Impaired Glucose ToleranceNCT01030978
Prevention of Type 2 Diabetes in Children With a Family-based Healthy Lifestyle Program
A study testing Bright Bodies Healthy Lifestyle Program in people with Impaired Glucose Tolerance, run by Yale University at 1 site in United States.
Trial summary
The purpose of this study is to determine if the Bright Bodies (BB) Healthy Lifestyle Program can help reverse early abnormalities in glucose metabolism and prevent the progression to type 2 diabetes (T2DM) in high-risk, obese youth with newly-diagnosed impaired glucose tolerance (IGT). Read more about this study
- Who is it for?
- Ages 11 to 16 years
- Conditions the study is for
- Impaired Glucose Tolerance
- What is being tested?
- Bright Bodies Healthy Lifestyle Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Sep 2011
- 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 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of IGT (glucose 140-199 at 2 hrs during OGTT)
- Age 11 to 16
- An interest in being enrolled in a healthy lifestyle program
- A parent/caregiver willing to participate with child in program
Who cannot join
- Psychiatric disorder or serious medical condition that would preclude participation in program
- Currently taking medication that potentially effects insulin sensitivity (eg Metformin) or causes weight gain (example: Risperidone) or weight loss (eg Xenical)
- Involvement in co-existing weight management/healthy lifestyle program
- Plans of moving out of the Greater New Haven area within six months
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale Center for Clinical Investigation
New Haven, Connecticut, 06520
About this study
The purpose of this study is to determine if the Bright Bodies (BB) Healthy Lifestyle Program can help reverse early abnormalities in glucose metabolism and prevent the progression to type 2 diabetes (T2DM) in high-risk, obese youth with newly-diagnosed impaired glucose tolerance (IGT).
Read the detailed description
Primary Aim: (1) To determine whether youth randomized to the Bright Bodies (BB) Healthy Lifestyle Program have lower 2-hr plasma glucose levels than those randomized to standard lifestyle counseling (control) after 6 months.
Secondary Aims: (2) To determine if greater conversions from IGT to normal glucose tolerance (NGT) and less development of T2DM occurs for those in the BB vs Control Group; (3)To determine if there is improvement in anthropometric/metabolic parameters in BB vs Control Group; and (4) To determine if there is an improvement in psychosocial and family dynamic outcomes of the child in BB vs Control Group.
- Conditions
- Impaired Glucose Tolerance
- Being tested
- Bright Bodies Healthy Lifestyle Program, Control
- Keywords
- Impaired Glucose Tolerance, PreDiabetes, Diabetes Prevention
- Medical subject headings
- Glucose Intolerance, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bright Bodies Healthy Lifestyle ProgramBehavioural
Subjects attend program with a caregiver or parent twice per week for 6 mos. Exercise is 2x/wk, behavior mod/nutrition 1 x/wk, and parent class 1 x/wk. Smart Moves curriculum is utilized for nutrition and behavior mod.
ControlBehavioural
Subjects will be given basic instruction by clinical provider and goals will be followed up every 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Family-based Healthy Lifestyle Program | Experimental | Subjects attend program with a caregiver or parent twice per week for 6 mos. Exercise is 2x/wk, behavior mod/nutrition 1 x/wk, and parent class 1 x/wk. Smart Moves curriculum is utilized for nutrition and behavior mod. Receives: Behavioral: Bright Bodies Healthy Lifestyle Program |
| Standard Diet & Activity Education (Control) | Active comparator | Not described Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-hour plasma glucose, category of glucose tolerance (IGT, NGT, T2DM)
Measured: 6 months
Secondary outcomes (9)
Homeostasis model assessment of insulin resistance (HOMA-IR)
Measured: 6 months
Lipid profile
Measured: 6 months
Alanine aminotransferase (ALT)
Measured: 6 months
Body mass index (BMI)
Measured: 6 months
Body fat mass and %
Measured: 6 months
Blood pressure (BP)
Measured: 6 months
Piers-Harris Self-concept scale score
Measured: 6 months
Child behavior checklist score
Measured: 6 months
Family assessment device (FAD) score
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2009 (estimated)
- Study startSep 2009
- Primary completionAug 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Impaired Glucose ToleranceStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Research Resources (NCRR)
- Responsible party
- Sponsor
- Investigators
- Robert S. Sherwin, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01030978
- Sponsor's protocol ID
- 0908005608
- Other IDs
- 3UL1RR024139-04S2
- Status last verified
- Jun 2014
- First submitted
- 10 Dec 2009
- Last updated
- 17 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Taylor JH, Xu Y, Li F, Shaw M, Dziura J, Caprio S, Tamborlane WV, Nowicka P, Savoye M. Psychosocial predictors and moderators of weight management programme outcomes in ethnically diverse obese youth. Pediatr Obes. 2017 Dec;12(6):453-461. doi: 10.1111/ijpo.12165. Epub 2016 Jul 7.
PubMed 27384496
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Type 2 Diabetes in Children With a Family-based Healthy Lifestyle Program
- ClinicalTrials.gov ID
- NCT01030978
- Acronym / sponsor ID
- 0908005608
- Conditions
- Impaired Glucose Tolerance
- Keywords
- Impaired Glucose Tolerance, PreDiabetes, Diabetes Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Research Resources (NCRR)
- Study start
- Sep 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 14 Dec 2009 (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.
The purpose of this study is to determine if the Bright Bodies (BB) Healthy Lifestyle Program can help reverse early abnormalities in glucose metabolism and prevent the progression to type 2 diabetes (T2DM) in high-risk, obese youth with newly-diagnosed impaired glucose tolerance (IGT).
Detailed description
Primary Aim: (1) To determine whether youth randomized to the Bright Bodies (BB) Healthy Lifestyle Program have lower 2-hr plasma glucose levels than those randomized to standard lifestyle counseling (control) after 6 months.
Secondary Aims: (2) To determine if greater conversions from IGT to normal glucose tolerance (NGT) and less development of T2DM occurs for those in the BB vs Control Group; (3)To determine if there is improvement in anthropometric/metabolic parameters in BB vs Control Group; and (4) To determine if there is an improvement in psychosocial and family dynamic outcomes of the child in BB vs Control Group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family-based Healthy Lifestyle Program | Experimental | Behavioral: Bright Bodies Healthy Lifestyle ProgramSubjects attend program with a caregiver or parent twice per week for 6 mos. Exercise is 2x/wk, behavior mod/nutrition 1 x/wk, and parent class 1 x/wk. Smart Moves curriculum is utilized for nutrition and behavior mod. |
| Standard Diet & Activity Education (Control) | Active comparator | Behavioral: Control |
Who may qualify
- Ages
- 11 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Diagnosis of IGT (glucose 140-199 at 2 hrs during OGTT)
- Age 11 to 16
- An interest in being enrolled in a healthy lifestyle program
- A parent/caregiver willing to participate with child in program
Key exclusion criteria (4 listed)
- Psychiatric disorder or serious medical condition that would preclude participation in program
- Currently taking medication that potentially effects insulin sensitivity (eg Metformin) or causes weight gain (example: Risperidone) or weight loss (eg Xenical)
- Involvement in co-existing weight management/healthy lifestyle program
- Plans of moving out of the Greater New Haven area within six months
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 Bodies Healthy Lifestyle ProgramSubjects attend program with a caregiver or parent twice per week for 6 mos. Exercise is 2x/wk, behavior mod/nutrition 1 x/wk, and parent class 1 x/wk. Smart Moves curriculum is utilized for nutrition and behavior mod. | Behavioural | Family-based Healthy Lifestyle Program |
| ControlSubjects will be given basic instruction by clinical provider and goals will be followed up every 3 months. | Behavioural | Standard Diet & Activity Education (Control) |
Primary outcome
2-hour plasma glucose, category of glucose tolerance (IGT, NGT, T2DM)
Time frame: 6 months
9 secondary outcomes
Homeostasis model assessment of insulin resistance (HOMA-IR)
Time frame: 6 months
Lipid profile
Time frame: 6 months
Alanine aminotransferase (ALT)
Time frame: 6 months
Body mass index (BMI)
Time frame: 6 months
Body fat mass and %
Time frame: 6 months
Blood pressure (BP)
Time frame: 6 months
Piers-Harris Self-concept scale score
Time frame: 6 months
Child behavior checklist score
Time frame: 6 months
Family assessment device (FAD) score
Time frame: 6 months
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 17 Jun 2014.
- Derived from this study: PubMed 27384496Taylor JH, Xu Y, Li F, Shaw M, Dziura J, Caprio S, Tamborlane WV, Nowicka P, Savoye M. Psychosocial predictors and moderators of weight management programme outcomes in ethnically diverse obese youth. Pediatr Obes. 2017 Dec;12(6):453-461. doi: 10.1111/ijpo.12165. Epub 2016 Jul 7.
Related trials for Impaired Glucose Tolerance
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Recruiting
CGM-Enhanced DPP to Prevent Type 2 Diabetes in Adults With Prediabetes
PreDiabetes
Active, not recruitingPhase 2
Extension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome
Cushing Syndrome
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.
Robert S. Sherwin, MD 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 Bodies Healthy Lifestyle Program in people with Impaired Glucose Tolerance, 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 4 inclusion and 4 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 17 Jun 2014. 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?
2-hour plasma glucose, category of glucose tolerance (IGT, NGT, T2DM) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01030978, which also lists 1 linked publication.
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 17 Jun 2014.