Clinical trial NCT05858580: The Bennett Kids PowerUP Project
Official title: Pilot Study of a Home-based Program to Promote Healthy Diet and Activity in Rural-dwelling Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity, Childhood
Type2diabetes
Keywords: Rural Population
Child Health
Physical Activity
Healthy Diet
Veggie Meter
Family-based Approach
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: American Diabetes Association
First posted: 2023-05-15
Enrollment: 60
Sex: ALL
Minimum age (years): 7
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: PREVENTION

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 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.

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

Primary outcomes:
measure: Change in Dietary Intake (MyPyramid Equivalents) at 7 months
timeFrame: Month 7
measure: Change in Fruit and Vegetable Intake (carotenoid concentration) at 7 months
timeFrame: Month 7
measure: Change in Sugar-Sweetened Beverage Intake (carbon isotope ratio) at 7 months
timeFrame: Month 7
Secondary outcomes:
measure: Change in Physical Activity at 7 months
timeFrame: Month 7
measure: Change in Screen Time at 7 months
timeFrame: Month 7
Other outcomes:
measure: Change in Glucose levels at 7 months
timeFrame: Month 7
measure: Change in Insulin values at 7 months
timeFrame: Month 7
measure: Change in Body Mass Index (BMI) values at 7 months
timeFrame: Month 7
measure: Program Engagement
timeFrame: Month 7
measure: Completion of coaching sessions
timeFrame: Month 7
measure: Use of toolbox number
timeFrame: Month 7
measure: Process Measures
timeFrame: Month 7
measure: Acceptability and Engagement Barriers
timeFrame: Month 7
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Katherine A Sauder, PhD
role: PRINCIPAL_INVESTIGATOR
References: