Multilevel Approaches for Promoting Physical Activity in Rural Communities
Phase: NA
Conditions: Physical Activity
Sponsor: Washington University School of Medicine

Protocol Title:   
Multilevel Intervention for Promoting Physical Activity in Rural 
Communities 
 
Protocol ID#: 
201809089/Grant # R01CA211323 
 
NCT#: 
NCT03683173 

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Rural PA Promotion Aim 2
PI:
Ross Brownson
IRB ID #: 201809089
Project Details
1. Demographics
1.1
Project Title:
Multilevel Intervention for Promoting Physical Activity in Rural Communities Aim 2
1.2
Short Title (required):
Rural PA Promotion Aim 2
1.3
Project is primarily:
Social Science/Behavioral (includes History/Anthropology)
1.4
Type of Study:
Other Interventional
1.4.a
Is your research study one in which one or more human subjects are prospectively assigned to one or more
interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-
related biomedical or behavioral outcomes (NIH clinical trial definition).
Yes
1.5
Select how you plan to obtain consent:
•  Letter or information sheet with no signature
•  Script for use either in person or over the phone with no signature
2. Source(s) of Support
2.1
Source(s) of Support
Type/Source
Grant Title
Name of PI on
Grant
Status
Federal Agency
NIH, National Cancer
Institute (NCI)
Multilevel approaches for promoting physical activity
in rural communities
Ross Brownson
AWARDED
Attachment Name
Category
Version
Date Attached
Rural_PA_Budget.docx
Grant from funding
source or private
foundation/association
1
02/05/18
Year 1 Rural
Communities_NIH_NOA_1R01CA211323-
01A1.pdf
Grant from funding
source or private
foundation/association
1
02/05/18
PA Rural Communities_A1.docx
Grant from funding
source or private
foundation/association
1
02/05/18
R01_Rural PA final package.pdf
Grant from funding
source or private
foundation/association
1
09/11/18
3. Research Team
3.1
Principal Investigator
Name
E-mail
Title
Ross Brownson
rbrownson@wustl.edu
Steven H.& Susan U. Lipstein Dist. Professor
3.2Team Members
Research Team Members
Role
Name
Role
Desc
Student
Email
Title
School
Department
Cont
PI
Ross Brownson, PHD
No
rbrownson@wustl.edu
Steven H.&
Susan U.
Brown
School
Brown School
Administration
Ye

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Lipstein
Dist.
Professor
Alan Beck, PHD
No
alan.beck@wustl.edu
Project
Coordinator
- Provost
Office
Central
Fiscal
Unit
(CFU)
CFU - Provost
Office
Strategic
Planning -
Administration
Ye
Dixie Duncan, BA
No
dixieduncan@wustl.edu
Research
Project
Coordinator
Brown
School
Brown School
Administration
N
Amy Eyler, PHD
No
aeyler@wustl.edu
Professor
of Public
Health
Brown
School
Brown School
Administration
N
Amanda Gilbert, MSW
No
a.s.gilbert@wustl.edu
Graduate
Teaching
Assistant
Brown
School
Brown School
Administration
N
Diana Parra Perez, BS, MPH, PHD
No
parrad@wustl.edu
Assistant
Professor
Brown
School
Brown School
Administration
N
Natalicio Serrano, MPH
No
nserrano@wustl.edu
Prevention
Research
Center
Brown
School
Brown School
Administration
N
Yan Yan, MD, Ph.D, MD
No
yany@wustl.edu
Prof of
Surgery
(Public
Health
Sciences)
School
of
Medicine
Surgery -
Public Health
Sciences
(PHS)
N
Team Member Financial Interest
Name
Financial Interests
Ross Brownson, PHD
none
Alan Beck, PHD
none
Dixie Duncan, BA
none
Amy Eyler, PHD
none
Amanda Gilbert, MSW
none
Diana Parra Perez, BS, MPH, PHD
none
Natalicio Serrano, MPH
none
Yan Yan, MD, Ph.D, MD
none
4. Other Institutional Reviews/Requirements
4.1
Do any of the objectives of this study involve the diagnosis, prevention, screening, evaluation, treatment or support of
cancer patients?
Yes
4.2
Are more than 30% of the patients involved in this study likely to have an active cancer diagnosis?
No
4.12
Will a Certificate of confidentiality be used for this research?
Yes, certificate automatically issued by funding agency
4.13
Does this project need to be registered on ClinicalTrials.gov?
Yes
4.13.a
Who is the Responsible Party for registering this study in ClinicalTrials.gov?
Principal Investigator
4.21
Mark all that apply to your study:
1. Protocol
1.1
Is there a separate, written protocol that will be submitted in addition to this form? (Note: a grant application is not
considered to be a protocol)
No
1.2
Select up to three key words below that best describe this research study:
•  Public Health
1.3
Provide a short summary/abstract of the purpose and procedures of the study proposed in this IRB application.

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DO NOT include information on studies not proposed in this application.
Use LAY terminology only. This must be easily understandable by IRB community members and nonscientists.
DO NOT cut and paste technical abstracts from source of support applications that may not be understood by a
general audience.
Up to half of all cancer related deaths are preventable via evidence-based lifestyle changes such as increasing physical
activity, enhancing nutrition, and reducing obesity.(1-3) Physical inactivity is a specific modifiable risk factor for breast
and colon cancer.(4) Rates of physical inactivity are lower in rural communities as compared to their urban and suburban
counterparts.(5) Nearly one-third of Missouri’s population lives in rural counties,(6) and the “Bootheel” region suffers
from a disproportionately high rate of cancer, in addition to physical inactivity and obesity.(7,8)
The purpose of the present study is to determine if a multilevel intervention (consisting of community events at local
walking trails, formation of walking groups, and text messaging) will increase physical activity among rural residents.
Intervention community members will receive the multilevel intervention while control communities will not. In the
intervention communities, it is preferable for all participants to partake in all aspects of the intervention; however, not
every person will partake in every level. We will create a dose-response variable hypothesizing participants who take
part in all aspects of the intervention (i.e., attend walking events, takes part in walking groups, and receives text
messages) will increase their physical activity more than people who engage in less of the intervention and those in
control communities. As a part of the walking group formation in intervention sites, we will be utilizing the Stanford
Healthy Neighborhood Discovery Tool application in order to receive feedback from participants related to the walking
trails in their towns.
1.4
Specify your research question(s), study aims or hypotheses:
Test the independent and moderating effects of a multilevel intervention and the community environment on physical
activity among rural residents.
1.5
Background and significance and/or Preliminary studies related to this project:
Key informant interviews were conducted in the intervention communities with three groups of people, walking trail
users, walking trail non users, and stakeholders. We received feedback on the best methods by which to utilize local
walking trails in the communities. Further, participants indicated to us their willingness to partake in future aspects of
the study. Walking trail users and walking trail non users may be asked to participate as participants, while
stakeholders may be asked to partake in a coalition to partner in increasing physical activity in rural southeast
Missouri.
1.6
Literature cited/references (if attaching a grant enter N/A):
1. Colditz GA, Wei EK. Preventability of cancer: the relative contributions of biologic and social and physical
environmental determinants of cancer mortality. Annu Rev Public Health. 2012;33: 137-156.
2. Colditz GA, Wolin KY, Gehlert S. Applying what we know to accelerate cancer prevention. Sc i Transl Med.
2012;4(127): 127rv124.
3. Curry S, Byers T, Hewit t M, eds. Fulfilling the Potential of Cancer Prevention and Early Detection. Washington, DC:
National Academies Press; 2003.
4. Lee IM, Shiroma EJ, Lobelo F, P uska P, Blair SN, Katzmarzyk PT. Effect of physical inactivity on major
noncommunicable
diseases worldwide: an analysis of burden of disease and life expectancy. Lancet.2012;380(9838):
219-229.
5. Parks SE, Housemann RA, Brownson RC. Differential correlates of physical activity in urban and rural adults of
various socioeconomic backgrounds in the United States. J Epidemiol Community Health. 2003;57(1): 29-35.
6. US Department of Commerce. 2010 census of population and housing.
http://www.census.gov/prod/cen2010/cph-2-27.pdf. Accessed December 28, 2015.
7. Centers for Disease Control and Prevention. Diabetes interactive atlas.
http://www.cdc.gov/diabetes/atlas/countydata/atlas.html. Accessed August 20, 2016.
8. Missouri Department of Health and Senior Services. Chronic disease deaths.
http://health.mo.gov/data/mica/mica/chronic_deathmap.php. Accessed December 28, 2015.
9. Freedman LS, Green SB, Byar DP. Assessing the gain in efficiency due to matching in a community intervention
study. Stat Med. Aug 1990;9(8):943-952.
10. Gail MH, Byar DP, Pechacek TF, Corle DK. Aspects of statistical design for the Community Intervention Trial for
Smoking Cessation (COMMIT). Control Clin Trials. Feb 1992;13(1):6-21.
11. Bock C, Jarczok MN, Litaker D. Community-based efforts to promote physical activity: a systematic review of
interventions considering mode of delivery, study quality and population subgroups. J Sci Med Sport. May
2013;17(3):276-282.
12. Brownson RC, Ballew P, Brown KL, et al. The effect of disseminating evidence-based interventions that promote
physical activity to health departments. Am J Public Health. Oct 2007;97(10):1900-1907.
13. Dobbins M, Hanna SE, Ciliska D, et al. A randomized controlled trial evaluating the impact of knowledge
translation and exchange strategies. Implement Sci. 2009;4:61.
14. Gulliford MC, Adams G, Ukoumunne OC, Latinovic R, Chinn S, Campbell MJ. Intraclass correlation coefficient and
outcome prevalence are associated in clustered binary data. J Clin Epidemiol. Mar 2005;58(3):246-251.
15. Gulliford MC, Ukoumunne OC, Chinn S. Components of variance and intraclass correlations for the design of
community-based surveys and intervention studies: data from the Health Survey for England 1994. Am J Epidemiol.
May 1 1999;149(9):876-883.
16. Jacobs JA, Dodson EA, Baker EA, Deshpande AD, Brownson RC. Barriers to evidence-based decision making in
public health: a national survey of chronic disease practitioners. Public Health Rep. Sep-Oct 2010;125(5):736-742.
17. Turner RM, Thompson SG, Spiegelhalter DJ. Prior distributions for the intracluster correlation coefficient, based
on multiple previous estimates, and their application in cluster randomized trials. Clin Trials. 2005;2(2):108-118.
18. Jacobs JA, Duggan K, Erwin P, et al. Capacity building for evidence-based decision making in local health
departments: scaling up an effective training approach. Implement Sci. Sep 24 2014;9(1):124.
19. Donner A, Klar N. Design and Analysis of Cluster Randomization Trials in Health Research. London: Arnold; 2000.

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20. Epstein LH, Raja S, Gold SS, Paluch RA, Pak Y, Roemmich JN. Reducing sedentary behavior: the relationship
between park area and the physical activity of youth. Psychol Sci. Aug 2006;17(8):654-659.
1.7
Describe EACH of your participant populations
Include description of any control group(s)
Specify the Inclusion/Exclusion criteria for EACH group
Intervention community members will be selected from seven communities in southeastern Missouri (n=600). Control
community members will selected from seven communities in southeastern Missouri (n=600). Communities are matched
based upon population, demographic makeup, and income; then, randomized to the control or intervention condition.
Inclusion criteria for both groups are adults, able to consent (e.g., no known cognitive impairments), able to be
physically active, residing in the targeted communities, and willing to complete a telephone survey at three time points.
1.8
Check all materials/methods that will be used in recruiting participants:
•  Telephone script
•  Website or Social Media (printed pages)
•  Word of Mouth/Snowball sampling
•  Referral
•  Other Methods/Source  -  Address based sampling, Random digit dialing
Attachment Name
Category
Version
Date Attached
Heartland_Moves_Screenshot.JPG
Recruitment: Website
1
11/05/18
Flyer.rtf
Recruitment Script: Phone
1
03/27/19
1.10
Describe where the consent discussion will occur (check all that apply):
•  By phone
•  Other  -  At local events (e.g., health fairs, walking events)
1.11
Participants and/or their legally authorized representative will have (check all that apply to the consent process and
explain process in Question 1.12 below):
•  As much time as they desire to consider enrolling in the study, including:
An opportunity to thoroughly review the consent materials with knowledgeable members of the research team,
and with family and/or friends as appropriate
Sufficient time to have all of their questions answered
1.12
Provide a description of the enrollment and consent process in sequential order and address EACH of the bulleted points
below:
Describe each study population separately including control population
Describe when recruitment and consent materials are used
Indicate how much time individuals will have to consider participation
If eConsent will be used to obtain an electronic signature, describe how the eConsent will be presented to
participants, how their questions will be answered and how the participant will receive a copy of the final, signed
consent
Describe the steps that will be taken by the research team to minimize the possibility of coercion or undue influence
during the consent process
To recruit intervention community participants Washington University in St. Louis (WashU) project staff will reach out via
telephone to those walking trail users and walking trail non users to determine their current interest in participating in
this study (see section 1.5) using the telephone script. Further, WashU project staff will reach out to stakeholders to
determine their interest in being a part of a coalition - in this capacity, project staff will use the informational sheet to
reach out to stakeholder constituents to determine their interest in partaking in the study.
Recruitment in control communities is detailed elsewhere. Participants in both intervention and control communities may
provide their consent immediately after asking any questions, or project staff can call the potential participant back at a
later time (typically within a week). It will be stated to participants that participation is completely voluntary, and they
are welcome to withdraw at any time.
1.13
Provide a detailed description in sequential order of the study procedures following the consent process - DO NOT cut
and paste from the Consent Document.
Describe study populations separately if they will be participating in different procedures
DESCRIBE:
Control populations, if applicable
Any randomization, if applicable
What participants will be asked to do/what happens in the study (in sequential order)
The time period over which procedures will occur
Long-term follow-up and how it occurs
Control and intervention participants will conduct a telephone survey at baseline and one follow-up timepoint (n=1241).
A subset recruited from the baseline telephone survey, will wear an accelerometer and global positioning devices for one

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week at baseline and one follow-up timepoint(n=300).
1.14
Will participants be randomized?
Yes
1.15
Will any of the following be used to collect information from the participant or others?
Screening questions or screening/eligibility questionnaires
Surveys
Questionnaires
Stimuli
Any other written assessments
Yes
Attachment Name
Category
Version
Date Attached
Amanda Program-
Perryville.docx
Subject Data Collection
Instruments
1
11/05/18
Amanda Program-
Piedmont.docx
Subject Data Collection
Instruments
1
11/05/18
Stanford Healthy Neighborhood
Discovery Tool.docx
Subject Data Collection
Instruments
1
11/08/18
[Master] E01 CareMessage
Exercise 24 Weeks (v.2) - ENG
E01 Accounts Schedule (1).pdf
Subject Data Collection
Instruments
1
11/05/18
Telephone Survey 2 Baseline
Intervention.docx
Subject Data Collection
Instruments
3
05/18/20
Telephone Survey 2 Baseline
Control.docx
Subject Data Collection
Instruments
3
05/18/20
1.16
Does this project involve creating any audio, video, or photographs?
No
1.17
Does the study include any form of deception (e.g., providing participants with false information, misleading information,
or withholding information about certain study procedures)?
Examples:
Procedure includes a cover story that provides a plausible but inaccurate account of the purposes of the research.
Participants will be provided with false information regarding the particular behaviors of interest in the research.
Procedures include a confederate pretending to be another participant in the study.
Participants will be told that the research includes completion of a particular task, when in fact, that task will not be
administered.
Study is designed to introduce a new procedure (or task) that participants are not initially told about.
No
1.18
Indicate any payments or reimbursements to participants (check all that apply)
Gift or Debit Card
1.19
Does this study have a plan to have an individual or committee review combined data from all participants on a periodic
basis (such as summary or aggregate safety and/or efficacy data)?
No
1.20
What have you done to minimize any risks?
•  No forseeable risks
1.21
What are the potential benefits related to this project for:
the participant (if any)
benefits to society (if any)
An increase in physical activity may lead to improved health. The benefit to society is the project, if successful, has
the potential to be scaled-up to reach a larger number of people.
1.22
Provide a summary of the analysis methods you will use, including, if applicable, the data points or outcomes you
will analyze.
The intervention is at the community, interpersonal, and intrapersonal levels, and the activity environment is
classified at the individual level. The basic model for the individual level analysis is: Yjk = αj + βIj + γXj + ηZjk + θ
Ij*Ejk + εjk; where Yjk is the change in physical activity for subject k in jth community (j = 1,2…12), I = 1 if
intervention and 0 otherwise, X = a vector of community level covariates, Z = a vector of individual level covariates
(including Ejk individual level of activity environment), and Ij*Ejk = intervention-by-environment interaction. The
parameter αj is the random intercept, β is the main effect for intervention, and θ is the interaction effect. In this
model, β is the expected difference in the physical activity level between intervention and control among those
whose physical activity is mainly indoor, and (θ + β) is the expected difference in the physical activity level between
intervention and control among those whose physical activity is mainly in the natural environment. Both main and

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interaction effects are adjusted for community level and individual level covariates. The primary analyses will be
conducted at the end of 1 and 2 year follow-up. In these analyses, baseline physical activity level will be used as one
of covariates.
1.23
Provide the rationale or power analysis to support the number of participants proposed to complete this study.
This study uses a paired, group-randomized design. By using matching criteria, we will balance potential community-
level confounding factors (e.g., community size, poverty level) with a gain in the statistical power [9,10]. Based on
the literature, we estimated accelerometer-measured MVPA in the control group at 42.5 minutes per week (m/w).[9]
In the intervention group, we assume a 16% increase (42.5*1.16 = 49.3), based on a recent meta-analysis [11]. We
used a much larger SD of 16 rather than that reported (6.2) to ensure a sufficient sample size both for testing the
intervention effect and for testing the intervention-by-environment interaction (moderation) effect. We assumed ICC
estimates in the range of 0.01-0.03, based on our pilot studies and values of ICCs in the literature [12-18]. With 12
communities and an average of 48 study subjects in each (a total of 576 subjects for accelerometry), the study has
power >90% with 2-sided α = 5% to detect the mean difference in MVPA between the control (42.5) and
intervention (49.3) groups, using Donner’s method [19]. For intervention-by-environment interaction, we assume in
the natural environment, the intervention and control difference is 57 m/w versus 44 m/w, and in the indoor
environment, the difference is 43 m/w versus 41 m/w. Estimates of interaction are based on our pilot work and
existing studies [20]. With a common SD in each of four subgroups = 10, we have 84% power to detect a significant
interaction using factorial analysis of variance methods (F-test) adjusting for clustering (ICC = 0.03). Our simulation
using two-level mixed effect models also indicates the power to detect the assumed interaction effect >90%. Our
sample size is determined for accelerometry subjects at the end of Year 2. With a yearly follow-up rate of 80%,
which is achievable given our previous work, we need to enroll 576/0.64 = 900 at baseline for accelerometry. For
telephone survey subjects, we need to enroll 900/0.75 = 1,200 at baseline.
1.25
Will any data from this project be stored for use in future research studies?
No
1.26
Does this project involve the collection or use of biological samples or genetic data?
No
1.27
Are you requesting institutional certification to contribute human data or samples to a repository or database for broad
sharing (public or restricted access)?
No
2. Participants
2.1
Will there be any adult participants?
Yes
2.1.a
How many adult participants do you expect to consent or enroll under a waiver for this project?
1200
2.1.b
What is the age of the youngest adult participant?
18.0
2.1.c
What is the age of the oldest adult participant?
No age limit
2.2
Will there be any minor participants?
No
2.3
Will there be any emancipated minor participants?
No
2.7
Do you plan to recruit/enroll non-English speaking people?
No
2.8
Do you propose to enroll any of the following in this study as participants?
Employee of the PI or employee of a research team member
Individual supervised by PI or supervised by member of research team
Individual subordinate to the PI or subordinate to any member of the research team
Student or trainee under the direction of the PI or under the direction of a member of the research team
No
2.9
Is this project about pregnant women?
No
2.10
Will this project involve fetuses?
No
2.11
Does this project involve the use of fetal tissue from any source?

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No
2.12
Does this project recruit adult participants who may be incompetent or have limited decision-making capacity on initial
enrollment into the study?
No
2.13
Does this project involve prisoners as participants?
No
3. Performance Sites
3.1
Indicate type of site(s) where research will occur (check all that apply):
•  Academic Institution
3.2
Where will project procedures take place (check all that apply)?
Danforth Campus
U.S. off-campus - Mississippi State University
3.3
Is this project also being conducted by other researchers at their own sites (e.g. a multi-site collaborative project)?
Yes
3.3.a
What is your site's role(s) for this project (check all that apply)?
Coordinating Center
3.3.b
Indicate the requirements for participating sites to report unanticipated problems to the coordinating center/lead
site:
Timeframe
Contact Method
• 24 Hours or less
• Email
• Phone
3.3.c
Indicate the requirements for the lead site to report unanticipated problems to the participating sites:
Timeframe
Contact Method
• 24 Hours or less
• Email
• Phone
3.3.d
Indicate the requirements for the lead site to communicate protocol modifications to the participating sites:
Timeframe
Contact Method
• Within 1 week
• Email
• Phone
3.3.e
Indicate the requirements for the lead site to communicate interim results to the participating sites:
Timeframe
Contact Method
• Within 1 week
• Email
3.3.f
Indicate the requirements for the lead site to communicate other new information to the participating sites:
Timeframe
Contact Method
• Within 1 week
• Email
3.3.g
What are participating site roles for this project?
Contract Research Organization - Mississippi State University Survey Research Laboratory
5. Privacy & Confidentiality
5.1
Indicate your plans to protect the privacy interests of the participants during the conduct of the study (check all that
apply):
•  Only the minimum necessary private information is collected for the purposes of the study
•  Any procedures or interventions conducted as part of the study will be conducted in private setting to the extent
possible
•  Recruitment/consent will occur in a private setting
•  Participants will be able to ask questions in a private setting

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5.2
Are you collecting or using the Social Security Number of any participants for any purpose?
Yes
5.2.a
Provide the intended usage of SSN:
To provide compensation to participants
5.3
Project uses paper or hard copy consents, surveys, data collection forms, research subject binders, or other hard copy
materials (check all that apply):
Yes
•  All materials are stored in secured environment
•  Access is limited to research team members only
5.4
Project collects, stores and/or transmits electronic data on mobile devices, desktop computers, servers including cloud
servers, email, or any other information in electronic form (check all that apply):
Yes
•  Password protected
•  Access is limited to research team only
5.5
Project collects or uses biologic specimens (check all that apply):
No
5.6
Identify any additional protections in place for data and or samples (check all that apply):
•  Formal research staff training process