Pediatric ObesityNCT02421198
Family Focused Community Program to Prevent Type 2 Diabetes in Peripubertal Youth
A study testing YMCA Family Diabetes Prevention Program (YFDPP) in people with Pediatric Obesity, run by University of Arizona.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obesity
- What is being tested?
- YMCA Family Diabetes Prevention Program (YFDPP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Jul 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 9 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
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- 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
Who cannot join
- 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.
About this study
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.
Read the 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.
- Conditions
- Pediatric Obesity
- Being tested
- YMCA Family Diabetes Prevention Program (YFDPP)
- Keywords
- Intervention Studies
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YMCA Family Diabetes Prevention Program (YFDPP)Behavioural
12 week, group education to promote behavioral change delivered either face-to-face or via a combination of face-to-face and mobile technologies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: YMCA Family Diabetes Prevention Program (YFDPP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, Week 12 (post-intervention)
Secondary outcomes (3)
Dietary Intake
Diet quality was assessed using the Healthy Eating Index-2010 (HEI-2010), which measures adherence to the 2010 Dietary Guidelines for Americans. Scores range from 0 to 100, with higher scores indicating greater adherence and better diet quality.
HEI-2010 scores were computed from 24-hour recall data collected at baseline and Week 12 (post-intervention).
Measured: Baseline, Week 12 (post-intervention)
Physical Activity
Physical activity was objectively measured using GT3X accelerometers worn on the hip for 7 consecutive days at baseline and again at Week 12 (post-intervention). Data were processed using ActiLife software with standard youth cut points to classify activity intensity levels.
Measured: Baseline, Week 12 (post-intervention)
Change in Waist Circumference
Waist circumference (cm) was measured at the level of the umbilicus using a non-stretchable measuring tape, following standard anthropometric procedures. Measurements were taken at baseline and at Week 12 (post-intervention) with participants standing and breathing normally.
The reported value represents the mean change in waist circumference from baseline to Week 12 across all participants. The change score was calculated as the Week 12 measurement minus the baseline measurement; positive values indicate an increase and negative values indicate a decrease in waist circumference over the 12-week intervention period.
Measured: Baseline, Week 12 (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2015 (estimated)
- Study startMay 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe 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
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melanie Hingle, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02421198
- Sponsor's protocol ID
- 1R21DK100805-01
- Status last verified
- Dec 2025
- First submitted
- 15 Apr 2015
- Last updated
- 26 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 26679186
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Focused Community Program to Prevent Type 2 Diabetes in Peripubertal Youth
- ClinicalTrials.gov ID
- NCT02421198
- Acronym / sponsor ID
- 1R21DK100805-01
- Conditions
- Pediatric Obesity
- Keywords
- Intervention Studies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 20 Apr 2015 (estimated)
- Results
- Posted 26 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| face-to-face | Experimental | Behavioral: YMCA Family Diabetes Prevention Program (YFDPP)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. |
| face-to-face + mobile hybrid | Experimental | Behavioral: YMCA Family Diabetes Prevention Program (YFDPP)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. |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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:
- 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)
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| YMCA Family Diabetes Prevention Program (YFDPP)12 week, group education to promote behavioral change delivered either face-to-face or via a combination of face-to-face and mobile technologies | Behavioural | face-to-face, face-to-face + mobile hybrid |
Primary outcome
Change in Percentage Overweight
Time frame: Baseline, Week 12 (post-intervention)
Percentage overweight will be calculated as percentage over the median body mass index (BMI) for age and gender and change in BMI zscore
3 secondary outcomes
Dietary Intake
Time frame: Baseline, Week 12 (post-intervention)
Physical Activity
Time frame: Baseline, Week 12 (post-intervention)
Change in Waist Circumference
Time frame: Baseline, Week 12 (post-intervention)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26679186Hingle 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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing YMCA Family Diabetes Prevention Program (YFDPP) in people with Pediatric Obesity, run by University of Arizona.
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 9 inclusion and 7 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 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 26 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Percentage Overweight (time frame: Baseline, Week 12 (post-intervention)). 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 NCT02421198, 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 26 Dec 2025.