The Added Value of Telephone Follow Up and Home Visits in Helping Children to Grow Up Healthy

NCT01973153 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2023-07-10

No results posted yet for this 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.

Conditions

Interventions

BEHAVIORAL

Brief Motivational Counseling (BMC)

3-5 minute BMC delivered by clinicians and nurses at well, sick, and WIC visits with the goal of reducing obesogenic behaviors. 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.

BEHAVIORAL

Brief Motivational Counseling Plus Phone Calls (BMC + Phone)

BMC as described above that is supplemented by monthly telephone contacts with community health workers designed to identify and overcome barriers to goal progress.

BEHAVIORAL

Brief Motivational Counseling Plus Home Visits (BMC + Home)

BMC as described above that is supplemented by monthly home visits with community health workers designed to identify and overcome barriers to goal progress.

Sponsors & Collaborators

  • Community Health Network

    collaborator OTHER
  • Connecticut Children's Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
50 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01973153 on ClinicalTrials.gov