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HomeTech Healthy Lifestyle Program for Mothers With Young Children

Primary Purpose

Overweight

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Tablet computer
Mailing information
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight focused on measuring Overweight, mother, childhood obesity prevention, Chinese American

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of California San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Mailing information

Tablet computer

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Change from Baseline body mass index 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

Secondary Outcome Measures

Change from baseline physical activity at 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.
Change from Baseline Sedentary activity at 2 months
Participants will complete Family Eating and Activity Habits Questionnaire at baseline and at 2 month.
Change from Baseline Parental Feeding Practice at 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.
Change from Baseline Self-efficacy regarding diet and physical activity at 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.
Change from baseline physical activity level at 5 months
Change in baseline physical actiivty level will be measured at 5 months.
Change from Baseline Sedentary activity at 5 months
Participants will complete Family Eating and Activity Habits Questionnaire at baseline and at 5 months.
Change from Baseline Parental Feeding Practice at 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.
Change from Baseline Self-efficacy regarding diet and physical activity at 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.

Full Information

First Posted
March 18, 2013
Last Updated
May 9, 2017
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT01819987
Brief Title
HomeTech Healthy Lifestyle Program for Mothers With Young Children
Official Title
Home-based & Technology-centered Childhood Obesity Prevention for Mothers With Young Children
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
January 2014 (Actual)
Primary Completion Date
June 1, 2016 (Actual)
Study Completion Date
June 1, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight
Keywords
Overweight, mother, childhood obesity prevention, Chinese American

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
A randomized, controlled study was used. The intervention group received tablet based intervention and the control group received printed health information relevant to preschool-aged children in Chinese over the eight weeks.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Participants, investigator and outcome assessor were blinded to the group assignment.
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mailing information
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Tablet computer
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Tablet computer
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mailing information
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline body mass index at 5 months
Description
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
Time Frame
Baseline and at 5 months
Secondary Outcome Measure Information:
Title
Change from baseline physical activity at 2 months
Description
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.
Time Frame
Baseline and 2 months
Title
Change from Baseline Sedentary activity at 2 months
Description
Participants will complete Family Eating and Activity Habits Questionnaire at baseline and at 2 month.
Time Frame
baseline and 2 months
Title
Change from Baseline Parental Feeding Practice at 2 months
Description
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.
Time Frame
baseline and 2 months
Title
Change from Baseline Self-efficacy regarding diet and physical activity at 2 months
Description
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.
Time Frame
baseline and 2 months
Title
Change from baseline physical activity level at 5 months
Description
Change in baseline physical actiivty level will be measured at 5 months.
Time Frame
Baseline and 5 months
Title
Change from Baseline Sedentary activity at 5 months
Description
Participants will complete Family Eating and Activity Habits Questionnaire at baseline and at 5 months.
Time Frame
baseline and 5 months
Title
Change from Baseline Parental Feeding Practice at 5 months
Description
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.
Time Frame
baseline and 5 months
Title
Change from Baseline Self-efficacy regarding diet and physical activity at 5 months
Description
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.
Time Frame
baseline and 5 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jyu-Lin Chen, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
64143
Country
United States

12. IPD Sharing Statement

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HomeTech Healthy Lifestyle Program for Mothers With Young Children

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