A Child Care-based Obesity Prevention Intervention

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.

Conditions

• Obesity

Interventions

BEHAVIORAL

primary obesity prevention

1. Training of child care providers. 2. Curriculum sessions for children. Child care providers will facilitate 12 interactive education sessions that focus on key obesity-related behaviors. 3. 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. 4. 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.

Sponsors & Collaborators

• National Council of Science and Technology, Mexico

  collaborator OTHER

• Instituto Mexicano del Seguro Social

  collaborator OTHER_GOV

• Harvard Pilgrim Health Care

  collaborator OTHER

• Instituto Nacional de Salud Publica, Mexico

  lead OTHER

Principal Investigators

• Hortensia Reyes-Morales, DrSc · Instituto Nacional de Salud Publica, Mexico

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

2 Years

Max Age

4 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2011-05-31

Primary Completion

2012-11-30

Completion

2013-05-31

Countries

• Mexico

Study Locations