NCT01565161

Brief 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. 1.Regularly eating meals together as a family
  2. 2.Obtaining adequate sleep
  3. 3.Limiting screen-viewing time

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jun 2011

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 28, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

February 23, 2018

Status Verified

February 1, 2018

Enrollment Period

1.2 years

First QC Date

March 26, 2012

Last Update Submit

February 22, 2018

Conditions

Obesity

Keywords

ObesityOverweight

Outcome Measures

Primary Outcomes (2)

  • Parent and child health behaviors

    Using parent self-report surveys, we will assess change from baseline to post-intervention in parent and child behaviors related to the following health outcomes: * TV viewing, including TV in the room where the child sleeps, time spent watching TV, total screen time * Sleep, including parent and child sleep duration and presence of a calming nighttime routine * Diet, including eating meals together as a family, lowering intake of fast food, and lowering intake of sugar-sweetened beverages

    Baseline, 6 months

  • TV Viewing Time

    Using two separate measures of Child TV viewing time (parent-report and measured TV time using the TV Allowance device, we will assess change from baseline to post-intervention in the amount of TV the child watches. Additionally, using parent-report surveys we will assess change from baseline to post-intervention in total screen time as well as observed presence of TV in the room where the child sleeps.

    Baseline, 6 months

Secondary Outcomes (4)

  • Child height and weight measurements

    Baseline, 6 months

  • Cognitive stimulation in the home

    Baseline, 6 months

  • Presence of media devices in the home

    Baseline, 6 months

  • Use of mobile technology

    Baseline

Study Arms (2)

Home-Based Health Coaching

EXPERIMENTAL

Intervention delivered in the home.

Behavioral: Home-Based Health Coaching

Control Arm

ACTIVE COMPARATOR

Mailed educational materials

Behavioral: Mailed materials

Interventions

Home-Based Health CoachingBEHAVIORAL

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.

Also known as: Healthy Habits, Happy Homes Health Coaching
Home-Based Health Coaching
Mailed materialsBEHAVIORAL

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.

Also known as: Healthy Habits, Happy Homes mailed materials
Control Arm

Eligibility Criteria

Age2 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Harvard Pilgrim Health Care

Boston, Massachusetts, 02215, United States

Location

University of Guelph

Guelph, Ontario, N1G 2W1, Canada

Location

Related Publications (3)

  • 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.

    PMID: 24317406DERIVED

  • 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.

    PMID: 24019074DERIVED

  • 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.

    PMID: 22960162DERIVED

MeSH Terms

Conditions

ObesityOverweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Elsie Taveras, MD, MPH

    Harvard Pilgrim Health Care

    PRINCIPAL INVESTIGATOR

  • Julia McDonald, MS, MPH

    Harvard Pilgrim Health Care

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 26, 2012

First Posted

March 28, 2012

Study Start

June 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

February 23, 2018

Record last verified: 2018-02

Locations

US(1)CA(1)