Overview

This trial is active, not recruiting.

Condition obesity prevention
Treatments health communication and obesity prevention, injury prevention arm
Phase phase 4
Sponsor Vanderbilt University
Collaborator Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Start date December 2009
End date March 2016
Trial size 865 participants
Trial identifier NCT01040897, 1R01HD059794-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose prevention
Arm
(Active Comparator)
At Active Comparative Sites, Pediatric Residents will be trained to address injury prevention issues using The Injury Prevention Program (TIPP) approach
injury prevention arm
Pediatric residents will be trained to address injury prevention using the American Academy of Pediatrics (AAP) TIPP materials.
(Experimental)
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
health communication and obesity prevention
Pediatric residents will be training in effective health communication skills and given a literacy/numeracy sensitive toolkit (GreenLight) to use with parents during all well child visits from 2 months to 18 months.

Primary Outcomes

Measure
Percent of children overweight or obese (BMI ≥ 85th%) at 2 years of life
time frame: 2 years

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 6 weeks up to 12 weeks old.

Specific Inclusion Criteria at the parent-child dyad level will include: - Consent from a primary caregiver (i.e., parent or legal guardian) - Caregiver's ability to speak English or Spanish - Infant presenting for a 2 month well-child visit (child is 6 ≥ 12 weeks old) - Caregiver agrees to participate in the study, and agrees to bring their child to all well-child care visits until their 2 year well-child care visit. Specific Exclusion Criteria at the parent-child dyad level will include: - Child born prior to 32 weeks' gestational age or with a birth weight < 1500 grams - Child with weight/length < 3rd percentile at 2 months of age - Child with a diagnosis of failure to thrive or with weight that has dropped ≥ 2 percentile curves since the previous well child visit - Child with known medical problems that may affect their ability to thrive or requires a special diet (e.g. metabolic disease, uncorrected congenital heart disease, renal disease, lung disease) - Caregiver with significant mental or neurologic illness likely to impair their ability to participate - Caregiver age < 18 years - Caregiver with known plans to move out of the immediate area during the study period - Caregiver with poor visual acuity (i.e. vision worse than 20/50 with Rosenbaum Pocket Screener as assessed at the time of recruitment) Specific Inclusion Criteria at the Pediatric Resident level will include: - Participation in the medical center's pediatric resident training program - Providing regular care (> 3 sessions per month) in the pediatric resident primary care clinic; AND - Consent to participate in the study Specific Exclusion Criteria at the Pediatric Resident level will include: - Providing no regular care in the pediatric resident primary care clinic (e.g., transitional-year resident, Medicine/Pediatrics resident); OR - Known plans to leave the training program during the ensuing 6 months

Additional Information

Official title Addressing Health Literacy and Numeracy to Prevent Childhood Obesity
Principal investigator Russell L Rothman, MD MPP
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Vanderbilt University.