- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01722032
USDA Healthy Caregivers/Healthy Children: A Childhood Obesity Prevention Program (HC2)
Healthy Caregivers/Healthy Children
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.
Study Overview
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment
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". |
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No Intervention: Control
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maintenance of a Child's Body Mass Index as a result of the intervention
Time Frame: up to two years
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
A Parent's perception of his/her child's weight status
Time Frame: up to two years
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ruby Natale, PhD, University of Miami
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2009-05065
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