The Great Plains Internet Wellness Study for Aging: The GP I-WAS Project
Phase: NA
Conditions: Internet Based Wellness Program, Obesity, Adult Population
Sponsor: North Dakota State University

 
 

Protocol and Statistical Analysis 
This Great Plains IDeA-CTR pilot project will utilize a prospective, within-participant design 
with multiple assessments across a 10-week intervention period and 1-month follow-up. 
Repeated measures optimize statistical power with smaller sample sizes and examination of 
within-person change over time. A 10-week intervention period was selected for this pilot project 
because this duration was consistent with the recommended amount of time it takes for habit 
formation to occur.1 The 1-month follow-up period was chosen because of project resources and 
to maintain adherence to our 1-year project timeline. Our study will recruit 20 participants based 
on Aim 3, which provides 80% power in detecting a large standardized effect size of 0.72 in 
terms of change in the outcome (physical activity) after 1-month follow-up, with an alpha level 
of 0.05 using a two-sided Wilcoxon Sign-Ranked test, assuming that the actual data distribution 
is normal and a drop-out rate of 10%.2 It should be noted that this is a pilot study with a smaller 
sample size. If the study yields smaller effect sizes when assessing the intervention effects, the 
study still provides useful information on feasibility, the trend of the intervention’s effect, and 
accurate effect sizes for estimation that can be generalized to guide future large trials. Adults 
aged at least 65 years that can use the internet daily, have a body mass index ≥30 kg/m2 , and are 
apparently healthy (i.e., medically able to participate in physical activity as determined by the 
PAR-Q+) will be eligible for study. We will utilize the North Dakota State University Research 
Participation Listserv for study recruitment. Word-of-mouth and flyers will also be used for 
recruitment purposes. Aim 1: Collaborate with stakeholders in all-phases of the internet-based 
wellness intervention to gain knowledge on the perspectives of the older adult population. 
Conducting community-based participatory research has demonstrated effectiveness in 
intervention studies and its use in research should be promoted, but few intervention studies in 
aging research exist where older adults have a research role.3 An important component of 
community-based participatory research is to have stakeholders contribute to all phases of a 
study.4 Specifically, we will recruit stakeholders to engage in the formative stages of the 
research, study execution, data interpretation, dissemination, and translation of results to 
practice.4 The stakeholders will also provide our research with an additional perspective from the 
older adult population, thereby strengthening the impact of the investigation for older adults. 5,6 
We intend for this pilot project to serve as a catalyst for future research projects that expand on 
the use of community-based participatory research such as developing a sustainable older adult 
community nucleus, allowing stakeholders to have equitable decision making of future research 
funding, and providing services to the older adult population that are outside of research.4 Two 
stakeholders with wellness experience will be recruited from the local area through word-of-
mouth and posting flyers at locations where older adults are known to gather. In order to better 
ensure representativeness, one stakeholder will be aged 65-69 years and the other will be aged at 
least 70 years. The Principal Investigator will select stakeholders for this project and they will be 
excluded as participants in the intervention. Based on our extant of the literature, a lack of 
professional guidance, inadequate distribution of appropriate educational materials, restrictions 
in transportation, and low motivation are barriers for older adults to engage in healthy 
behaviors.7-9 Using behavior change theoretical framework in wellness interventions has been 
identified as a research requirement to advance the field.10 Including motivation to engage in 
healthy behaviors for this project will come from two psychological theories that are often 

applied to wellness motivation studies: self-determination theory and social cognitive theory.11-14 
Participation in physical activity, diet modification, and restorative sleep were targeted because 
they are each considered important for the health of older adults and can be impacted by 
motivation.15, 16 Didactic information (e.g., videos and readings) for the health benefits of 
physical activity, a healthy diet, and restorative sleep will be delivered to participants, including 
how each of these factors effect health and longevity. With the help of the investigators and 
stakeholders, participants will design their own goal-oriented program. Progression towards 
longer-term goals will include a stepwise process of achieving short-term goals. Modifications 
toward these goals can be made based on progress and discussions with each participant. 
Intervention usability guidelines and resources from the United States Department of Health and 
Human Services will be used.17 During the kick-off meeting, the investigators will introduce the 
initial conceptual model to the stakeholders. Discussions between the investigators and 
stakeholders will help to refine the strategies that will be used to enhance each construct relative 
to lifestyle behaviors. Investigators and stakeholders will develop a project plan and timeline, 
delegate roles and responsibilities, and refine the conceptual model. The contents of the internet-
based wellness intervention will be uploaded on Google Classroom, a free online learning 
platform that can be used for administering internet-based health interventions.18 There is always 
a risk that our intervention will not reflect the needs and priorities of the users; therefore, prior to 
launching the intervention, 3-5 individuals (non-participants) will pilot the contents in Google 
Classroom and measurement tools to provide feedback, thereby bolstering the reliability and 
quality of the platform, contents and measures. During the study period, the investigators will 
work with stakeholders in administering the intervention. The stakeholders will act as role 
models for participants by sharing experiences, initiating communications and providing 
information. Combining the use of a role model with other motivation factors has been 
recognized as a facilitator for practicing healthy behaviors in intervention studies with older 
adults.19 Aim 2: Assess the feasibility of an internet-based wellness intervention for obese older 
adults. According to Bowen et al.’s20 phases of intervention development, this stage of 
development for the intervention is key in assessing the “can it work?” components such as: 
acceptability, demands and implementation. These feasibility components are heavily focused on 
the actual use of the internet for a wellness intervention and any barriers or facilitators that 
participants may experience when using it. To evaluate potential efficacy, components that 
contribute to healthy behaviors such as acceptability, demand, and implementation will be 
evaluated. Specific items to be evaluated within these components include satisfaction with the 
platform, intent to continue, interest, recommendations to peers, usability, improved knowledge, 
and general recommendations for improvement. Each of the feasibility components will be 
evaluated with a 5-point Likert scale developed by the investigators and stakeholders, and may 
include open-ended items for more detailed feedback. Feasibility questionnaires will be 
completed online by participants at the mid-point and end of the intervention period. Participants 
will also be asked about their readiness to change wellness behaviors at the beginning, mid-point, 
and end of the intervention period by selecting their stage of change: pre-contemplation, 
contemplation, preparation, action, maintenance and termination.21 Adherence and compliance 
will be quantified as the proportion of participants who fully completed the intervention. Results 
from the feasibility examination will be presented as mean and standard deviation or frequency 

and percentage where appropriate. During weekly meetings, the investigators and stakeholders 
will assess if they are able to effectively communicate with participants using the internet, time 
commitment for learning, and overall feasibility of the intervention. Guidelines from the United 
States Department of Health and Human Services for program evaluation will help to guide how 
we determine feasibility.22 Aim 3: Determine if completing an internet-based wellness 
intervention improves healthy behaviors among obese older adults. Participants will be asked to 
visit Exercise Science Labs at North Dakota State University at the beginning and end of the 
intervention, and at 1-month follow-up. After providing written informed consent, each 
participant will complete a descriptive questionnaire at the beginning of the intervention period, 
and a health-related questionnaire at the beginning and end of the intervention, and at follow-up 
that includes self-rated health, current smoking status, smoking history, alcohol use, morbid 
conditions, functional disability, and depression status. Standing height and waist circumference 
will be collected with a tape measure. Body weight and composition will be measured with the 
InBody 570 (InBody; Cerritos, CA). Previous research has demonstrated that the InBody 570 has 
strong reliability and validity for measuring body composition that is comparable to duel x-ray 
absorptiometry.23,24 Anthropometric and body composition assessments will be collected from 
participants at the beginning and end of the intervention, and at follow-up. 6 Objectively 
Measured Physical Activity and Sleep Physical activity will be collected with an ActiGraph 
GT9X-BT accelerometer (ActiGraph; Pensacola, FL). The ActiGraph accelerometer has strong 
reliability and validity for capturing free-living physical activity.25 Accelerometers will be given 
to participants during lab visits and sent back in a pre-paid mail envelope after wearing the 
accelerometer for all hours of the day on their waist for 7 consecutive days. Data will be 
considered valid if participants wore the accelerometer for at least 10 hours/day during waking 
hours, for at least four days including one weekend day.26 The Choi et al.27 non-wear algorithm 
will be used for determining wear time compliance. Accelerometer specific cut-points will 
examine time spent sedentary and in each intensity of physical activity. 28,29 As part of the 
physical activity measurements, the ActiGraph accelerometer will also measure total sleeping 
time. ActiGraph accelerometers have strong reliability and validity for assessing sleep.30,31 
Participants will be asked to wear the accelerometer during sleep and record periods of sleep in a 
log.32 The Cole-Kripke algorithm embedded in Actilife 6 software will be used to score the sleep 
actigraphy.33 Physical Activity Recall Use of time will be quantified using the Multimedia 
Activity Recall for Children and Adults, a computerized 24- hour recall. Each participant will 
recall their daily activities using a segmented day format with a resolution of 5 minutes or more. 
Participants choose from 500 different activities organized under a number of rubrics such as 
“self-care”, “occupation”, and “leisure”, with each activity linked to a compendium of energy 
expenditures.34 The adult version shows excellent test-retest reliability and good convergent and 
criterion validity with accelerometers and doubly-labeled water, respectively.35-37 The 
Multimedia Activity Recall for Children and Adults will be administered by 30 minute 
computer-assisted telephone interviews, with two consecutive days being recalled each time. The 
same 4 days will be recalled at each time-point (intervention beginning and end, and follow-up), 
including at a weekday and weekend day. Dietary Recall Participants will complete the Arizona 
Food Frequency Questionnaire (AFFQ) to assess dietary intake at the beginning and end of the 
intervention, and at 1-month follow-up. The AFFQ is a modified version of the Health Habits 

Questionnaire and has demonstrated strong reliability and validity for assessing dietary 
intake.38,39 The semi-quantitative, scannable, 153-item AFFQ asks respondents to report how 
often they consumed each particular food item during the last month. Participants will receive a 
report of estimated nutritional intake compared to recommendations with each AFFQ. In 
addition, each report will contain a personalized message from the dietitian to each participant. 
Intake of nutritionally dense foods (e.g., vegetables, lean proteins) and decreased intake of 
calorically dense foods (e.g., high sugar foods) will be compared to assess dietary change. 
Statistical Analysis Analyses will be conducted with SAS 9.4 software (Cary, NC). Means and 
standard deviations for continuous data or proportions for categorical data will be used for 
presenting the measures at baseline and measures at each data collection time point during the 
study period. Linear mixed effects models for continuous data or generalized linear mixed effects 
models for categorical data with fixed time effects, and random person effects will be used to 
evaluate changes in the outcomes. Repeated measures analysis requires consideration of the 
correlation between outcomes across the intervention period (covariance structures). To examine 
optimal covariance structures, Akaike information criterion will be used to determine the model 
of best fit. Potential covariates include age, sex, ethnicity, marital status, self-rated health, 
current smoking status, smoking history, alcohol use, morbid conditions, functional disability 
and depression status. Separate models will be used to assess changes in 1) physical activity, 2) 
diet, and 3) sleep. An alpha level of 0.05 will be used for all analyses. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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