The Bennett Kids PowerUP Project

NCT05858580 | Completed DMC

• 2 other identifiers: IRB0010026640010049
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type2diabetes; Obesity, Childhood

Keywords

Rural Population; Child Health; Physical Activity; Healthy Diet; Veggie Meter; Family-based Approach

Outcome Measures

Primary Outcomes (3)

• 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).

  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.

  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.

  Month 7

Secondary Outcomes (2)

• Change in Physical Activity at 7 months

  Month 7

• Change in Screen Time at 7 months

  Month 7

Other Outcomes (8)

• Change in Glucose levels at 7 months

  Month 7

• Change in Insulin values at 7 months

  Month 7

• Change in Body Mass Index (BMI) values at 7 months

  Month 7

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

NO INTERVENTION

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.

Interventions

Bennett Kids PowerUP Project BEHAVIORAL

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.

Intervention Group

Eligibility Criteria

• Age: 7 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• to-10-years-old
• Living in rural Colorado or rural North Carolina
• English- or Spanish-speaking
• Has 1 parent or primary caregiver willing to actively participate

You may not qualify if:

• 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

Sponsors & Collaborators

• American Diabetes Association: collaborator
• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Pediatric Obesity; Motor Activity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Katherine A Sauder, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data collectors will be blinded to the participant's assigned group.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: May 15, 2023
• Study Start: March 1, 2024
• Primary Completion: March 6, 2026
• Study Completion: March 6, 2026
• Last Updated: May 6, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)