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NCT04142034 · ClinicalTrials.gov registry record · NA
Feasibility Trial of the iAMHealthy Intervention
A NA study, sponsored by IDeA States Pediatric Clinical Trials Network.
- Completed
- Registry status
- NA
- Development phase
- 104
- Enrollment target
NCT04142034 is a NA study that has completed, run by IDeA States Pediatric Clinical Trials Network. The registered enrollment target is 104 participants.
The verdict
NCT04142034, a NA study, has completed, sponsored by IDeA States Pediatric Clinical Trials Network.
- COMPLETED
- Registry status
- NA
- Development phase
- 104 participants
- Enrollment target
Study Summary
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
Interventions
- BEHAVIORAL the iAmHealthy Behavioral Intervention
- BEHAVIORAL Newsletter only arm
- OTHER Consecutive Recruitment
- OTHER Traditional Recruitment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2020-02-03 |
| Est. Completion | 2021-03-25 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04142034
The ClinicalTrials.gov registry entry for NCT04142034 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 104 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is IDeA States Pediatric Clinical Trials Network, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which the iAmHealthy Behavioral Intervention is the first listed.
NCT04142034 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04142034 about?
NCT04142034 is a clinical study titled "Feasibility Trial of the iAMHealthy Intervention". 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...
What is the current status of trial NCT04142034?
This trial is currently completed. It is a NA study. The enrollment target is 104 participants. The study started on 2020-02-03. Estimated completion is 2021-03-25.
What interventions are being tested in trial NCT04142034?
The interventions under investigation include: the iAmHealthy Behavioral Intervention (BEHAVIORAL), Newsletter only arm (BEHAVIORAL), Consecutive Recruitment (OTHER), Traditional Recruitment (OTHER).
Who is sponsoring clinical trial NCT04142034?
This trial is sponsored by IDeA States Pediatric Clinical Trials Network, which has 7 total clinical trials registered on ClinicalTrials.gov.
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