Educational Intervention on Weight Management in Chinese-American Children (ABC)

This study has been completed.
Sponsor:
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00522964
First received: August 28, 2007
Last updated: August 16, 2009
Last verified: August 2009
  Purpose

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.


Condition Intervention Phase
Overweight
Behavioral: behavioral intervention
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Educational Intervention on Weight Management in Chinese American Children

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • health behaviors, psychosocial function, and anthropometrics of Chinese-American children [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • insulin, cholesterol, high-density lipoproteins (HDLs), low-density lipoproteins (LDLs), and triglycerides (TGs) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: May 2006
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.

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.

  Eligibility

Ages Eligible for Study:   8 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00522964

Locations
United States, California
UCSF
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Jyu-Lin Chen, PhD University of California, San Francisco
  More Information

No publications provided

Responsible Party: Jyu-Lin Chen; Assistant Professor, UCSF
ClinicalTrials.gov Identifier: NCT00522964     History of Changes
Other Study ID Numbers: KL2RR024130, NIH KL2 RR024130
Study First Received: August 28, 2007
Last Updated: August 16, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Chinese-American
Children
Obesity
health behaviors
Behavioral intervention
normal

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014