- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01819987
HomeTech Healthy Lifestyle Program for Mothers With Young Children
May 9, 2017 updated by: University of California, San Francisco
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
Intervention / Treatment
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.
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