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

January 12, 2018 updated by: Yale University

School Wellness Policy: RCT to Implement & Evaluate Impact on Childhood Obesity

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Consistent with NIH priorities, our long-term objective is to reduce the rates and risk of childhood obesity via school-based nutrition and physical activity policies. We propose to monitor and evaluate how Connecticut's first-ranked School 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. We will evaluate a strategy of implementation at 12 targeted schools using a randomized design. Focusing on targeted schools will enable a more rigorous evaluation of School Wellness Policy implementation, barriers/facilitators, and ultimately the behavioral and health impacts of school-based policies on childhood obesity. We propose a multi-level assessment of factors that may influence childhood obesity using the Ecological Model as a guiding framework.

Thus we propose a multi-sectoral, multi-level approach, focused on children, families, schools, and community. This ambitious project is possible because of the expertise and strong collaborative partnerships between The New Haven Public Schools and two Yale University research centers: The Rudd Center for Food Policy and Obesity and CARE: Community Alliance for Research and Engagement. Our partnership builds on Principles and Guidelines for Community-University Research Partnerships developed by a 12-member committee of community and university leaders and endorsed by Yale University and community partners in 2009.

This study is designed to significantly advance empirical research on school wellness policies: focused on implementation and measurable impact on student health. No matter how well written, a school wellness policy must be effectively implemented to achieve its potential impact. Further, students within schools represent only two components of a larger socio-ecological system that influences eating behavior, physical activity, and weight status. The federal mandate for school wellness policies requires districts to address many aspects of the school environment (e.g., nutrition education, nutrition standards for foods sold, and opportunities for physical activity). To maximize improvements, this type of multi-component policy is needed. However, this complexity makes it difficult to evaluate policy impact and draw conclusions about the causal relationships between specific policies and student health. With our team's unique strengths and these challenges in mind, we designed this research study with the following Specific Aims:

  1. Track and evaluate a strategy of targeted implementation of a School Wellness Policy.
  2. Identify factors that facilitate or impede implementation of The School Wellness Policy, including neighborhood, school, and student determinants; and
  3. Evaluate the impact of implementation of The School Wellness Policy on obesogenic behaviors and health outcomes as well as school performance.

We will collaborate with the District to implement a subset of nutrition and physical activity policies in 12 schools using a randomized 2 x 2 research design. This will permit comparison of the potential unique and synergistic effects of these nutrition and physical activity policies on student behaviors and related health outcomes. We will follow a cohort of 5th grade students (N≈700) annually for four years to assess potential changes to student eating behaviors, physical activity levels, and BMI. We use a multi-method approach to collect data and examine predictors of these outcomes from across levels of the socio-ecological framework: student variables, family characteristics, school policies, and neighborhood features.

This multidisciplinary proposal is synchronous with specific research objectives articulated in Program Announcement (PA-10-052) School Nutrition and Physical Activity Policies, Obesogenic Behaviors and Weight Outcomes. As noted, few studies to date have examined the policy implementation process. We directly target the implementation and impact of health-related policies in schools, measuring obesogenic behaviors and BMI as primary outcomes. We have an active tracking system to monitor impact of policies, and we focus on minority populations traditionally vulnerable and underserved. As stated by NIH in this program announcement, policy-based approaches to combat obesity in schools exist; however, knowledge is lacking in key areas concerning the optimal policies, key implementation strategies for such policies, and the impact of these policies on important health and social outcomes. The proposed project will advance scientific knowledge and understanding in this arena and provide important evidence to guide future interventions in schools and communities translating science to improved health of the public.

Study Type

Interventional

Enrollment (Actual)

796

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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: 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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in body mass index (BMI).
Time Frame: Baseline through Follow-up: Grades 5-6-7-8
Body weight and height to calculate BMI annually from baseline (grade 5) through follow-up (grade 8)
Baseline through Follow-up: Grades 5-6-7-8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in student nutritional habits (eating behaviors).
Time Frame: Baseline through Follow-up: Grades 5-6-7-8
Surveying student nutritional habits and close observation of nutritional habits (food consumed) in school.
Baseline through Follow-up: Grades 5-6-7-8
Change in level of physical activity.
Time Frame: Baseline through Follow-up: Grades 5-6-7-8
Surveying of student physical activity habits and observation of student participation in class time or after school physical activity programs.
Baseline through Follow-up: Grades 5-6-7-8
Mental Health
Time Frame: Baseline through Follow-up: Grades 5-6-7-8
Strengths and Difficulties Questionnaire screens child mental health problems, five subscales: emotional problems, hyperactivity, relationship, conduct and pro-social behavior.
Baseline through Follow-up: Grades 5-6-7-8
Standardized test scores
Time Frame: Baseline through Follow-up: Grades 5-6-7-8
Standardized test scores, reading and mathematics
Baseline through Follow-up: Grades 5-6-7-8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

  • Principal Investigator: Jeannette Ickovics, PHD, Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

January 20, 2014

First Submitted That Met QC Criteria

January 20, 2014

First Posted (Estimate)

January 23, 2014

Study Record Updates

Last Update Posted (Actual)

January 17, 2018

Last Update Submitted That Met QC Criteria

January 12, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1008007295
  • 5R01HD070740 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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