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

Obesity Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01565161
• Other study ID #: U48 DP001946-5033375
• Status: Completed
• Phase: N/A
• First received: March 26, 2012
• Last updated: February 22, 2018
• Start date: June 2011
• Est. completion date: August 2012

Study information

• Verified date: February 2018
• Source: Harvard Pilgrim Health Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• Home-Based 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.
• 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.

Locations

Country	Name	City	State
Canada	University of Guelph	Guelph	Ontario
United States	Harvard Pilgrim Health Care	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Harvard Pilgrim Health Care	Centers for Disease Control and Prevention, Harvard School of Public Health

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Child height and weight measurements	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.	Baseline, 6 months
Secondary	Cognitive stimulation in the home	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.	Baseline, 6 months
Secondary	Presence of media devices in the home	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.	Baseline, 6 months
Secondary	Use of mobile technology	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.	Baseline