Study to Evaluate the Health and Wellness Policies of the New Haven Public School District. (H&A)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Yale University
Sponsor:
Information provided by (Responsible Party):
Jeannette Ickovics, Yale University
ClinicalTrials.gov Identifier:
NCT02043626
First received: January 20, 2014
Last updated: NA
Last verified: January 2014
History: No changes posted
  Purpose

Our long-term objective is to reduce the rates and risk of childhood obesity via school-based nutrition and physical activity policies. Using a randomized design, we propose to monitor and evaluate how Connecticut's first-ranked District Wellness Policy, in the New Haven Public School district, is implemented and determine its impact on children's obesogenic behaviors, weight outcomes, and school performance. This study is designed to significantly advance empirical research on school wellness policies and to provide important evidence to guide future interventions in schools and communities - translating science to improved health of the public.


Condition Intervention
Chronic Diseases
Obesity
Other: DISTRICT WELLNESS COMMITTEE
Other: NUTRITIONAL QUALITY OF FOODS AND BEVERAGES ON CAMPUS
Other: HEALTH PROMOTION AND MARKETING
Other: OPPORTUNITIES FOR PHYSICAL ACTIVITY

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: School Wellness Policy: RCT to Implement & Evaluate Impact on Childhood Obesity

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Change in body mass index (BMI). [ Time Frame: 1 Year (baseline to end of year 1) ] [ Designated as safety issue: No ]
    Body weight and height will be measured in order to calculate BMI from baseline to end of year 1.

  • Change in body mass index (BMI). [ Time Frame: 2 Years (baseline to end of year 2). ] [ Designated as safety issue: No ]
    Body weight and height will be measured in order to calculate BMI from baseline to end of year 2.

  • Change in body mass index (BMI). [ Time Frame: 3 Years (baseline to end of year 3) ] [ Designated as safety issue: No ]
    Body weight and height will be measured in order to calculate BMI from baseline to end of year 3.


Secondary Outcome Measures:
  • Change in student nutritional habits (eating behaviors). [ Time Frame: 1 Year (baseline to end of year 1) ] [ Designated as safety issue: No ]
    Surveying student nutritional habits and close observation of nutritional habits (food consumed) in school.

  • Change in student nutritional habits (eating behaviors). [ Time Frame: 2 Years (baseline to the end of year 2) ] [ Designated as safety issue: No ]
    Surveying student nutritional habits and close observation of nutritional habits (food consumed) in school.

  • Change in student nutritional habits (eating behaviors). [ Time Frame: 3 Years (baseline to the end of year 3) ] [ Designated as safety issue: No ]
    Surveying student nutritional habits and close observation of nutritional habits (food consumed) in school.


Other Outcome Measures:
  • Change in level of physical activity. [ Time Frame: 1 Year (baseline to end of year 1) ] [ Designated as safety issue: No ]
    Surveying of student physical activity habits and observation of student participation in class time or after school physical activity programs.

  • Change in level of physical activity. [ Time Frame: 2 Years (baseline to end of year 2) ] [ Designated as safety issue: No ]
    Surveying of student physical activity habits and observation of student participation in class time or after school physical activity programs.

  • Change in level of physical activity. [ Time Frame: 3 Years (baseline to end of year 3) ] [ Designated as safety issue: No ]
    Surveying of student physical activity habits and observation of student participation in class time or after school physical activity programs.


Estimated Enrollment: 1100
Study Start Date: August 2011
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Physical Activity Only
Students in 3 designated study schools will receive educational intervention and increased opportunities for physical activity.
Other: OPPORTUNITIES FOR PHYSICAL ACTIVITY
District-wide policies include mandates for daily physical activity and PE and development of policies that prohibit withholding PE for punitive reasons. To further increase physical activity, the School Wellness Policy specifies expanding programs/activities that meet need, interest, and abilities of students. Exer-gaming consoles will be provided to 6 schools and will be integrated into 5th-8th grade PE classes and after-school programs. New and innovate gym equipment will be purchased for the 6 target schools for use in gym class and after school programming. Various pedometer and interactive programs encouraging physical activity in and outside of school are planned for the 6th grade.
No Intervention: Delayed Interventions Only
Students in 3 designated schools will receive educational interventions on health topics not related to nutrition or physical activity (i.e. peer relations, sleep, dental care, etc.)
Experimental: Nutrition and Physical Activity
Students in 3 designated schools will receive nutrition education, nutrition standards for foods sold, and opportunities for physical activity.
Other: DISTRICT WELLNESS COMMITTEE
Three Targeted Schools (N+PA) will expand the District's school based wellness initiative, PAW-Physical Activity and Wellness. With District support, PAW schools develop School Wellness Teams (SWTs) to identify school health priorities, implement and sustain health initiatives through school campaigns, promote healthy behavior, and support wellness policies. Results from a 3-year evaluation suggest significant and sustained positive impact on school health culture, student behavior, time-on-task, and increased physical activity among students.
Other: NUTRITIONAL QUALITY OF FOODS AND BEVERAGES ON CAMPUS
Policy changes will focus on 6 target schools. District will expand nutrition education by integrating other opportunities to learn and practice healthy behaviors across disciplines. Farm-to-School programs will include school visits by farmers to teach students about agriculture, healthy foods and nutrition, coinciding with Farmer's Market Menu Days. Schools will receive four 45 minute nutrition workshops per year. Community educators will offer culturally appropriate, interactive nutrition workshops and cooking demonstrations. Cafeterias will receive youth friendly nutritional messaging, regular promotion of new menu foods, and a variety of monthly nutrition-focused activities. The goals are to: increase number of students who try new menu items regularly, increase acceptance of healthy foods, and improve nutrition literacy. Policy states schools will limit celebrations that involve food to no more than 1 per class/month: 6 schools will pilot alternatives to food for celebrations.
Other: HEALTH PROMOTION AND MARKETING
SWP addresses health promotion and marketing by limiting product marketing in schools, expanding nutrition education and broadening health communication with parents. In 3 targeted schools, we expand to include Staff Wellness Promotion. Adults in schools are trusted and influential role models for students; by increasing their positive health behaviors, students may be influenced to adopt similar behaviors. The District will work with the City's Employee Wellness Program to increase school staff participation.
Other: OPPORTUNITIES FOR PHYSICAL ACTIVITY
District-wide policies include mandates for daily physical activity and PE and development of policies that prohibit withholding PE for punitive reasons. To further increase physical activity, the School Wellness Policy specifies expanding programs/activities that meet need, interest, and abilities of students. Exer-gaming consoles will be provided to 6 schools and will be integrated into 5th-8th grade PE classes and after-school programs. New and innovate gym equipment will be purchased for the 6 target schools for use in gym class and after school programming. Various pedometer and interactive programs encouraging physical activity in and outside of school are planned for the 6th grade.
Experimental: Nutrition Only Interventions
Students in 3 designated study schools will receive multiple interventions regarding nutrition education and nutrition standards for foods sold.
Other: NUTRITIONAL QUALITY OF FOODS AND BEVERAGES ON CAMPUS
Policy changes will focus on 6 target schools. District will expand nutrition education by integrating other opportunities to learn and practice healthy behaviors across disciplines. Farm-to-School programs will include school visits by farmers to teach students about agriculture, healthy foods and nutrition, coinciding with Farmer's Market Menu Days. Schools will receive four 45 minute nutrition workshops per year. Community educators will offer culturally appropriate, interactive nutrition workshops and cooking demonstrations. Cafeterias will receive youth friendly nutritional messaging, regular promotion of new menu foods, and a variety of monthly nutrition-focused activities. The goals are to: increase number of students who try new menu items regularly, increase acceptance of healthy foods, and improve nutrition literacy. Policy states schools will limit celebrations that involve food to no more than 1 per class/month: 6 schools will pilot alternatives to food for celebrations.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   9 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Student of the New Haven School District--State of Connecticut
  • Enrolled in 12 eligible schools participating in study
  • Child between the ages of 9 and 14 or in grades 5-8 as of the fall of 2011
  • Primary Language of communication is English

Exclusion Criteria:

  • Not enrolled in one of 12 participating schools
  • Not in target grade (5-8) as of the fall 2011
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02043626

Contacts
Contact: Jeannette Ickovics, PHD jeannette.ickovics@yale.edu
Contact: Suzette Benitez 203-737-6873 Suzette.Benitez@yale.edu

Locations
United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06520
Contact: Jeannette Ickovics, PHD       jeannette.ickovics@yale.edu   
Principal Investigator: Jeannette Ickovics, PHD         
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Jeannette Ickovics, PHD Yale University
  More Information

Publications:
Responsible Party: Jeannette Ickovics, Professor, Yale University
ClinicalTrials.gov Identifier: NCT02043626     History of Changes
Other Study ID Numbers: 5RO1HD070740
Study First Received: January 20, 2014
Last Updated: January 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
childhood nutrition
physical activity
school wellness
school health
nutritional policies
childhood obesity

Additional relevant MeSH terms:
Chronic Disease
Obesity
Disease Attributes
Pathologic Processes
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014