The Bennett Kids PowerUP Project

Obesity, Childhood Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 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. ;

Related Conditions & MeSH terms

• Obesity, Childhood
• Pediatric Obesity

• NCT number: NCT05858580
• Study type: Interventional
• Source: Wake Forest University Health Sciences
• Contact: Cristel Castelo
• Phone: 336-716-1280
• Email: ccastel@wakehealth.edu
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Completion date: June 2025