Overview

This trial is active, not recruiting.

Condition obesity
Treatments home-based health coaching, mailed materials
Sponsor Harvard Pilgrim Health Care
Collaborator Centers for Disease Control and Prevention
Start date September 2009
End date August 2012
Trial size 117 participants
Trial identifier NCT01565161, U48 DP001946-5033375

Summary

While childhood obesity rates may have plateaued in some US population subgroups, such as whites and those of higher socioeconomic status, overall rates of obesity remain high and racial/ethnic and socioeconomic disparities appear to be widening. Among the most promising approaches for childhood obesity prevention and management are interventions that begin early in life and that support change at the individual and community levels.

The goal of this project is to develop and test an intervention delivered to racial/ethnic minority and low income parents of 2-5 year old children in their homes, designed to promote adoption of household routines and parenting strategies that are preventive of obesity. To achieve this goal, the investigators will work with community health centers in Boston, Cambridge, and Somerville to recruit families to participate in an individual-level randomized controlled trial. The investigators partner community health centers include the Roxbury Comprehensive Community Health Center, Dimock Community Health Centers, and the Cambridge Health Alliance (CHA).

Participants will be randomized to receive either 1) mailed educational materials for the duration of the 6-month program (control), or 2) home-based health coaching visits and phone calls with a health educator, text messages, and educational materials promoting the adoption of household routines and target behaviors (intervention).

The investigators goal is to evaluate the feasibility and effectiveness of the investigators designed intervention (as compared to the control condition) using baseline and post-intervention data. In order to do so, the investigators will assess change from baseline to post-intervention in the investigators key behavioral outcomes of interest, including adoption of three household routines:

1. Regularly eating meals together as a family

2. Obtaining adequate sleep

3. Limiting screen-viewing time

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Intervention delivered in the home.
home-based health coaching Healthy Habits, Happy Homes Health Coaching
The 6-month intervention arm consists of 3 components: In-home coaching visits with a health educator trained in motivational interviewing to encourage behavior change. In addition to 4 monthly in-home coaching visits, participants receive 4 monthly coaching phone calls to supplement the in-person visits. Use of mobile technology to deliver health information by text message - participants receive messages twice weekly for 16 weeks and then weekly for 8 weeks of the program. Those without a phone capable of receiving text messages receive postcards by mail. Printed materials, including educational handouts, newsletters, and activities highlighting target behaviors, sent monthly for 4 months.
(Active Comparator)
Mailed educational materials
mailed materials Healthy Habits, Happy Homes mailed materials
We designed materials for our control group focusing on Developmental milestones during early childhood to provide information that participants would find relevant and helpful for parenting, but that would also not influence intervention behaviors, such as TV viewing or household routines related to sleeping, eating, or television viewing. Participants received 4 monthly mailing packages, each focusing thematically on one of four milestone domains: motor, language, cognitive and social/emotional. Educational materials were adapted from the Center for Disease Control's "Positive Parenting Tips for Healthy Child Development", and the mailing included child-appropriate incentives to reinforce the concepts presented in the educational materials.

Primary Outcomes

Measure
Parent and child health behaviors
time frame: Baseline, 6 months
TV Viewing Time
time frame: Baseline, 6 months

Secondary Outcomes

Measure
Child height and weight measurements
time frame: Baseline, 6 months
Cognitive stimulation in the home
time frame: Baseline, 6 months
Presence of media devices in the home
time frame: Baseline, 6 months
Use of mobile technology
time frame: Baseline

Eligibility Criteria

Male or female participants from 2 years up to 5 years old.

Inclusion Criteria: - Parent with child between 2-5 years old - Child has a TV in the room where s/he sleeps - Parent is comfortable reading, writing and having conversations in English or Spanish - Child was seen for a well-child care visit at one of collaborating community health centers in the last 90 days Exclusion Criteria: - Parent is not 18 years or older - Family is planning to move from the Boston area in the net 6 months - Child has a physical/mental health condition which requires chronic care

Additional Information

Official title Healthy Habits, Happy Homes: An Intervention to Improve Household Routines for Obesity Prevention
Principal investigator Elsie Taveras, MD, MPH
Trial information was received from ClinicalTrials.gov and was last updated in March 2012.
Information provided to ClinicalTrials.gov by Harvard Pilgrim Health Care.