Clinical trial NCT02043626: Study to Evaluate the Health and Wellness Policies of the New Haven Public School District.
Official title: School Wellness Policy: RCT to Implement & Evaluate Impact on Childhood Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Diseases
Obesity
Keywords: childhood nutrition
physical activity
school wellness
school health
nutritional policies
childhood obesity
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2014-01-23
Enrollment: 796
Sex: ALL
Minimum age (years): 9
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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:

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.

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

Primary outcomes:
measure: Change in body mass index (BMI).
timeFrame: Baseline through Follow-up: Grades 5-6-7-8
Secondary outcomes:
measure: Change in student nutritional habits (eating behaviors).
timeFrame: Baseline through Follow-up: Grades 5-6-7-8
measure: Change in level of physical activity.
timeFrame: Baseline through Follow-up: Grades 5-6-7-8
measure: Mental Health
timeFrame: Baseline through Follow-up: Grades 5-6-7-8
measure: Standardized test scores
timeFrame: Baseline through Follow-up: Grades 5-6-7-8
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Jeannette Ickovics, PHD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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