Ignite Creation Date:
2024-05-06 @ 8:32 AM
Last Modification Date:
2024-10-26 @ 12:02 PM
Study NCT ID:
NCT02768987
Status:
COMPLETED
Last Update Posted:
2018-05-30
First Post:
2016-05-04
Brief Title:
Bright 1 Bodies Weight Management Program
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Bright 1 Bodies Extending the Bright Bodies Weight Management Program to Adolescents With Type 1 Diabetes
Status:
COMPLETED
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
B1B
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 n25 OW compared with sedentary adolescents with T1D and normal weight n25 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 overweightobesity 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 n25 OW compared with sedentary adolescents with T1D and normal weight n25 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 overweightobesity and T1D appear to interact yet no study has tested the influence of physical activity upon biological pathways related to overweightobesity for patients with T1D Accordingly our secondary aim is to evaluate changes in adipocytokines and epigenetic factors related to the etiology of overweightobesity 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
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 n25 OW compared with sedentary adolescents with T1D and normal weight n25 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 overweightobesity and T1D appear to interact yet no study has tested the influence of physical activity upon biological pathways related to overweightobesity for patients with T1D Accordingly our secondary aim is to evaluate changes in adipocytokines and epigenetic factors related to the etiology of overweightobesity 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None