overweight, obesity, body composition, adherence

Eligibility Criteria

11 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • Yale Children's Diabetes Program

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Overweight

Normal Weight

Arm Description

Sedentary adolescents with T1D and overweight

Sedentary adolescents with T1D and normal weight

Outcomes

Primary Outcome Measures

Change from baseline body mass index (BMI) over 24 weeks
Change from baseline in daily physical activity energy expenditure over 24 weeks

Secondary Outcome Measures

Change from baseline in Progressive Aerobic Cardiovascular Endurance Run score over 24 weeks
Change from baseline in blood pressure over 24 weeks
Change from baseline daily insulin usage over 24 weeks
Change from baseline lipid profile over 12 weeks
Change from baseline adipocytokines over 12 weeks
Change from baseline inflammatory factors including C-reactive protein, interleukin-6, fibrinogen, and plasminogen activator inhibitor-1 over 12 weeks
Change from baseline micro RNA expression over 12 weeks
Change from baseline pediatric quality of life questionnaire score over 24 weeks
Change from baseline diabetes self-care inventory score over 24 weeks
Change from baseline hypoglycemia fear survey score over 24 weeks
Change from baseline psychosocial determinants of physical activity behavior questionnaire score over 24 weeks
Change from baseline self-perception profile for adolescents questionnaire social acceptance subscale score over 24 weeks
Change from baseline in handgrip strength over 24 weeks
Change from baseline in sit-and-reach test over 24 weeks
Change from baseline in push-up test over 24 weeks

Full Information

First Posted
May 4, 2016
Last Updated
May 29, 2018
Sponsor
Yale University
Collaborators
University of the West of Scotland, Texas A&M University
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1. Study Identification

Unique Protocol Identification Number
NCT02768987
Brief Title
Bright 1 Bodies Weight Management Program
Acronym
B1B
Official Title
Bright 1 Bodies: Extending the Bright Bodies Weight Management Program to Adolescents With Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
October 31, 2017 (Actual)
Study Completion Date
November 8, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
University of the West of Scotland, Texas A&M University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Prevalence of overweight among patients with type 1 diabetes (T1D) of all ages has grown at alarming rates since the 1980s. Physical inactivity occurs among 65% to 95% of youth with T1D and doubles their risk of overweight. A major factor limiting their physical activity appears to be self-managed problem solving around exercise such as adjustments to insulin and diet, which is practiced regularly by less than half of our adolescent patients with T1D and less frequently than any other self-management behavior. Our previous interventions applying coping skills training (ABCs of Diabetes and TeenCope) as well as diabetes self-management (Managing Diabetes) successfully improved problem-solving and other aspects of self-management along with health outcomes among adolescents with T1D, but did not focus on those who were overweight nor promotion of physical activity and weight loss. The Yale Bright Bodies intensive lifestyle program successfully promotes physical activity and weight loss, enrolling >100 overweight youth from greater New Haven annually but does not presently accommodate those with T1D. 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 from Bright Bodies 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 (body mass index percentile for age, body fat percentage), and self-management behaviors following this 12-week lifestyles 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. Although physical activity is recommended for weight loss, outcomes from increased physical activity have been heterogeneously distributed-not all overweight participants lose weight and some even gain weight. Furthermore the etiologies of overweight/obesity and T1D appear to interact, yet no study has tested the influence of physical activity upon biological pathways related to overweight/obesity for patients with T1D. Accordingly, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
Keywords
exercise, physical activity, behavior modification, coping skills, self management, glycemic control, overweight, obesity, body composition, adherence

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Overweight
Arm Type
Experimental
Arm Description
Sedentary adolescents with T1D and overweight
Arm Title
Normal Weight
Arm Type
Experimental
Arm Description
Sedentary adolescents with T1D and normal weight
Intervention Type
Behavioral
Intervention Name(s)
Bright 1 Bodies
Intervention Description
A 12-week intensive lifestyle program utilizing group exercise classes adapted for this population, supplemented with coping skills training and diabetes self-management education.
Primary Outcome Measure Information:
Title
Change from baseline body mass index (BMI) over 24 weeks
Time Frame
Baseline, 12 weeks, 24 weeks
Title
Change from baseline in daily physical activity energy expenditure over 24 weeks
Time Frame
Baseline, 12 weeks, 24 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in Progressive Aerobic Cardiovascular Endurance Run score over 24 weeks
Time Frame
Baseline, 12 weeks, 24 weeks
Title
Change from baseline in blood pressure over 24 weeks
Time Frame
Baseline, 12 weeks, 24 weeks
Title
Change from baseline daily insulin usage over 24 weeks
Time Frame
Baseline, 12 weeks, 24 weeks
Title
Change from baseline lipid profile over 12 weeks
Time Frame
Baseline, 12 weeks
Title
Change from baseline adipocytokines over 12 weeks
Time Frame
Baseline, 12 weeks
Title
Change from baseline inflammatory factors including C-reactive protein, interleukin-6, fibrinogen, and plasminogen activator inhibitor-1 over 12 weeks
Time Frame
Baseline, 12 weeks
Title
Change from baseline micro RNA expression over 12 weeks
Time Frame
Baseline, 12 weeks
Title
Change from baseline pediatric quality of life questionnaire score over 24 weeks
Time Frame
Baseline, 12 weeks, 24 weeks
Title
Change from baseline diabetes self-care inventory score over 24 weeks
Time Frame
Baseline, 12 weeks, 24 weeks
Title
Change from baseline hypoglycemia fear survey score over 24 weeks
Time Frame
Baseline, 12 weeks, 24 weeks
Title
Change from baseline psychosocial determinants of physical activity behavior questionnaire score over 24 weeks
Time Frame
Baseline, 12 weeks, 24 weeks
Title
Change from baseline self-perception profile for adolescents questionnaire social acceptance subscale score over 24 weeks
Time Frame
Baseline, 12 weeks, 24 weeks
Title
Change from baseline in handgrip strength over 24 weeks
Time Frame
Baseline, 12 weeks, 24 weeks
Title
Change from baseline in sit-and-reach test over 24 weeks
Time Frame
Baseline, 12 weeks, 24 weeks
Title
Change from baseline in push-up test over 24 weeks
Time Frame
Baseline, 12 weeks, 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Garrett I Ash, PhD, CSCS
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale Children's Diabetes Program
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Bright 1 Bodies Weight Management Program

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