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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline, Week 12 (post-intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting Lipids | Total cholesterol (mg/dL) was measured from fasting venous blood samples collected at baseline and Week 12 (post-intervention). The reported value represents the mean change in fasting total cholesterol from baseline to Week 12 across all participants. The change score was calculated as the Week 12 value minus the baseline value for each participant; positive values indicate an increase and negative values indicate a decrease in total cholesterol during the 12-week intervention period. Because this was a feasibility study not powered to detect between-group differences, results for both delivery formats (face-to-face and hybrid) were analyzed in aggregate. Arm-level estimates were not calculated or retained, as separate estimates were not meaningful for this exploratory outcome. |
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:
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
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26679186 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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 |
| FG001 | 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. 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Pre- and post-intervention measurements for each of the 36 participating youth were used to calculate difference in chance in % overweight between those two study time points by intervention arm (n=18 in each arm). | Posted | Mean | Standard Deviation | change in percent overweight | Baseline, Week 12 (post-intervention) |
|
Participants were monitoring during the time they participated in the study: 6 months (12 week intervention + 14-week follow-up)
The definition of adverse and/or serious adverse event does not differ than the clinicaltrials.gov definition.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Melanie D Hingle | University of Arizona | 520-621-3087 | hinglem@email.arizona.edu |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| 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. | 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. | Baseline, Week 12 (post-intervention) |
| Baseline, Week 12 (post-intervention) |
| Fasting Glucose | Fasting plasma glucose (mg/dL) was measured from venous blood samples collected after an overnight fast at baseline and at Week 12 (post-intervention). The reported value represents the mean change in fasting glucose from baseline to Week 12 for all participants combined. The change score was calculated as the Week 12 value minus the baseline value for each participant; positive values indicate an increase and negative values indicate a decrease in fasting glucose during the 12-week intervention period. Because this was a feasibility study not powered for between-group comparisons, data from both intervention formats (face-to-face and hybrid) were analyzed in aggregate. Arm-level results were not calculated or retained, as separate estimates were not meaningful for this exploratory outcome. | Baseline and 12 week (post-intervention) |
| Fasting Insulin | Fasting insulin (µU/mL) was measured from venous blood samples collected after an overnight fast at baseline and at Week 12 (post-intervention). The reported value represents the mean change in fasting insulin from baseline to Week 12 for all participants combined. The change score was calculated as the Week 12 value minus the baseline value for each participant; positive values indicate an increase in fasting insulin over the 12-week intervention period, and negative values indicate a decrease. Because this was a feasibility study not powered for between-group comparisons, results were analyzed in aggregate across both intervention arms. | Baseline, Week 12 (post-intervention) |
| Blood Pressure | Blood pressure was measured in duplicate after 5 minutes of seated rest using an automated oscillometric device. The mean of the two readings was used. Because the study was designed to assess feasibility and not efficacy, blood pressure change was analyzed descriptively across the combined cohort. | Baseline, Week 12 (post-intervention) |
| BG001 | 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. 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| BMI z score | Scores of 0 correspond to the average BMI for age and sex. Positive z-scores indicate a BMI above the population average (higher relative weight for height), and negative z-scores indicate a BMI below the population average (lower relative weight for height). For example, a BMI z-score of +1.96 corresponds approximately to the 97.5th percentile for BMI, indicating that an individual's BMI is higher than 97.5% of age- and sex-matched peers in the reference population. | Mean | Standard Deviation | z-score |
|
| OG001 | 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. 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 |
|
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| Secondary | 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). | Thirty-seven participants who completed both baseline and Week 12 dietary recalls were included in this analysis. | Posted | Mean | Standard Deviation | score (1-100) | Baseline, Week 12 (post-intervention) |
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| Secondary | 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. | Thirty-three participants who provided valid accelerometer data (≥4 days of wear time, ≥10 hours per day) at both baseline and Week 12 were included in this analysis. | Posted | Mean | Standard Deviation | minutes | Baseline, Week 12 (post-intervention) |
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| Secondary | 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. | Posted | Mean | 95% Confidence Interval | cm | Baseline, Week 12 (post-intervention) |
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| Other Pre-specified | Fasting Lipids | Total cholesterol (mg/dL) was measured from fasting venous blood samples collected at baseline and Week 12 (post-intervention). The reported value represents the mean change in fasting total cholesterol from baseline to Week 12 across all participants. The change score was calculated as the Week 12 value minus the baseline value for each participant; positive values indicate an increase and negative values indicate a decrease in total cholesterol during the 12-week intervention period. Because this was a feasibility study not powered to detect between-group differences, results for both delivery formats (face-to-face and hybrid) were analyzed in aggregate. Arm-level estimates were not calculated or retained, as separate estimates were not meaningful for this exploratory outcome. | Not Posted | Baseline, Week 12 (post-intervention) | Participants |
| Other Pre-specified | Fasting Glucose | Fasting plasma glucose (mg/dL) was measured from venous blood samples collected after an overnight fast at baseline and at Week 12 (post-intervention). The reported value represents the mean change in fasting glucose from baseline to Week 12 for all participants combined. The change score was calculated as the Week 12 value minus the baseline value for each participant; positive values indicate an increase and negative values indicate a decrease in fasting glucose during the 12-week intervention period. Because this was a feasibility study not powered for between-group comparisons, data from both intervention formats (face-to-face and hybrid) were analyzed in aggregate. Arm-level results were not calculated or retained, as separate estimates were not meaningful for this exploratory outcome. | Not Posted | Baseline and 12 week (post-intervention) | Participants |
| Other Pre-specified | Fasting Insulin | Fasting insulin (µU/mL) was measured from venous blood samples collected after an overnight fast at baseline and at Week 12 (post-intervention). The reported value represents the mean change in fasting insulin from baseline to Week 12 for all participants combined. The change score was calculated as the Week 12 value minus the baseline value for each participant; positive values indicate an increase in fasting insulin over the 12-week intervention period, and negative values indicate a decrease. Because this was a feasibility study not powered for between-group comparisons, results were analyzed in aggregate across both intervention arms. | Not Posted | Baseline, Week 12 (post-intervention) | Participants |
| Other Pre-specified | Blood Pressure | Blood pressure was measured in duplicate after 5 minutes of seated rest using an automated oscillometric device. The mean of the two readings was used. Because the study was designed to assess feasibility and not efficacy, blood pressure change was analyzed descriptively across the combined cohort. | Not Posted | Baseline, Week 12 (post-intervention) | Participants |
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| 25 |
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| 25 |
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| 25 |
| EG001 | 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. 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 | 0 | 22 | 0 | 22 | 0 | 22 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |