Trial Outcomes & Findings for Family Focused Community Program to Prevent Type 2 Diabetes in Peripubertal Youth (NCT NCT02421198)
NCT ID: NCT02421198
Last Updated: 2025-12-26
Results Overview
Percentage overweight will be calculated as percentage over the median body mass index (BMI) for age and gender and change in BMI zscore
COMPLETED
NA
47 participants
Baseline, Week 12 (post-intervention)
2025-12-26
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
22
|
|
Overall Study
COMPLETED
|
18
|
18
|
|
Overall Study
NOT COMPLETED
|
7
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Family Focused Community Program to Prevent Type 2 Diabetes in Peripubertal Youth
Baseline characteristics by cohort
| Measure |
Face-to-face
n=25 Participants
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
|
Face-to-face + Mobile Hybrid
n=22 Participants
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
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
2 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=30 Participants
|
5 Participants
n=30 Participants
|
10 Participants
n=60 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=30 Participants
|
9 Participants
n=30 Participants
|
20 Participants
n=60 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=30 Participants
|
7 Participants
n=30 Participants
|
15 Participants
n=60 Participants
|
|
BMI z score
|
1.97 z-score
STANDARD_DEVIATION 0.08 • n=30 Participants
|
1.96 z-score
STANDARD_DEVIATION 0.09 • n=30 Participants
|
1.97 z-score
STANDARD_DEVIATION 0.37 • n=60 Participants
|
|
Age, Categorical
<=18 years
|
25 Participants
n=30 Participants
|
22 Participants
n=30 Participants
|
47 Participants
n=60 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Age, Continuous
|
10.8 years
STANDARD_DEVIATION 1.17 • n=30 Participants
|
11 years
STANDARD_DEVIATION 1.3 • n=30 Participants
|
10.9 years
STANDARD_DEVIATION 1.21 • n=60 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=30 Participants
|
10 Participants
n=30 Participants
|
21 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=30 Participants
|
12 Participants
n=30 Participants
|
26 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=30 Participants
|
8 Participants
n=30 Participants
|
19 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=30 Participants
|
8 Participants
n=30 Participants
|
15 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=30 Participants
|
6 Participants
n=30 Participants
|
13 Participants
n=60 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12 (post-intervention)Population: 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).
Percentage overweight will be calculated as percentage over the median body mass index (BMI) for age and gender and change in BMI zscore
Outcome measures
| Measure |
Face-to-face
n=18 Participants
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
|
Face-to-face + Mobile Hybrid
n=18 Participants
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
|
|---|---|---|
|
Change in Percentage Overweight
|
1.92 change in percent overweight
Standard Deviation 0.10
|
1.91 change in percent overweight
Standard Deviation 0.09
|
SECONDARY outcome
Timeframe: Baseline, Week 12 (post-intervention)Population: Thirty-seven participants who completed both baseline and Week 12 dietary recalls were included in this analysis.
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).
Outcome measures
| Measure |
Face-to-face
n=24 Participants
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
|
Face-to-face + Mobile Hybrid
n=13 Participants
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
|
|---|---|---|
|
Dietary Intake
Baseline
|
48.6 score (1-100)
Standard Deviation 9
|
47.7 score (1-100)
Standard Deviation 9.5
|
|
Dietary Intake
Week 12
|
47.8 score (1-100)
Standard Deviation 9.4
|
51.4 score (1-100)
Standard Deviation 10.2
|
SECONDARY outcome
Timeframe: Baseline, Week 12 (post-intervention)Population: 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.
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.
Outcome measures
| Measure |
Face-to-face
n=20 Participants
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
|
Face-to-face + Mobile Hybrid
n=13 Participants
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
|
|---|---|---|
|
Physical Activity
Baseline
|
22.6 minutes
Standard Deviation 11.1
|
35.8 minutes
Standard Deviation 16.6
|
|
Physical Activity
Week 12
|
27.8 minutes
Standard Deviation 20
|
33.5 minutes
Standard Deviation 17.4
|
SECONDARY outcome
Timeframe: Baseline, Week 12 (post-intervention)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.
Outcome measures
| Measure |
Face-to-face
n=18 Participants
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
|
Face-to-face + Mobile Hybrid
n=18 Participants
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
|
|---|---|---|
|
Change in Waist Circumference
|
0.25 cm
Interval -8.61 to 9.11
|
-1.15 cm
Interval -15.68 to 13.37
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 12 (post-intervention)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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 12 week (post-intervention)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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 12 (post-intervention)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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 12 (post-intervention)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.
Outcome measures
Outcome data not reported
Adverse Events
Face-to-face
Face-to-face + Mobile Hybrid
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place