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

NCT02421198 | Completed Results

• 1 other identifier: 1R21DK100805-01
• Study Type: interventional
• Target: 47
• Locations: 0 countries
• Sites: N/A

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, 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.

Conditions

Pediatric Obesity

Keywords

Intervention Studies

Outcome Measures

Primary Outcomes (1)

• Change in Percentage Overweight

  Percentage overweight will be calculated as percentage over the median body mass index (BMI) for age and gender and change in BMI zscore

  Baseline, Week 12 (post-intervention)

Secondary Outcomes (3)

• Dietary Intake

  Baseline, Week 12 (post-intervention)

• Physical Activity

  Baseline, Week 12 (post-intervention)

• Change in Waist Circumference

  Baseline, Week 12 (post-intervention)

Other Outcomes (4)

• Fasting Lipids

  Baseline, Week 12 (post-intervention)

• Fasting Glucose

  Baseline and 12 week (post-intervention)

• Fasting Insulin

  Baseline, Week 12 (post-intervention)

Study Arms (2)

face-to-face

EXPERIMENTAL

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.

Behavioral: YMCA Family Diabetes Prevention Program (YFDPP)

face-to-face + mobile hybrid

EXPERIMENTAL

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.

Behavioral: YMCA Family Diabetes Prevention Program (YFDPP)

Interventions

YMCA Family Diabetes Prevention Program (YFDPP) BEHAVIORAL

12 week, group education to promote behavioral change delivered either face-to-face or via a combination of face-to-face and mobile technologies

face-to-face; face-to-face + mobile hybrid

Eligibility Criteria

• Age: 9 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• child's age between 9 to 12 years
• child body mass index (BMI) 85th percentile for age and sex
• child has T2D risk factors:
• st 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Arizona: lead

Related Publications (1)

• 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.

  PMID: 26679186 DERIVED

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Melanie D Hingle
• Organization: University of Arizona

hinglem@email.arizona.edu

520-621-3087

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 15, 2015
• First Posted: April 20, 2015
• Study Start: May 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: December 26, 2025
• Results First Posted: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share