An interventional study of Bennett Kids PowerUP Project in Obesity, Childhood and Type2diabetes, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 7 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-06.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Prevention
The study proposes a randomized pilot and feasibility study of a lifestyle modification program to promote healthy diet and activity in rural-dwelling children to reduce Type 2 Diabetes risks.
Intervention participants will receive 6 months of programming to include:
Control participants will receive 6 activity packs promoting science, technology, engineering, and math (STEM) learning and 6 check-in calls to support retention.
The rising prevalence of obesity and type 2 diabetes (T2D) at increasingly younger ages compels development of new strategies to combat these preventable conditions. Healthy diet and activity are critical to reducing risk, yet these behaviors decline starting in childhood. These trends are most troubling in rural areas, where youth consume more calories and sugar-sweetened beverages but less fruit and whole grains; engage in less physical activity; and are more likely to have overweight or obesity than urban peers. Given unhealthy behaviors are set by adolescence, promoting healthy diet and activity in rural children is crucial to reducing rural-urban disparities in obesity and T2D across the lifecourse.
The investigators have developed a multi-component, family-based intervention to improve diet and activity in children at risk of youth-onset obesity and T2D. The pilot study will gather necessary and sufficient data on feasibility, acceptability, and effect size to finalize the design of a clinical trial.
The investigators will recruit 60 English- or Spanish-speaking children in 2nd to 5th grades from rural communities in Colorado or North Carolina. Participants will be randomized to 6 months of intervention or control programming. Intervention participants will receive approximately 25 hours of programming over 6 months through a) 16 self-contained, parent-guided activity kits, b) 9 one-on-one health coach/support sessions in-person or virtual by a trained health coach, and c) unlimited access to a resource toolbox. Control participants will receive 6 activity kits promoting science, technology, engineering, and math (STEM) learning and will receive 6 check-in calls to support retention.
Standardized measures will be collected at 0 and 7 months. Qualitative interviews will also be conducted at 7 months. Process measures will be tracked by staff throughout the study. With positive results, this innovative pilot study will form the foundation of a clinical trial to evaluate the sustained impact of an at-home, family-based intervention to promote diet and activity in rural children, which can subsequently be disseminated and implemented among the 13 million children living in rural US settings and reduce T2D risks.
1,117 studies on the registry are indexed under Pediatric Obesity; 189 are open to participants now.
This study's enrollment of 72 is below the median of 103 across 862 interventional studies indexed under Pediatric Obesity.
Browse Pediatric Obesity studies →Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Intervention participants will receive approximately 25 hours of programming (over a 6-month period) related to the promotion of physical activity and healthy diet through: 1. 16 self-contained, parent-guided activity kits, 2. 9 one-on-one health coach/support sessions in-person or virtual by a trained health coach, 3. unlimited access to a resource toolbox.
Behavioral: Bennett Kids PowerUP Project
Control group programming consists of: 1. 6 parent-guided activity kits focused on STEM activities, 2. 6 monthly check-in calls to support retention. The investigators will use Home Science Lab STEM kits designed for English- and Spanish-speaking children aged 6-11 years. The STEM kits do not include any physical health content. Kits will be mailed monthly to the participants' home. To maximize retention in the control group, staff will contact participants each month to confirm the kit was received, encourage completion of the kits, ask about their experience, and answer questions.
Information targeting dietary and activity behaviors while also identifying and addressing barriers to permanent lifestyle change. The foundation of the curriculum is the Diabetes Prevention Program Lifestyle Balance and its subsequent adaptations for non-Native adult, Native adult, and Native child populations.
Change in Dietary Intake (MyPyramid Equivalents) at 7 months
Diet will be assessed with 24-hour dietary recalls using the Automated Self Administered system (ASA24). This system uses the USDA multiple-pass method to query all foods and supplements consumed in the prior 24 hours and produces daily and individual food estimates for macronutrients, micronutrients, and MyPyramid Equivalents (such as servings of vegetables, fruits, whole grains, solid fats, and added sugars).
Time frame: Month 7
Change in Fruit and Vegetable Intake (carotenoid concentration) at 7 months
Use the Veggie Meter (Longevity Link, Salt Lake City, UT) to assess carotenoids, a biomarker of fruit and vegetable intake. The device estimates total dermal carotenoid concentration by illuminating the fingertip with a blue wavelength laser light and detecting vibrational/rotational energy levels of molecules, correcting for hemoglobin and melanin levels.
Time frame: Month 7
Change in Sugar-Sweetened Beverage Intake (carbon isotope ratio) at 7 months
Collect red blood cells to measure the carbon isotope ratio, a biomarker of sugar-sweetened beverage intake. Samples will be analyzed via continuous-flow isotope ratio mass spectrometry at the University of Alaska Stable Isotope Facility.
Time frame: Month 7
Change in Physical Activity at 7 months
7-day accelerometry using the wGT3X-BT water resistant tri-axial accelerometer (Actigraph LLC, Pensacola, FL). Monitors are worn on an elastic band on the waist for 7 days. Recordings with greater than or equal to 10 hours of data on 4 or more days will be coded using established youth cut-points to determine the daily minutes of moderate-vigorous activity and sedentary time.
Time frame: Month 7
Change in Screen Time at 7 months
CommonSense Media Use Survey to estimate minutes/day across relevant categories (e.g. recreational use vs communication vs educational). Our screen time analyses will focus on recreational screen time but also report on the other types.
Time frame: Month 7
Change in Glucose levels at 7 months
Fasting serum samples analysis (Hexokinase, UV)
Time frame: Month 7
Change in Insulin values at 7 months
Fasting serum samples analysis (chemiluminescence immunoassay)
Time frame: Month 7
Change in Body Mass Index (BMI) values at 7 months
Measured height, weight - Under 18.5 - you are very underweight and possibly malnourished. 18.5 to 24.9 - you have a healthy weight range for young and middle-aged adults. 25.0 to 29.9 - you are overweight. Over 30 - you are obese.
Time frame: Month 7
Program Engagement
Number of activity kits completed
Time frame: Month 7
Completion of coaching sessions
Number of health coach sessions completed
Time frame: Month 7
Use of toolbox number
Report on frequency of use of the resource toolbox
Time frame: Month 7
Process Measures
Staff records of the actual schedule (order and timing) of mailed activity kits and health coach sessions
Time frame: Month 7
Acceptability and Engagement Barriers
Semi-structured interviews
Time frame: Month 7
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
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Wake Forest University Health Sciences