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NCT01973153 · ClinicalTrials.gov registry record · NA
The Added Value of Telephone Follow Up and Home Visits in Helping Children to Grow Up Healthy
A NA study, sponsored by Connecticut Children's Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 81
- Enrollment target
NCT01973153 is a NA study that has completed, run by Connecticut Children's Medical Center. The registered enrollment target is 81 participants.
The verdict
NCT01973153, a NA study, has completed, sponsored by Connecticut Children's Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 81 participants
- Enrollment target
Study Summary
Leading medical organizations have called on primary care pediatricians to take a central role in the prevention of childhood obesity. Weight counseling typically has not been incorporated into routine pediatric practice due to time and training constraints. Brief interventions with simple behavior change messages are needed to reach high-risk children, particularly Latino and Black children who are disproportionately affected by obesity and related comorbidities. Steps to Growing Up Healthy (Added Value) is a randomized controlled trial testing the efficacy of brief motivational counseling (BMC) delivered by primary care clinicians and the added value of supplementing BMC with monthly contact by community health workers (CHW) in the prevention/reversal of obesity in Latino and Black children ages 2-4 years old. Mother-child dyads (targeted n=150) are recruited for this 12-month randomized trial at an inner-city pediatric primary care clinic and randomized to: 1) BMC delivered by clinicians and nurses at well, sick, and WIC visits with the goal of reducing obesogenic behaviors (BMC); 2) BMC plus monthly phone calls by a CHW (BMC+Phone); or 3) BMC plus monthly home visits by a CHW (BMC+Home). During BMC, the medical team facilitates the selection of a specific goal (i.e., reduce sugar sweetened beverage consumption) that is meaningful to the mother and teaches the mother simple behavioral strategies. Monthly contacts with CHWs are designed to identify and overcome barriers to goal progress. Dyads are assessed at baseline and 12 months and the primary outcome is change in the child's BMI percentile. We hypothesize that BMC+Phone and BMC+Home will produce greater reductions in BMI percentiles than BMC alone and that BMC+Home will produce greater reductions in BMI percentiles than BMC+Phone.
Interventions
- BEHAVIORAL Brief Motivational Counseling (BMC)
- BEHAVIORAL Brief Motivational Counseling Plus Phone Calls (BMC + Phone)
- BEHAVIORAL Brief Motivational Counseling Plus Home Visits (BMC + Home)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2012-01 |
| Est. Completion | 2013-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01973153
The ClinicalTrials.gov registry entry for NCT01973153 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 81 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Connecticut Children's Medical Center, which has 55 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Brief Motivational Counseling (BMC) is the first listed.
NCT01973153 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01973153 about?
NCT01973153 is a clinical study titled "The Added Value of Telephone Follow Up and Home Visits in Helping Children to Grow Up Healthy". Leading medical organizations have called on primary care pediatricians to take a central role in the prevention of childhood obesity. Weight counseling typically has not been incorporated into routine pediatric practice due to time and training constraints. Brief interventions with simple behavior ...
What is the current status of trial NCT01973153?
This trial is currently completed. It is a NA study. The enrollment target is 81 participants. The study started on 2012-01. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01973153?
The interventions under investigation include: Brief Motivational Counseling (BMC) (BEHAVIORAL), Brief Motivational Counseling Plus Phone Calls (BMC + Phone) (BEHAVIORAL), Brief Motivational Counseling Plus Home Visits (BMC + Home) (BEHAVIORAL).
Who is sponsoring clinical trial NCT01973153?
This trial is sponsored by Connecticut Children's Medical Center, which has 55 total clinical trials registered on ClinicalTrials.gov.
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