Engaging Rural Men With Mobile Technologies for Weight Loss: A Randomized Controlled Trial.
Phase: NA
Conditions: Weight Loss
Sponsor: University of Nebraska

Study Protocol and StaƟsƟcal Analysis Plan 
The Rural Mens Health Study 
NCT03329079 
05-27-2022 
 
 

Protocol and StaƟsƟcal Analysis Plan 
Summary 
Obesity is a major public health problem that disproportionately affects rural men1and 
promotes the development of chronic conditions such as diabetes, cardiovascular 
disease, arthritis, and cancer2. This study proposes to evaluate a 6-month mobile self-
monitoring application (app) with Wi-Fi scale and text messaging intervention (MT+: 
mobile technology plus) for achieving weight loss in overweight and obese rural men. 
Weight loss interventions for rural men constitute a gap both in the literature and current 
NIH-NINR research portfolios. Using a pragmatic randomized controlled trial and 
community engaged research (CEnR) approaches, this study aims to: 1) determine the 
feasibility and acceptability of a smart phone self-monitoring app (Lose-It Premium) plus 
SMS text-based and daily weighing via Wi-Fi scale intervention (MT+) for achieving 
weight loss, 2) determine preliminary efficacy of MT+ to a comparison group receiving 
only a self- monitoring app (Lose-It Basic) (MT) in achieving the outcomes of weight 
loss (kg and % body weight-primary) and improved dietary and physical activity (PA) 
behaviors (secondary) at 3 and 6 months postbaseline, and 3) determine quantitative 
and qualitative indicators of community capacity to support a contextually relevant 
weight loss intervention. Eighty men (ages 40-69) with BMI of 28 kg/m2 or higherwill be 
randomly assigned (1:1 ratio) to intervention group (MT+) or comparison group (MT). 
Men will complete baseline assessments (weight (kg), % body fat, BMI, height, blood 
pressure (BP), health history, dietary intake, PA intensity) and receive orientation to the 
mobile technologies (Lose-It app features, SMS, Wi-Fi scale). Men will track their 
dietary intake, PA, and weight on the Lose-It app for 26 weeks. After the 6-month 
intervention, post-measure assessments (weight-kg, % body fat, BMI, dietary intake, PA 
frequency/intensity, and technology usability surveys) will be collected at 3 and 6 
months post-baseline. At 6 months post-baseline, two groups (n=8 each) of MT+ 
completers will be purposively selected to share their perceptions of the intervention 
efficacy in evaluative focus groups. A community advisory board (CAB) comprising local 
leaders within the men's social network, together with investigators and UNMC student 
nurses will guide community outreach efforts for study recruitment, implementation, and 
evaluation. Study findings will be evaluated with the CAB to inform local dissemination, 
future intervention revision, and determination of community capacity for support of a 
larger clinical trial. 
 
Purpose 
 
The specific aims of this study are: 
 
Aim #1: Determine the feasibility and acceptability of a MT+ intervention for achieving 
weight loss in rural overweight and obese men. The aim will specifically address groups 
by 1) participation rates including number of men recruited and randomized over a 6 
month period; 2) retention rates; 3) feasibility, usability, satisfaction ratings; 4) 
adherence record of logging by men in the intervention group; and 5) evaluative focus 
group feedback. 
 

Aim #2: Determine preliminary efficacy of a MT+ intervention to a comparison group 
receiving only a basic self-monitoring app (MT) in achieving 1) weight loss (primary), 
and 2) improved dietary and PA behaviors (secondary) at 3 months post-baseline and 
follow-up at 6 months post-baseline in rural men. 
 
Aim #3: Determine quantitative and qualitative indicators of community capacity 
(resource mobilization, learning opportunities-skills development, partnership linkages, 
participatory decision-making, and leadership) to support a relevant weight loss 
intervention for rural men. 
 
Feasibility Substudy Aim:To determine the feasibility of men currently enrolled in our 
clinical trial to wear an activity sensor (Actigraph GT9X) for seven continuous days to 
objectively measure their continuous physical activity among the total volume of activity 
bouts across three gait dimensions: intensity, symmetry, and variability. 
 
Background and Rationale 
 
Obesity is disproportionately prevalent among rural men. Overweight/obesity rates 
among midlife and older men in Nebraska have tripled in the past 20 years, with 30% of 
men obese (n=133,470)3, 4. Associated with overweight and obesity, rural midlife men 
are at higher risk for metabolic syndrome and cardiovascular disease (CVD)5. Our 
preliminary study findings showed a high number of (CVD) risk factors (hypertension, 
etc.) among rural men6. The implication of high prevalence of overweight and obesity in 
rural men is a reduced life expectancy compared to rural women7, and overall poorer 
health than urban men,1 which contributes to increased economic and psychological 
burden to rural women and families.8,9 Historically, rural men were less likely to be 
overweight and obese due to the high levels of physical activity involved in agriculture 
(Ag)-based occupations. Recently, the mechanization of Ag-service industries has 
shifted men's work roles to more sedentary, technology-driven lifestyles, increasing the 
likelihood of developing overweight/obesity. Despite the burden of obesity, no self-
monitoring mobile technology interventions for weight loss in rural, U.S. males were 
found. Men, compared to women, are less likely to use weight control practices,10 
attempt weight loss, or participate in weight loss programs.11-13 Access to weight loss 
resources is one reason.14 Rural men tend to exhibit dominant masculine 
norms,15 which view help-seeking behaviors and health promotion strategies as 
feminine and weak.6, 15 Health promotion activities oriented to rural men's work roles are 
preferred.16 Therefore, a weight loss intervention whose content is adapted to the local 
norms, is accessible through the privacy of a smartphone, and communicated in an 
acceptable tone is critical to engaging rural men. 
 
Community engagement is imperative when designing a weight loss intervention for 
rural men. Community engagement is a collaborative process in which people affiliated 
by geographic proximity, special interest, or similar situations address locally relevant 
issues.17 National Institutes of Health (NIH)18 advocates for community engagement in 
clinical trials to improve recruitment/retention, research quality, relevance, and 
enhanced research impact in addressing health disparities.19 Community-engaged 

research (CEnR) with underserved, rural Ag populations has demonstrated positive 
outcomes for 1) improving service access,20, 21; 2) establishing service learning 
opportunities for college students22; 3) healthcare training models, and 4) garnering 
local health priorities for action.23 Our preliminary study was the first to provide 
information about the feasibility of engaging rural men into clinical research with mobile 
technologies using community leaders from the men's social networks. CEnR strategies 
applied in our study supported 100% recruitment and retention of our sample.6 We will 
use similar, but expanded community engagement efforts for this study in the form of 
community outreach guided by student nurses and a community advisory board (CAB). 
Community outreach via nurses has demonstrated improved study engagement and 
completion rates in previous pragmatic RCTs in rural Ag settings.24 Using a CAB will 
create structure for obtaining local feedback and promote the social validity of our study, 
providing input across all study time points.25-28 CABs improve the clarity of recruitment 
materials, social marketing strategies, and, when inclusive of lay representatives, 
enhance community engagement with hard-to-reach populations.28-31 Using a 
collaborative group structure with bidirectional sharing of information across all 
members is important in establishing trust, power balance, and resource sharing.32 The 
NIH R-15 Area Award that funds this proposal requires the involvement of 
undergraduate students in the research plan. Undergraduate student nurses 
are a community outreach and engagement resource for rural communities because of 
their previous experience as a student nurse on the rural, UNMC Northern Division 
campus in Norfolk, NE. Not only does the student's formal training in community 
outreach / community engagement as a component of their NRSG 413- Population-
Centered Care course provide them with the skills to conduct community outreach and 
engagement planning, but they are more likely to plan meaningful and locally effective 
outreach strategies that can enhance partnership building for CAB and subject 
recruitment. 
 
Self-monitoring eating and activity with smartphone-based applications helps 
overcome disparities related to access to weight loss resources in rural men. Self-
monitoring (SM) of eating, activity, and weight is one of the most effective behavior-
change techniques for weight loss.33-35 Yet, SM is labor-intensive and compliance is 
often difficult, 34as reported by rural men in our preliminary study.6 At the individual level, 
men have reported that SM interventions frequently adopted by women do not apply to 
their gender-specific preferences.36 Though, once men join a weight loss program, they 
are more likely to complete the program.37 The rural environment, by nature of its 
unique make-up of culture, socioeconomic stressors, and geographic determinants, 
impedes access to resources for SM.6, 38 Whereas smartphone technologies have now 
bridged this gap with the development of SM apps and Wi-Fi scales that permit real-
time support for tracking eating, activity, and weight, a SM quality desired by men.39-41 
Rural men in our preliminary study tested mobile SM technology and found it most 
acceptable when it was easy to use, conveniently accessible, and feasible to wear 
across their varied work settings and roles.6 
 
New smartphone-based apps, such as the Lose-It app, permit real-time engagement 
with users for tracking of eating and activity and don't require the wearing/managing of 
additional devices or paper-pencil self-monitoring, which may enhance adherence with 

dietary logging, satisfaction, and usability among adults.42 Recent analyses of SM 
interventions using mobile apps, including Lose-It, have recorded greater weight loss 
outcomes associated with the increased frequency of SM of eating and activity.43Lose-
It's incorporation of evidence-based behavioral strategies for weight loss and persuasive 
technology lends to its superiority among other mobile weight loss apps,44-45 including its 
access on a variety of platforms including android, iPhone, web, and tablet.46 We 
propose to compare 1) a publicly available free version of a smart phone app (Lose-It 
basic) (MT) that permits a convenient, ready to use application that could potentially be 
recommended by any given health care provider with 2) a more comprehensive self-
monitoring smart phone-base app (Lose-It Premiumwhich includes a social comparison 
group), combined with behavior change SMS messaging and daily self-weighing with a 
Wi-Fi scale (MT+). Our goal is to assess efficacy in overcoming disparities related to 
weight loss resources for rural men. The intent is to compare the Lose-It Basic app (free 
version) (MT) for tracking of daily weight, dietary intake, and physical activity with its 
companion, Lose-It Premium (paid version), that tracks a wider range of SM metrics for 
up-loading of weight with a Wi-Fi scale, physical activity, dietary, goal setting, and a 
private social comparison group, which enhances the value in the realtime tracking of 
these measures with comparison of past performance to one's goals, previous 
accomplishments, and the performance norms of similar groups.47-50Both the premium 
version of Lose-It app and the Nokia Body+ Smart Scale are publicly available for 
purchase.The premium version of the app costs 40.00 per year and offers enhanced 
goal setting functions and personalized weekly report for tracking progress. The Nokia 
Body+ Smart Scale costs 100.00 to purchase and syncs with the Lose-It app (either 
version) to provide real-time progress towards tracking weight loss goals. 
 
Text messaging is an effective channel for promoting SM behaviors to achieve weight 
loss among rural men. Text messaging provides motivation, knowledge, and social 
support for behavior change.40, 51-54 When supported by other program components, text 
messaging has been effective for improving SM behaviors (reducing weight, improving 
eating, increasing physical activity),52, 55-57 resulting in greater than 5% baseline body 
weight loss after 3 months.51 Behavior change augmented by text messaging has the 
advantage of reaching men instantly, yet allowing access to the message at the 
convenience of the recipient. Daily receipt of text messages at 8:00am, with content 
presented in a novel and non-repetitive fashion, has been documented as the preferred 
frequency and time for men,56 including rural men.6 In addition, texting is cost effective 
58and allows multiple messaging, with each text containing a different theme.59 Message 
content addresses at least one behavior change concept,60 such as motivation, 
education, and reminders.59 Text messages can be directed toward the specific 
motivations for and barriers to physical activity 61and healthy eating identified by men, 
39can encourage behavioral support outreach to family and friends, and should use 
concise language 40and humor.6 An example of a text message targeting interpersonal 
support for behavior change: Today, tell one friend or family member what your favorite 
healthy snacks are. When targeting weight loss, men's preference for the content of text 
messaging has ranged from behaviors to be enacted and avoided, strategies for 
overcoming challenges and creating healthy food environments, and healthy living 
challenges.56, 62-63 This study seeks to build on the available evidence from our 

preliminary study and other available evidence that text messaging may enhance 
selfmonitoring and behavior change for weight loss. 
 
Social Ecological Perspective (SEP) frames multiple influences on rural men's health 
behaviors. Rural men are less likely to implement their own physical activity and weight 
loss interventions due to access constraints and environmental influences.6, 64 Thus, 
combining individual health behavior change approaches with environmental-based 
support is necessary. 65SEP asserts that the degree of fit between a persons biological, 
behavioral, and sociocultural needs and the environmental resources available to them 
serves as a key determinant of health.66 This MT+ intervention applies SEP to impact 
multiple, nested layers of active and passive influence on men's health behaviors for 
weight loss.66 Use of the Lose-It app and Wi-Fi scale enable intrapersonal behavior 
change through the daily SM behavior of logging eating, activity, and weight. Real- time 
feedback via the app promotes individual evaluation of eating and activity behaviors. 
The real-time social comparison and group support provided via the Lose-It app and 
text messaging promote interpersonal support to influence behavioral change. The use 
of CEnR strategies, through the CAB involvement and student nurse outreach, permit 
social networking and improved community-level support for rural men's weight loss. 
Social networking will garner resources to inform locally relevant social marketing 
strategies and enhance study recruitment. The CAB will provide input across all 
stages of the study, supporting the relevance of the intervention and optimizing the 
engagement of local resources. (See Figure 1). Serrano and colleagues 43report of a 
largescale weight loss study using theLose-It app (n=12,427,196) found that 15% of app 
users lost 5% of more of their baseline body weight. Subsample analyses from this 
study indicated that higher intensity app use (SM frequency) and the use of custom app 
features characterized higher levels of weight loss success (73% achieved clinically 
significant weight loss)- suggesting that customizing SM information via Lose-It app to 
particular subgroups could enhance weight loss success. Key behavioral factors found 
to be related to varying proportions of weight loss success can be enhanced by the 
frequency of self-monitoring, real-time feedback from self-monitoring which permits self-
evaluation, and the receipt of prompts supporting eating and activity behavior change. 
These behavioral elements are associated with improved weight loss and decreased 
occurrence of weight regain.34 Social support and customizable goal setting are 
additional evidence-based behavioral strategies associated with optimum weight loss.34 
Therefore, we plan to compare the efficacy outcomes between the widely available 
Lose-It Basic app (free) with a custom version of the Lose-It app (Lose-It Premium- paid 
$40) supplemented with intrapersonal, interpersonal, and community-level supports to 
maximize self-monitoring behaviors for weight loss success. 
 
In summary, this study addresses a significant health disparity among overweight and 
obese rural men: access to and engagement with mobile technologies to achieve weight 
loss. Meeting the study aims will provide intervention protocol testing for application in a 
larger, fully powered R01 clinical study. This R01 will generate new scientific knowledge 
as there are few weight loss inquiries targeted to men in the U.S., and no such analyses 
were found with rural men. Scientific knowledge gained through community-engaged 
partnerships addresses a significant barrier to progress in the field of rural mens weight 

loss research by garnering recruitment, retention, and local preferences for this hard-to-
reach, underserved population. This study will have a substantial effect on 
strengthening the research environment at the UNMC-College of Nursings (CON) 
Northern Division (ND), located in Norfolk, NE (population 22,400, RUCA code 4-
micropolitan area core) by providing CEnR opportunities for rural undergraduate and 
graduate students. This study also has the potential to impact nursing science through 
the training of future nurse researchers in rural research. 
 
This study is innovative in that 1) it applies an intervention shown to be effective for 
weight loss in other populations, SM, to an unstudied and underserved population of 
overweight and obese rural, U.S. men, 2) while SM was found to be feasible and 
acceptable in our preliminary study, the delivery of a more comprehensive MT+ 
intervention (SM app with social comparison group, Wi-Fi scale, and SMS via 
smartphone intervention) has not been studied, and 3) the integration of CEnR with a 
pragmatic RCT is a novel way to design and deliver a weight loss intervention that 
facilitates local buy-in and is sensitive to context. The use of student nurses to support 
community outreach, the CAB to inform all stages of the study, and the use of both 
qualitative and quantitative data methods/analyses will support maximum community 
engagement for comprehensive understanding of SM eating and activity for weight loss. 
By involving rural undergraduate and graduate students in CEnR, we hope to ignite new 
opportunities for inquiry in this area based upon the ongoing, nurtured research 
relationships that community-engaged approaches have established and through 
learning from the experiences of others.67 
 
A preliminary study demonstrated CEnR strategies and mobile technologies support 
feasible means to test weight loss interventions with rural men. Dr. Eisenhauer (PI) led 
an interdisciplinary team, which included two doctoral students and one MSN student, to 
examine the feasibility and acceptability of an mHealth SM intervention that included 
health related text messages and the use of the FitBit One® (fitness monitor) with a 
comparison app to log daily food intake and monitor activity. Using CEnR strategies, 
eight community leaders from six rural towns participated by contacting prospective 
participants directly, sharing materials about the study, and verifying their interest in 
participating prior to contact with the PI. Twelve rural men were recruited and 
participated in an initial assessment and orientation session. For three weeks, they 
received text messages and used the FitBit One® to self-monitor eating and activity, 
after which they attended a 90-minute focus group session. FitBit One® and text 
messaging were acceptable and useful; however, the food log options needed 
adaptation to reflect dietary norms of rural men.6This preliminary study informs the 
proposed study by determining that rural men were interested in SM of eating 
and activity behaviors and will send and receive text messages.6 This study will continue 
using CEnR strategies, but will recruit a larger sample, utilize text messaging, and use a 
smartphone app designed for weight loss (Lose-It) with enhanced features for 
monitoring eating and activity. Obesity prevention and access to resources to promote 
healthy eating and activity is a local priority by both the district public health department 
68and among lay community members in our study region.23 
 
 
 

Undergraduate students are a CEnR resource for rural communities. This study will 
expose 42 undergraduate and 2 graduate assistant student nurses (GAs) from the 
College of Nursing (CON) Northern Division (ND) to rural research. The two graduate 
assistants will not be asked to participate in the study for purposes of data collection. 
Rather these students will work in role of research assistant, for which they do not need 
consents but rather listed as a team members on the IRB protocol. The CON ND 
campus has 96 enrolled students, and 70% of the student body are from 
Northeast Nebraska. Senior-level undergraduate student nurses (n=42) during their 
populations health course are currently trained in community engagement and 
partnership building for health promotion. Study months 1-4, students will participate in 
groups of 6-8 (on a clinical rotation schedule to maintain feasibility) in designing and 
evaluating community outreach strategies (recruitment, social marketing for businesses, 
developing/adapting community engagement strategies for community leaders, best 
practice approaches for facilitating CAB) which will permit students critical analysis of 
and experience with community outreach and engagement. Under the direct supervision 
of their course faculty and in collaboration with the PI and Norfolk GA, students will 
develop, implement, and evaluate community outreach strategies for community 
engagement. Activities may include 1) developing multiple media recruitment materials, 
2) strategically determining recruitment material dissemination, 3) establish community 
resource maps, and 4) identifying community leaders and lay persons to foster study 
engagement. Not only will the students formal course training provide them with the 
skills necessary to conduct these roles in this research study, but their understanding of 
the rural region makes them a valuable resource, as they are more likely to plan 
meaningful and locally effective outreach strategies. Two graduate-level students will be 
hired as graduate assistants on the project. The involvement of rural students from the 
ND in a community-based pragmatic trial has high impact. Through nurturing future rural 
nurse researchers and clinical nurses by training for community engagement/outreach 
principles that work best with rural populations, this creates the potential to stimulate 
research on this campus and in this rural region. The PI has supervised graduate 
assistants in the past and has adequate experience to hire and train students for the 
present study. The PI has previously mentored undergraduate students in rural 
community outreach 69and doctoral students in qualitative data collection/analysis and 
dissemination.6 
 
 
Sub-study 
 
Physical activity behaviors (mode, intensity, and duration) are linked to promoting 
healthy weight, maintaining overall health, optimizing functional abilities such as gait 
and mobility patterns, and reducing risk of disability3. Knowledge about physical activity 
behaviors among hard-to-reach rural men is limited. In our current feasibility trial (R15) 
for promoting weight loss in rural men, we are using smart phones to measure mens 
step count as a general indicator of total physical activity. This method does not allow 
for complex analysis of activity quantity or quality, nor does it produce reliable gait data 
because of step count underestimation due to phone non-carrying time4. Wearable 
sensor-based multidimensional gait analysis is a quantitative method for predicting 
critical biomechanical measures of physical activity in specific populations and in real-
world settings5. To our knowledge, there has been no established objective baseline for 

complex analysis of physical activity behaviors, such as activity pattern analyses using 
a multidimensional gait metric in rural men. 
 
Accrual 
 
A total of 8-10 community advisory board members (CAB), 42 student nurses from the 
UNMC Northern Division NRSG 413 Population Centered Care course, and 80 rural 
male subjects (40 per group) are needed to achieve the proposed objectives. The 
sample will consist of 80 men (40/group) who meet the inclusion criteria. Hertzog 
74suggested that 30 participants per group in a pilot study is a sufficient sample size 
for aims involving between group differences and if the results are to be used to 
estimate the needed sample size for a future, fully- powered study. It is important for 
this study that we obtain reliable estimates of effect size with which to perform a power 
analysis for subsequent research, so 40 participants per group will be sought, for a total 
of 80. Some participants will likely not complete the study, so we will enroll 80 men to 
allow for up to a 30% attrition rate. Power for the repeated measures analysis of 
variance (RM-ANOVA) was determined using G*Power 3.1.9. A within-between 
interaction will be the primary test of significance (time*group interaction). Assuming a 
small effect size (f=.10),75 a significance level of .05, 3 time points, and an estimate of 
.5 for the correlation between time points, 164 participants (82 per group) would be 
needed to have 80% power. Because this is a pilot study, a smaller sample size is 
justified, and the results of the pilot study will be used to update the power analysis prior 
to a future study. 
Purposeful justification for the total number of community advisory board members and 
student nurses is based upon their information rich knowledge of the rural context as 
either community leaders or students in a rural college of nursing. Justification of the 
total sample size desired for the community advisory board is based upon optimal group 
function / interaction (8-10 persons) documented in previous advisory board work in 
agricultural based locales (Kingman, Yoder, Hodge, Ortega, & Field, 2004). Justification 
for inclusion of 42 student nurses was based upon the aim of the R-15 AREA NIH 
mechanism to expose undergraduate students to research. Community outreach is a 
concept taught in NRSG 413- Population Centered Care. It was deemed feasible to 
involve all students enrolled in this NRSG 413 course to the community outreach activity 
of this study- without excluding any student. 
 
Kingman, D., Yoder, A., Hodge, N., Ortega, R., & Field, W. (2004). Utilizing expert 
panels in agricultural safety and health research. Journal of Agricultural Safety and 
Health, 11(1), 61-74. 
 
Feasibility Substudy: We would like to recruit 15 men, newly joining and currently 
enrolled in our weight loss trial, via convenience sampling (asked in the calendar order 
they present for their baseline, 3-month, or 6-month assessment visit in the current 
clinical trial) to participate in this sub-study. Both arms in our clinical trial receive the 
same education/instruction about physical activity (i.e. goal of 10,000 steps per day). 
The men will be invited to participate in this sub-study during their regularly scheduled 
baseline, 3 month, or 6-month assessment visit with the research nurse at the Northeast 

Nebraska Public Health Department in Wayne, NE. Intervention subjects: 40-69 years 
of age Community advisory board members: 19 or older UNMC Northern Division 
Student Nurses enrolled in NRSG 413: 19 or older. 
 
Inclusion Criteria 
 
Intervention Subject Inclusion criteria include 1) man age 40-69, 2) reside in the 
Northeast Nebraska region, 3) BMI between 28 (kg/m2) or higher and weight not 
greater than 396 pounds (BMI 50 or higher with clinician clearance), 4) smartphone 
owner with enabled text messaging, 5) speak and read English, 6) have an email 
account, 7) answer "no" to all questions on the PAR-Q17 health history assessment or 
are willing to get physician clearance prior to enrolling, 8) willing to share SM logs with 
investigative team, and 9) attend three assessment visits in Wayne, NE. 
Community advisory board member inclusion criteria includes 1) adult (age 19 or older) 
who is identified by self or others as a community leader in Cedar, Dixon, Wayne, or 
Thurston counties, 2) willing to participate in monthly community advisory board 
meetings for duration of the study, 3) smartphone owner with enabled text messaging. 
Student nurse inclusion criteria includes 1) adult (age 19 or older) who is enrolled in the 
UNMC Northern Division's NRSG 413- Population-Centered Care course, 2) willing to 
participate in a small group discussion about rural community engagement/ community 
outreach strategies with other students enrolled in NRSG 413 and the principal 
investigator, Dr. Christine Eisenhauer, during their assigned course time, willing to 
complete a survey before and after this experience self-assessing their understanding 
of the public health nurses' role in conducting rural community engagement and 
outreach. 
 
Substudy: Inclusion criteria would include 1) currently enrolled in the Rural Men's Health 
Study, and 2) willing to wear on the Actigraph GT9X on your waist for 7 continuous days 
(except for bathing) and mail back device in the stamped, pre-addressed envelope. 
 
Exclusion Criteria 
 
1) have recently lost 5% or more of body weight 
2) are currently taking medications that cause or are influenced by weight loss (oral 
steroids, tricyclic antidepressants, lipase inhibitors) 
3) have used weight loss app in the past to lose weight 
4) family member from same household is enrolled in this study 
5) Type I diabetes or Type II diabetes with insulin dependence. 
 
UNMC Northern Division Student Nurses Enrolled in NRSG 413 Exclusion Criteria: 
none 
 
Substudy exclusion criteria would include a man not currently enrolled in the Rural 
Men's Health study clinical trial. 
 
 
 

Methods 
 
This team will use multiple strategies to recruit rural 
men based upon approaches that have been used successfully in this region and 
demonstrated positive outcomes for recruitment and retention.6, 23, 76, 77One CEnR 
strategy will be to develop a community advisory board. In study months 1-4, formal and 
informal community leaders within rural men's social network/region (i.e., farmers, 
insurance sales/machinery-implement dealers, extension board staff, and community 
health workers) will be sought via community outreach strategies identified by UNMC 
Northern Division (ND) student nurses and the PI. The PI and GA will invite community 
leaders to serve on a CAB to inform the local priority issue of overweight/obesity among 
rural men. The CAB composition will include 8-10 community members from the 
sampling region78 whose knowledge and experience provides insight into the 
preferences and needs of the local men and hold potential to be stakeholders for 
successful implementation of the study. 79CAB members will meet face-to-face quarterly 
across the three year study for a total of 12 meetings. Members will receive a stipend in 
consideration of their time and travel costs.80 CAB meetings will occur in person at the 
Northeast Nebraska Public Health Department, led by two investigators trained in 
CEnR, to promote group cohesion. Meetings will also include snacks, consistent with 
CAB best practice in Ag-centered communities 79, 80. Meetings will also be available via 
Zoom video chat technology to CAB members, which is freely accessible on the internet 
and feasible to use in low-band width internet locales via smartphone, PC, tablet, or 
laptops, to limit access barriers (weather, time) which might inhibit attendance. 
Community leaders will be encouraged to co-lead the CAB meetings supporting mutual 
partnership and leadership development. CAB members will assist recruitment by 1) 
informing the approach, material content and imaging, and targeted venues for social 
marketing, and 2) the dissemination of recruitment materials and direct referral of 
eligible participants. CAB members will be given the option to refuse to have their 
opinions collected as research data, consistent with CEnR principles. 
 
UNMC Northern Division Student Nurses Enrolled in NRSG 413- Population Centered 
Care course receive training in community outreach / community engagement as an 
expected course outcome. Students in this course will spend 2 hours of their assigned 
course clinical time in group discussion with the principal investigator, Christine 
Eisenhauer, who is an advanced practice public health nurse. The discussion will 
involve planning community outreach and community engagement strategies for our 
study region that may enhance recruitment and retention of CAB members and 
subjects. Students will be asked to identify strategies for enhancing the planned 
community outreach and community engagement specific to rural populations for this 
study. Activities will include determining strategic recruitment material dissemination, 
creating community resource maps, and identifying community leaders and lay persons 
pivotal to enhancing community parternship. Prior to beginning the discussion, students 
will be asked to complete a short survey about their understanding of the public health 
nurse role in community outreach / community engagement. The students will be asked 
to complete the same survey post discussion to determine if the discussion experience 
enhanced their understanding of this role. 

 
Intervention: The proposed feasibility study is a pragmatic RCT. Rural men (ages 40-
69) will be recruited over a 12 month period to obtain a target enrollment of 80 subjects. 
Subjects will either be allocated to the intervention (Lose-It Premium with social 
comparison group, Wi-Fi scale for self-monitoring, plus SMS support messages for 
weight loss- MT+) (n=40) or the comparison group (Lose-It Basic- MT) (n=40). These 
group sizes reflect oversampling by 30% in each group to allow for attrition, based upon 
attrition rate averages. 
 
Following informed consent and completion of baseline visit, eligible 
participants will be randomized 1:1 to either intervention or comparison group. 
Participants randomized to the MT+ group will receive Lose-It Premium version (value 
$40) and Wi-Fi Nokia Body+ scale ($100). Participants randomized to the MT group will 
receive Lose-It Basic version (free) plus a $25 stipend for their participation in each 
assessment point (3). The men will be randomly assigned to the intervention and 
comparison groups as they are enrolled using an allocation schedule created by the 
project statistician. The research nurses will not be blinded to the group assignment as 
they must conduct the app download on the subject's phone and conduct orientation 
training of the app with the subject that is specific to their assignment (basic app vs. 
premium app). Randomization will be predetermined using a random number generator 
and urn randomization to ensure equal sample sizes. 
 
A comparison group (MT) (n=40) of men will receive the Lose-It Basic app. The basic 
app permits daily self-monitoring of eating and physical activity and manual logging of 
daily weight. MT participants will be asked at baseline to self-monitor their eating, 
activity, and weight daily. They will receive no text message prompts for self-monitoring, 
self-monitoring trend reports, or peer interaction via   group. MT participants will 
complete assessments at baseline, 3 and 6 months postbaseline. MT participants will 
only receive text message reminders for their assessment visit appointment times. 
 
Description of the Intervention Group (MT+). Lose-It Premium permits enhanced 
customization of goal setting, app automated self-monitoring reminders, customized 
email reports that outline self-monitoring trends important in supporting motivation and 
confidence during periods of behavioral action. The Nokia Wi-Fi scale will provide 
automated coaching, rewards and recording of weight synced to the Lose-It app 
permitting immediate feedback and visual maps of weight trends.  
 
Research Staff Support-Reminder Prompts: MT+ participants will have research staff 
support available via phone. They will also receive reminder prompts for self-monitoring 
via text and phone when non-adherence with self-monitoring of dietary intake, physical 
activity or weight is incomplete for 5 days of greater. 
 
Social Comparison Group: MT+ participants will be enrolled in a private social 
comparison group on Lose-It Premium comprised of other intervention group subjects 
from this study (same group composition as their texting subgroup). The purpose of the 
social group is to provide social comparison of others self-monitoring experiences 

providing a mechanism to influence judgment and behavior change towards ones own 
self-monitoring. The social group will also provide social support to MT+ participants 
while completing the trial to promote long-term success.81, 82 The social comparison 
groups will be moderated by a male investigator who will suggest topics for guiding 
discussion and peer challenges (ie. 10,000 steps per day for physical activity or 8-10 
glasses of water per day). Men will also be encouraged to post useful strategies and 
progress reports related to self-monitoring and weight loss. Participants will be 
encouraged to post a minimum of weekly. 
 
Text Messages: A text message library will be developed by the team based upon 
messaging content that has demonstrated usefulness for behavior change51, 59, 83, 84and 
preferred by men.56, 62, 63Text message content will include a variety of topics including 
reminders, nutrition and physical activity behaviors to be enacted and avoided, SM 
portion control, strategies for overcoming barriers, and health living challenges. Content 
for text messages will be adapted from healthy eating and physical activity promoting 
resources that include USDA Choose My Plate85and CDC and Prevention: Physical 
Activity86including targeted aerobic physical activity, monitoring of body weight, 
behaviors needed to sustain weight loss, promoting success and rewarding oneself, 
preventing failure and avoiding temptations.51 Messages will also target interpersonal 
support surrounding weight loss behaviors (i.e. Tell your partner/friend about a way you 
have found to get in more physical activity steps a day). See exemplar of text messages 
in attached documents. Additional text messages developed will be submitted to IRB for 
approval. CAB members will inform the content of the text messages for local relevance 
prior to dissemination with the MT+ participants. 
 
Research nurses will conduct face-to-face assessments and surveys with participants at 
baseline, 3 and 6 months post-baseline. Feasibility and acceptability measures of the 
intervention will be collected across the study. We will also conduct two evaluative focus 
groups with a purposively selected subsection of the intervention group (n=8 per group) 
to obtain perspectives on perceived outcomes and utilization of behavioral strategies 
from the intervention and the feasibility and acceptability of the technologies. (See 
Figure 2). 
 
Procedures / Data Collection and Management. CAB. The community advisory board 
(CAB) will trial Lose-It Premium, including the social comparison group page, during 
study months 1-6 to identify potential areas in which male subjects may need additional 
instruction, facilitation, and ongoing support. The investigative team will discuss the 
CABs feedback and the PI will keep reflective research notes tracking 
decision-making processes. The CAB will also review the text message library to ensure 
message content is locally relevant and meaningful prior to intervention dissemination. 
 
Rural Male Subjects. Two trained research nurses will conduct the assessments and 
will be flexible in working hours that match participants availability. The baseline visit will 
take approximately 90 minutes to complete. Men will complete questionnaires and have 
their blood pressure, weight, and resting heart rate assessed. Those men exhibiting risk 
that may contraindicate increasing physical activity or weight loss will be referred to their 

primary care provider for written clearance to participate.99 All questionnaires and 
biomarkers will be entered into a secure site through the Internet. All data will be 
entered in the REDCap server. The UNMC Research IT Office instructs investigators in 
its use and hosts the REDCap database of project data. 
 
Baseline Instructions Provided to Both Groups. Each man will receive his Lose-It user 
ID and password, as well as written instructions to access the research nurse, and 
information about technical support. Temporary emails will be set up for each subject 
that contain no personal identifiers (ie. MensHealth1@gmail.com). These email 
accounts will be used only for the purpose of setting up a Lose-It account and receiving 
automated Lose-It account reports. No personal communication with subjects will 
happen through these email accounts. At baseline, both groups will receive an 
informational packet with verbal instruction focused on a lifestyle change plan for 
healthy eating and activity to accomplish weight loss. Our goal is that the participants 
will demonstrate a weight loss of 5% or more of their baseline body weight, which is the 
minimum weight loss documented to produce a decrease in health risks (diabetes, 
cardiovascular disease, hypertension).100-101. 
 
Smartphone Use: Each subject will be asked to wear their smart phone during waking 
hours on their hip or in a pocket. 
 
Nutritional Plan: Recommended approaches for achieving negative energy balance 
through reduced caloric intake and increasing physical activity to recommended levels 
will be provided with the primary goal of losing 1-2 pounds a week during the 3 month 
intervention. Participants caloric eating plan goals will be calculated by the Lose-It app 
based on their age, gender, height, and activity level tracked in the app. 
 
Physical Activity Plan: Current recommendations from public health agencies and 
scientific organizations including the NHLBI,(102) DHHS/CDC,103, 104 and the ACSM 104, 
105outline physical activity as an important part of weight management. 
Participants will be advised to gradually meet minimal targets 10,000 steps per day 
(goal PA outcome on Lose- It apps) and 150 minutes a week of moderate-intensity or 
greater activity. 
 
Daily Self-Weighing: Participants will be provided instructions for measuring and 
recording their weight daily. All participants will be 1) oriented to the text messaging 
process, 2) respond to a test text message to ensure receipt. Participants will receive an 
orientation, with written instructions and physical demonstration, to Lose-It Basic app. 
Instructional content will include how to post nutritional intake, recording physical activity 
and weight. Participants will be asked to wear their smart phone during waking hours 
over the next 26 weeks to input their dietary intake and track physical activity, and 
record their self-measured weight daily. Assessment visits at 3 and 6 months post-
baseline will evaluate the participants change in biomarkers, self-report scales, and 
ongoing engagement with the Lose-It app and other health technologies. Each man will 
make an appointment for his next reassessment at the end of each visit. The nurse will 
text a visit reminder 2 weeks prior to the next appointment. 

Additional Instructions for MT+. At the conclusion of the baseline visit, those participants 
randomized to the MT+ group will be given instructional training with demonstration for 
use of the 1) Nokia Body+ Wi-Fi scale, 2) instructional picture booklets demonstrating 
correct setup and use of the Wi-Fi scale 106and the Lose-It Premium version app 
features, and 3) a technology support phone number. The GA will call the men within 
two days of their baseline visit to verify their success in using these feature and answer 
any questions. Investigators will monitor app usage statistics for MT+ participants daily 
and a GA will provide reminder prompts via text message, followed by phone call, when 
non-adherence is observed for greater than 5 days. Participants can also contact 
research staff for technical support via phone. Remind.com will be used to send the text 
messages. Remind.com provides free text messaging to any smartphone device 
through SMS and doesnt require app download. MT+ participants will receive a text 
message at 8:00am throughout the 3-month intervention period. MT participants will 
only receive a text reminder related to their next assessment point appointment by the 
research nurse. 
 
Lose-It Account Retention Option for Subjects at end of Study: As subjects have 
matriculated through our study, many have requested their desire to retain their Lose-It 
account food log and physical activity data. Because we set up the accounts using 
dummy username and passwords- the men are not able to retain their log information in 
Lose-It (basic or premium accounts) unless we conduct a username and password 
change of ownership. We consulted with our community advisory board members on 1-
14-19- whom 
were in full support of offering subjects an option to change ownership of their Lose-It 
account upon study completion. We have written and tested a procedure for changing 
username and password (See Protocol for Lose-It accounts at the end of the study 
document) that will permit the subjects to select/input a password that is not known to 
us which will ensure the privacy of their Lose-It account after the time of password 
change. We will inform the subjects of this option for change of ownership at their 6-
month visit, at which time a revised written consent will be obtained. For those subjects 
who have already completed the six month visit, we will contact them by text and email 
informing them of the option. Those completers who desire this option will be provided a 
telephone call during which an electronic version of the revised written consent will be 
obtained (as consistent with our procedures for obtaining informed consent at point of 
enrollment). 
 
Focus Groups. Two evaluative focus groups will be held at 6 months post-baseline with 
a purposive sample of intervention group completers stratified according to their weight 
loss outcome (successful/unsuccessful in achieving 5% baseline body weight loss) to 
solicit their perceptions on the MT+ intervention efficacy, including 
acceptability/feasibility.107 Use of two focus groups permits cross-case comparative 
analysis of the intervention.70, 108 Focus group participants will receive $25 for their 
attendance and will be asked to maintain confidentiality of the contents of the focus 
group discussion. The 90-minute focus groups will be held at the same community 
center as the assessments and audio recorded. The PI, an experienced focus group 
moderator, will lead the discussion with a semi-structured interview guide informed by 
the tenets of the social ecological perspective and study aims. The focus group 

questions will be pretested by the honors research students, who will also serve as 
scribes during the focus groups, noting non-verbal expressions/gestures, interactions, 
and other impressions that occur during the group discussion. Questions will be aimed 
at eliciting the men's experience and perceptions: How did you find the experience of 
tracking your eating, activity, and weight with the Lose-It app?, How did you find the 
experience of participating in a group comparison page with other study participants? 
Immediately after the interviews, the moderator and scribes will write reflective notes as 
to the groups interaction, which created/sustained the descriptive detail shared and 
provide peer-debriefing. The audio files will be transcribed verbatim. Collectively, the 
interview transcript, peer-debriefing, and reflexive memos will create a decision trail 
which will serve as an audit trail to demonstrate accountability.109Audio recordings will 
be deleted after being used to assure the accuracy of written transcripts during analysis. 
 
Variable * Measure Description (Data Collection Time Points) 
Baseline & Screening 
 
PAR-Q17 (S****) PAR-Q17, Physical 
AcƟvity Readiness 
QuesƟonnaire- ACSM 
Recommended88-90 
(Baseline) 
Demographic (S****) Demographic- (e.g., 
race, gender, age, 
educaƟon, marital 
status, occupaƟon)- 
from 
CENTRIC(Baseline) 
Aim 1 Feasibility and Acceptability 
Fidelity (F***) Component Speciﬁc Fidelity Check-list- 
Design, Training, Delivery, Receipt, Enactment. 
Checklist from previous study92 (Baseline, 3, 6 
mo.) 
Recruitment / RetenƟon (O*) Weekly monitoring of recruitment and retenƟon 
counts (frequencies and percentages, PI 
research notes specifying recruitment and 
retenƟon strategies/outcomes (weekly) 
SM Adherence (CO**) Calculated as the % of actual number of days 
data entered over 1 week- from Tsai et. al 
study91 (weekly) 
Health ITUES Survey(O*) Health InformaƟon Technology Usability 
EvaluaƟon Scale (Health ITUES) Impact 
subscale (3 item) Perceived Usefulness 
subscale (12 item)- adapted from Schnall 
study(3, 6 mo.) 
Acceptability and Feasibility of SMS (O*) SMS Survey- from Eisenhauer et al study6 (3 
mo.) 
Two EvaluaƟve Focus Groups (MT+) (O*) Semi-Structured Interview quesƟons (guided by 
aims 1,2, and social ecological perspecƟve) with 

probes ParƟcipants percepƟons of the 
intervenƟon experience (i.e. perceived eﬃcacy, 
behavioral strategies, challenges with 
adherence, saƟsfacƟon with technology) (6 mo.) 
Aim 2- Preliminary Eﬃcacy 
Fruit and Vegetables Servings (O*) BRFSS -Fruit and vegetable dietary intake 
module (6 items)- CDC- moderate validity and 
reliability93 (Baseline, 3, 6 mo.) 
Sugar-Sweetened/ Total Beverage Energy 
Intake (O*) 
Brief QuesƟonnaire to Assess Beverage 
Intake (BEVQ-15)- Cronbach's a ranged .97 to 
.99, signiﬁcantly correlated with three 24-hour 
dietary recalls94 (Baseline, 3, 6 mo.) 
Report of Daily Log of Dietary Intake, PA, and 
Weight (O*) 
Lose-It app programmed to send automaƟc daily 
reports to researchers- Protocol from previous 
study using Lose-It app43 (weekly) 
Physical AcƟvity (O*) BRFSS- Physical acƟvity module (7 items)- 
CDC- moderate validity and reliability95 
(Baseline, 3, 6 mo.) 
Weight (O*) Tanita Scale (TBF-300)- Tanita model 
manufacturer instrucƟons [TBF-300, Tanita 
CorporaƟon of America] (Baseline, 3, 6 mo.) 
Nokia Body+ Wi-Fi Scale- Nokia model 
manufacturer instrucƟons (MT+ group-daily) 
Blood Pressure (O*) Protocol outlined by Perloﬀ et al.96 (Baseline, 3, 6 mo.) 
ResƟng Heart Rate (O*) Protocol outlined by Perloﬀ et al.96 (Baseline, 3, 6 mo.) 
Aim 3 Indicators of Community Capacity 
Community Partners Proﬁle (S****) Demographic Form (community locaƟon, leadership role, 
characterisƟcs- Demographic Form from Eisenhauer et al.6 
(Baseline) 
Community Capacity (O*) Community Capacity EvaluaƟon Survey (Baseline, 12, 
24, 36 mo.)- from previous study97 for measures on 
dimensions of communicaƟon, trust, parƟcipaƟon and 
inﬂuence, leadership, community power, collecƟve eﬃcacy, 
accomplishments and impact, group roles, parƟcipatory 
decision-making procedures, resource mobilizaƟon, 
sustainability, partnership linkages, and overall saƟsfacƟon. 
PIs research notes / audit acƟviƟes reports/logs / CAB 
minutes / Student quesƟonnaire: CAB- Tracking of 
parƟcipaƟon level of members in recruitment/retenƟon 
strategies (i.e. # meeƟngs, acƟviƟes, resources allocated, 
partnership/network linkages, leadership roles assumed, 
parƟcipatory-decision-making), member atriƟon with 
reasons, perceived beneﬁts/skills gained, barriers and 
facilitators of retenƟon, proposed strategies to increase 

retenƟon. STUDENTS- log of community outreach acƟviƟes, 
implementaƟon Ɵme, and outcome, QuesƟonnaire evaluaƟng 
perceived community outreach skill (idenƟfy, engage, 
evaluate, leadership) administered pre-post clinical rotaƟon, 
GA/Honors students acƟvity log, disseminaƟon events. 
 
After providing informed consent, the men will be oriented to the ActiGraph GT9X by the 
research nurse. The men will be instructed to wear the ActiGraph GT9X on their right 
hip continuously for seven days5,6,7, only removing the device for bathing. Subjects will 
also be provided with written instructions for device use in addition to the hands-on 
demonstration, a troubleshooting number, an activity questionnaire to capture 
recreational and vocational activity, and postage-paid return envelope. After wearing the 
device for seven days, the men will mail the device back to the UNO investigators, Drs. 
Knarr and Youn. Those men who return the device as indicated will be issued/mailed a 
$25.00 incentive for their participation. Phone and text reminders will be sent to subjects 
on the eighth day (the day after completing the 7-day testing) reminding them to return 
their ActiGraph by our GA. Those men not returning the Actigraph after the phone and 
text reminder will be sent a mailed letter encouraging them to return the device with a 
reminder that failure to return the device will result in no incentive received for their 
participation. 
 
Analysis: Accelerometers that contain a minimum of five 10-hour days, including both 
weekday and weekend days, of tracking will be eligible for analysis7, 8. Our collaborating 
investigators-UNO biomechanical engineer, Dr. Knarr, and Information Science and 
Technology Specialist, Dr. Youn, will supervise the advanced analyses of our ActiGraph 
data with their UNO graduate students across four forms: 1) Traditional ActiGraph 
analysis (raw accelerations and step counts per 15 second bouts, 2) Custom bout and 
sedentary analysis, 3) Nonlinear activity pattern analysis, and 4) Applying deep-learning 
and advanced analytics5,9. Subjects who participate in this sub-study will be mailed a 
single-page, individualized, easy to read, plain language, 
graph report containing their peak activity and sedentary times, as well as a report of 
minutes of minimum, moderate, and vigorous physical activity from their 7-day 
measurement period. Subjects will be given the same troubleshooting number to call if 
they have any questions regarding interpreting this individualized physical activity 
report. 
 
Statistical Analysis 
 
Descriptive statistics will be calculated on all variables, including frequencies and 
percentages for recruitment/retention, demographic, and categorical variables. Means 
and standard deviations will be calculated for all continuous variables and measures at 
each time point. Feasibility and acceptability analyses for aim 1 are largely descriptive, 
as we will be assessing participation rates and percentages of 
eligible men and which were the more effective recruitment methods. Qualitative 
content analysis, as described by Hsieh and Shannon (110) will guide interpretation of 
the focus group findings from the intervention participant groups. The interview 
transcript, reflective memos and observation notes taken during each focus group will 

comprise one unit of analysis for within/across case comparison. The topics outlined by 
semi-structured interview guide will be extracted and organized. The researcher will 
read the transcripts for substantive coding. Data facts will be organized under a priori 
coding categories. The categories are named a priori because they are built into the 
interview guide questions. A data fact will be defined as those data elements that 
recurred in the interview without lack of consensus or were least participant to errors in 
inference (111). All data provided in a response to each question will be coded together. 
Incomplete, competing, or alternative topics that present in the discussion but were not 
identified a priori will be aggregated by the researcher and examined to determine their 
fit with the purpose. These topics will be compared with the synthesized findings to 
challenge alternative explanations and unnoticed flaws in the researchers  
argument.(112). A data matrix will be used to display the coded data to search for 
patterns across coding categories. The PI and honors students will return to the data to 
explore patterns further, supporting iterative analysis. Data categories will be re-
contextualized into an account that makes sense for the entire studys data set. 
Meaning, the findings are integrated to provide new understanding or explanation to the 
interpretation of the intervention outcome data (112). Peer-debriefing and audit 
checking will occur weekly across the analysis by the PI and GA to assure accuracy of 
the findings. 
 
Aim #2: Determine preliminary efficacy of a MT+ intervention to a comparison group 
receiving only a basic self-monitoring app (MT) in achieving 1) weight loss (primary), 
and 2) improved diet and increased PA (secondary) at 3 months post-baseline and 
follow-up at 6 months post-baseline in rural men. The efficacy analyses for aim 2 will be 
tested via RM-ANOVA models, as they provide a direct measure of differences between 
the intervention and comparison groups in weight loss and dietary and PA behaviors 
across the study, as well as effect size estimates. Huynh-Feldt corrected F-tests will be 
used in order to account for any possible violation of sphericity. If there is a higher than 
expected attrition rate, a maximum likelihood estimation method (e.g. mixed models) will 
be used instead of RM-ANOVA in order to utilize all available data and not delete cases 
in a listwise manner. Overall weight lost at follow-up will be assessed via an 
independent groups t-test. Outcome variables that are not normally distributed will either 
be transformed or assessed with nonparametric methods. 
 
Aim #3: Determine quantitative and qualitative indicators of community capacity 
(resource mobilization, learning opportunities-skills development, partnership 
linkages, participatory decision- making, leadership) to support a relevant weight 
loss intervention for rural men. For aim 3, multiple indicators of community capacity will 
be used to evaluate support for the weight loss intervention applying best practice 
recommendations (113), 1) CAB- assessed community capacity change survey report 
by CAB, participation level of members (i.e. # meetings, activities, resources allocated, 
partnership/network linkages, leadership roles assumed), member attrition with reasons, 
Qualitative indicators of community capacity in CAB include perceived benefits/skills 
gained, barriers and facilitators of retention, proposed strategies to increase retention, 
CAB evaluation of student outreach activities, 2) STUDENTS- clinical log of community 
outreach activities (type, number, hours) developed, implemented, and outcome, 

leadership activities (dissemination via honors projects, clinical conference and class 
presentations). Qualitative indicators of community capacity among students will include 
perceived skill development, and leadership confidence. Graduate level students help in 
training sessions, data collection and implementation of intervention.  
3) PARTICIPATORY DECISION- MAKING as an indicator of community capacity will be 
evaluated via CAB survey and tracked ongoing through study. PI research-field notes 
will record student-engaged activities and time points. 
 
SubStudy Aim: To determine the feasibility among a convenience sample of rural men 
currently enrolled in our Rural Men's health study to wear the Actigraph GT9X (single 
wearable sensor) for seven continuous days to measure their physical activity among 
the total volume of activity bouts across three gait dimensions: intensity, symmetry, and 
variability.