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Addressing Health Literacy and Numeracy to Prevent Childhood Obesity

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ClinicalTrials.gov Identifier: NCT03370445
Recruitment Status : Recruiting
First Posted : December 12, 2017
Last Update Posted : January 25, 2019
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:
The aim of the proposed study is to assess the efficacy of a low-literacy/numeracy-oriented intervention to promote healthy lifestyles and preventing obesity among young children in under-resourced communities. The study will occur in pediatric resident physician care practices since nationally, resident practice sites provide care to more than one-fifth of the socioeconomically disadvantaged families in the US.

Condition or disease Intervention/treatment Phase
Childhood Obesity Behavioral: Control Group Behavioral: Greenlight Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Addressing Health Literacy and Numeracy to Prevent Childhood Obesity
Actual Study Start Date : December 31, 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Literacy

Arm Intervention/treatment
Active Comparator: Control "Attention" Intervention
This injury prevention program will act as an "attention placebo" to control against the added attention provided to the intervention group. In addition this injury prevention program will act as an incentive for Pediatric Resident Clinics to participate and maximize retention throughout the study period - as they will know that they will be randomized to one of two beneficial resident education programs.
Behavioral: Control Group
In contrast to the Intervention study, NO training in communication skills will be provided, and NONE of the nutrient/physical activity oriented educational materials will be provided to the Control groups.

Experimental: Greenlight Intervention
The intervention includes the following components: (1) training of pediatric resident physicians in improved health communication skills and (2) a low literacy and numeracy-oriented educational toolkit which promotes healthy diet and physical activity practices.
Behavioral: Greenlight Intervention
The GREENLIGHT Tool Kit will use low-literacy handouts and study-related "gifts" to assess nutrition and physical activity behaviors, and reinforce evidence-based recommendations about early childhood nutrition and physical activity.




Primary Outcome Measures :
  1. Proportion of children at age 24 months who are not overweight [ Time Frame: 24 Months ]
    (defined as BMI <85 percentile for age and gender per the 2000 CDC Growth Charts for Children Age 0-2, and recent Expert Panel Consensus definitions of overweight and obese).


Secondary Outcome Measures :
  1. Weight status of children at 5 years of age [ Time Frame: 5 Years ]
    determined by BMI z-score. BMI z-scores are standardized for BMI percentile, adjusted for age and gende



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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 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

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

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): NCT03370445


Contacts
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Contact: Evelyn Cruzatte, MD 646 501 4286 Evelyn.Cruzatte@nyumc.org

Locations
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United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Evelyn Cruzatte    646-501-4286    Evelyn.Cruzatte@nyumc.org   
Principal Investigator: Hsiang Yin, MD         
Sponsors and Collaborators
NYU Langone Health
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Hsiang Yin, MD NYU Langone Health

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03370445     History of Changes
Other Study ID Numbers: 08-644
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms