Obesity Clinical Trial
To conduct an integrated, multiple-component, school- and community-based intervention targeting both primary and secondary prevention of obesity among third-fourth-and fifth-graders ("School- and Family-Based Obesity Prevention for Children").
BACKGROUND:
An estimated 25-40 percent of United States pre-adolescents and adolescents are obese.
Higher rates have been noted among minority youth. Onset of obesity in late childhood and
early adolescence is associated with increased risks of "tracking" of obesity into
adulthood, subsequent obesity-related morbidity and mortality, and obesity- related
psychosocial morbidity. However, there is limited ability to accurately identify those
children who will become obese adults and those who will suffer obesity-related morbidities,
Existing treatments for child and adolescent obesity have yielded modest, unsustained
effects, and single-component prevention interventions have been relatively ineffective.
DESIGN NARRATIVE:
The intervention model was derived from principles of Bandura's social cognitive theory, and
included activities in the school, and the home, and a clinically oriented component for
high-risk children. The school component included: a computer-based classroom curriculum; a
physical education curriculum; and a school lunch intervention. The home component included
correspondence materials and a videotape for parents. Children identified as "high risk"
were eligible to enroll in an intensive intervention. In addition, several innovative
approaches were included: interventions to influence food preferences and television
viewing, interventions promoting health advocacy, and computer-assisted instruction.
An "efficacy trial" evaluated the three-year intervention in a cohort of approximately 1200
3rd graders, in 14 ethnically diverse elementary schools, with follow-up in the 6th grade. 7
schools were randomly assigned to the comprehensive intervention, and 7 schools received an
attention-placebo classroom curriculum. Anthropometric measures and assessments of food
preferences, cardio-respiratory fitness and self-reported behavior, attitudes and knowledge
occurred every six months. Parent interviews occurred annually. Although a careful
assessment of effects on parents and the schools was conducted, the crucial question was
whether the overall intervention had an impact on student adiposity and behaviors.
The primary objective was to significantly reduce the prevalence of obesity, compared to
controls, at the end of the three year intervention. Secondary objectives included
maintenance of effects at 6-month follow-up, reducing obesity among high-risk children,
improving cardio-respiratory fitness, increasing physical activity, decreasing sedentary
activity, reducing the prevalence of unhealthful weight control methods, and improving
knowledge, attitudes and perceived self-efficacy regarding the adoption of healthful
behaviors. In addition, the investigators identified personal, behavioral and environmental
(including family) factors prospectively associated with development of obesity, maintenance
of normal weight, weight reduction among overweight children and obesity-related behaviors.
Finally, they examined longitudinal changes in height, weight, body mass index (BMI),
triceps skin fold thickness, and waist and hip circumferences in girls and boys 8 - 12 years
of age, with respect to stages of pubertal development.
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