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OpenTrials
Completed

NCT Number: NCT01819987

HomeTech Healthy Lifestyle Program 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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of California San Francisco

San Francisco, California, 64143, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tablet computer

Behavioral

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.

Mailing information

Behavioral

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 28, 2013
Registry last updated
May 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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