Clinical trial NCT01565161: Healthy Habits, Happy Homes: An Intervention to Improve Household Routines for Obesity Prevention
Official title: Healthy Habits, Happy Homes: An Intervention to Improve Household Routines for Obesity Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Overweight
Lead sponsor: Harvard Pilgrim Health Care
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
name: Harvard School of Public Health (HSPH)
First posted: 2012-03-28
Enrollment: 117
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility 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

Primary outcomes:
measure: Parent and child health behaviors
timeFrame: Baseline, 6 months
measure: TV Viewing Time
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Child height and weight measurements
timeFrame: Baseline, 6 months
measure: Cognitive stimulation in the home
timeFrame: Baseline, 6 months
measure: Presence of media devices in the home
timeFrame: Baseline, 6 months
measure: Use of mobile technology
timeFrame: Baseline
Other outcomes:
Locations:
city: Boston
country: United States
facility: Harvard Pilgrim Health Care
state: Massachusetts
city: Guelph
country: Canada
facility: University of Guelph
state: Ontario
Study officials:
affiliation: Harvard Pilgrim Health Care
name: Elsie Taveras, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard Pilgrim Health Care
name: Julia McDonald, MS, MPH
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.