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

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ClinicalTrials.gov Identifier: NCT02982759
Recruitment Status : Recruiting
First Posted : December 5, 2016
Last Update Posted : September 11, 2019
Sponsor:
Collaborator:
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center

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.

Condition or disease Intervention/treatment Phase
Obesity, Childhood Behavioral: Multi-Level Intervention Behavioral: Genetic Newsletters Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Together We STRIDE (Strategizing Together Relevant Interventions for Diet and Exercise)
Study Start Date : April 2016
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Comparison Arm
The comparison group will receive 2 generic newsletters
Behavioral: Genetic Newsletters
The comparison will receive generic newsletters

Experimental: Intervention Arm
The intervention arm will receive the multi-level intervention.
Behavioral: Multi-Level Intervention
The multi-level interventions will include activities at the individual level, family level, school level, and community level.




Primary Outcome Measures :
  1. Body Mass Index z-score [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Physical Activity with accelerometer [ Time Frame: 3 years ]
  2. Dietary Pattern with questionnaire [ Time Frame: 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Exclusion Criteria:

  • Exclusion criteria include children with clinically-diagnosed dementia, terminal (<5 years) illness, major psychiatric illness, severe hearing impairment, and inability to move, which will be assessed during the distribution of the study recruitment packets to parents.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02982759


Contacts
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Contact: Linda K Ko, PhD 206-667-7182 Lko@fredhutch.org

Locations
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United States, Washington
Fred Hutchinson Cancer Research Center Recruiting
Seattle, Washington, United States, 98115
Contact: Linda K Ko, PhD    206-667-7182    Lko@fredhutch.org   
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
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Principal Investigator: Linda K Ko, PhD Fred Hutchinson Cancer Research Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT02982759     History of Changes
Other Study ID Numbers: 8417
1U01MD010540-01 ( U.S. NIH Grant/Contract )
NCI-2018-02632 ( Registry Identifier: NCI / CTRP )
RG1001379 ( Other Identifier: Fred Hutch / University of Washington Cancer Consortium )
First Posted: December 5, 2016    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Pediatric Obesity
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms