Addressing Health Literacy and Numeracy to Prevent Childhood Obesity (GreenLight)
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|ClinicalTrials.gov Identifier: NCT01040897|
Recruitment Status : Active, not recruiting
First Posted : December 30, 2009
Last Update Posted : July 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Obesity Prevention||Behavioral: Health Communication and Obesity Prevention Behavioral: Injury Prevention Arm||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||865 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Addressing Health Literacy and Numeracy to Prevent Childhood Obesity|
|Study Start Date :||December 2009|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||December 2018|
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
Behavioral: Injury Prevention Arm
Pediatric residents will be trained to address injury prevention using the American Academy of Pediatrics (AAP) TIPP materials.
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
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.
- Percent of children overweight or obese (BMI ≥ 85th%) at 2 years of life [ Time Frame: 2 years ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01040897
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||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|