- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05858580
The Bennett Kids PowerUP Project
Pilot Study of a Home-based Program to Promote Healthy Diet and Activity in Rural-dwelling Children
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Cristel Castelo
- Phone Number: 336-716-1280
- Email: ccastel@wakehealth.edu
Study Locations
-
-
North Carolina
-
Winston-Salem, North Carolina, United States, 27157
- Recruiting
- Wake Forest University Health Sciences
-
Contact:
- Katherine A Sauder, PhD
- Phone Number: 336-716-1280
- Email: ksauder@wakehealth.edu
-
Principal Investigator:
- Katherine A Sauder, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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:
|
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.
|
No Intervention: Control Group
Control group programming consists of:
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Dietary Intake (MyPyramid Equivalents) at 7 months
Time Frame: Month 7
|
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
Time Frame: Month 7
|
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
Time Frame: Month 7
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Physical Activity at 7 months
Time Frame: Month 7
|
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
|
Change in Screen Time at 7 months
Time Frame: Month 7
|
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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Glucose levels at 7 months
Time Frame: Month 7
|
Fasting serum samples analysis (Hexokinase, UV)
|
Month 7
|
Change in Insulin values at 7 months
Time Frame: Month 7
|
Fasting serum samples analysis (chemiluminescence immunoassay)
|
Month 7
|
Change in Body Mass Index (BMI) values at 7 months
Time Frame: Month 7
|
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
|
Program Engagement
Time Frame: Month 7
|
Number of activity kits completed
|
Month 7
|
Completion of coaching sessions
Time Frame: Month 7
|
Number of health coach sessions completed
|
Month 7
|
Use of toolbox number
Time Frame: Month 7
|
Report on frequency of use of the resource toolbox
|
Month 7
|
Process Measures
Time Frame: Month 7
|
Staff records of the actual schedule (order and timing) of mailed activity kits and health coach sessions
|
Month 7
|
Acceptability and Engagement Barriers
Time Frame: Month 7
|
Semi-structured interviews
|
Month 7
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Katherine A Sauder, PhD, Wake Forest University Health Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00100266
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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