NCT03595332

Brief Summary

Almost 50% of Native American and Hispanic children are overweight or obese by the 5th grade. Research has demonstrated that the 'obesity gap' facing minority students is largely due to summer weight gain. However, very few summer programs have been tested among these populations. To encourage summer physical activity, the CDC developed a program that partners with local businesses to provide children with a 'scorecard' of subsidized or free local activities. The program has not been tested among Hispanic or Native American children. This study aims to test the impact of the scorecard program on Body Mass Index percentile, physical activity, sedentary behavior, barriers to physical activity and self-efficacy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
222

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2018

Typical duration 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 4, 2018

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

June 22, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 23, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2020

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

September 29, 2022

Completed
Last Updated

October 5, 2022

Status Verified

September 1, 2022

Enrollment Period

1.9 years

First QC Date

June 22, 2018

Results QC Date

July 18, 2022

Last Update Submit

September 28, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Body Mass Index Percentile Score Change at 10 Weeks

    Body mass index (BMI) will be calculated as kg/m2 and BMI-percentile score calculated using the L, M, S parameters published by the Centre for Disease Control and Prevention. BMI Percentile-score are measures of relative weight adjusted for child age and sex. The percentile indicates value relative to reference populations for age and sex, with at or below 5th percentile indicating the child being underweight, between 5 and 85th percentile as having a healthy weight, 85th to 95th percentile as being overweight and 95th percentile and above indicative of having obesity.

    Measured at baseline and 10-weeks after baseline

  • Overweight Participants Body Mass Index Percentile Score Change

    Body mass index (BMI) will be calculated as kg/m2 and BMI percentile calculated using the L, M, S parameters published by the Centre for Disease Control and Prevention. BMI percentiles are measures of relative weight adjusted for child age and sex. This analysis includes only those children who were overweight by CDC standards (equal or greater to 85th percentile for age and sex), as they were the high-risk group of interest for the study.

    Baseline to 10 weeks

Secondary Outcomes (2)

  • Body Mass Index Percentile Score Change at 1 Year

    Measured 1-year after baseline

  • Change in Intention to Engage in Physical Activity From Baseline to 10 Weeks

    Measured at baseline and at 10-weeks (after summer program)

Study Arms (2)

Immediate intervention

EXPERIMENTAL

Summer activity program: Children will receive the summer scorecard program during the first summer of the 2-year study.

Other: Summer activity program

Delayed intervention

EXPERIMENTAL

Summer activity program: Children will receive the summer scorecard program during the second summer of the 2-year study.

Other: Summer activity program

Interventions

Children receive a summer scorecard to facilitate access to local facilities for exercise.

Delayed interventionImmediate intervention

Eligibility Criteria

Age5 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children who are enrolled in one of the 4 high-risk schools in 2nd through 5th grade, whose parents/legal guardians provide consent and provide assent.

You may not qualify if:

  • Children who are not enrolled in the selected schools, or whose parents/legal guardians do not provide consent, or whom do not provide assent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fit kids of Arizona

Flagstaff, Arizona, 86004, United States

Location

Related Publications (2)

  • Huhman ME, Potter LD, Duke JC, Judkins DR, Heitzler CD, Wong FL. Evaluation of a national physical activity intervention for children: VERB campaign, 2002-2004. Am J Prev Med. 2007 Jan;32(1):38-43. doi: 10.1016/j.amepre.2006.08.030.

    PMID: 17218189BACKGROUND
  • Huhman M, Potter LD, Wong FL, Banspach SW, Duke JC, Heitzler CD. Effects of a mass media campaign to increase physical activity among children: year-1 results of the VERB campaign. Pediatrics. 2005 Aug;116(2):e277-84. doi: 10.1542/peds.2005-0043.

    PMID: 16061581BACKGROUND

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Limitations include a specific setting in the Southwestern United States. Second, any dose-response analyses were reliant on self-report. Loss to follow-up, likely due to children moving schools, reduced the final sample from 222 to 186 with at least partial follow-up measures (178 completed). Finally, COVID-19 prevented collection of secondary outcome 1-year follow-up BMI Percentile (Apr 2020) for one group as the school district shut down (and remote for a year after reopening).

Results Point of Contact

Title
Dr. Hendrik de Heer
Organization
Northern Arizona University

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

June 22, 2018

First Posted

July 23, 2018

Study Start

June 4, 2018

Primary Completion

April 22, 2020

Study Completion

April 22, 2020

Last Updated

October 5, 2022

Results First Posted

September 29, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations