Overweight Clinical Trial
Official title:
Educational Intervention on Weight Management in Chinese American Children
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
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