Addressing Health Literacy and Numeracy to Prevent Childhood Obesity

Not Applicable

Completed

• Conditions: Obesity Prevention
• Interventions: Behavioral: Injury Prevention Arm; Behavioral: Health Communication and Obesity Prevention

• Registration Number: NCT01040897
• Lead Sponsor: Vanderbilt University

Brief Summary

In 2003, Surgeon General Richard Carmona suggested that low health literacy is "one of the largest contributors to our nation's epidemic of overweight and obesity." Over 26% of preschool children are now overweight or obese, and children who are overweight by age 24 months are five times as likely as non-overweight children to become overweight adolescents. The aim of the study is to assess the efficacy of a low-literacy/numeracy-oriented intervention aimed at teaching pediatric resident physicians to promote healthy family lifestyles and prevent overweight among young children (age 0-2) and their families in under-resourced communities.

Detailed Description

In 2003, Surgeon General Richard Carmona stated that low health literacy was "one of the largest contributors to our nation's epidemic of overweight and obesity." This assertion is supported by recent studies which have found that low health literacy or numeracy is associated with poorer caregiver breastfeeding knowledge, incorrect mixing of infant formula, difficulty understanding food labels and portion sizes, and higher Body Mass Index (BMI) in adults and children. Of particular concern is the impact of the obesity epidemic on our youngest children. Over 26% of preschool children are now overweight (BMI≥85%) or obese (BMI≥95%) (based on 2007 Health and Human Services/Centers for Disease Control Expert Panel definitions). Rates of obesity in preschool children have doubled over the past decade, with the highest increases among low income and minority children-- the same communities most affected by low health literacy.

To date, clinical efforts to prevent or treat childhood obesity have had limited efficacy. Efforts need to start early, because children who are overweight by age two are five times as likely to become overweight adolescents, and subsequently at higher risk for obesity-related complications including early-onset Type-2 Diabetes and cardiovascular disease. No published clinical studies have rigorously addressed obesity prevention prior to age 2 with a specific low-literacy and numeracy focus. Addressing caregiver health literacy in early childhood is an innovative strategy to promote healthy nutrition and activity among these families and prevent unhealthy weight gain across the child's life, which would have great public health significance by preventing both child and adult chronic illness.

The proposed study is a multi-site randomized, controlled trial to assess the efficacy of a low-literacy/numeracy-oriented intervention designed to promote healthy family lifestyles and to prevent early childhood obesity. The intervention will be delivered through pediatric resident physicians in primary care settings in under-resourced communities. Four academic medical centers will be randomized: Vanderbilt University, the University of Miami, the University of North Carolina at Chapel Hill, and New York University. Two centers will receive the intervention, while the other two centers will receive an active control. At each site, a cohort of 250 English- or Spanish-speaking caregiver-child dyads will be enrolled and followed from the child's 2 month well-child visit through the 24-month well-child visit. The intervention will include a low-literacy-oriented toolkit for pediatric residents to use with families and clear health communication training for the pediatric residents. At control sites, pediatric residents will provide "usual care" with respect to lifestyle counseling, but they will also receive an injury-prevention education program to act as an attention control. The primary hypotheses are that the intervention will improve family dietary and physical activity behaviors and that it will reduce the rate of childhood overweight (BMI≥85%) at age 24 months.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2009-12-28
• Study First Submitted QC: 2009-12-28
• Study First Posted: 2009-12-30
• Study Start: 2010-04-28
• Primary Completion: 2014-10-01
• Study Completion: 2014-10-01
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-19
• Last Update Posted: 2018-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 865

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active Control Arm	Injury Prevention Arm	At Active Comparative Sites, Pediatric Residents will be trained to address injury prevention issues using The Injury Prevention Program (TIPP) approach
Health Communication and Obesity Prevention	Health Communication and Obesity Prevention	Pediatric Residents will be training in effective health communication skills and given a toolkit of literacy/numeracy sensitive educational materials to use with families with children age 2 months to18 months during each well child visit

Primary Outcome Measures

Name	Time	Method
Percent of children overweight or obese (BMI ≥ 85th%) at 2 years of life	2 years

Secondary Outcome Measures

Name	Time	Method
Parental self-efficacy	2 years
Physician knowledge and satisfaction	2 years
Change in Weight/Length z-score over time	2 years
BMI z score	2 years
Parental report of infant eating and physical activity behaviors	assessed at each well child visit
Parental assessment of physician communication	each clinic visit

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States