NCT03683173

Brief Summary

The purpose of the study is to test a multilevel intervention's impact on increasing physical activity among rural residents. It is expected that participants who participate in more of the intervention (e.g., all levels) will increase their physical activity more than the control group and individuals who participate in less of the intervention (e.g., one level of the intervention).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,241

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2018

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

First Submitted

Initial submission to the registry

September 18, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 25, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

December 17, 2018

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 24, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 24, 2022

Completed
1 year until next milestone

Results Posted

Study results publicly available

January 8, 2024

Completed
Last Updated

January 8, 2024

Status Verified

January 1, 2024

Enrollment Period

4 years

First QC Date

September 18, 2018

Results QC Date

December 14, 2023

Last Update Submit

January 5, 2024

Conditions

Keywords

Physical ActivityRuralCancer Prevention

Outcome Measures

Primary Outcomes (1)

  • Change in Objective Physical Activity Measured by Accelerometer Measured at Baseline and 18-month Follow-up

    * Participants will wear an accelerometer to measure physical activity. * The outcome measure will measure the weekly minutes of moderate to vigorous physical activity. * Physical activity was measured using the Freedson Adult cutpoint categories from 1998. Each count was measured every 60 seconds/per minute. * Sedentary: 0-99 counts per minute * Light: 100-1951 counts per minute * Moderate: 1952-5724 counts per minute * Vigorous: 5725-9498 counts per minute * Very vigorous: 9499 and up counts per minute

    Baseline and 18-month follow-up

Secondary Outcomes (1)

  • Number of Participants Who Met the Subjective Physical Activity Recommendations as Measured by the Global Physical Activity Questionnaire at Baseline and 18-month Follow-up

    Baseline and 18-month follow-up.

Study Arms (2)

Multilevel Intervention

EXPERIMENTAL

Participants will receive the multilevel intervention consisting of community events, walking group formation, and short messaging service.

Behavioral: Intervention

Control

NO INTERVENTION

Does not receive the multilevel intervention.

Interventions

InterventionBEHAVIORAL

Participants in the intervention arm may receive community events, partake in walking groups, and receive short messaging service.

Multilevel Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults (18+)
  • No cognitive impairments
  • Able to physically active
  • Willing to complete telephone survey at three time points
  • Located in targeted communities in southeast Missouri

You may not qualify if:

  • Participants not located in targeted communities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University in St. Louis

St Louis, Missouri, 63130, United States

Location

Related Publications (4)

  • Beck AM, Serrano N, Duncan D, Eyler AA, Gilbert A, Naghiloo F, Reis R, Tabak RG, Brownson RC. Cluster randomized multilevel intervention for promoting physical activity in rural communities. Front Public Health. 2025 Aug 29;13:1577056. doi: 10.3389/fpubh.2025.1577056. eCollection 2025.

  • Serrano N, Beck A, Salvo D, Eyler A, Reis R, Steensma JT, Gilbert A, Brownson RC. Examining the Associations of and Interactions Between Intrapersonal and Perceived Environmental Factors With Objectively Assessed Physical Activity Among Rural Midwestern Adults, USA. Am J Health Promot. 2023 May;37(4):511-515. doi: 10.1177/08901171221134797. Epub 2022 Oct 21.

  • Gilbert A, Beck A, Serrano N, Brownson RC. Objective Measures of Physical Activity in Rural Communities: Factors Associated With a Valid Wear and Lessons Learned. J Phys Act Health. 2022 Apr 1;19(4):267-274. doi: 10.1123/jpah.2021-0677. Epub 2022 Mar 10.

  • Beck AM, Eyler AA, Aaron Hipp J, King AC, Tabak RG, Yan Y, Reis RS, Duncan DD, Gilbert AS, Serrano NH, Brownson RC. A multilevel approach for promoting physical activity in rural communities: a cluster randomized controlled trial. BMC Public Health. 2019 Jan 30;19(1):126. doi: 10.1186/s12889-019-6443-8.

MeSH Terms

Conditions

Motor Activity

Interventions

Methods

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

Title
Diana Parra Perez, Ph.D.
Organization
Washington University School of Medicine

Study Officials

  • Ross C Brownson, PhD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 18, 2018

First Posted

September 25, 2018

Study Start

December 17, 2018

Primary Completion

December 24, 2022

Study Completion

December 24, 2022

Last Updated

January 8, 2024

Results First Posted

January 8, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations