HomeTech Healthy Lifestyle Program for Mothers With Young Children

Overweight Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01819987
• Other study ID #: HomeTech healthy lifestyle
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 18, 2013
• Last updated: May 9, 2017
• Start date: January 2014
• Est. completion date: June 1, 2016

Study information

• Verified date: May 2017
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 1, 2016
• Est. primary completion date: June 1, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Overweight

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of California San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline and at 5 months
Secondary	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.	Baseline and 2 months
Secondary	Change from Baseline Sedentary activity at 2 months	Participants will complete Family Eating and Activity Habits Questionnaire at baseline and at 2 month.	baseline and 2 months
Secondary	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.	baseline and 2 months
Secondary	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.	baseline and 2 months
Secondary	Change from baseline physical activity level at 5 months	Change in baseline physical actiivty level will be measured at 5 months.	Baseline and 5 months
Secondary	Change from Baseline Sedentary activity at 5 months	Participants will complete Family Eating and Activity Habits Questionnaire at baseline and at 5 months.	baseline and 5 months
Secondary	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.	baseline and 5 months
Secondary	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.	baseline and 5 months