- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02421198
Family Focused Community Program to Prevent Type 2 Diabetes in Peripubertal Youth (EPIC Kids)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The investigators objective is to develop a family-centered, community-based program for T2D prevention in peripubertal (9-12-year-old) youth. Efficacious community programs for youth are not available (although promising components exist), and thus the investigators propose to adapt the successful adult-focused YMCA Diabetes Prevention Program (YDPP) for youth and families, and assess its impact on anthropometric, behavioral and physiological outcomes in support of the design (power calculation) of a full-scale trial. The proposed study will evaluate the adapted program using two formats (with and without mobile technologies). Secondary endpoints will include participant perceived burden, adherence, and program costs.
Aim 1: Adapt an efficacious diabetes prevention program in adults (the YMCA Diabetes Prevention Program, or YDPP) for delivery to overweight peripubertal youth and their families, thereby establishing a YMCA Family Diabetes Prevention Program (YFDPP).
Aim 2: Test the feasibility, participant acceptance (child and parent) and retention rates of the YFDPP using two formats, a 12-week YMCA-based face-to-face program and a 12-week program with content delivered through a combination of face-to-face and mobile devices.
Aim 3: Test the impact of the new YFDPP using two formats on anthropometric (height, weight, BMI and waist circumference), behavioral (diet and physical activity), and physiological (fasting insulin, glucose, lipid) outcomes, using the resulting data to design an appropriately powered full-scale trial.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Inclusion Criteria for Children and Parents/Primary Caregivers
- child's age between 9 to 12 years
- child body mass index (BMI) 85th percentile for age and sex
child has T2D risk factors:
- 1st or 2nd degree relative with T2D
- conditions associated with insulin resistance/metabolic syndrome (e,g, acanthosis nigricans, hypertension, dyslipidemia, PCOS, or small for gestational age birth weight, maternal history of T2D or gestational diabetes)
- parent/primary caregiver must be willing to participate in intervention sessions and activities (note: primary caregiver is the adult guardian who most frequently prepares/obtains food, regulates media use, and provides physical activity opportunities for the child)
- parent/child willing to use a study-provided mobile device during intervention
- parent and child speak and read English
Exclusion Criteria:
Exclusion Criteria for Children (Index Participants) and Parents/Primary Caregivers
- child/parent unwillingness to participate in group activities or to use study-provided mobile device
- child previously diagnosed T1 or T2D
- child with psychiatric disturbances or mental illness
- child with inability to be physically active
- child/parent inability to speak and read English
- child takes weight loss medications or medications known to cause weight gain or affect appetite.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: face-to-face
Delivery and testing of YMCA Family Diabetes Prevention Program (YFDPP) delivered face-to-face by YMCAs over 12 weeks to children age 9-12 and one parent/guardian.
|
12 week, group education to promote behavioral change delivered either face-to-face or via a combination of face-to-face and mobile technologies
|
Experimental: face-to-face + mobile hybrid
Delivery and testing of YMCA Family Diabetes Prevention Program (YFDPP) delivered face-to-face and via a mobile platform by YMCAs over 12 weeks to children age 9-12 and one parent/guardian.
|
12 week, group education to promote behavioral change delivered either face-to-face or via a combination of face-to-face and mobile technologies
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in percentage overweight
Time Frame: Baseline, Week 12 (post-intervention), Week 24
|
Percentage overweight will be calculated as percentage over the median body mass index (BMI) for age and gender
|
Baseline, Week 12 (post-intervention), Week 24
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood pressure
Time Frame: Baseline, Week 12 (post-intervention), Week 24
|
Systolic and diastolic blood pressure
|
Baseline, Week 12 (post-intervention), Week 24
|
Fasting insulin
Time Frame: Baseline, Week 12 (post-intervention), Week 24
|
Baseline, Week 12 (post-intervention), Week 24
|
|
Fasting glucose
Time Frame: Baseline, Week 12 (post-intervention), Week 24
|
Baseline, Week 12 (post-intervention), Week 24
|
|
Fasting lipids
Time Frame: Baseline, Week 12 (post-intervention), Week 24
|
Total cholesterol, Triglycerides, HDL, and LDL
|
Baseline, Week 12 (post-intervention), Week 24
|
Dietary intake
Time Frame: Baseline, Week 12 (post-intervention), Week 24
|
2, 24-hour dietary recalls
|
Baseline, Week 12 (post-intervention), Week 24
|
Physical activity
Time Frame: Baseline, Week 12 (post-intervention), Week 24
|
accelerometry
|
Baseline, Week 12 (post-intervention), Week 24
|
Waist circumference
Time Frame: Baseline, Week 12 (post-intervention), Week 24
|
Waist circumference at umbilicus
|
Baseline, Week 12 (post-intervention), Week 24
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R21DK100805-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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