Clinical trial NCT02421198: Family Focused Community Program to Prevent Type 2 Diabetes in Peripubertal Youth
Official title: Family Focused Community Program to Prevent Type 2 Diabetes in Peripubertal Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Obesity
Keywords: Intervention Studies
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2015-04-20
Enrollment: 47
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Over one-third of children and adolescents are overweight and nearly 1 in 5 of them are obese. Metabolic syndrome, a strong predictor of Type 2 diabetes (T2D) and cardiovascular disease (CVD), occurs in up to 44% of obese youth, foreshadowing greater prevalence and earlier onset of T2D. Without effective interventions, "diabesity" will worsen, T2D prevalence will increase, and adults will face its consequences at younger ages. Given the strong association between obesity and chronic disease risk factors in youth, the investigators contend T2D prevention (and CVD prevention) is akin to weight control and obesity prevention. The objective of the proposed project is to develop a family-centered, community-based program for T2D prevention in peripubertal (9- to 12-year-old) youth. Using participatory methods, the investigators intend to adapt the successful adult-focused YMCA Diabetes Prevention Program (YDPP) for youth and families and assess the feasibility, participant acceptance of and adherence to the YFDPP using two delivery formats: a 12-week YMCA-based face-to-face program and a 12-week combined face-to-face plus mobile device-based program. The proposed study will test the investigators premise that delivery with technology can reduce participant perceived burden, improve adherence, and lead to improved anthropometric (height, weight and BMI and waist circumference), behavioral (diet and physical activity) and physiological outcomes (fasting insulin, glucose, lipid, blood pressure). The investigators will use the resulting data to design an appropriately powered full-scale trial. The importance of the proposed study is underscored both by the statistics cited above and the recent call for proposals to translate efficacious clinical interventions into effective community programs for youth. The potential impact of the proposed intervention is great in that the program will be delivered by paraprofessionals from the community without university researchers; significant in that it targets a major public health challenge in children and includes assessment of objective behavioral and clinical data; and innovative in that it focuses on an at-risk population, takes place at a popular, accessible community venue, and uses mobile technologies to extend reach and increase engagement of youth and families with intervention content. The long-term goal is to create a scalable, replicable, and sustainable program that overcomes existing barriers to implementation and dissemination of evidence-based, research-proven diabetes prevention programs to youth and families, thereby improving population health.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in percentage overweight
timeFrame: Baseline, Week 12 (post-intervention), Week 24
Secondary outcomes:
measure: Blood pressure
timeFrame: Baseline, Week 12 (post-intervention), Week 24
measure: Fasting insulin
timeFrame: Baseline, Week 12 (post-intervention), Week 24
measure: Fasting glucose
timeFrame: Baseline, Week 12 (post-intervention), Week 24
measure: Fasting lipids
timeFrame: Baseline, Week 12 (post-intervention), Week 24
measure: Dietary intake
timeFrame: Baseline, Week 12 (post-intervention), Week 24
measure: Physical activity
timeFrame: Baseline, Week 12 (post-intervention), Week 24
measure: Waist circumference
timeFrame: Baseline, Week 12 (post-intervention), Week 24
Other outcomes:
Locations:
Study officials:
References:
citation: Hingle MD, Turner T, Kutob R, Merchant N, Roe DJ, Stump C, Going SB. The EPIC Kids Study: a randomized family-focused YMCA-based intervention to prevent type 2 diabetes in at-risk youth. BMC Public Health. 2015 Dec 18;15:1253. doi: 10.1186/s12889-015-2595-3.