Together We STRIDE (Strategizing Together Relevant Interventions for Diet and Exercise)

NCT ID: NCT02982759

Last Updated: 2021-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

888 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2020-08-28

Brief Summary

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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.

Detailed Description

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Childhood obesity rates in the Lower Yakima Valley of Washington State are alarming: 34% of youth are obese compared to the state average of 23%. A large proportion of those children are Hispanic; Hispanics represent 47% of the population in Yakima County and 67% of the population in the Lower Yakima Valley. In January 2013, the investigators study received a planning grant from the National Institute of Minority Health and Health Disparities to build and enhance community capacity and infrastructure on childhood obesity initiatives in the Lower Yakima Valley. This project began with the community as they expressed concern at the high incidence of obesity among Hispanic children in the Valley. In the ensuing two and a half years, the investigators and the community used community-based participatory research (CBPR) to 1) form a community advisory board (CAB); 2) build a Steering Committee; 3) conduct a comprehensive multi-level needs assessment; 4) develop and institute a pilot study; and 5) evaluate our activities. In response to RFA MD-15-010, the investigators and the community are now prepared to implement the intervention activities that were successful in our pilot study into a large-scale quasi-experimental intervention trial. The multi-level interventions will include activities at the individual level, family level, school level, and community level. Activities include distributing comic books to students about healthy eating and physical activity, a multi-generational level family intervention that teaches families about healthy eating and cooking skills as well as physical activity, a variety of school events to teach children about the food industry as well as encourage them to be physically activity at small intervals in the classroom, and community activities to foster the idea of the community being a healthy place for kids. The overall goal of this project is to continue to use a CBPR approach; in so doing, test the effectiveness of the comprehensive, multi-level intervention on reducing children's BMI z-scores, the primary endpoint. BMI z scores will be assessed by taking height and weight measures of the children at baseline, 12 months, and 24 months. This study will recruit and enroll a total of 900 Hispanic children in grades 3rd to 5th (ages 8-12 years) who attend the four elementary schools in the intervention community and the four elementary schools in the comparison community. Schools in both communities will be matched based on student standardized test scores, percent of students eligible to receive free or reduced-price lunch, and school size. Secondary outcomes include dietary patterns and accelerometer data of physical activity in a subgroup of 180 Hispanic children. Community participation in this project has been extraordinary and our letters of support indicate the communities' enthusiasm for this project.

Conditions

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Obesity, Childhood

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Comparison Arm

The comparison group will receive 2 generic newsletters

Group Type OTHER

Genetic Newsletters

Intervention Type BEHAVIORAL

The comparison will receive generic newsletters

Intervention Arm

The intervention arm will receive the multi-level intervention.

Group Type EXPERIMENTAL

Multi-Level Intervention

Intervention Type BEHAVIORAL

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

Interventions

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Multi-Level Intervention

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

Intervention Type BEHAVIORAL

Genetic Newsletters

The comparison will receive generic newsletters

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.
Minimum Eligible Age

8 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Linda K Ko, PhD

Role: PRINCIPAL_INVESTIGATOR

Fred Hutchinson Cancer Center

Locations

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Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 29501741 (View on PubMed)

Other Identifiers

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1U01MD010540-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2018-02632

Identifier Type: REGISTRY

Identifier Source: secondary_id

RG1001379

Identifier Type: OTHER

Identifier Source: secondary_id

8417

Identifier Type: -

Identifier Source: org_study_id

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