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

Primary Purpose

Chronic Diseases, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DISTRICT WELLNESS COMMITTEE
NUTRITIONAL QUALITY OF FOODS AND BEVERAGES ON CAMPUS
HEALTH PROMOTION AND MARKETING
OPPORTUNITIES FOR PHYSICAL ACTIVITY
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Diseases focused on measuring childhood nutrition, physical activity, school wellness, school health, nutritional policies, childhood obesity

Eligibility Criteria

9 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Yale University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Experimental

Experimental

Arm Label

Physical Activity Only

Delayed Interventions Only

Nutrition and Physical Activity

Nutrition Only Interventions

Arm Description

Students in 3 designated study schools will receive educational intervention and increased opportunities for physical activity.

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.)

Students in 3 designated schools will receive nutrition education, nutrition standards for foods sold, and opportunities for physical activity.

Students in 3 designated study schools will receive multiple interventions regarding nutrition education and nutrition standards for foods sold.

Outcomes

Primary Outcome Measures

Change in body mass index (BMI).
Body weight and height to calculate BMI annually from baseline (grade 5) through follow-up (grade 8)

Secondary Outcome Measures

Change in student nutritional habits (eating behaviors).
Surveying student nutritional habits and close observation of nutritional habits (food consumed) in school.
Change in level of physical activity.
Surveying of student physical activity habits and observation of student participation in class time or after school physical activity programs.
Mental Health
Strengths and Difficulties Questionnaire screens child mental health problems, five subscales: emotional problems, hyperactivity, relationship, conduct and pro-social behavior.
Standardized test scores
Standardized test scores, reading and mathematics

Full Information

First Posted
January 20, 2014
Last Updated
January 12, 2018
Sponsor
Yale University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT02043626
Brief Title
Study to Evaluate the Health and Wellness Policies of the New Haven Public School District.
Acronym
H&A
Official Title
School Wellness Policy: RCT to Implement & Evaluate Impact on Childhood Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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: Track and evaluate a strategy of targeted implementation of a School Wellness Policy. Identify factors that facilitate or impede implementation of The School Wellness Policy, including neighborhood, school, and student determinants; and 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Diseases, Obesity
Keywords
childhood nutrition, physical activity, school wellness, school health, nutritional policies, childhood obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
796 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physical Activity Only
Arm Type
Experimental
Arm Description
Students in 3 designated study schools will receive educational intervention and increased opportunities for physical activity.
Arm Title
Delayed Interventions Only
Arm Type
No Intervention
Arm Description
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.)
Arm Title
Nutrition and Physical Activity
Arm Type
Experimental
Arm Description
Students in 3 designated schools will receive nutrition education, nutrition standards for foods sold, and opportunities for physical activity.
Arm Title
Nutrition Only Interventions
Arm Type
Experimental
Arm Description
Students in 3 designated study schools will receive multiple interventions regarding nutrition education and nutrition standards for foods sold.
Intervention Type
Other
Intervention Name(s)
DISTRICT WELLNESS COMMITTEE
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
NUTRITIONAL QUALITY OF FOODS AND BEVERAGES ON CAMPUS
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
HEALTH PROMOTION AND MARKETING
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
OPPORTUNITIES FOR PHYSICAL ACTIVITY
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in body mass index (BMI).
Description
Body weight and height to calculate BMI annually from baseline (grade 5) through follow-up (grade 8)
Time Frame
Baseline through Follow-up: Grades 5-6-7-8
Secondary Outcome Measure Information:
Title
Change in student nutritional habits (eating behaviors).
Description
Surveying student nutritional habits and close observation of nutritional habits (food consumed) in school.
Time Frame
Baseline through Follow-up: Grades 5-6-7-8
Title
Change in level of physical activity.
Description
Surveying of student physical activity habits and observation of student participation in class time or after school physical activity programs.
Time Frame
Baseline through Follow-up: Grades 5-6-7-8
Title
Mental Health
Description
Strengths and Difficulties Questionnaire screens child mental health problems, five subscales: emotional problems, hyperactivity, relationship, conduct and pro-social behavior.
Time Frame
Baseline through Follow-up: Grades 5-6-7-8
Title
Standardized test scores
Description
Standardized test scores, reading and mathematics
Time Frame
Baseline through Follow-up: Grades 5-6-7-8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeannette Ickovics, PHD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24320151
Citation
Ickovics JR, Carroll-Scott A, Peters SM, Schwartz M, Gilstad-Hayden K, McCaslin C. Health and academic achievement: cumulative effects of health assets on standardized test scores among urban youth in the United States. J Sch Health. 2014 Jan;84(1):40-8. doi: 10.1111/josh.12117.
Results Reference
background
PubMed Identifier
23671041
Citation
Kallem S, Carroll-Scott A, Rosenthal L, Chen E, Peters SM, McCaslin C, Ickovics JR. Shift-and-persist: a protective factor for elevated BMI among low-socioeconomic-status children. Obesity (Silver Spring). 2013 Sep;21(9):1759-63. doi: 10.1002/oby.20195. Epub 2013 May 13.
Results Reference
background
PubMed Identifier
23631343
Citation
Kallem S, Carroll-Scott A, Gilstad-Hayden K, Peters SM, McCaslin C, Ickovics JR. Children's report of lifestyle counseling differs by BMI status. Child Obes. 2013 Jun;9(3):216-22. doi: 10.1089/chi.2012.0100. Epub 2013 Apr 30.
Results Reference
background
PubMed Identifier
26989876
Citation
Wang S, Schwartz MB, Shebl FM, Read M, Henderson KE, Ickovics JR. School breakfast and body mass index: a longitudinal observational study of middle school students. Pediatr Obes. 2017 Jun;12(3):213-220. doi: 10.1111/ijpo.12127. Epub 2016 Mar 17.
Results Reference
background
PubMed Identifier
26469652
Citation
Carroll-Scott A, Gilstad-Hayden K, Rosenthal L, Eldahan A, McCaslin C, Peters SM, Ickovics JR. Associations of Neighborhood and School Socioeconomic and Social Contexts With Body Mass Index Among Urban Preadolescent Students. Am J Public Health. 2015 Dec;105(12):2496-502. doi: 10.2105/AJPH.2015.302882. Epub 2015 Oct 15.
Results Reference
background
PubMed Identifier
26320906
Citation
Chandler I, Rosenthal L, Carroll-Scott A, Peters SM, McCaslin C, Ickovics JR. Adolescents Who Visit the Emergency Department Are More Likely to Make Unhealthy Dietary Choices: An Opportunity for Behavioral Intervention. J Health Care Poor Underserved. 2015 Aug;26(3):701-11. doi: 10.1353/hpu.2015.0086.
Results Reference
background
PubMed Identifier
25676784
Citation
Schwartz DL, Gilstad-Hayden K, Carroll-Scott A, Grilo SA, McCaslin C, Schwartz M, Ickovics JR. Energy drinks and youth self-reported hyperactivity/inattention symptoms. Acad Pediatr. 2015 May-Jun;15(3):297-304. doi: 10.1016/j.acap.2014.11.006. Epub 2015 Feb 9.
Results Reference
background
PubMed Identifier
26317365
Citation
Schwartz MB, Gilstad-Hayden K, Henderson KE, Luedicke J, Carroll-Scott A, Peters SM, McCaslin C, Ickovics JR. The Relationship between Parental Behaviors and Children's Sugary Drink Consumption Is Moderated by a Television in the Child's Bedroom. Child Obes. 2015 Oct;11(5):560-8. doi: 10.1089/chi.2014.0041. Epub 2015 Aug 28.
Results Reference
background
PubMed Identifier
24155192
Citation
Rosenthal L, Earnshaw VA, Carroll-Scott A, Henderson KE, Peters SM, McCaslin C, Ickovics JR. Weight- and race-based bullying: health associations among urban adolescents. J Health Psychol. 2015 Apr;20(4):401-12. doi: 10.1177/1359105313502567. Epub 2013 Oct 22.
Results Reference
background
PubMed Identifier
25724990
Citation
Jernigan MM, Rosenthal L, Carroll-Scott A, Peters SM, McCaslin C, Ickovics JR. Emotional Health Predicts Changes in Body Mass Index (BMI-z) Among Black and Latino Youth. Clin Pediatr (Phila). 2015 Jun;54(7):693-6. doi: 10.1177/0009922815574080. Epub 2015 Feb 26. No abstract available.
Results Reference
background
PubMed Identifier
24990227
Citation
Smith LP, Gilstad-Hayden K, Carroll-Scott A, Ickovics J. High waist circumference is associated with elevated blood pressure in non-Hispanic White but not Hispanic children in a cohort of pre-adolescent children. Pediatr Obes. 2014 Dec;9(6):e145-8. doi: 10.1111/ijpo.246. Epub 2014 Jul 3.
Results Reference
background
PubMed Identifier
25040118
Citation
Gilstad-Hayden K, Carroll-Scott A, Rosenthal L, Peters SM, McCaslin C, Ickovics JR. Positive school climate is associated with lower body mass index percentile among urban preadolescents. J Sch Health. 2014 Aug;84(8):502-6. doi: 10.1111/josh.12177.
Results Reference
background
PubMed Identifier
24955021
Citation
Earnshaw VA, Rosenthal L, Carroll-Scott A, Peters SM, McCaslin C, Ickovics JR. Teacher Involvement as a Protective Factor from the Association between Race-Based Bullying and Smoking Initiation. Soc Psychol Educ. 2014 Jun 1;17(2):197-209. doi: 10.1007/s11218-014-9250-1.
Results Reference
background
PubMed Identifier
23642646
Citation
Carroll-Scott A, Gilstad-Hayden K, Rosenthal L, Peters SM, McCaslin C, Joyce R, Ickovics JR. Disentangling neighborhood contextual associations with child body mass index, diet, and physical activity: the role of built, socioeconomic, and social environments. Soc Sci Med. 2013 Oct;95:106-14. doi: 10.1016/j.socscimed.2013.04.003. Epub 2013 Apr 10.
Results Reference
background
PubMed Identifier
30573151
Citation
Ickovics JR, Duffany KO, Shebl FM, Peters SM, Read MA, Gilstad-Hayden KR, Schwartz MB. Implementing School-Based Policies to Prevent Obesity: Cluster Randomized Trial. Am J Prev Med. 2019 Jan;56(1):e1-e11. doi: 10.1016/j.amepre.2018.08.026.
Results Reference
derived
PubMed Identifier
30467088
Citation
Assoumou SA, Wang J, Tasillo A, Eftekhari Yazdi G, Tsui JI, Strick L, Linas BP. Hepatitis C Testing and Patient Characteristics in Washington State's Prisons Between 2012 and 2016. Am J Prev Med. 2019 Jan;56(1):8-16. doi: 10.1016/j.amepre.2018.08.016. Epub 2018 Nov 19.
Results Reference
derived

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Study to Evaluate the Health and Wellness Policies of the New Haven Public School District.

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