Feasibility Trial of the iAMHealthy Intervention
Public ClinicalTrials.gov record NCT04142034. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Feasibility Trial of the iAMHealthy Intervention for Healthy Weight in Rural Children Recruited From Primary Care Clinics
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This research study is being done to find out which of 2 ways works best to get rural participants interested in joining a research study about children who weigh more than is considered healthy. One method researchers will use is the traditional method of reaching out to potential participants. The traditional method includes using flyers, posters, and booklets. The other method will be to target people who might be especially interested in the study. The second method uses medical records to find potential participants who are most likely to qualify for the study. This study is also being done to what works to help keep participants in a study like this. Another goal of the study is to find out what methods work well to help get and keep children's and caregiver's weight in the healthy range. Researchers also want to see what works well to help children with a high Body Mass Index be more physically active and to eat healthier foods. The test methods researchers will use for this part of the study are (1) newsletters only and (2) newsletters plus online meetings. Participants will be randomly assigned to 1 of the 2 groups (newsletter or newsletter plus meetings.) The newsletter-only group will receive monthly newsletters about children's health; this group will receive these letters for 6 months. The 'newsletter plus meeting group' will also receive the same monthly newsletter for 6 months. The latter group will also have online meetings with other children and adults as well as a group leader. Those in the 'newsletter plus meeting group' will also individually meet with a dietician. This study will involve children and one of their caregivers (parent/guardian). The child and caregiver must live in a rural area. The child must be 6 to 11 years old. The child must be considered to have an unhealthy weight (high Body Mass Index). Both the child and caregiver must speak English. Up to 224 children will enter into this study. Participants will be consented through 4 different sites that are part of the IDeA States Pediatric Network.
Study identification
- NCT ID
- NCT04142034
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 104 participants
Conditions and interventions
Conditions
Interventions
- the iAmHealthy Behavioral Intervention Behavioral
- Newsletter only arm Behavioral
- Consecutive Recruitment Other
- Traditional Recruitment Other
Behavioral · Other
Eligibility (public fields only)
- Age range
- 6 Years to 11 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 2, 2020
- Primary completion
- Mar 24, 2021
- Completion
- Mar 24, 2021
- Last update posted
- Sep 12, 2022
2020 – 2021
United States locations
- U.S. sites
- 4
- U.S. states
- 4
- U.S. cities
- 4
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Nemours/Alfred I. duPont Hospital for Children | Wilmington | Delaware | 19803 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68114 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| West Virginia University | Morgantown | West Virginia | 26330 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04142034, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 12, 2022 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04142034 live on ClinicalTrials.gov.