NCT02982759

Brief Summary

Obesity among Hispanic children in the Lower Yakima Valley of Washington State is alarmingly high. This study proposes to implement a comprehensive, multi-level intervention among children, families, the schools, and the community to combat this problem. The two year intervention will be measured by examining changes in children's body mass index.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
888

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2016

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

April 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 5, 2016

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2020

Completed
Last Updated

January 22, 2021

Status Verified

January 1, 2021

Enrollment Period

4.4 years

First QC Date

November 30, 2016

Last Update Submit

January 19, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Body Mass Index z-score

    3 years

Secondary Outcomes (2)

  • Physical Activity with accelerometer

    3 years

  • Dietary Pattern with questionnaire

    3 years

Study Arms (2)

Comparison Arm

OTHER

The comparison group will receive 2 generic newsletters

Behavioral: Genetic Newsletters

Intervention Arm

EXPERIMENTAL

The intervention arm will receive the multi-level intervention.

Behavioral: Multi-Level Intervention

Interventions

The multi-level interventions will include activities at the individual level, family level, school level, and community level.

Intervention Arm

The comparison will receive generic newsletters

Comparison Arm

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Hispanic children in grade levels 3rd-5th (ages 8-12 years) who attend elementary schools in these two communities will be eligible to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98115, United States

Location

Related Publications (2)

  • Ko LK, Rillamas-Sun E, Kratz M, Jimenez E, Jang SH, Mendoza JA, Bishop S, Xiao L. A Multi-Level Intervention to Address Childhood Obesity in Rural Hispanic Communities. Obes Sci Pract. 2026 Jan 23;12(1):e70116. doi: 10.1002/osp4.70116. eCollection 2026 Feb.

  • Ko LK, Rillamas-Sun E, Bishop S, Cisneros O, Holte S, Thompson B. Together We STRIDE: A quasi-experimental trial testing the effectiveness of a multi-level obesity intervention for Hispanic children in rural communities. Contemp Clin Trials. 2018 Apr;67:81-86. doi: 10.1016/j.cct.2018.02.013. Epub 2018 Mar 5.

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Linda K Ko, PhD

    Fred Hutchinson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2016

First Posted

December 5, 2016

Study Start

April 1, 2016

Primary Completion

August 28, 2020

Study Completion

August 28, 2020

Last Updated

January 22, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations