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Trial record 2 of 9 for:    Coping skills training in type 1 diabetes

Bright 1 Bodies Weight Management Program (B1B)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Yale University
Sponsor:
Collaborators:
University of the West of Scotland
Texas A&M University
Information provided by (Responsible Party):
Garrett Ash, Yale University
ClinicalTrials.gov Identifier:
NCT02768987
First received: May 4, 2016
Last updated: July 29, 2016
Last verified: July 2016
  Purpose
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.

Condition Intervention
Diabetes Mellitus, Type 1
Behavioral: Bright 1 Bodies

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Bright 1 Bodies: Extending the Bright Bodies Weight Management Program to Adolescents With Type 1 Diabetes

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Change from baseline body mass index (BMI) over 24 weeks [ Time Frame: Baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in daily physical activity energy expenditure over 24 weeks [ Time Frame: Baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in Progressive Aerobic Cardiovascular Endurance Run score over 24 weeks [ Time Frame: Baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline in blood pressure over 24 weeks [ Time Frame: Baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline daily insulin usage over 24 weeks [ Time Frame: Baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline lipid profile over 12 weeks [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline adipocytokines over 12 weeks [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Change from baseline micro RNA expression over 12 weeks [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline pediatric quality of life questionnaire score over 24 weeks [ Time Frame: Baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline diabetes self-care inventory score over 24 weeks [ Time Frame: Baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline hypoglycemia fear survey score over 24 weeks [ Time Frame: Baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline psychosocial determinants of physical activity behavior questionnaire score over 24 weeks [ Time Frame: Baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline self-perception profile for adolescents questionnaire social acceptance subscale score over 24 weeks [ Time Frame: Baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in handgrip strength over 24 weeks [ Time Frame: Baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline in sit-and-reach test over 24 weeks [ Time Frame: Baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline in push-up test over 24 weeks [ Time Frame: Baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: July 2016
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Overweight
Sedentary adolescents with T1D and overweight
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.
Experimental: Normal Weight
Sedentary adolescents with T1D and normal weight
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.

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.

  Eligibility

Ages Eligible for Study:   11 Years to 19 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02768987

Contacts
Contact: Garrett I Ash, PhD, CSCS 2034443079 garrett.ash@yale.edu
Contact: Kevin Joiner, PhD, RN 4156903774 kevin.joiner@yale.edu

Locations
United States, Connecticut
Yale Children's Diabetes Program Recruiting
New Haven, Connecticut, United States, 06511
Contact: Garrett I Ash, PhD, CSCS    203-444-3079    garrett.ash@yale.edu   
Contact: Kevin Joiner, PhD, RN    4156903774    kevin.joiner@yale.edu   
Sub-Investigator: Margaret Grey, DrPH, RN         
Sub-Investigator: Stuart A. Weinzimer, MD         
Principal Investigator: Julien Baker, PhD, DSc         
Principal Investigator: Mahua Choudhury, PhD         
Sub-Investigator: Mary Savoye, RD, CDE         
Sub-Investigator: Matthew Stults-Kohlemainen, PhD, EP-C         
Sub-Investigator: Kevin Joiner, PhD, RN         
Sponsors and Collaborators
Yale University
University of the West of Scotland
Texas A&M University
Investigators
Principal Investigator: Garrett I Ash, PhD, CSCS Yale University
  More Information

Responsible Party: Garrett Ash, Postdoctoral Research Fellow, Yale University
ClinicalTrials.gov Identifier: NCT02768987     History of Changes
Other Study ID Numbers: Ash001 
Study First Received: May 4, 2016
Last Updated: July 29, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Yale University:
exercise
physical activity
behavior modification
coping skills
self management
glycemic control
overweight
obesity
body composition
adherence

Additional relevant MeSH terms:
Diabetes Mellitus
Body Weight
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Signs and Symptoms
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 30, 2016