Ignite Creation Date:
2025-12-24 @ 2:30 PM
Ignite Modification Date:
2026-02-22 @ 6:44 PM
Study NCT ID:
NCT02982759
Status:
COMPLETED
Last Update Posted:
2021-01-22
First Post:
2016-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Together We STRIDE (Strategizing Together Relevant Interventions for Diet and Exercise)
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Study Overview
Official Title:
Together We STRIDE (Strategizing Together Relevant Interventions for Diet and Exercise)
Status:
COMPLETED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1U01MD010540-01 | NIH | None | https://reporter.nih.gov/quic… | View |
| NCI-2018-02632 | REGISTRY | NCI / CTRP | View | |
| RG1001379 | OTHER | Fred Hutch / University of Washington Cancer Consortium | View |