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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05858580
• Other study ID #: IRB00100266
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: June 2025

Study information

• Verified date: September 2023
• Source: Wake Forest University Health Sciences
• Contact: Cristel Castelo
• Phone: 336-716-1280
• Email: ccastel[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity, Childhood
• Pediatric Obesity

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	American Diabetes Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Glucose levels at 7 months	Fasting serum samples analysis (Hexokinase, UV)	Month 7
Other	Change in Insulin values at 7 months	Fasting serum samples analysis (chemiluminescence immunoassay)	Month 7
Other	Change in Body Mass Index (BMI) values at 7 months	Measured height, weight - Under 18.5 - you are very underweight and possibly malnourished. 18.5 to 24.9 - you have a healthy weight range for young and middle-aged adults. 25.0 to 29.9 - you are overweight. Over 30 - you are obese.	Month 7
Other	Program Engagement	Number of activity kits completed	Month 7
Other	Completion of coaching sessions	Number of health coach sessions completed	Month 7
Other	Use of toolbox number	Report on frequency of use of the resource toolbox	Month 7
Other	Process Measures	Staff records of the actual schedule (order and timing) of mailed activity kits and health coach sessions	Month 7
Other	Acceptability and Engagement Barriers	Semi-structured interviews	Month 7
Primary	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
Primary	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
Primary	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	Change in 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.	Month 7
Secondary	Change in 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.	Month 7