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Obesity, ChildhoodNCT02982759

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

A study testing Multi-Level Intervention and Genetic Newsletters in people with Obesity, Childhood, run by Fred Hutchinson Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 8 to 12 yearsHealthy volunteers can take part
Conditions the study is for
Obesity, Childhood
What is being tested?
Multi-Level Intervention and Genetic Newsletters
Could I receive a placebo?
No, everyone receives an active treatment
How many people
888 participants
Where
1 siteUnited States
Study dates
Apr 2016to 28 Aug 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98115

Other trials in United States

About this study

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.

Read the 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.

Being tested
Multi-Level Intervention, Genetic Newsletters
Medical subject headings
Pediatric Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multi-Level InterventionBehavioural

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

  • Genetic NewslettersBehavioural

    The comparison will receive generic newsletters

Study groups in NCT02982759
Study groupRoleWhat they receive
Comparison ArmOtherThe comparison group will receive 2 generic newsletters
Receives: Behavioral: Genetic Newsletters
Intervention ArmExperimentalThe intervention arm will receive the multi-level intervention.
Receives: Behavioral: Multi-Level Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body Mass Index z-score

    Measured: 3 years

Secondary outcomes (2)
  1. Physical Activity with accelerometer

    Measured: 3 years

  2. Dietary Pattern with questionnaire

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2016 (estimated)
  2. Study startApr 2016
  3. Primary completion28 Aug 2020
  4. Study completion28 Aug 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
888 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02982759
Sponsor's protocol ID
8417
Other IDs
1U01MD010540-01, NCI-2018-02632, RG1001379
Status last verified
Jan 2021
First submitted
30 Nov 2016
Last updated
22 Jan 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 41584860
  • 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.

    PubMed 29501741

Questions about this trial

What is this clinical trial studying?

A study testing Multi-Level Intervention and Genetic Newsletters in people with Obesity, Childhood, run by Fred Hutchinson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body Mass Index z-score (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02982759, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2021.

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