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NCT02343367 · ClinicalTrials.gov registry record · NA
Health4Kids Intervention Trial for Hispanic Families
A NA study, sponsored by The University of Texas Health Science Center at San Antonio.
- Completed
- Registry status
- NA
- Development phase
- 518
- Enrollment target
NCT02343367 is a NA study that has completed, run by The University of Texas Health Science Center at San Antonio. The registered enrollment target is 518 participants.
The verdict
NCT02343367, a NA study, has completed, sponsored by The University of Texas Health Science Center at San Antonio.
- COMPLETED
- Registry status
- NA
- Development phase
- 518 participants
- Enrollment target
Study Summary
The H4K Trial is a randomized controlled trial to improve children's body composition by testing a comprehensive, culturally and linguistically relevant, family-oriented intervention for overweight and obese Hispanic children (ages 6-11) in three pediatric clinics in San Antonio, Texas. The H4K trial will test the efficacy of a 6-month pediatric obesity management intervention (physician counseling plus telephone counseling, newsletters and text messages) compared to standard care (physician counseling only) on three outcomes: 1) body composition (i.e., waist circumference, weight and z-BMI); 2) insulin, glucose and cholesterol levels; and 3) behavior change in physical activity (PA), sedentary behavior and consumption of sugary beverages and fruits and vegetables. The investigators will recruit 230 overweight and obese children-and a parent or guardian for each-and randomize them to the H4K intervention (n = 115 child/parent dyads) or standard care (n = 115 child/parent dyads). The investigators hypothesize that intervention children will significantly improve their body composition, increased their PA levels and diet quality (more fruits and vegetables and less sugary beverages), and decrease their sedentary activity, compared to children in standard care. If successful, this study will generate new scientific knowledge about effective Hispanic family-based approaches for obesity prevention with high potential for replication in underserved areas across the nation.
Interventions
- BEHAVIORAL behavioral counseling
- BEHAVIORAL Text messages
- BEHAVIORAL Telephone Counseling
- OTHER Education Materials
- BEHAVIORAL Face to face counseling session
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 518 participants |
| Start Date | 2015-01 |
| Est. Completion | 2020-03-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02343367
The ClinicalTrials.gov registry entry for NCT02343367 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 518 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Texas Health Science Center at San Antonio, which has 378 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which behavioral counseling is the first listed.
NCT02343367 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02343367 about?
NCT02343367 is a clinical study titled "Health4Kids Intervention Trial for Hispanic Families". The H4K Trial is a randomized controlled trial to improve children's body composition by testing a comprehensive, culturally and linguistically relevant, family-oriented intervention for overweight and obese Hispanic children (ages 6-11) in three pediatric clinics in San Antonio, Texas. The H4K tria...
What is the current status of trial NCT02343367?
This trial is currently completed. It is a NA study. The enrollment target is 518 participants. The study started on 2015-01. Estimated completion is 2020-03-31.
What interventions are being tested in trial NCT02343367?
The interventions under investigation include: behavioral counseling (BEHAVIORAL), Text messages (BEHAVIORAL), Telephone Counseling (BEHAVIORAL), Education Materials (OTHER), Face to face counseling session (BEHAVIORAL).
Who is sponsoring clinical trial NCT02343367?
This trial is sponsored by The University of Texas Health Science Center at San Antonio, which has 378 total clinical trials registered on ClinicalTrials.gov.
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