Obesity PreventionGreenLightNCT01040897
Addressing Health Literacy and Numeracy to Prevent Childhood Obesity
A study testing Health Communication and Obesity Prevention and Injury Prevention Arm in people with Obesity Prevention, run by Vanderbilt University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 12 weeksHealthy volunteers can take part
- Conditions the study is for
- Obesity Prevention
- What is being tested?
- Health Communication and Obesity Prevention and Injury Prevention Arm
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 865 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2010to 1 Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 weeks
- All sexes
- Healthy volunteers accepted
- Child
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
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.
Read the 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.
- Conditions
- Obesity Prevention
- Being tested
- Health Communication and Obesity Prevention, Injury Prevention Arm
- Keywords
- Obesity prevention, Health Literacy, Health Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Communication and Obesity PreventionBehavioural
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.
Injury Prevention ArmBehavioural
Pediatric residents will be trained to address injury prevention using the American Academy of Pediatrics (AAP) TIPP materials.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: Health Communication and Obesity Prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of children overweight or obese (BMI ≥ 85th%) at 2 years of life
Measured: 2 years
Secondary outcomes (6)
BMI z score
Measured: 2 years
Change in Weight/Length z-score over time
Measured: 2 years
Parental report of infant eating and physical activity behaviors
Measured: assessed at each well child visit
Parental assessment of physician communication
Measured: each clinic visit
Parental self-efficacy
Measured: 2 years
Physician knowledge and satisfaction
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2009 (estimated)
- Study start28 Apr 2010
- Primary completion1 Oct 2014
- Study completion1 Oct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Obesity PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 865 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- 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, Duke University
- Responsible party
- Principal investigator, Russell Rothman, Vanderbilt University
- Investigators
- Russell L Rothman, MD MPP, Principal investigator, Vanderbilt UniversityLee Sanders, MD MPH, Principal investigator, Stanford UniversityKori Flower, MD MS MPH, Principal investigator, UNC Chapel HillShonna Yin, MD MS, Principal investigator, NYUAlan Delamater, LP PhD, Principal investigator, University of MiamiEliana Perrin, MD MPH, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01040897
- Sponsor's protocol ID
- 1R01HD059794-01
- Acronym
- GreenLight
- Status last verified
- Aug 2018
- First submitted
- 28 Dec 2009
- Last updated
- 21 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Orr CJ, Perrin EM, Heerman WJ, Yang Y, Lin FC, Rothman RL, Sanders LM, Yin HS, Wood CT, Delamater AM, Flower KB. Timing of Food Insecurity and Associations with Parent Feeding Behaviors and Toddler Weight Status. Child Obes. 2026 Apr;22(3):173-181. doi: 10.1177/21532176261423260. Epub 2026 Feb 27.
PubMed 41761570Sanders 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.
PubMed 33911032Schilling 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.
PubMed 33104944Heerman 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.
PubMed 27291075Wood 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.
PubMed 27273748Brown 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.
PubMed 27002214Sanders 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.
PubMed 24819570Perrin 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.
PubMed 24639273
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Health Literacy and Numeracy to Prevent Childhood Obesity
- ClinicalTrials.gov ID
- NCT01040897
- Acronym / sponsor ID
- GreenLight / 1R01HD059794-01
- Conditions
- Obesity Prevention
- Keywords
- Obesity prevention, Health Literacy, Health Communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 865 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- 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, Duke University
- Study start
- 28 Apr 2010 (actual)
- Primary completion
- 1 Oct 2014 (actual)
- Study completion
- 1 Oct 2014 (actual)
- First posted
- 30 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Control Arm | Active comparator | Behavioral: Injury Prevention ArmAt 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 | Experimental | Behavioral: Health Communication and Obesity PreventionPediatric 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 |
Who may qualify
- Ages
- 6 to 12 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health Communication and Obesity PreventionPediatric 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. | Behavioural | Health Communication and Obesity Prevention |
| Injury Prevention ArmPediatric residents will be trained to address injury prevention using the American Academy of Pediatrics (AAP) TIPP materials. | Behavioural | Active Control Arm |
Primary outcome
Percent of children overweight or obese (BMI ≥ 85th%) at 2 years of life
Time frame: 2 years
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2018.
- Derived from this study: PubMed 41761570Orr CJ, Perrin EM, Heerman WJ, Yang Y, Lin FC, Rothman RL, Sanders LM, Yin HS, Wood CT, Delamater AM, Flower KB. Timing of Food Insecurity and Associations with Parent Feeding Behaviors and Toddler Weight Status. Child Obes. 2026 Apr;22(3):173-181. doi: 10.1177/21532176261423260. Epub 2026 Feb 27.
- Derived from this study: PubMed 33911032Sanders 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.
- Derived from this study: PubMed 33104944Schilling 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.
- Derived from this study: PubMed 27291075Heerman 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.
- Derived from this study: PubMed 27273748Wood 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.
- Derived from this study: PubMed 27002214Brown 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.
- Derived from this study: PubMed 24819570Sanders 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.
- Derived from this study: PubMed 24639273Perrin 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.
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Healthy Volunteers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Russell L Rothman, MD MPP principal investigator
Vanderbilt University
Lee Sanders, MD MPH principal investigator
Stanford University
Kori Flower, MD MS MPH principal investigator
UNC Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Communication and Obesity Prevention and Injury Prevention Arm in people with Obesity Prevention, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of children overweight or obese (BMI ≥ 85th%) at 2 years of life (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01040897, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2018.