Pediatric Obesity
Conditions
Keywords
Intervention Studies
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.
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.
Interventions
BEHAVIORALYMCA 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
Sponsors
University of Arizona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
9 Years to 12 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Percentage Overweight | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dietary Intake | Baseline, Week 12 (post-intervention) | 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). |
| Physical Activity | Baseline, Week 12 (post-intervention) | 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. |
| Change in Waist Circumference | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Fasting Lipids | 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. |
| Fasting Glucose | 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. |
| Fasting Insulin | 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. |
| Blood Pressure | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 25 |
| 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 | 22 |
| Total | 47 |
Baseline characteristics
| Characteristic | Face-to-face | Face-to-face + Mobile Hybrid | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 25 Participants | 22 Participants | 47 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 10.8 years STANDARD_DEVIATION 1.17 | 11 years STANDARD_DEVIATION 1.3 | 10.9 years STANDARD_DEVIATION 1.21 |
| BMI z score | 1.97 z-score STANDARD_DEVIATION 0.08 | 1.96 z-score STANDARD_DEVIATION 0.09 | 1.97 z-score STANDARD_DEVIATION 0.37 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants | 8 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 8 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 7 Participants | 6 Participants | 13 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 5 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants | 7 Participants | 15 Participants |
| Race (NIH/OMB) White | 11 Participants | 9 Participants | 20 Participants |
| Sex: Female, Male Female | 11 Participants | 10 Participants | 21 Participants |
| Sex: Female, Male Male | 14 Participants | 12 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 22 |
| other Total, other adverse events | 0 / 25 | 0 / 22 |
| serious Total, serious adverse events | 0 / 25 | 0 / 22 |
Outcome results
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
Time frame: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Face-to-face | Change in Percentage Overweight | 1.92 change in percent overweight | Standard Deviation 0.1 |
| Face-to-face + Mobile Hybrid | Change in Percentage Overweight | 1.91 change in percent overweight | Standard Deviation 0.09 |
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.
Time frame: Baseline, Week 12 (post-intervention)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Face-to-face | Change in Waist Circumference | 0.25 cm |
| Face-to-face + Mobile Hybrid | Change in Waist Circumference | -1.15 cm |
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).
Time frame: Baseline, Week 12 (post-intervention)
Population: Thirty-seven participants who completed both baseline and Week 12 dietary recalls were included in this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Face-to-face | Dietary Intake | Baseline | 48.6 score (1-100) | Standard Deviation 9 |
| Face-to-face | Dietary Intake | Week 12 | 47.8 score (1-100) | Standard Deviation 9.4 |
| Face-to-face + Mobile Hybrid | Dietary Intake | Baseline | 47.7 score (1-100) | Standard Deviation 9.5 |
| Face-to-face + Mobile Hybrid | Dietary Intake | Week 12 | 51.4 score (1-100) | Standard Deviation 10.2 |
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Face-to-face | Physical Activity | Baseline | 22.6 minutes | Standard Deviation 11.1 |
| Face-to-face | Physical Activity | Week 12 | 27.8 minutes | Standard Deviation 20 |
| Face-to-face + Mobile Hybrid | Physical Activity | Baseline | 35.8 minutes | Standard Deviation 16.6 |
| Face-to-face + Mobile Hybrid | Physical Activity | Week 12 | 33.5 minutes | Standard Deviation 17.4 |
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.
Time frame: Baseline, Week 12 (post-intervention)
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.
Time frame: Baseline and 12 week (post-intervention)
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.
Time frame: Baseline, Week 12 (post-intervention)
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.
Time frame: Baseline, Week 12 (post-intervention)