HomeTech Healthy Lifestyle Program for Mothers With Young Children

Home-based & Technology-centered Childhood Obesity Prevention for Mothers With Young Children

About 17% of Chinese American preschool children are obese, compared to 12.4%of all children from age three to five years residing in the US; the prevalence of obesity is expected to increase in the future. Therefore, the proposed study will adapt a home-based and technology-centered childhood obesity prevention program for low-income Chinese American mothers of children three to five years old. The aims of the study are to assess the feasibility of the intervention and estimate the effect sizes on children's and mothers' outcomes.

Study Overview

Status

Completed

Conditions

Detailed Description

This study aims to adapt and implement a family-centered and technology-based intervention to prevent obesity in young Chinese American children from low-income families with overweight mothers. The proposed study framework is based on the Information Motivation Behavioral Skills Model, which includes the mothers' gained knowledge/information, increased personal and social motivators, and acquired behavioral skills towards behavioral changes. The intervention will be developed with a Community Advisory Committee and validated for cultural appropriateness through a beta-testing process. The validated intervention will be implemented thereafter. Eligible overweight mothers with young Chinese American children (ages three to five years) will be recruited from local day care settings, low-income housing and Head Start programs to participate in the study. Participants will be randomized into either the intervention (N=15) or control group (N=15). Participants in the intervention group will receive the 8-week online interactive sessions and activities delivered through tablet computers. Participants in the control group will receive general health promotion topics relevant to preschool-age children via mailing materials weekly for eight weeks.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • San Francisco, California, United States, 64143
        • University of California San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Children:
  • must be between ages three and five
  • have a mother who identifies her child as Chinese;
  • be healthy-defined as free of chronic or acute illness.
  • Mothers:
  • must identify themselves as Chinese
  • the primary provider of the child,
  • be able to speak and read Chinese or English;
  • with a BMI >= 23.0;
  • meet low-income requirements in the Bay Area.

Exclusion Criteria:

  • Have acute or chronic conditions that prevent performing daily activities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Mailing information
Participants in the mailing information group will receive general health promotion topics relevant to preschool-age children (such as immunization, injury prevention and school readiness) via mailing materials that are bilingual weekly for eight weeks. These materials will be obtained from CDC and AAP.
Participants in the control group will receive general health promotion topics relevant to preschool-age children (such as immunization, injury prevention and school readiness) via mailing materials that are bilingual weekly for eight weeks. These materials will be obtained from CDC and AAP.
Experimental: Tablet computer
Participants in the intervention group will receive eight weekly online sessions and interactive activities delivered through tablet computers. Intervention participants will receive instructions for accessing the program via the tablet at an in-person session. Automated weekly emails will be sent to participating mothers for the intervention duration to encourage study engagement.
Participants in the intervention group will receive eight weekly online sessions and interactive activities delivered through tablet computers. Intervention participants will receive instructions for accessing the program via the tablet at an in-person session. Automated weekly emails will be sent to participating mothers for the intervention duration to encourage study engagement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline body mass index at 5 months
Time Frame: Baseline and at 5 months
Participants will have their weight and height measured and body mass index will be calculated. Change of BMI from baseline will be assessed at 5 months post baseline
Baseline and at 5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline physical activity at 2 months
Time Frame: Baseline and 2 months
Participants will wear Actigraphy for 7 days at baseline and at 2 months. Change of physical activity from baseline will be assessed at 2 months post baseline.
Baseline and 2 months
Change from Baseline Sedentary activity at 2 months
Time Frame: baseline and 2 months
Participants will complete Family Eating and Activity Habits Questionnaire at baseline and at 2 month.
baseline and 2 months
Change from Baseline Parental Feeding Practice at 2 months
Time Frame: baseline and 2 months
Participants will complete Child Feeding Questionnaire at baseline and at 2 months . Change of parental feeding practice from baseline will be assessed at 2 months.
baseline and 2 months
Change from Baseline Self-efficacy regarding diet and physical activity at 2 months
Time Frame: baseline and 2 months
Participants will complete self-efficacy questionnaire regarding nutrition and physical behavior at baseline and at 2 months. Change of self-efficacy from baseline will be assessed at 2 months.
baseline and 2 months
Change from baseline physical activity level at 5 months
Time Frame: Baseline and 5 months
Change in baseline physical actiivty level will be measured at 5 months.
Baseline and 5 months
Change from Baseline Sedentary activity at 5 months
Time Frame: baseline and 5 months
Participants will complete Family Eating and Activity Habits Questionnaire at baseline and at 5 months.
baseline and 5 months
Change from Baseline Parental Feeding Practice at 5 months
Time Frame: baseline and 5 months
Participants will complete Child Feeding Questionnaire at baseline and at 5 months . Change of parental feeding practice from baseline will be assessed at 5 months.
baseline and 5 months
Change from Baseline Self-efficacy regarding diet and physical activity at 5 months
Time Frame: baseline and 5 months
Participants will complete self-efficacy questionnaire regarding nutrition and physical behavior at baseline and at 5 months. Change of self-efficacy from baseline will be assessed at 5 months.
baseline and 5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jyu-Lin Chen, PhD, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

March 18, 2013

First Submitted That Met QC Criteria

March 22, 2013

First Posted (Estimate)

March 28, 2013

Study Record Updates

Last Update Posted (Actual)

May 10, 2017

Last Update Submitted That Met QC Criteria

May 9, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HomeTech healthy lifestyle

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Overweight

Clinical Trials on Mailing information

3
Subscribe