A program to promote healthy eating and activity in rural children
Pilot Study of a Home-based Program to Promote Healthy Diet and Activity in Rural-dwelling Children
NA · Wake Forest University Health Sciences · NCT05858580
This study is testing a program to help rural kids aged 7 to 10 eat healthier and be more active to see if it can lower their risk of Type 2 diabetes.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 7 Years to 10 Years |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences (other) |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Trial ID | NCT05858580 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate a lifestyle modification program designed to encourage healthy diet and physical activity among rural children aged 7 to 10 years, with the goal of reducing the risk of Type 2 diabetes. Participants will be randomly assigned to either an intervention group, receiving activity packs, health coaching, and resources, or a control group, receiving STEM-related activity packs and check-in calls. The study will gather data on the feasibility and acceptability of the program, as well as its potential effectiveness in promoting healthier behaviors. The focus is on addressing the rising rates of obesity and Type 2 diabetes in rural youth, where unhealthy habits are more prevalent.
Who should consider this trial
Good fit: Ideal candidates are children aged 7 to 10 years living in rural Colorado or North Carolina, who can participate with a parent or caregiver.
Not a fit: Children with a medical diagnosis of diabetes or serious health concerns that interfere with participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly reduce the risk of Type 2 diabetes in rural children by promoting healthier lifestyle choices.
How similar studies have performed: Other studies have shown success in similar lifestyle intervention approaches for obesity and diabetes prevention in children, indicating potential for this program.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Winston-Salem, North Carolina
- Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States (RECRUITING)
Study contacts
- Principal investigator: Katherine A Sauder, PhD — Wake Forest University Health Sciences
- Study coordinator: Cristel Castelo
- Email: ccastel@wakehealth.edu
- Phone: 336-716-1280
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Obesity, Childhood, Type2diabetes, Rural Population, Child Health, Physical Activity, Healthy Diet, Veggie Meter, Family-based Approach