A Child Care-based Obesity Prevention Intervention
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The overall objective is to determine the impact of comprehensive, multifaceted, child
      care-based intervention to prevent obesity among children 2 through 5 years of age. The
      specific aims are:

        1. To determine the extent to which the intervention, compared with the control condition,
           results in a smaller age-associated increase in body mass index (BMI) after a 6-month
           intervention (primary outcome) and a 1-year follow-up period among children.

        2. To determine the extent to which the intervention, compared with the control condition,
           reduces the proportion of children who are obese (BMI >95th percentile for age and sex).

        3. To determine the extent to which the intervention, compared with the control condition,
           results in:

             1. improved dietary, physical activity and television-viewing behaviors among
                children, specifically, reducing the consumption of sugar-sweetened beverages, high
                calorie/low nutrient-dense snack foods, and fast food, increasing active time, and
                reducing TV/video viewing time;

             2. improved home food and activity environment, specifically, decreasing availability
                of sugar-sweetened beverages and high calorie/low nutrient-dense snack foods, and
                increasing parental support for healthy eating and regular physical activity;

             3. improved child care center food and activity environment, specifically, increasing
                opportunities for healthy eating and physical activity, and increasing support and
                encouragement of children's behavior change by child care providers;

        4. To assess the feasibility and acceptability of the intervention among child care
           providers and families.

      METHODS. The investigators will conduct a cluster-randomized controlled trial in 16 IMSS
      child care centers in Mexico City. The investigators will randomly assign 8 child care
      centers to the intervention condition and 8 to an assessment-only control condition.

      Multifaceted intervention. The resulting intervention will involve four main components:

        1. Training of child care providers.

        2. Curriculum sessions for children.

        3. Family outreach activities.

        4. Maintenance activities. Outcome and process measurements. Age-associated BMI (child's),
           changes in child's key obesity-related behaviors, changes in the child's home food and
           activity environment, and changes in child care food and activity environment. At the
           intervention and control child care sites, changes from baseline to one year for all
           outcome variables will be measured.
    

Detailed description: 
      Over the past 20 years, the prevalence of obesity in Mexico has increased dramatically among
      individuals across the lifespan, including even the youngest populations.National data from
      the Mexican Institute of Social Security (IMSS) population estimate that nearly 15% of
      children aged 2 to 5 years are obese as defined by World Health Organization criteria.
      Obesity among preschool-aged children is of serious public health concern due to its adverse
      effects on children's physical and psychosocial well-being,and its association with obesity
      risk in later childhood, adolescence, and young adulthood. Furthermore, because dietary and
      activity patterns have not been firmly established, early childhood represents a critical
      window for prevention.

      Given the high number of preschool children enrolled in out-of-home child care in Mexico,
      important opportunities exist for developing child care-based obesity prevention
      interventions focused on promoting healthy activity and dietary behaviors among children.
      Child care centers provide an ideal setting for a multi-level, ecologic intervention that
      includes strategies aimed at environmental level changes within the child care center, as
      well as individual level behavior change among the children. In addition, child care-based
      interventions have the potential to reach out to the children's families to improve the
      child's home food and activity environment.

      Setting and study population. There are 142 IMSS child care centers in Mexico City. To allow
      for adequate attention to details in the development of the intervention and evaluation
      protocol and to contain costs prior to broad dissemination of the program, the investigators
      will focus on 16 IMSS child care sites for this proposal, which together provide care for
      approximately 450 children aged 2 to 5 years. At each IMSS child care center a team
      consisting of a nutritionist, a nurse, an educator, and child care technicians provides the
      daily care and education programs for the children. This extensive personnel structure
      provides the ideal infrastructure for implementing the proposed multifaceted intervention.

      Since the intervention is a primary prevention program, the investigators will make the
      program available to all children, aged 2 to 5 years, at the child care centers, regardless
      of their current weight status. Children with chronic conditions that limit ability to
      measure height and weight or substantially interfere with growth, physical activity, or
      dietary recommendations will be excluded.

      Data analysis for outcome measures. Intent-to-treat analyses to compare study outcomes
      between the intervention and control groups at post-intervention and at 6-months follow-up
      will be used. To compare the difference the age-associated increase in body mass index (BMI)
      among intervention and control groups (Aim 1), the mixed effects model with group (child care
      center) as the clustering factor will be used, as recommended by several authoritative
      sources. Similar analyses to compare the difference in prevalence of overweight (Aim 2), in
      the children's weight-related behaviors (Aim 3a), in the children's home environment (Aim
      3b), and in the environment of the child care center (Aim 3c) will be performed.
    

Intervention name(s): primary obesity prevention
Intervention type(s): Behavioral
Intervention description(s): Training of child care providers.
Curriculum sessions for children. Child care providers will facilitate 12 interactive education sessions that focus on key obesity-related behaviors.
Family outreach activities. Child care providers and research staff will communicate behavior change messages to families through ten take-home activities focused on key obesity-related behaviors and through monthly family workshops at the child care center.
Maintenance activities. Over the six months following the main intervention, research staff will conduct eight booster sessions for the children and one booster session for the family that will build upon activities and behavior change messages of the main intervention.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: obesity prevention; cluster-randomized controlled trial; preschool-aged children