- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00522964
Educational Intervention on Weight Management in Chinese-American Children (ABC)
Educational Intervention on Weight Management in Chinese American Children
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Fas
- Fas 3
Kontakter och platser
Studieorter
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California
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San Francisco, California, Förenta staterna, 94143
- UCSF
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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).
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Faktoriell uppgift
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: Intervention
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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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
health behaviors, psychosocial function, and anthropometrics of Chinese-American children
Tidsram: 6 months
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6 months
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Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
insulin, cholesterol, high-density lipoproteins (HDLs), low-density lipoproteins (LDLs), and triglycerides (TGs)
Tidsram: 6 months
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6 months
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Samarbetspartners och utredare
Utredare
- Huvudutredare: Jyu-Lin Chen, PhD, University of California, San Francisco
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- KL2RR024130 (U.S.S. NIH-anslag/kontrakt)
- NIH KL2 RR024130
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