NCT02043626

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
796

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

January 20, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 23, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

January 17, 2018

Status Verified

January 1, 2018

Enrollment Period

4.8 years

First QC Date

January 20, 2014

Last Update Submit

January 12, 2018

Conditions

Keywords

childhood nutritionphysical activityschool wellnessschool healthnutritional policieschildhood obesity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Change in student nutritional habits (eating behaviors).

    Baseline through Follow-up: Grades 5-6-7-8

  • Change in level of physical activity.

    Baseline through Follow-up: Grades 5-6-7-8

  • Mental Health

    Baseline through Follow-up: Grades 5-6-7-8

  • Standardized test scores

    Baseline through Follow-up: Grades 5-6-7-8

Study Arms (4)

Physical Activity Only

EXPERIMENTAL

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

Other: OPPORTUNITIES FOR PHYSICAL ACTIVITY

Delayed Interventions Only

NO INTERVENTION

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.)

Nutrition and Physical Activity

EXPERIMENTAL

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

Other: DISTRICT WELLNESS COMMITTEEOther: NUTRITIONAL QUALITY OF FOODS AND BEVERAGES ON CAMPUSOther: HEALTH PROMOTION AND MARKETINGOther: OPPORTUNITIES FOR PHYSICAL ACTIVITY

Nutrition Only Interventions

EXPERIMENTAL

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

Interventions

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.

Nutrition and Physical Activity

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.

Nutrition Only InterventionsNutrition and Physical Activity

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.

Nutrition and 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.

Nutrition and Physical ActivityPhysical Activity Only

Eligibility Criteria

Age9 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Not enrolled in one of 12 participating schools
  • Not in target grade (5-8) as of the fall 2011

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University

New Haven, Connecticut, 06520, United States

Location

Related Publications (16)

  • 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.

    PMID: 24320151BACKGROUND
  • 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.

    PMID: 23671041BACKGROUND
  • 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.

    PMID: 23631343BACKGROUND
  • 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.

    PMID: 26989876BACKGROUND
  • 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.

    PMID: 26469652BACKGROUND
  • 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.

    PMID: 26320906BACKGROUND
  • 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.

    PMID: 25676784BACKGROUND
  • 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.

    PMID: 26317365BACKGROUND
  • 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.

    PMID: 24155192BACKGROUND
  • 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.

    PMID: 25724990BACKGROUND
  • 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.

    PMID: 24990227BACKGROUND
  • 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.

    PMID: 25040118BACKGROUND
  • 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.

    PMID: 24955021BACKGROUND
  • 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.

    PMID: 23642646BACKGROUND
  • 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.

  • 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.

MeSH Terms

Conditions

Chronic DiseaseObesityMotor ActivityPediatric Obesity

Interventions

Health PromotionMarketingExercise

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesCommerceTechnology, Industry, and AgricultureMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jeannette Ickovics, PHD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2014

First Posted

January 23, 2014

Study Start

August 1, 2011

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

January 17, 2018

Record last verified: 2018-01

Locations