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

Obesity Clinical Trial

— H&A  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02043626
• Other study ID #: 1008007295
• Secondary ID: 5R01HD070740
• Status: Completed
• Phase: N/A
• First received: January 20, 2014
• Last updated: January 12, 2018
• Start date: August 2011
• Est. completion date: June 2016

Study information

• Verified date: January 2018
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 796
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Diseases
• Obesity

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (14)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body mass index (BMI).	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	Change in student nutritional habits (eating behaviors).	Surveying student nutritional habits and close observation of nutritional habits (food consumed) in school.	Baseline through Follow-up: Grades 5-6-7-8
Secondary	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.	Baseline through Follow-up: Grades 5-6-7-8
Secondary	Mental Health	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
Secondary	Standardized test scores	Standardized test scores, reading and mathematics	Baseline through Follow-up: Grades 5-6-7-8