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OpenTrials
Completed

NCT Number: NCT01973153

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 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.

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Key information

Age range

2 year–50 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Child is 2-4 years old
  • Latino or Black descent by maternal report
  • Receiving services through the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC)

Exclusion criteria

  • Mother is younger than 18 years old
  • Dad does not live in the Greater Hartford area or if they have plans to move out of the area in the next 12 months
  • Child or mother has special needs (dietary, physical, and/or emotional) that would make the intervention inappropriate (e.g. failure to thrive, type 1 diabetes, cystic fibrosis)

Treatment and study plan

Brief Motivational Counseling (BMC)

Behavioral

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.

Brief Motivational Counseling Plus Phone Calls (BMC + Phone)

Behavioral

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

Brief Motivational Counseling Plus Home Visits (BMC + Home)

Behavioral

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

Primary outcomes

  1. Change in BMI Percentile

    Time frame: baseline and 12 months

    BMI Percentile calculated using the 2000 revised CDC/NCH growth charts for the United States

Sponsors and collaborators

Lead sponsor

Connecticut Children's Medical Center

Other

Collaborators

  • Community Health Network

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 31, 2013
Registry last updated
Jul 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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