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NCT01565161 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by Harvard Pilgrim Health Care.

Completed
Registry status
NA
Development phase
117
Enrollment target

NCT01565161: Completed NA study, sponsored by Harvard Pilgrim Health Care.

NCT01565161 is a NA study that has completed, run by Harvard Pilgrim Health Care. The registered enrollment target is 117 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01565161, a NA study, has completed, sponsored by Harvard Pilgrim Health Care.

COMPLETED
Registry status
NA
Development phase
117 participants
Enrollment target

Study 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

Primary Outcome

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

Interventions

  • BEHAVIORAL Home-Based Health Coaching
  • BEHAVIORAL Mailed materials

Trial Details

FieldValue
Enrollment Target 117 participants
Start Date 2011-06
Est. Completion 2012-08
Phase NA
Harvard Pilgrim Health Care

28 total trials

What the finished NCT01565161 record still lists

NCT01565161 is an interventional study that assigns participants to a tested intervention. The registered 117 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower).

The record links to 0 conditions, and to 2 interventions - of which Home-Based Health Coaching is the first listed.

NCT01565161 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01565161 about?

NCT01565161 is a clinical study titled "Healthy Habits, Happy Homes: An Intervention to Improve Household Routines for Obesity Prevention". 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 obe...

What is the current status of trial NCT01565161?

This trial is currently completed. It is a NA study. The enrollment target is 117 participants. The study started on 2011-06. Estimated completion is 2012-08.

What interventions are being tested in trial NCT01565161?

The interventions under investigation include: Home-Based Health Coaching (BEHAVIORAL), Mailed materials (BEHAVIORAL).

Who is sponsoring clinical trial NCT01565161?

This trial is sponsored by Harvard Pilgrim Health Care, which has 28 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01565161's enrollment target sits among peer trials

117 807th of 2000 higher than 1,193 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01565161, the US trial registry maintained by the National Library of Medicine. NCT01565161 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.