Educational Intervention on Weight Management in Chinese-American Children

Overweight Clinical Trial

— ABC  

Official title:

Educational Intervention on Weight Management in Chinese American Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00522964
• Other study ID #: KL2RR024130
• Secondary ID: NIH KL2 RR024130
• Status: Completed
• Phase: Phase 3
• First received: August 28, 2007
• Last updated: August 16, 2009
• Start date: May 2006
• Est. completion date: April 2009

Study information

• Verified date: August 2009
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 10 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Overweight

Intervention

Behavioral:
• behavioral intervention
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.

Locations

Country	Name	City	State
United States	UCSF	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	health behaviors, psychosocial function, and anthropometrics of Chinese-American children		6 months	No
Secondary	insulin, cholesterol, high-density lipoproteins (HDLs), low-density lipoproteins (LDLs), and triglycerides (TGs)		6 months	No