Obesity, ChildhoodNCT05858580
The Bennett Kids PowerUP Project
A study testing Bennett Kids PowerUP Project in people with Obesity, Childhood and Type2diabetes, run by Wake Forest University Health Sciences at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 7 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Childhood, Type2diabetes
- What is being tested?
- Bennett Kids PowerUP Project
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2024to 6 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: 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.
Read the 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
- Being tested
- Bennett Kids PowerUP Project
- Keywords
- Rural Population, Child Health, Physical Activity, Healthy Diet, Veggie Meter, Family-based Approach
- Medical subject headings
- Pediatric Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bennett Kids PowerUP ProjectBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Behavioral: Bennett Kids PowerUP Project |
| Control Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Month 7
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.
Measured: Month 7
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.
Measured: Month 7
Secondary outcomes (2)
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.
Measured: Month 7
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.
Measured: Month 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2023
- Study start1 Mar 2024
- Primary completion6 Mar 2026
- Study completion6 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- American Diabetes Association
- Responsible party
- Sponsor
- Investigators
- Katherine A Sauder, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05858580
- Sponsor's protocol ID
- IRB00100266
- Other IDs
- 40010049
- Status last verified
- Jun 2025
- First submitted
- 16 Mar 2023
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of a Home-based Program to Promote Healthy Diet and Activity in Rural-dwelling Children
- ClinicalTrials.gov ID
- NCT05858580
- Acronym / sponsor ID
- IRB00100266
- Conditions
- Obesity, Childhood, Type2diabetes
- Keywords
- Rural Population, Child Health, Physical Activity, Healthy Diet, Veggie Meter, Family-based Approach
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- American Diabetes Association
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 6 Mar 2026 (actual)
- Study completion
- 6 Mar 2026 (actual)
- First posted
- 15 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Bennett Kids PowerUP ProjectIntervention 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. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bennett Kids PowerUP ProjectInformation 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. | Behavioural | Intervention Group |
Primary outcome
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).
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.
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.
2 secondary outcomes
Change in Physical Activity at 7 months
Time frame: Month 7
Change in Screen Time at 7 months
Time frame: Month 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine A Sauder, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bennett Kids PowerUP Project in people with Obesity, Childhood and Type2diabetes, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Dietary Intake (MyPyramid Equivalents) at 7 months (time frame: Month 7). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.