Addressing Health Literacy and Numeracy to Prevent Childhood Obesity

Childhood Obesity Clinical Trial

Official title:

Addressing Health Literacy and Numeracy to Prevent Childhood Obesity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03370445
• Other study ID #: 08-644
• Status: Recruiting
• Phase: N/A
• Start date: December 31, 2018
• Est. completion date: March 2020

Study information

• Verified date: January 2019
• Source: New York University School of Medicine
• Contact: Evelyn Cruzatte, MD
• Phone: 646 501 4286
• Email: Evelyn.Cruzatte[@]nyumc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Childhood Obesity
• Obesity
• Pediatric Obesity

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York University School of Medicine	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of children at age 24 months who are not overweight	(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).	24 Months
Secondary	Weight status of children at 5 years of age	determined by BMI z-score. BMI z-scores are standardized for BMI percentile, adjusted for age and gende	5 Years