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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Harvard Pilgrim Health Care.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Harvard School of Public Health
Information provided by (Responsible Party):
Elsie Taveras, Harvard Pilgrim Health Care
ClinicalTrials.gov Identifier:
NCT01565161
First received: March 26, 2012
Last updated: March 27, 2012
Last verified: March 2012
  Purpose

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

Condition Intervention
Obesity
Behavioral: Home-Based Health Coaching
Behavioral: Mailed materials

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Healthy Habits, Happy Homes: An Intervention to Improve Household Routines for Obesity Prevention

Resource links provided by NLM:


Further study details as provided by Harvard Pilgrim Health Care:

Primary Outcome Measures:
  • Parent and child health behaviors [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]

    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

  • TV Viewing Time [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Child height and weight measurements [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
    We will assess change in child BMI and BMI z-score from baseline to post-intervention using in-person child height and weight measurements, taken by trained research staff using a standing Schorr board to measure height and an electronic scale to measure weight.

  • Cognitive stimulation in the home [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
    We will assess change from baseline to post-intervention in total score on the STIMQ, a validated instrument that captures the presence of cognitive stimulation in the home. This instrument is administered as an in-person interview with the primary caregiver.

  • Presence of media devices in the home [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
    We will assess the home environment at baseline and post-intervention, using a developed instrument called the Home Environment Media Inventory (HEMI). From this, we will be able to observe change from baseline to follow up in the presence of media devices in the home, as well as basic neighborhood and household characteristics. Media devices measured include: TV, DVD, DVR/Tivo, Cable, and Computer.

  • Use of mobile technology [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    We will assess the participant's use of mobile technology at baseline, such as text messaging and downloaded applications, as well as whether participants have had their cell service cut off for any reason.


Enrollment: 117
Study Start Date: September 2009
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Home-Based Health Coaching
Intervention delivered in the home.
Behavioral: 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.
Other Name: Healthy Habits, Happy Homes Health Coaching
Active Comparator: Control Arm
Mailed educational materials
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.

Other Name: Healthy Habits, Happy Homes mailed materials

  Eligibility

Ages Eligible for Study:   2 Years to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01565161

Locations
United States, Massachusetts
Harvard Pilgrim Health Care
Boston, Massachusetts, United States, 02215
Canada, Ontario
University of Guelph
Guelph, Ontario, Canada, N1G 2W1
Sponsors and Collaborators
Harvard Pilgrim Health Care
Harvard School of Public Health
Investigators
Principal Investigator: Elsie Taveras, MD, MPH Harvard Pilgrim Health Care
Study Director: Julia McDonald, MS, MPH Harvard Pilgrim Health Care
  More Information

No publications provided by Harvard Pilgrim Health Care

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Elsie Taveras, Associate Professor, Harvard Pilgrim Health Care
ClinicalTrials.gov Identifier: NCT01565161     History of Changes
Other Study ID Numbers: U48 DP001946-5033375
Study First Received: March 26, 2012
Last Updated: March 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Harvard Pilgrim Health Care:
Obesity
Overweight

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 01, 2014