Educational Intervention on Weight Management in Chinese-American Children (ABC)
Primary Purpose
Overweight
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
behavioral intervention
Sponsored by

About this trial
This is an interventional prevention trial for Overweight focused on measuring Chinese-American, Children, Obesity, health behaviors, Behavioral intervention, normal
Eligibility Criteria
Inclusion Criteria:
Eight and ten-year-old Chinese-American children and their parents will be eligible for enrollment if they meet the following criteria:
- Children must be overweight (BMI is between 85th% tile and 94th% tile) or obese (BMI is greater than 95th% tile) based on CDC growth chart
- The adult and child self-identify ethnicity to be Chinese or of Chinese origin and they must reside in the same household to be eligible. A dyad of one adult and one child is the minimum necessary for a household to participate. Two adults per child will be encouraged to participate.
- The child is able to speak and read English.
- The child is in good health, defined as free of an acute or life-threatening disease and able to attend to activities of daily living such as going to school.
- Parents are able to speak English, Mandarin, or Cantonese, and are able to read in English or Chinese and to complete questionnaires.
Exclusion Criteria:
- Children with chronic health problems that include any dietary modifications or activity limitations will be excluded (e.g., diabetes, exercise-induced asthma).
Sites / Locations
- UCSF
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention
Arm Description
Outcomes
Primary Outcome Measures
health behaviors, psychosocial function, and anthropometrics of Chinese-American children
Secondary Outcome Measures
insulin, cholesterol, high-density lipoproteins (HDLs), low-density lipoproteins (LDLs), and triglycerides (TGs)
Full Information
NCT ID
NCT00522964
First Posted
August 28, 2007
Last Updated
August 16, 2009
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT00522964
Brief Title
Educational Intervention on Weight Management in Chinese-American Children
Acronym
ABC
Official Title
Educational Intervention on Weight Management in Chinese American Children
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of California, San Francisco
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A randomized study is proposed to determine effects of 8 weeks of an interactive multimedia educational program compared to waiting list control group on improving health and weight status in Chinese-American children, ages 8 and 10, over a 6 months period. A total of 60 Chinese-American children and their families will be randomized to either the intervention group or waiting list control group. The intervention is based on Social Cognitive Theory and principles of Chinese culture and practices. The intervention program includes a one-hour small-group session for eight weeks for children and two 2-hour small-group sessions for parents. Baseline data will be collected before assigning the children to the intervention or control group. Follow-up data will be collected immediately after the intervention and 3 months and 6-months post intervention. A repeated measures (longitudinal) design employing a linear mixed models approach will be used for analysis.
Detailed Description
The most recent data indicate that the prevalence of overweight and risk of becoming overweight among Chinese Americans aged 6 to 11 years is 31%. Several physical and psychosocial health consequences are associated with childhood overweight and poor physical fitness, including cardiovascular diseases (CVDs), sleep disorders, type 2 diabetes mellitus, low self-esteem, and social withdrawal. Chinese Americans are at a higher risk of developing CVDs and T2DM than are non-Hispanic whites possibly due to genetic differences in body composition and metabolic responses. Therefore, developing programs that focus on preventing overweight and promoting healthy lifestyles in early childhood is imperative in preventing long-term adverse effects of overweight, especially in Chinese-Americans. A randomized study is proposed to examine feasibility and efficacy of a child-centered and family-focused behavioral intervention on improving health behavior, psychosocial function, anthropometrics, and biochemical indices in Chinese-American children.
The primary aim is to test the effect of a multimedia behavioral intervention on the health behaviors, psychosocial function, and anthropometrics of Chinese-American children, ages 8 and 10.
Aim 1a. Children in the intervention group will report a healthier dietary intake (more vegetable and fiber and lower fat) than will children in the control group at 2 months, 4 months and 6-months post baseline assessment.
Aim 1b. Children in the intervention group will report being more active than will children in the control group at 2 months, 4 months and 6-months post baseline assessment.
Aim 1c. Children in the intervention group will report a significantly higher self-efficacy in relation to nutrition and physical activity than will children in the control group at 2 months, 4 months and 6-months post baseline assessment.
Aim 1d. Children in the intervention group will report significantly better coping than will children in the control group at 2 months, 4 months and 6-months post baseline assessment.
Aim 1e. Children in the intervention group will report a greater decrease in BMI than will children in the control group at 6-months post baseline assessment.
Aim 1f. Children in the intervention group will experience a greater decrease in fat mass than will children in the control group at 6-months post baseline assessment.
The secondary aim is to examine the effect of the multimedia behavioral intervention on biochemical indices of health in Chinese-American children, ages 8 and 10.
Aim 2a. Children in the intervention group will experience an increase in insulin sensitivity vs. children in the control group at 6-months post baseline assessment.
Aim 2b. Children in the intervention group will experience an improvement in cholesterol, high-density lipoproteins (HDLs), low-density lipoproteins (LDLs), and triglycerides (TGs) vs. children in the control group at 6- months post baseline assessment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight
Keywords
Chinese-American, Children, Obesity, health behaviors, Behavioral intervention, normal
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
behavioral intervention
Intervention Description
The intervention is based on Social Cognitive Theory and principles of Chinese culture and practices. The intervention program includes a one-hour small-group session for eight weeks for children and two 2-hour small-group sessions for parents.
Primary Outcome Measure Information:
Title
health behaviors, psychosocial function, and anthropometrics of Chinese-American children
Time Frame
6 months
Secondary Outcome Measure Information:
Title
insulin, cholesterol, high-density lipoproteins (HDLs), low-density lipoproteins (LDLs), and triglycerides (TGs)
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Eight and ten-year-old Chinese-American children and their parents will be eligible for enrollment if they meet the following criteria:
Children must be overweight (BMI is between 85th% tile and 94th% tile) or obese (BMI is greater than 95th% tile) based on CDC growth chart
The adult and child self-identify ethnicity to be Chinese or of Chinese origin and they must reside in the same household to be eligible. A dyad of one adult and one child is the minimum necessary for a household to participate. Two adults per child will be encouraged to participate.
The child is able to speak and read English.
The child is in good health, defined as free of an acute or life-threatening disease and able to attend to activities of daily living such as going to school.
Parents are able to speak English, Mandarin, or Cantonese, and are able to read in English or Chinese and to complete questionnaires.
Exclusion Criteria:
Children with chronic health problems that include any dietary modifications or activity limitations will be excluded (e.g., diabetes, exercise-induced asthma).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jyu-Lin Chen, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Educational Intervention on Weight Management in Chinese-American Children
We'll reach out to this number within 24 hrs