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| Name | Class |
|---|---|
| University of the West of Scotland | OTHER |
| Texas A&M University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Overweight | Experimental | Sedentary adolescents with T1D and overweight |
|
| Normal Weight | Experimental | Sedentary adolescents with T1D and normal weight |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Garrett I Ash, PhD, CSCS | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale Children's Diabetes Program | New Haven | Connecticut | 06511 | United States |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D009043 | Motor Activity |
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 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 |
| Change from baseline inflammatory factors including C-reactive protein, interleukin-6, fibrinogen, and plasminogen activator inhibitor-1 over 12 weeks | Baseline, 12 weeks |
| Change from baseline micro RNA expression over 12 weeks | Baseline, 12 weeks |
| Change from baseline pediatric quality of life questionnaire score over 24 weeks | Baseline, 12 weeks, 24 weeks |
| Change from baseline diabetes self-care inventory score over 24 weeks | Baseline, 12 weeks, 24 weeks |
| Change from baseline hypoglycemia fear survey score over 24 weeks | Baseline, 12 weeks, 24 weeks |
| Change from baseline psychosocial determinants of physical activity behavior questionnaire score over 24 weeks | Baseline, 12 weeks, 24 weeks |
| Change from baseline self-perception profile for adolescents questionnaire social acceptance subscale score over 24 weeks | Baseline, 12 weeks, 24 weeks |
| Change from baseline in handgrip strength over 24 weeks | Baseline, 12 weeks, 24 weeks |
| Change from baseline in sit-and-reach test over 24 weeks | Baseline, 12 weeks, 24 weeks |
| Change from baseline in push-up test over 24 weeks | Baseline, 12 weeks, 24 weeks |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001519 | Behavior |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |