Addressing Health Literacy and Numeracy to Prevent Childhood Obesity

NCT01040897 | Completed DMC

• 1 other identifier: 1R01HD059794-01
• Study Type: interventional
• Target: 865
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity Prevention

Keywords

Obesity prevention; Health Literacy; Health Communication

Outcome Measures

Primary Outcomes (1)

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

  2 years

Secondary Outcomes (6)

• BMI z score

  2 years

• Change in Weight/Length z-score over time

  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

• Parental self-efficacy

  2 years

Study Arms (2)

Active Control Arm

ACTIVE COMPARATOR

At Active Comparative Sites, Pediatric Residents will be trained to address injury prevention issues using The Injury Prevention Program (TIPP) approach

Behavioral: Injury Prevention Arm

Health Communication and Obesity Prevention

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

Behavioral: Health Communication and Obesity Prevention

Interventions

Health Communication and Obesity Prevention BEHAVIORAL

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.

Health Communication and Obesity Prevention

Injury Prevention Arm BEHAVIORAL

Pediatric residents will be trained to address injury prevention using the American Academy of Pediatrics (AAP) TIPP materials.

Active Control Arm

Eligibility Criteria

• Age: 6 Weeks - 12 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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
• 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

Sponsors & Collaborators

• Vanderbilt University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• University of Miami: collaborator
• University of North Carolina, Chapel Hill: collaborator
• New York University: collaborator
• Stanford University: collaborator
• Duke University: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (7)

• Sanders LM, Perrin EM, Yin HS, Delamater AM, Flower KB, Bian A, Schildcrout JS, Rothman RL; Greenlight Study Team. A Health-Literacy Intervention for Early Childhood Obesity Prevention: A Cluster-Randomized Controlled Trial. Pediatrics. 2021 May;147(5):e2020049866. doi: 10.1542/peds.2020-049866.

  PMID: 33911032 DERIVED

• Schilling S, Ritter VS, Skinner A, Yin HS, Sanders LM, Rothman RL, Delamater AM, Perrin EM. Relationship Between Parental Locus of Control and Childhood Injury. J Prim Prev. 2020 Dec;41(6):547-565. doi: 10.1007/s10935-020-00615-y. Epub 2020 Oct 26.

  PMID: 33104944 DERIVED

• Heerman WJ, Perrin EM, Sanders LM, Yin HS, Coyne-Beasley T, Bronaugh AB, Barkin SL, Rothman RL. Racial and Ethnic Differences in Injury Prevention Behaviors Among Caregivers of Infants. Am J Prev Med. 2016 Oct;51(4):411-8. doi: 10.1016/j.amepre.2016.04.020. Epub 2016 Jun 9.

  PMID: 27291075 DERIVED

• Wood CT, Skinner AC, Yin HS, Rothman RL, Sanders LM, Delamater AM, Perrin EM. Bottle Size and Weight Gain in Formula-Fed Infants. Pediatrics. 2016 Jul;138(1):e20154538. doi: 10.1542/peds.2015-4538. Epub 2016 Jun 7.

  PMID: 27273748 DERIVED

• Brown CL, Skinner AC, Yin HS, Rothman RL, Sanders LM, Delamater AM, Ravanbakht SN, Perrin EM. Parental Perceptions of Weight During the First Year of Life. Acad Pediatr. 2016 Aug;16(6):558-64. doi: 10.1016/j.acap.2016.03.005. Epub 2016 Mar 19.

  PMID: 27002214 DERIVED

• Sanders LM, Perrin EM, Yin HS, Bronaugh A, Rothman RL; Greenlight Study Team. "Greenlight study": a controlled trial of low-literacy, early childhood obesity prevention. Pediatrics. 2014 Jun;133(6):e1724-37. doi: 10.1542/peds.2013-3867. Epub 2014 May 12.

  PMID: 24819570 DERIVED

• Perrin EM, Rothman RL, Sanders LM, Skinner AC, Eden SK, Shintani A, Throop EM, Yin HS. Racial and ethnic differences associated with feeding- and activity-related behaviors in infants. Pediatrics. 2014 Apr;133(4):e857-67. doi: 10.1542/peds.2013-1326. Epub 2014 Mar 17.

  PMID: 24639273 DERIVED

MeSH Terms

Interventions

Health Communication

Intervention Hierarchy (Ancestors)

Health Care Facilities Workforce and Services

Study Officials

• Russell L Rothman, MD MPP

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

• Lee Sanders, MD MPH

  Stanford University

  PRINCIPAL INVESTIGATOR

• Kori Flower, MD MS MPH

  UNC Chapel Hill

  PRINCIPAL INVESTIGATOR

• Shonna Yin, MD MS

  NYU

  PRINCIPAL INVESTIGATOR

• Alan Delamater, LP PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

• Eliana Perrin, MD MPH

  Duke University

  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: Associate Professor, Internal Medicine & Pediatrics

Study Record Dates

• First Submitted: December 28, 2009
• First Posted: December 30, 2009
• Study Start: April 28, 2010
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: August 21, 2018

Record last verified: 2018-08

Locations

US (1)