A Child Care-based Obesity Prevention Intervention

NCT01679938 | Completed DMC

• 1 other identifier: SALUD-2009-01-114027
• Study Type: interventional
• Target: 640
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 3.To determine the extent to which the intervention, compared with the control condition, results in:
4. 4.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;
5. 5.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;
6. 6.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;
7. 7.To assess the feasibility and acceptability of the intervention among child care providers and families.
8. 8.Training of child care providers.
9. 9.Curriculum sessions for children.
10. 10.Family outreach activities.
11. 11.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

Keywords

obesity prevention; cluster-randomized controlled trial; preschool-aged children

Outcome Measures

Primary Outcomes (1)

• Child's age-associated Body Mass Index

  The investigators will measure standing height for all participants over the age of 3 years, and from 2-3 years when possible. For some participants between age 2 and 3 years requiring recumbent lengths, a recumbent board and the recumbent to standing correction factor recommended by the U.S. Centers for Disease Control and Prevention (0.8 cm)will be used.In all cases, BMI will be the ratio of weight (kg) to the square of standing height (m). Accepted definition of obese (BMI \>95th percentile for age and sex) and overweight (BMI 85th - 95th percentile for age and sex)will be used. All height and weight measurements will be conducted in a private area at the child care sites.

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

Secondary Outcomes (2)

• Children's home environment

  Change from baseline at one year follow-up.

• Children's key obesity-related behaviors.

  Change from baseline at one year of follow-up.

Study Arms (2)

primary obesity prevention

EXPERIMENTAL

The intervention will involve four main components: 1. Training of child care providers. 2. Curriculum sessions for children. 3. Family outreach activities. 4. Maintenance activities.

Behavioral: primary obesity prevention

Control group

NO INTERVENTION

For the control group, usual care will be provided

Interventions

primary obesity prevention BEHAVIORAL

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.

primary obesity prevention

Eligibility Criteria

• Age: 2 Years - 4 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Nacional de Salud Publica, Mexico: lead
• National Council of Science and Technology, Mexico: collaborator
• Instituto Mexicano del Seguro Social: collaborator
• Harvard Pilgrim Health Care: collaborator

Study Sites (1)

Instituto Nacional de Salud Pública

Cuernavaca, Morelos, 62100, Mexico

Location

Related Publications (1)

• Rodriguez-Oliveros G, Haines J, Ortega-Altamirano D, Power E, Taveras EM, Gonzalez-Unzaga MA, Reyes-Morales H. Obesity determinants in Mexican preschool children: parental perceptions and practices related to feeding and physical activity. Arch Med Res. 2011 Aug;42(6):532-9. doi: 10.1016/j.arcmed.2011.10.006. Epub 2011 Oct 21.

  PMID: 22019411 RESULT

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hortensia Reyes-Morales, DrSc

  Instituto Nacional de Salud Publica, Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 24, 2012
• First Posted: September 6, 2012
• Study Start: May 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: May 1, 2013
• Last Updated: August 21, 2018

Record last verified: 2018-08

Locations

ME (1)