The Bennett Kids PowerUP Project

NCT ID: NCT05858580

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2026-03-31

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.

Detailed Description

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.

Conditions

Obesity, Childhood; Type2diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Intervention Group

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.

Group Type: EXPERIMENTAL

Bennett Kids PowerUP Project

Intervention Type: 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.

Control Group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Bennett Kids PowerUP Project

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 Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 7-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

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

American Diabetes Association

OTHER

Sponsor Role: collaborator

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Katherine A Sauder, PhD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

40010049

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00100266

Identifier Type: -

Identifier Source: org_study_id