NCT03118635

Brief Summary

Convergent findings from several studies document that children, especially those who are already overweight or obese or from racial / ethnic minority groups, are at risk for accelerated weight gain during the summer months. Therefore, this project is comprised of three separate community-based interventions designed to increase access to healthy meals and physical activity opportunities to minimize excess summer weight gain in elementary school children from a diverse, low-income Rhode Island community. Specifically, we will complete a quasi-experimental study in which we will design and deliver a physical activity intervention in conjunction with the Summer Food Service Program (SFSP) to 50 children living in a low-income, urban community. We anticipate that the addition of physical activity programming to the SFSP, a federal program funded by the USDA which reimburses states for serving lunch meals to children during the summer in communities where at least 50% of students are eligible for free or reduced-price school meals, will increase both the acceptability and effectiveness of the SFSP and affect 1) physical activity levels, 2) sedentary behavior, and 3) diet quality. The primary outcome (change in BMI z-score) will be compared between the 50 kids enrolled in the active intervention and 50 children enrolled in the control condition, both recruited from the same community.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

Shorter than P25 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

June 15, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 18, 2017

Completed
Last Updated

September 4, 2019

Status Verified

March 1, 2017

Enrollment Period

3 months

First QC Date

April 4, 2017

Last Update Submit

September 3, 2019

Conditions

Keywords

SummerDietPhysical ActivitySedentary behaviorLow-income

Outcome Measures

Primary Outcomes (1)

  • Change in BMI z-score over the summer

    BMI was measured at the baseline visit (early June 2016) and three months later at the end of the summer (late August, 2016). Outcome of interest was change (BMIz at f/u - BMIz at baseline)

    Three months (summer)

Secondary Outcomes (3)

  • Physical Activity

    Cross-sectional measure taken for 7 days during the window of weeks 4-6 of the 8 week intervention

  • Sedentary Behavior

    Cross-sectional measure taken for 7 days during the window of weeks 4-6 of the 8 week intervention

  • Energy intake

    Cross-sectional measure taken for 7 days during the window of weeks 4-6 of the 8 week intervention

Study Arms (2)

Intervention

EXPERIMENTAL

Daily, four-hour physical activity intervention

Behavioral: Intervention

Control

NO INTERVENTION

No treatment control

Interventions

InterventionBEHAVIORAL

Physical activity programming in accordance with the SPARK - After School curriculum as well as engaging activities provided by local community partners. The intervention proceeded the SFSP lunch meal service, so that children received approximately three hours of physical activity programming daily.

Intervention

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Low-income (defined as qualifying for free or reduced-price meals as part of the National School Lunch Program)
  • Ages 6-12 years
  • Ability of child to speak, read and write English (for purposes of assessment and intervention)
  • Parent/guardian involvement
  • Agreement to study participation
  • Intent to participate in the SFSP in the upcoming summer

You may not qualify if:

  • Medical condition that would interfere with participation in physical activity
  • Enrolled in a camp or other physical activity based summer program.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Related Publications (1)

  • Evans EW, Bond DS, Pierre DF, Howie WC, Wing RR, Jelalian E. Promoting health and activity in the summer trial: Implementation and outcomes of a pilot study. Prev Med Rep. 2018 Feb 16;10:87-92. doi: 10.1016/j.pmedr.2018.02.008. eCollection 2018 Jun.

MeSH Terms

Conditions

Pediatric ObesityMotor ActivitySedentary Behavior

Interventions

Methods

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

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

Study Record Dates

First Submitted

April 4, 2017

First Posted

April 18, 2017

Study Start

June 15, 2016

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

September 4, 2019

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations