Diabetes Mellitus, Type 1B1BNCT02768987
Bright 1 Bodies Weight Management Program
A study testing Bright 1 Bodies in people with Diabetes Mellitus, Type 1, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 19 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Bright 1 Bodies
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to 8 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale Children's Diabetes Program
New Haven, Connecticut, 06511
About this study
Official title: Bright 1 Bodies: Extending the Bright Bodies Weight Management Program to Adolescents With Type 1 Diabetes
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Bright 1 Bodies
- Keywords
- exercise, physical activity, behavior modification, coping skills, self management, glycemic control, overweight, obesity, body composition, adherence
- Medical subject headings
- Diabetes Mellitus, Type 1, Motor Activity, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bright 1 BodiesBehavioural
A 12-week intensive lifestyle program utilizing group exercise classes adapted for this population, supplemented with coping skills training and diabetes self-management education.
| Study group | Role | What they receive |
|---|---|---|
| Overweight | Experimental | Sedentary adolescents with T1D and overweight Receives: Behavioral: Bright 1 Bodies |
| Normal Weight | Experimental | Sedentary adolescents with T1D and normal weight Receives: Behavioral: Bright 1 Bodies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline body mass index (BMI) over 24 weeks
Measured: Baseline, 12 weeks, 24 weeks
Change from baseline in daily physical activity energy expenditure over 24 weeks
Measured: Baseline, 12 weeks, 24 weeks
Secondary outcomes (15)
Change from baseline in Progressive Aerobic Cardiovascular Endurance Run score over 24 weeks
Measured: Baseline, 12 weeks, 24 weeks
Change from baseline in blood pressure over 24 weeks
Measured: Baseline, 12 weeks, 24 weeks
Change from baseline daily insulin usage over 24 weeks
Measured: Baseline, 12 weeks, 24 weeks
Change from baseline lipid profile over 12 weeks
Measured: Baseline, 12 weeks
Change from baseline adipocytokines over 12 weeks
Measured: Baseline, 12 weeks
Change from baseline inflammatory factors including C-reactive protein, interleukin-6, fibrinogen, and plasminogen activator inhibitor-1 over 12 weeks
Measured: Baseline, 12 weeks
Change from baseline micro RNA expression over 12 weeks
Measured: Baseline, 12 weeks
Change from baseline pediatric quality of life questionnaire score over 24 weeks
Measured: Baseline, 12 weeks, 24 weeks
Change from baseline diabetes self-care inventory score over 24 weeks
Measured: Baseline, 12 weeks, 24 weeks
Change from baseline hypoglycemia fear survey score over 24 weeks
Measured: Baseline, 12 weeks, 24 weeks
Change from baseline psychosocial determinants of physical activity behavior questionnaire score over 24 weeks
Measured: Baseline, 12 weeks, 24 weeks
Change from baseline self-perception profile for adolescents questionnaire social acceptance subscale score over 24 weeks
Measured: Baseline, 12 weeks, 24 weeks
Change from baseline in handgrip strength over 24 weeks
Measured: Baseline, 12 weeks, 24 weeks
Change from baseline in sit-and-reach test over 24 weeks
Measured: Baseline, 12 weeks, 24 weeks
Change from baseline in push-up test over 24 weeks
Measured: Baseline, 12 weeks, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study startJul 2016
- Primary completion31 Oct 2017
- Study completion8 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- University of the West of Scotland, Texas A&M University
- Responsible party
- Sponsor
- Investigators
- Garrett I Ash, PhD, CSCS, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02768987
- Sponsor's protocol ID
- 1605017843
- Acronym
- B1B
- Status last verified
- May 2018
- First submitted
- 4 May 2016
- Last updated
- 30 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bright 1 Bodies: Extending the Bright Bodies Weight Management Program to Adolescents With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT02768987
- Acronym / sponsor ID
- B1B / 1605017843
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- exercise, physical activity, behavior modification, coping skills, self management, glycemic control, overweight, obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- University of the West of Scotland, Texas A&M University
- Study start
- Jul 2016
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- 8 Nov 2017 (actual)
- First posted
- 11 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Overweight | Experimental | Behavioral: Bright 1 BodiesSedentary adolescents with T1D and overweight |
| Normal Weight | Experimental | Behavioral: Bright 1 BodiesSedentary adolescents with T1D and normal weight |
Who may qualify
- Ages
- 11 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bright 1 BodiesA 12-week intensive lifestyle program utilizing group exercise classes adapted for this population, supplemented with coping skills training and diabetes self-management education. | Behavioural | Normal Weight, Overweight |
Primary outcome
Change from baseline body mass index (BMI) over 24 weeks
Time frame: Baseline, 12 weeks, 24 weeks
Change from baseline in daily physical activity energy expenditure over 24 weeks
Time frame: Baseline, 12 weeks, 24 weeks
15 secondary outcomes
Change from baseline in Progressive Aerobic Cardiovascular Endurance Run score over 24 weeks
Time frame: Baseline, 12 weeks, 24 weeks
Change from baseline in blood pressure over 24 weeks
Time frame: Baseline, 12 weeks, 24 weeks
Change from baseline daily insulin usage over 24 weeks
Time frame: Baseline, 12 weeks, 24 weeks
Change from baseline lipid profile over 12 weeks
Time frame: Baseline, 12 weeks
Change from baseline adipocytokines over 12 weeks
Time frame: Baseline, 12 weeks
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
Change from baseline micro RNA expression over 12 weeks
Time frame: Baseline, 12 weeks
Change from baseline pediatric quality of life questionnaire score over 24 weeks
Time frame: Baseline, 12 weeks, 24 weeks
Change from baseline diabetes self-care inventory score over 24 weeks
Time frame: Baseline, 12 weeks, 24 weeks
Change from baseline hypoglycemia fear survey score over 24 weeks
Time frame: Baseline, 12 weeks, 24 weeks
Change from baseline psychosocial determinants of physical activity behavior questionnaire score over 24 weeks
Time frame: Baseline, 12 weeks, 24 weeks
Change from baseline self-perception profile for adolescents questionnaire social acceptance subscale score over 24 weeks
Time frame: Baseline, 12 weeks, 24 weeks
Change from baseline in handgrip strength over 24 weeks
Time frame: Baseline, 12 weeks, 24 weeks
Change from baseline in sit-and-reach test over 24 weeks
Time frame: Baseline, 12 weeks, 24 weeks
Change from baseline in push-up test over 24 weeks
Time frame: Baseline, 12 weeks, 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Garrett I Ash, PhD, CSCS principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bright 1 Bodies in people with Diabetes Mellitus, Type 1, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline body mass index (BMI) over 24 weeks (time frame: Baseline, 12 weeks, 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2018.