Citizen Science to Promote Sustained Physical Activity in Low-Income Communities
Phase: NA
Conditions: Physical Activity
Sponsor: Stanford University

 
Citizen Science to Promote Sustained Physical 
Activity in Low-Income Communities 
NCT03041415 
8/31/2021 
Abby C King, Principal Investigator 
Stanford University 
Stanford, California 94305 
1. 
PURPOSE OF THE STUDY 
a. 
Brief Summary 
The major objective of the study is to increase physical activity among inactive, low 
income midlife to older adults living in or near public housing sites.  
Participants are randomized into 2 groups: 1) receive a physical activity program (i.e., 
Active Living Every Day (ALED) Program) + tradition health education; or 2) receive 
physical activity program (i.e., Active Living Every Day (ALED) Program) + Our Voice  
intervention in which study participants use the Discovery Tool app to document (photos 
and audio narratives) features of their neighborhood that make it easier or harder to be 
physically active to then discuss and advocate for change in their community with the 
purpose to promote healthier communities. 
b. 
Objectives 
We hope to learn: Whether or not ALED alone OR ALED + Our Voice intervention will 
achieve sustained physical activity increases at multiple levels over time.  
If there are changes in a select set of multi-level variables (e.g., personal agency for 
influencing community decisions; neighborhood cohesion) as potential mediators of 
intervention effects; and explore the relative costs of the two interventions for PA change.  
Importance of the new knowledge: If the preliminary evidence supporting the promise of 
the Our Voice community engagement program is confirmed, it will provide a means for  
expanding and sustaining the impacts and reach of person-level PA interventions beyond 
individual participants to the broader neighborhood setting, and can provide a scalable 
means for sustainable PA promotion that potentially could be enacted across the 
population 
c. 
Rationale for Research in Humans 

There is compelling evidence that regular moderate-intensity and more vigorous physical 
activity (PA) substantially reduces the risk of diabetes, heart disease and certain cancers 
in mid-life and older adults. Regular physical activity also helps regulate body weight, a 
risk factor for a variety of diseases, as well as improving psychological and cognitive 
functioning in older adults. Despite these documented health benefits, a very small 
percentage of adults aged 45 years and older meet the national PA guidelines (i.e., that all 
U.S. adults accumulate at least 30 minutes of daily moderate-intensity PA 5 or more  
days/week). Low-income older adults are among the most sedentary groups in the U.S. 
Thus, human subjects, must be used to test the efficacy of the physical activity promotion 
program. 
2. 
STUDY PROCEDURES 
a. 
Procedures 
 
Recruitment 
Subjects will be recruited from affordable housing serving mid-life and older adults from 
the San Francisco Bay Area.  
The primary recruitment methods will consist of targeted mailings to residents of  
each housing site or low income older adults living near these affordable housing sites. 
We will supplement these approaches with outreach communications tailored to each housing site 
(e.g., flyers posted in housing site common areas). 
 
 
Eligibility Screen 
Individuals will go through an initial telephone, face-to-face or online screening process.  
Those who are initially eligible will proceed to an information session where the study 
activities and procedures will be explained in greater detail. If interested in continuing  
at that point, individuals will read and sign an informed consent form approved by 
Stanford University IRB. 
Those adults meeting study criteria in relation to age, physical activity and general health 
status, and interest will be invited to participate in a baseline assessment. Demographic, 
health/medical, perceived environment, and psychosocial and behavioral information will 
be collected from study participants by interview or self-administered questionnaire.  
 
Study Assessments 
Study assessments will be collected at baseline, 6, 12, 18, and 24 months for all study 
participants. Physiologic measures will include ambulatory activity monitors that 
measure movement throughout the day in the person's natural environment, and physical 
measurements (height, weight, resting blood pressure, physical function field tests) 
collected from study participants by trained study staff. These data and material will be 
obtained specifically for research purposes.  
Persons completing this assessment who are eligible will be enrolled in  
the study. 
Study Interventions 
Study interventions consists of housing site-based randomization to one of the  
two study arms: (1) the Active Living Every Day (ALED) program plus a Health 

education program, or (2) ALED plus Our Voice neighborhood engagement program. 
The intervention period for each study arm lasts for at least 12 months and up to 24 
months.  
b. 
Procedure Risks 
The research procedures are not invasive and pose minimal risk to study participants. 
c. 
Use of Deception in the Study 
NA 
d. 
Use of Audio and Video Recordings 
As part of the Our Voice neighborhood engagement program, subjects will  
take photos and record audio narratives about features of their environment  
that support or hinder physical activity 
e. 
Alternative Procedures or Courses of Treatment 
There are no alternative procedures or courses of treatment. The alternative to this 
research project is not to participate. 
f. 
Will it be possible to continue the more (most) appropriate therapy for the 
participant(s) after the conclusion of the study? 
NA 
g. 
Study Endpoint(s) 
No treatments are being evaluated in this study. The study will be  
stopped when all the eligible, consented participants have completed the final  
survey as planned. The proposed study design represents the minimal amount of time 
and number of participants necessary to evaluate the objectives. 
3. 
BACKGROUND  
a. 
Past Experimental and/or Clinical Findings 
While national guidelines for population-wide PA promotion emphasize the 
importance of appealing, convenient physical activities such as walking, a 
significant proportion of Americans (33%) remain inactive. This is particularly 
true for older (45% inactive), low-income (46%), and ethnic minority adults 
(44%). Such groups have disproportionately high rates of obesity and other 
chronic conditions (e.g., diabetes), 24 a disparity often compounded by reduced 
access to affordable programs to improve health.  
Among the small number of evidence-based PA programs that have been 
effectively translated and made available to the public is the “lifestyle”- oriented 
Active Living Every Day program (ALED), for which Dr. King served originally 
as a scientific consultant. The effectiveness of ALED in teaching relevant 
individually-adapted behavioral skills and improving PA rates of participating 

adults has been validated through several decades of rigorous clinical trials. 
However, as with the vast majority of person-level behavioral skill building 
interventions, the ALED program has relatively little focus on understanding and 
changing local physical and social environmental determinants of PA that have 
been identified as key contributors to sustainable PA levels across a community.  
The potential of training residents as local environment data gatherers and 
contributors to interventions for promoting health has been increasingly explored. 
Our initial investigations in which local residents from under- resourced 
communities have been trained as “citizen scientists” have shown that residents of 
all ages, armed with simple assessment tools, can effectively capture physical and 
social aspects of their neighborhoods that either foster or hinder walking and other 
physical activities.  
While Some studies have found older adults living in housing sites to be less 
active than other older adults, they typically have common space in which to run 
resident programs, and many housing sites have support services managers whose 
job it is to develop and/or implement programs to enhance the welfare of 
residents. 
b. 
Findings from Past Animal Experiments 
NA 
4. 
PARTICIPANT POPULATION 
a. 
Planned Enrollment 
We plan to recruit up to 432 subjects for this study. Our rationale for focusing on the 40 
years and older age range is based on data showing that during these decades of life (i.e., 
the sixth and up) the risks of a number of chronic health conditions (including cancer) 
increase significantly among women and men. Regular PA begun during this time is 
associated with the amelioration or control of a number of these conditions. 
b. 
Age, Gender, and Ethnic Background 
Age range: 40 years and older  
Gender: Men and women  
Race/Ethnicity: The racial/ethnic background is diverse and will reflect that of the 
housing site residents. 
 
c. 
Vulnerable Populations 
Because we are focusing on affordable housing residents for low income older adults, it 
is possible that these individuals are economically and/or educationally disadvantaged. 
 
Minimizing Potential Risk  
Study assessments will be conducted at the designated housing sites by extensively 
trained and supervised study staff who have experience in collecting the planned study 
measures in an effort to minimize potential risk. All participants will be fully informed 

regarding the purpose and procedures of the study, as well as the risks and benefits. The 
surveys will be administered by a research assistant who has been trained not to coerce 
study participants, and participants will be informed that they can refuse to answer any 
questions that make them feel uncomfortable.  
 
It is possible that a percentage of participants will have relatively low educational levels. 
Thus, we have also taken the following safeguards to ensure that all participants fully 
understand their rights:  
•Use bullet points to easily identify each component of the consent form and use simple 
wording, understandable for those who may have no more than a grade school education  
•Employ bilingual (Spanish/English) staff to translate and clearly explain all components 
of the study verbally  
•Utilize one-on-one sessions to assist participants with the informed consent process and 
the completion of questionnaires. Study personnel will be responsible for implementing 
the consent process and completion of questionnaires. 
d. 
Rationale for Exclusion of Certain Populations 
Women and minorities are included in this study. Children are excluded from this trial 
because children as a group tend to be more active and at reduced risk for chronic 
diseases relative to older adults. 
e. 
Stanford Populations 
No participants will be laboratory personnel, employees, and/or students of Stanford 
University 
f. 
Healthy Volunteers 
All participants will be sedentary, healthy volunteers, free of any medical condition or 
disorder that would limit participation in moderate intensity physical activity (such as 
sustained walking), including life-threatening disorders, myocardial ischemia, and major 
functional disabilities in the orthopedic area. Healthy volunteers are included to reduce 
the risk of any complications that could arise from participation in a moderate-intensity 
physical activity program. 
 
Psychological risks of the evaluation. There is a remote risk that persons completing 
questionnaires focusing on behavioral or psychological content may become distressed 
from discussing and revealing personal content. There is no evidence that any permanent 
psychological dysfunction has resulted from such assessments. Participants will have the 
option to refuse to answer any question. 
 
Medical risks of physical activity programs. The major risks of physical activity 
programs by initially inactive persons aged 50 and over are orthopedic and cardio-
respiratory. Orthopedic problems primarily are of the overuse variety and usually can be 
treated by rest and change in the mode and amount of physical activity. Frequent minor 
problems will occur, including temporary soreness or irritation of muscles, tendons and 
joints. The likelihood of orthopedic and cardio-respiratory risks are greatly minimized 
through the use of a moderate-intensity exercise program that involves primarily mild to 

moderate-intensity walking, as proposed in the current study, and an individualized, 
progressive approach to physical activity as proposed in the current program. 
 
Measures to Minimize Risk.  
• Study assessments will be conducted at the housing sites by extensively trained and 
supervised study staff  
• To ensure participant safety in this study, we will apply the set of screening and 
oversight procedures that are recommended in the American College of Sports 
Medicine’s (ACSM) guidelines and that we have used successfully in our research 
studies over the past 20 years. The exercise programs that we have delivered to mid-life 
and older adults have been shown to be safe, with no participant experiencing a major 
medical problem or injury related to the physical activity program. As recommended in 
the current ACSM guidelines, to screen potential participants for appropriateness for the 
physical activity program, we will have each individual complete the Physical Activity 
Readiness Questionnaire (PAR-Q), an extensively validated and used screening 
questionnaire that has been used throughout Canada and the U.S. to screen individuals for 
community-based physical activity programs. If individuals answer ‘yes’ to any of the 
medically related screening items, they will be directed to get physician clearance prior to 
entry into the study. This protocol has been shown to ensure participant safety without 
creating unnecessary medical expenses and barriers to participation for persons not 
deemed at risk for physical activity-related complications---an important issue for the 
low-income population being targeted. The use of a mild form of physical activity 
(walking) already being undertaken to at least some extent by community-dwelling 
individuals to accomplish their daily activities also diminishes risk 
 
The risks of injury resulting from participating in the prescribed physical activity 
programs will be minimized in several ways:  
•Exclusion from the study of any person with overt cardiovascular disease or acute 
symptomatology.  
•Individualized physical activity program aimed at slow, gradual progression of physical 
activity amount.  
•The use of moderate-intensity physical activity programs, involving primarily walking, 
for all study participants.  
•Careful instruction of participants by experienced staff.  
•Ongoing supervision of physical activity participation both in person and as part of the 
intervention program.  
•Careful attention to gentle warm-up and cool-down exercises related to walking, as well 
as to the experience of physical discomfort during physical activity. 
g. 
Recruitment Details 
In collaboration with LeadingAge and housing site administrators and staff, we will 
employ a variety of community outreach strategies that will include making brief 
presentations at the participating sites' informational meetings and community events, 
placing posters and flyers at the entrances of the senior center, placing announcements in 
LeadingAge newsletters as well as other publications produced by the sites, and mailing 
brochures and personalized letters to older adult residents residing in the sites. 

h. 
Eligibility Criteria 
i. 
Inclusion Criteria 
Male and female adults  
Aged greater than or equal to 40 years  
No plans to move within the next two years  
Participants must be willing to increase walking minutes per week if they are not 
meeting national recommendations of 150 min per week of moderate physical 
activity or if they are meeting the recommended guidelines they should be willing to 
maintain their levels of physical activity.  
Able to participate in study intervention and assessments 
ii. 
Exclusion Criteria 
1. Any medical condition or disorder that would limit participation in moderate 
intensity PA (such as sustained walking), including life-threatening disorders, 
myocardial ischemia, and major functional disabilities in the orthopedic area 
2. Not stable on their medications, including hormone replacement therapy, for ≥ 3 
months (given that changes in medications can create additional stress and 
burden over and above attempts to change lifestyle behaviors); 
3. Inability to participate in the ALED program as a participant 
4. Reporting being pregnant, planning to be pregnant or had a baby in the last 12 
months. 
i. 
Screening Procedures 
Individuals will go through an initial telephone, face-to-face or online screening process. 
The screening process will consist of answering a series of questions related to 
inclusion/exclusion criteria. They will also complete an information session.  
Consent will be obtained prior to collecting any data. Further, all participants will receive 
and overview and explanation of the study purpose, time commitment, assessment 
schedule, and intervention. 
j. 
Participation in Multiple Protocols 
During the eligibility screen participants will be asked if they are participating in any 
other research study.  
k. 
Payments to Participants 
Randomized trial participants will receive a gift equivalent to approximately $10 in value 
for each assessment completed. Based on previous work, these monetary amounts 
typically do not place undue pressure on the participant to volunteer for our studies. 
l. 
Costs to Participants 
There will be no financial costs associated with participation in this study. 
m. 
Planned Duration of the Study 
Participant screening: 60-90 minutes  

Duration of participation in the study would be the at least 12 months with follow up for 
a total of 24 months  
Active participation in study: 60- 90 minutes/every other week for up to 6 months, at 
least once a month for the rest of the study. 
5. 
RISKS 
a. 
Potential Risks 
i. 
Investigational devices 
NA 
ii. 
Investigational drugs 
NA 
iii. 
Commercially available drugs, biologics, reagents or chemicals 
NA 
iv. 
Procedures 
NA 
v. 
Radioisotopes/radiation-producing machines 
NA 
vi. 
Physical well-being 
The major risks of physical activity programs by initially inactive persons aged 40 and 
over are orthopedic and cardio-respiratory. Orthopedic problems primarily are of the 
overuse variety and usually can be treated by rest and change in the mode of physical 
activity. Frequent minor problems will occur, including temporary soreness or irritation 
of muscles, tendons and joints. The likelihood of orthopedic and cardio-respiratory risks 
are greatly minimized through the use of a moderate-intensity exercise program that 
involves primarily mild to moderate-intensity walking, as proposed in the current study, 
and an individualized, progressive approach to physical activity as proposed in the 
current program.  
For participants in the attention-control condition, there is a small risk that making 
changes to eating habits (i.e., introducing new foods) may cause transient gastrointestinal 
upset. 
vii. 
Psychological well-being 
There is a remote risk that persons completing questionnaires focusing on behavioral or 
psychological content may become distressed. There is no evidence that any permanent 
psychological dysfunction has resulted from such assessments. 
viii. 
Economic well-being 
NA 
ix. 
Social well-being 

NA 
x. 
Overall evaluation of risk 
The risk for participating in this research study is minimal, similar to regular daily 
activities such as walking. 
b. 
International Research Risk Procedures 
NA 
c. 
Procedures to Minimize Risk 
Study assessments will be conducted at the designated housing sites by extensively 
trained and supervised study staff who have experience in collecting the planned study 
measures. 
Physical activity programs. Our research team has had substantial experience in the 
formulation and execution of physical activity programs for a wide range of patient and 
non-patient populations, including community-dwelling older adults and other subjects at 
increased risk for cardiac or orthopedic complications during exercise (those having had 
coronary artery bypass graph surgery, post-myocardial infarction, hypertension, 
hyperlipidemia, mobility impairments, and obese patients). For over 30 years we have 
been prescribing individually-tailored home- and neighborhood-based physical activity 
programs for midlife and older adults without any major cardiac or other medical 
complications resulting from the physical activity of which we are aware. To ensure 
participant safety in this study, we will apply the set of screening and oversight 
procedures that are recommended in the American College of Sports Medicine’s (ACSM) 
guidelines and that we have used successfully in our research studies over the past 30 
years. The physical activity programs that we have delivered to mid-life and older adults 
(a number that have been more intensive than the moderate-intensity primarily walking 
program being targeted in the current research) have been shown to be safe, with no 
participant experiencing a major medical problem or injury related to the physical activity 
program. As recommended in the current ACSM guidelines, to screen potential 
participants for appropriateness for the physical activity program, we will have each 
individual complete the Physical Activity Readiness Questionnaire (PAR-Q), an 
extensively validated and used screening questionnaire that has been used throughout 
Canada and the U.S. to screen individuals for community-based physical activity 
programs. If individuals answer ‘yes’ to any of the medically related screening items, 
they will be directed to get physician clearance prior to entry into the study. This protocol 
has been shown to ensure participant safety without creating unnecessary medical 
expenses and barriers to participation for persons not deemed at risk for physical activity-
related complications---an important issue for the low-income population being targeted. 
The use of a mild form of physical activity (walking and similar easy-to-do types of 
physical activity) also diminishes risk. In addition, all subjects will be evaluated for 
adverse events as part of the study assessments conducted every 6 months using the 
standard forms approved for use by the Stanford Institutional Review Board.  
 
The risks of injury resulting from participating in the prescribed physical activity 
programs will be minimized in several ways:  

- Exclusion from the study of any person with overt cardiovascular or orthopedic disease.  
- Individualized physical activity program aimed at slow, gradual progression of physical 
activity amount.  
- The use of moderate-intensity physical activity programs, involving walking and similar 
activities, for all study participants.  
- Personalized instruction of participants as part of the evidence-based physical activity 
programs being used.  
- Ongoing attention to and advice related to the experience of physical discomfort during 
physical activity as part of the evidence-based physical activity programs.  
 
The content of the moderate-intensity physical activity program that is being targeted is 
commensurate with the current national guidelines for physical activity promotion in 
older adults.  
 
Confidentiality of participant data. Confidentiality of participant data will be maintained 
by handling individual data by ID number, rather than by name; storing all individual 
data in locked file cabinets and secured, password protected electronic hard drives and 
data servers; and not disclosing individual data to anyone other than project staff, except 
as requested by the participant in writing.  
 
Adverse event monitoring and reporting. Adverse events information will be collected at 
all assessment points and recorded on standard forms that have been used in our other 
studies. We will collect information on all potential types of adverse events, including 
musculo-skeletal soreness and injury, as well as major medical events including injuries 
or conditions that result in health care provider visits, hospitalization, etc. Consistent with 
NIH and Stanford IRB policy, adverse events will be promptly reported in writing to the 
NIH and Stanford IRB. 
d. 
Study Conclusion 
Current recommendations are for all healthy adults to engage in physical activity on 
most, preferably all days of the week. The intervention in this project is designed to 
encourage people to meet the physical activity goals for 12 months, which is an 
appropriate length of time to expect people to establish new health habits. There are no 
guidelines for early termination of an intervention designed to encourage a physically 
active lifestyle. However, if physical or other conditions develop such that continued 
participation would constitute undue risk, participation will be discontinued. Guidance on 
this matter will also be provided by the Project Advisory Committee. Advice given is 
consistent with current health guidelines, so there is no guideline for early termination. 
However, if conditions develop such that continued participation would constitute undue 
risk, participation will be discontinued. Guidance on this matter will also be provided by 
the Project Advisory Committee 
e. 
Data Safety Monitoring Plan (DSMC) 
i. 
Data and/or events subject to review 
NA 

ii. 
Person(s) responsible for Data and Safety Monitoring 
NA 
iii. 
Frequency of DSMB meetings 
NA 
iv. 
Specific triggers or stopping rules 
NA 
v. 
DSMB Reporting 
NA 
vi. 
Will the Protocol Director be the only monitoring entity? (Y/N) 
Y 
vii. 
Will a board, committee, or safety monitor be responsible for study monitoring? 
(Y/N) 
N 
f. 
Risks to Special Populations 
NA 
6. 
BENEFITS 
We believe that all participants will benefit by learning (from the study questionnaires and 
measurements) about their health and physical activity levels. Those who successfully improve 
their physical activity levels will have achieved desired goals. Over the study period all 
participants will benefit from receiving health information.  
 
We believe society will benefit from the results of this project in that it will inform further 
research aimed at developing effective and appropriate physical activity programs for low-income 
populations in this age group.  
It will shed light on how best to deliver physical activity advice to enhance adoption and 
maintenance of regular physical activity through programs that include individual-level 
behavioral skill-building and identification of neighborhood assets for and barriers to regular 
physical activity. The delivery of these programs in community settings such as congregate  
housing sites by trained lay advisors and facilitators can substantially broaden the reach of the 
physical activity interventions to underserved populations at potentially lower-cost than 
traditional face-to-face or health care provider-delivered approaches. These are public health 
issues of immense proportions, particularly with the continued growth of the older segment of the 
U.S. population and the substantial prevalence of inactivity among that population group in 
general and lower-income segments in particular. In summary, we believe the risks can be kept 
very low whereas the benefits to participants and society are quite substantial. 
7. 
PRIVACY AND CONFIDENTIALITY 

All participant information and specimens are handled in compliance with the Health Insurance 
Portability and Accountability Act (HIPAA) and privacy policies of Stanford University, Stanford 
Health Care, and Stanford Children’s Health.