HomeTech Healthy Lifestyle Program for Mothers With Young Children

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2013 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01819987
First received: March 18, 2013
Last updated: September 23, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Overweight
Behavioral: Tablet computer
Behavioral: Mailing information
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Home-based & Technology-centered Childhood Obesity Prevention for Mothers With Young Children

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Change from Baseline body mass index at 5 months [ Time Frame: Baseline and at 5 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 2 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline and 2 months ] [ Designated as safety issue: No ]
    Participants will complete Family Eating and Activity Habits Questionnaire at baseline and at 2 month.

  • Change from Baseline Parental Feeding Practice at 2 months [ Time Frame: baseline and 2 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline and 2 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 5 months ] [ Designated as safety issue: No ]
    Change in baseline physical actiivty level will be measured at 5 months.

  • Change from Baseline Sedentary activity at 5 months [ Time Frame: baseline and 5 months ] [ Designated as safety issue: No ]
    Participants will complete Family Eating and Activity Habits Questionnaire at baseline and at 5 months.

  • Change from Baseline Parental Feeding Practice at 5 months [ Time Frame: baseline and 5 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline and 5 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 30
Study Start Date: January 2014
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: Mailing information
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.
Behavioral: 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01819987

Contacts
Contact: Jyu-Lin Chen, PhD 415-502-6015 jyu-lin.chen@nursing.ucsf.edu

Locations
United States, California
University of California San Francisco Not yet recruiting
San Francisco, California, United States, 64143
Contact: Jyu-Lin Chen, PhD    415-502-6015    jyu-lin.chen@nursing.ucsf.edu   
Principal Investigator: Jyu-Lin Chen, PhD         
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Jyu-Lin Chen, PhD University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01819987     History of Changes
Other Study ID Numbers: HomeTech healthy lifestyle
Study First Received: March 18, 2013
Last Updated: September 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Overweight
mother
childhood obesity prevention
Chinese American

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 24, 2014