Healthy Habits, Happy Homes: An Intervention to Improve Household Routines for Obesity Prevention

NCT ID: NCT01565161

Last Updated: 2018-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

117 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-08-31

Brief Summary

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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

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Home-Based Health Coaching

Intervention delivered in the home.

Group Type EXPERIMENTAL

Home-Based Health Coaching

Intervention Type BEHAVIORAL

The 6-month intervention arm consists of 3 components:

1. 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.
2. 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.
3. Printed materials, including educational handouts, newsletters, and activities highlighting target behaviors, sent monthly for 4 months.

Control Arm

Mailed educational materials

Group Type ACTIVE_COMPARATOR

Mailed materials

Intervention Type BEHAVIORAL

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.

Interventions

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Home-Based Health Coaching

The 6-month intervention arm consists of 3 components:

1. 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.
2. 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.
3. Printed materials, including educational handouts, newsletters, and activities highlighting target behaviors, sent monthly for 4 months.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Healthy Habits, Happy Homes Health Coaching Healthy Habits, Happy Homes mailed materials

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centers for Disease Control and Prevention

FED

Sponsor Role collaborator

Harvard School of Public Health (HSPH)

OTHER

Sponsor Role collaborator

Harvard Pilgrim Health Care

OTHER

Sponsor Role lead

Responsible Party

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Elsie Taveras

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elsie Taveras, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Harvard Pilgrim Health Care

Julia McDonald, MS, MPH

Role: STUDY_DIRECTOR

Harvard Pilgrim Health Care

Locations

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Harvard Pilgrim Health Care

Boston, Massachusetts, United States

Site Status

University of Guelph

Guelph, Ontario, Canada

Site Status

Countries

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United States Canada

References

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Sharifi M, Dryden EM, Horan CM, Price S, Marshall R, Hacker K, Finkelstein JA, Taveras EM. Leveraging text messaging and mobile technology to support pediatric obesity-related behavior change: a qualitative study using parent focus groups and interviews. J Med Internet Res. 2013 Dec 6;15(12):e272. doi: 10.2196/jmir.2780.

Reference Type DERIVED
PMID: 24317406 (View on PubMed)

Haines J, McDonald J, O'Brien A, Sherry B, Bottino CJ, Schmidt ME, Taveras EM. Healthy Habits, Happy Homes: randomized trial to improve household routines for obesity prevention among preschool-aged children. JAMA Pediatr. 2013 Nov;167(11):1072-9. doi: 10.1001/jamapediatrics.2013.2356.

Reference Type DERIVED
PMID: 24019074 (View on PubMed)

Taveras EM, McDonald J, O'Brien A, Haines J, Sherry B, Bottino CJ, Troncoso K, Schmidt ME, Koziol R. Healthy Habits, Happy Homes: methods and baseline data of a randomized controlled trial to improve household routines for obesity prevention. Prev Med. 2012 Nov;55(5):418-26. doi: 10.1016/j.ypmed.2012.08.016. Epub 2012 Aug 30.

Reference Type DERIVED
PMID: 22960162 (View on PubMed)

Other Identifiers

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U48DP001946

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U48 DP001946-5033375

Identifier Type: -

Identifier Source: org_study_id

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