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

Childhood Obesity Clinical Trial

— HC2  

Official title:

Healthy Caregivers/Healthy Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01722032
• Other study ID #: 2009-05065
• Status: Completed
• Phase: N/A
• First received: October 26, 2012
• Last updated: November 2, 2012
• Start date: June 2010
• Est. completion date: September 2012

Study information

• Verified date: November 2012
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: University of Miami, Human Subjects Research Office
• Study type: Interventional

Clinical Trial 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.

Description:

Over one third of preschoolers were either overweight (18.4%) or obese (16.5%). The majority (92%) of caregivers of an overweight/obese child inaccurately perceived that their child was in a normal BMI category. Foreign-born caregivers were significantly more likely to inaccurately perceive their child's BMI percentile category, versus US-born caregivers (OR=0.65, 95% CI, 0.48-0.88). Specifically, those born in South America [OR=0.59. 95% CI, 0.36-0.98), Central America/Mexico (OR=0.59, 95% CI,0.41-0.85), and Caribbean Hispanic nations [OR=0.54, 95% CI 0.35-0.83) were significantly less likely to accurately perceive their child's BMI category, versus US-born caregivers.

Conclusions: The results of this study suggest that foreign-born parents of preschool-age overweight/obese children in particular do not accurately perceive their child's BMI status. Pediatricians and other healthcare providers serving foreign-born caregivers may consider additional healthy weight counseling for these families.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1100
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 5 Years

Eligibility

Inclusion Criteria. Centers must have met the following criteria to be included: (1) have > 30 children ages 2-5 enrolled; (2) Serve low income families who are a part of the USDA food program and SNAP eligible; (3) Reflect the ethnic distribution of the Miami-Dade County Public School System (63 percent Hispanic, 19 percent African American, 18 percent white); and (4) Center directors agree to participate and sign a letter of commitment. Studies were excluded if they did not meet these criteria.

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Childhood Obesity
• Obesity
• Pediatric Obesity

Intervention

Other:
• Childhood Obesity

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	A Parent's perception of his/her child's weight status	Caregiver Measures. To assess parent perception of child weight status, the child's actual weight status (determined by BMI percentile group) was compared to the caregivers' response to the question "Do you consider your child to be overweight, underweight or about right weight for (his/her) age?" Food insecurity was measured by the short form of the USDA's Food Security Scale. This information was obtained by means of a structured parent interview or a self-administered survey. Caregiver BMI was obtained by self reported height and weight included on the caregivers survey. Parent acculturation was measured by items from the Stephenson Acculturation Scale.	up to two years	No