CompletedNot Applicable

Family Focused Community Program to Prevent Type 2 Diabetes in Peripubertal Youth

47 participantsStarted 2015-05

Plain-language 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, acceptance 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, behavioral and physiological outcomes. 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.

Who can participate

Age range

9 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Percentage Overweight

Timeframe: Baseline, Week 12 (post-intervention)

Trial details

NCT IDNCT02421198

SponsorUniversity of Arizona

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-07

Results submitted2017-03-31

View on ClinicalTrials.gov More Pediatric Obesity trials