Addressing Health Literacy and Numeracy to Prevent Childhood Obesity (GreenLight)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Miami
University of North Carolina, Chapel Hill
New York University
Stanford University
Information provided by (Responsible Party):
Russell Rothman, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01040897
First received: December 28, 2009
Last updated: December 17, 2013
Last verified: December 2013

December 28, 2009
December 17, 2013
December 2009
June 2014   (final data collection date for primary outcome measure)
Percent of children overweight or obese (BMI ≥ 85th%) at 2 years of life [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Percent of children overweight or obese (BMI >=85th%) at 2 years of life [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01040897 on ClinicalTrials.gov Archive Site
  • BMI z score [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Change in Weight/Length z-score over time [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Parental report of infant eating and physical activity behaviors [ Time Frame: assessed at each well child visit ] [ Designated as safety issue: No ]
  • Parental assessment of physician communication [ Time Frame: each clinic visit ] [ Designated as safety issue: No ]
  • Parental self-efficacy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Physician knowledge and satisfaction [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Addressing Health Literacy and Numeracy to Prevent Childhood Obesity
Addressing Health Literacy and Numeracy to Prevent Childhood Obesity

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Obesity Prevention
  • Behavioral: 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.
  • Behavioral: Injury Prevention Arm
    Pediatric residents will be trained to address injury prevention using the American Academy of Pediatrics (AAP) TIPP materials.
  • Active Comparator: Active Control Arm
    At Active Comparative Sites, Pediatric Residents will be trained to address injury prevention issues using The Injury Prevention Program (TIPP) approach
    Intervention: Behavioral: Injury Prevention Arm
  • Experimental: 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
    Intervention: Behavioral: Health Communication and Obesity Prevention
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
865
June 2014
June 2014   (final data collection date for primary outcome measure)

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
Both
6 Weeks to 12 Weeks
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01040897
1R01HD059794-01
Yes
Russell Rothman, Vanderbilt University
Vanderbilt University
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • University of Miami
  • University of North Carolina, Chapel Hill
  • New York University
  • Stanford University
Principal Investigator: Russell L Rothman, MD MPP Vanderbilt University
Principal Investigator: Lee Sanders, MD MPH Stanford University
Principal Investigator: Eliana Perrin, MD MPH UNC Chapel Hill
Principal Investigator: Shonna Yin, MD MS NYU
Principal Investigator: Alan Delamater, LP PhD University of Miami
Vanderbilt University
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP