Addressing Health Literacy and Numeracy to Prevent Childhood Obesity
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03370445|
Recruitment Status : Recruiting
First Posted : December 12, 2017
Last Update Posted : January 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Childhood Obesity||Behavioral: Control Group Behavioral: Greenlight Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||450 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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).
- 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
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
|Contact: Evelyn Cruzatte, MD||646 501 4286||Evelyn.Cruzatte@nyumc.org|
|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|
|Principal Investigator:||Hsiang Yin, MD||NYU Langone Health|