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ObesityHHNCT01565161

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

A study testing Home-Based Health Coaching and Mailed materials in people with Obesity, run by Harvard Pilgrim Health Care at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 2 to 5 yearsHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
Home-Based Health Coaching and Mailed materials
Could I receive a placebo?
No, everyone receives an active treatment
How many people
117 participants
Where
2 sitesin 2 countries
Study dates
Jun 2011to Aug 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 5 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site

  • Harvard Pilgrim Health Care

    Boston, Massachusetts, 02215

Other trials in United States

Canada1 site

  • University of Guelph

    Guelph, Ontario, N1G 2W1

Other trials in Canada

About this study

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).

Read more

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
Conditions
Obesity
Being tested
Home-Based Health Coaching, Mailed materials
Keywords
Obesity, Overweight
Medical subject headings
Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Home-Based Health CoachingBehavioural

    Also called Healthy Habits, Happy Homes 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.

  • Mailed materialsBehavioural

    Also called Healthy Habits, Happy Homes 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.

Study groups in NCT01565161
Study groupRoleWhat they receive
Home-Based Health CoachingExperimentalIntervention delivered in the home.
Receives: Behavioral: Home-Based Health Coaching
Control ArmActive comparatorMailed educational materials
Receives: Behavioral: Mailed materials

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Baseline, 6 months

  2. 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.

    Measured: Baseline, 6 months

Secondary outcomes (4)

  1. 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.

    Measured: Baseline, 6 months

  2. 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.

    Measured: Baseline, 6 months

  3. 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.

    Measured: Baseline, 6 months

  4. 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.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2012 (estimated)
  2. Study startJun 2011
  3. Primary completionAug 2012
  4. Study completionAug 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
117 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01565161
Sponsor's protocol ID
U48 DP001946-5033375
Other IDs
U48DP001946
Acronym
HH
Status last verified
Feb 2018
First submitted
26 Mar 2012
Last updated
23 Feb 2018
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 24317406

  • 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.

    PubMed 24019074

  • 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.

    PubMed 22960162

Questions about this trial

What is this clinical trial studying?

A study testing Home-Based Health Coaching and Mailed materials in people with Obesity, run by Harvard Pilgrim Health Care at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Parent and child health behaviors (time frame: Baseline, 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01565161, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2018.

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