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HomeTech Healthy Lifestyle Program for Mothers With Young Children

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ClinicalTrials.gov Identifier: NCT01819987
Recruitment Status : Completed
First Posted : March 28, 2013
Last Update Posted : May 10, 2017
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Overweight Behavioral: Tablet computer Behavioral: Mailing information Phase 1 Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Participants, investigator and outcome assessor were blinded to the group assignment.
Primary Purpose: Prevention
Official Title: Home-based & Technology-centered Childhood Obesity Prevention for Mothers With Young Children
Actual Study Start Date : January 2014
Primary Completion Date : June 1, 2016
Study Completion Date : June 1, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Healthy Living
U.S. FDA Resources

Arms and Interventions

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.
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.


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01819987


Locations
United States, California
University of California San Francisco
San Francisco, California, United States, 64143
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Jyu-Lin Chen, PhD University of California, San Francisco
More Information

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01819987     History of Changes
Other Study ID Numbers: HomeTech healthy lifestyle
First Posted: March 28, 2013    Key Record Dates
Last Update Posted: May 10, 2017
Last Verified: May 2017

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