The Bennett Kids PowerUP Project

Study Overview
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Brief Summary
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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: 16 activity packs; 9 health coach sessions; unlimited access to a resource toolbox. Control participants will receive 6 activity packs promoting science, technology, engineering, and math (STEM) learning and 6 check-in calls to support retention. Our specific aims are: Determine reach, feasibility, and acceptability of our intervention and a complementary control program in a randomized pilot study. Estimate the magnitude of the intervention's effect on diet, activity, and metabolic risk factors. Engage partners from additional rural communities to scale and evaluate the intervention in a clinical trial.

Detailed Description
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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 a rural community in Colorado. 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.

Official Title
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Pilot Study of a Home-based Program to Promote Healthy Diet and Activity in Rural-dwelling Children

Conditions
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Obesity, Childhood, Type2diabetes

Intervention / Treatment
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* Behavioral: Bennett Kids PowerUP Project


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 7-to-10-years-old Living in the area of Bennett, Colorado English- or Spanish-speaking Has 1 parent or primary caregiver willing to actively participate Exclusion Criteria: Medical diagnosis of diabetes Serious child or parent health concerns that would interfere with participation Plans to move out of the area during the study period Lives with another child who previously participated in the study

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomized 1:1 in blocks of 6 to the intervention or control groups with the Randomization Module of the Research Data Capture (REDCap).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>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: 16 self-contained, parent-guided activity kits, 9 one-on-one health coach/support sessions in-person or virtual by a trained health coach, unlimited access to a resource toolbox. | Behavioral: Bennett Kids PowerUP Project<br>* 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.<br>|
| No Intervention: Control Group<br>Control group programming consists of: 6 parent-guided activity kits focused on STEM activities, 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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Dietary Intake at 7 months | Diet will be assessed with 24-hour dietary recalls using the Automated SelfAdministered 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). | Baseline (0 months) and Post-intervention (7 months) | 
| Change from Baseline Fruit and Vegetable Intake at 7 months | Use the VeggieMeter (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. | Baseline (0 months) and Post-intervention (7 months) | 
| Change from Baseline Sugar-Sweetened Beverage Intake 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. | Baseline (0 months) and Post-intervention (7 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline 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. | Baseline (0 months) and Post-intervention (7 months) | 
| Change from Baseline 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. | Baseline (0 months) and Post-intervention (7 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rural Population, Child Health, Physical Activity, Healthy Diet, Veggie Meter, Family-based Approach