USDA Healthy Caregivers/Healthy Children: A Childhood Obesity Prevention Program

NCT01722032 | Completed

• 1 other identifier: 2009-05065
• Study Type: interventional
• Target: 1,100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: Many unhealthy dietary and physical activity habits that foster the development of obesity are established by the age of five. Presently, approximately 70 percent of children in the United States are currently enrolled in early childcare facilities, making this an ideal setting to implement and evaluate childhood obesity prevention efforts. We describe here the methods for conducting an obesity prevention intervention randomized trial in the child care setting. Methods/Design: A randomized, controlled obesity prevention trial in 28 low-income, ethnically diverse child care centers located throughout Miami-Dade County, FL is currently being conducted over two years (2010-present) to test the efficacy of an intervention that poises teachers and parents as lifestyle change agents. The Healthy Caregivers-Healthy Children (HC2) program includes a curriculum focusing specifically on healthy food choices, increased exercise, and role modeling. The program targets food policy changes throughout the school, and via the child, caregiver, and teacher. Major outcome measures include child body mass index percentile and z score, fruit and vegetable and other nutritious food intake, and amount of physical activity. Discussion: Although few attempts have been made to prevent obesity during the first years of life, this period may represent the best opportunity for obesity prevention. Findings from this investigation should inform both the fields of childhood obesity prevention and early childhood research about the effects of an obesity prevention program housed in the childcare setting. (H1) A child care center-based obesity prevention intervention program that includes a teacher and parent nutritional gatekeeper and role modeling program will be more effective in maintaining BMI in 3-5 year olds compared to a control group. (H2) Role modeling (teacher and parent) will be identified as a significant mediator in preventing obesity among intervention children versus controls. (H3) A child care center-based multi-level obesity prevention intervention program will improve child nutrition (increased consumption of fruits and vegetables, decreased consumption of sweetened beverages) and increase physical activity level compared to a control group.

Conditions

Childhood Obesity

Keywords

childhood obesity, early childhood, nutrition

Outcome Measures

Primary Outcomes (1)

• Maintenance of a Child's Body Mass Index as a result of the intervention

  Assessment of demographic variables, anthropometrics, food insecurity and parent perception were performed. Sociodemographic variables included age and gender of the children, country of birth of parent and child, years living in the US, and parental education (highest grade completed). Child Health Measures:Anthropometric Variables. Assessment of body composition included height (by stadiometer), weight (by digital scale), which was converted to BMI (weight in kilograms/height in meters squared) and then to a BMI age-and sex-adjusted BMI percentile. Participants were asked to remove shoes and any heavy outer clothing prior to measurement. Weight and height measurements were collected by trained staff based on US Department of Health and Human Services (HHS) guidelines for accurate anthropomorphic measurement. Research grade stadiometers and scales were used, and were brought from site to site by the staff.

  up to two years

Secondary Outcomes (1)

• A Parent's perception of his/her child's weight status

  up to two years

Study Arms (2)

Treatment

EXPERIMENTAL

The intervention centers' menus were modified to include more fresh fruit, fresh vegetables, low-fat (1%) or skim milk, water, less juice, and less simple carbohydrate snacks. The centers were also encouraged to incorporate fresh fruits and vegetables as often as possible for snack and meal time. Physical Activity. Physical activity was promoted for at least 60 minutes per day. TV viewing, watching movies and playing computer games were logged and limited to 30 minutes or less per day. Schools adopted "Best-Practice Policies".

Other: Childhood Obesity

Control

NO INTERVENTION

Those schools randomized to the control arm received a safety curriculum and some child care center locations received an attention control consisting of three visits from the University of Miami Safety Van which provided parents and teachers with home, car and child seat safety information. The control group received all the same pre-post measures as the intervention arms. They also received the same incentives as the intervention arms to foster involvement and ensure retention/reduce loss to follow up.

Interventions

Childhood Obesity OTHER

Treatment

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

Sponsors & Collaborators

• University of Miami: lead

Related Publications (1)

• Natale R, Scott SH, Messiah SE, Schrack MM, Uhlhorn SB, Delamater A. Design and methods for evaluating an early childhood obesity prevention program in the childcare center setting. BMC Public Health. 2013 Jan 28;13:78. doi: 10.1186/1471-2458-13-78.

  PMID: 23356862 DERIVED

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Ruby Natale, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Research Professor

Study Record Dates

• First Submitted: October 26, 2012
• First Posted: November 6, 2012
• Study Start: June 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: November 6, 2012

Record last verified: 2012-11