CompletedNot Applicable

A Child Care-based Obesity Prevention Intervention

Mexico640 participantsStarted 2011-05

Plain-language 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.

Who can participate

Age range

2 Years – 4 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * IMSS child care centers with at least 40 children aged 2-4 years * Child care center director that is willing to participate in the study and agrees to be randomized to control or intervention conditions. Since the intervention is a primary prevention program, the program will be available to all children, aged 2 to 4 years, at the child care centers, regardless of their current weight status * Children's parents who sign a consent form indicating their permission for their child to participate in the study and their willingness to participate in the measurement activities Exclusion Criteria: * Children with chronic conditions that limit ability to measure height and weight or substantially interfere with growth, physical activity, or dietary recommendations from the measurement activities

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Child's age-associated Body Mass Index

Timeframe: Change from baseline (May 2011) at one year follow-up (November 2012)

Trial details

NCT IDNCT01679938

SponsorInstituto Nacional de Salud Publica, Mexico

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-11

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