Mobile Health Obesity Wellness Intervention in Rural Older Adults (MOWI): Qualitative Assessment
Conditions: Obesity
Sponsor: Dartmouth-Hitchcock Medical Center

Official Title: 
Mobile Health Obesity Wellness Intervention in Rural Older 
Adults (MOWI): Qualitative Assessment  
NCT number: 
Document Type: 
Study Protocol and Statistical Analysis Plan and  
Informed Consent Form 
Date of the 
Document: 
July 3, 2018 
NCT03041831

 
Overview: The study will: 1) Obtain input on feasibility, usability, and acceptability of using mHealth in 
behavior change by adapting a device for rural older adults; 2) Develop, refine and tailor MOWI in research 
settings; 3) Conduct MOWI in subjects’ homes. The overall goal is to improve older adult physical function in 
rural areas and use the results as a basis for an R01 randomized trial testing the MOWI’s delivery in the home.  
 
Study Setting/Population: Dartmouth-Hitchcock (D-H) serves 1.5 million persons from a circumscribed area 
of rural New Hampshire/Vermont. The site of Lebanon, NH, is a typical rural New England town (16.2% aged 
≥65 years; 95.4% Caucasian83). Of 13,293 primary care patients ≥65years old at D-H, 3,987 are study eligible 
(~30% obese84). The Center for Health & Aging (CHA) has rooms for study assessments. In-home evaluations 
will use CHA video equipment.  
 
Recruitment: As a Geriatrician working with an interdisciplinary team, I 
have ready access to potential subjects from a practice panel of ~3000 
older adults. In addition the Centers for Health and Aging provide a venue 
for recruitment, as indicated by successfully recruiting 111 elderly subjects 
this past year for pilot studies by 3 junior faculty. Patients meeting study 
criteria will be identified using record review and e-mailed/mailed letters 
describing the study (after HIPAA waiver). Posters/handouts will be placed 
strategically at D-H. Colleagues will give information materials to patients 
requesting permission for contact by the study research assistant. With 
respect to the qualitative component, the PI will recruit 6 clinicians (from 87 
in the provider network) to participate in interviews. Dr. Bartels will use the 
CHA’s extensive aging services network to recruit 4 leaders of aging 
services organizations for study participation.  
 
Selection Criteria: Focus groups, interviews, and usability testing will target English-speaking obese older 
adults (age≥65years and BMI ≥30kg/m217 or waist circumference ≥88/102cm85 in females/males). Excluded 
from eligibility are adults with severe mental or life-threatening illness, dementia, substance use, history of 
bariatric surgery, suicidal ideation, unable to provide consent/perform measures, or residing in a nursing home. 
Aim 1a provider interviews will target English-speaking, licensed, outpatient, primary care clinicians and 
community aging service program directors. Older adult participants in Aims 2 & 3 will require the presence of 
home Wi-Fi high-speed internet, medical clearance, have less than a 5% weight loss in the past 6 months, and 
be without advanced co-morbidity, exercise restrictions88 or involvement in other research studies. 
 
Screening/Consent: Subjects expressing interest will be mailed/emailed forms, evaluated by chart review to 
confirm eligibility, and those meeting criteria invited to an RA-led session to verify final eligibility, review and 
complete consent forms, and answer queries. Competence for consent will be assured by: no diagnosis of 
dementia (all Aims) and a Callahan score ≥4 (Aims 2 & 3). Written consent will be obtained before enrollment. 
The RA will obtain screening/baseline measures, and provide a list of contact details (see Human Subjects).   
 
Aim 1a (Qualitative assessment): Determine the acceptability, utility, and perceived value of mHealth in 
helping older adults overcome barriers to health behavior change: Semi-structured interviews and focus 
groups will inform modification of existing interventions ensuring MOWI is acceptable and useful for rural 
elders. MOWI is based on caloric restriction, activity, and intensive behavioral therapy23,24,26,28,89-95 and includes 
weekly individual dietary counseling, 2x/week group exercise visits, and Amulet, a mHealth device. I will 
conduct 4 focus groups (6-8 people each) and 6-8 interviews (60-90 min each), audiotaped and transcribed by 
the RA at the CHA. A supportive group context will: facilitate identification of sensitive issues (ie: barriers to 
behavior change); solicit advice on the pilot’s acceptability and feasibility; provide input on feedback messages 
(see Appendix) based on activation and self-monitoring domains with short, simple words (≤2 syllables); 
identify program improvement; and offer ideas for improving the technology interface. The RA will demonstrate 
the use of the Amulet to subjects allowing specific feedback rather than hypothetical suggestions. A codebook 
based on converging themes will be guided by Dr. Carpenter-Song. I will conduct semi-structured interviews 
with 6 clinicians and 4 community leaders (senior centers; local programs) exploring barriers to delivering rural 
wellness interventions, input on MOWI and its possible challenges, audiotaped and transcribed by the RA. 
FIGURE 2:  STUDY OVERVIEW 

Recruitment and Retention Strategies 
Participants will be recruited from referrals from Family Medicine/General Internal Medicine providers 
(Primary Care), providers from the Dartmouth Weight & Wellness Center, and community members attending 
the Dartmouth Center for Health and Aging (DCHA). I will inform clinicians of Family Medicine and General 
Internal Medicine and the staff at the Weight & Wellness Center of the proposed study during section 
meetings. Dr. Bartels has an extensive network of community-care providers and will send e-mails/letters to 
the CHA’s listserv and mailing list requesting participation. Posters will be placed in each examination room, in 
the patient waiting areas and in common areas of the DCHA. All posters will have been pre-approved by 
DHMC patient/family advisors and the Committee for the Protection for Human Subjects. Additionally, postings 
in the DCHA quarterly newsletter, the DHMC weekly D-H Today online bulletin, the weekly Geisel School of 
Medicine at Dartmouth newsletter, and electronic mailing lists will promote the study. We anticipate advertising 
in the local newspaper as well. A dedicated phone number and e-mail will be assigned to this study.   
Patients will be identified from the PI’s clinical practice group at D-H, word of mouth, or other means as 
indicated below. We will also identify prospective individuals fulfilling basic eligibility criteria after obtaining a 
HIPAA waiver for electronic record review from the Committee for the Protection of Human Subjects. A pre-
assessment eligibility would be performed to limit the burden on patients should they be ineligible after full 
informed consent for the requisite aims. This will allow the investigators to query our electronic medical record 
and if necessary send targeted messages and/or letters to individuals that may possibly qualify for this study. If 
needed, the study staff will send a letter to prospective individuals requesting their involvement either by mail 
or email (through the electronic medical record). This letter will describe the study and provide contact 
information for those interested. The CTO will also have details of the study. Any individuals that have 
expressed interest will be contacted by the team by phone or by email which will be the most preferable 
method of communication. A pre-screening questionnaire or electronic link to RedCAP (See below) or by 
phone will be mailed/emailed to participants (depending on patient preference).  
As part of Aim 1a, eligible patients will be asked to participate in qualitative focus groups and individual semi-
structured interviews with a member of the team. It is anticipated that the focus group will occur 4-6 weeks 
after interest is expressed. The investigators will perform four separate patient focus groups. Semi-structured 
interviews will take place for clinicians and community leaders of health and senior centers. At the time of 
communication, the consent form will be sent to these individuals for review (paper or electronic) and if they 
agree to the terms of the consent, the individuals will attend these sessions at a mutually convenient time for 
the study participants and the Research Team. A reminder letter will be sent either via myDH (through the 
electronic medical record) by the PI, and/or a hard copy letter to the patient’s address.   
As part of Aim 1b, eligible patients will be asked to attend the DCHA to confirm eligibility and informed consent 
process by the RA/PI (See Section on Informed Consent Procedures for Full details). Those ineligible will be 
informed by the team and any information will be destroyed. We anticipate that eligibility to study onset will be 
roughly 4-6 weeks after screening.  
As part of Aim 2 and 3 (including the pre-pilot Aim 2), eligible patients will be asked either to attend a baseline 
visit with the RA or PI at the DCHA to confirm study full eligibility for measurements and full informed consent 
process by the RA/PI (See Section on Informed Consent Procedures for Full Details). Those ineligible will be 
informed by the team and any information will be destroyed. We anticipate that eligibility to study onset will be 
roughly 4-6 weeks after screening. The patient’s primary care provider will provide medical clearance prior to 
study enrollment and sign a paper or electronic form allowing the individual to undergo this intervention. They 
will be kept informed of any abnormal symptoms or problems throughout the study.  
The investigators recognize that this intervention may lead to attrition. To reduce the risk of participant 
drop-out, participants will be reminded of sessions with a phone call, e-mail, and Amulet messaging reminder 
from the RA. Individuals will be compensated with sandwiches/snacks plus $25 gift card for the focus groups of 
the qualitative aim (Aim 1a), $25 gift card for the subject semi-structured interviews, a nominal $10/hour 
payment for the prevalidation phase of Aim 1b (cash, gift-card), a $25 gas card each for Aim 1b, $100 for 
completing >80% of the visits and assessments for the three-month program (Aim 2) - $25 per assessment, 
and $200 for completing >80% of the visits and assessments at 6-months (Aim 3). Payment will be made at 
study conclusion according to institutional policies. They will also receive a fixed schedule of items (pens, 
notepads, thank you cards) to recognize their participation to date. Participants will have the option of declining 
such incentives at any time. We will provide a $25 gas card or equivalent for each visit (Aim 4).  
 
No involvement of special vulnerable population such as fetuses, neonates, pregnant woman, children, 
prisoners, institutionalized individuals or others who may be considered vulnerable will be included in this 
study. The study will be a single-arm study and there will be no assignment to a study group for this study.  

 
Retention 
We recognize that attrition rates in obesity studies range between 25-50%. For Aim 1a (qualitative 
studies), we will target 4 focus groups of 6-8 individuals (24-32 individuals total), 6-8 individual semi-structured 
interviews, 6 primary care clinicians, and 4 community leaders for a maximum total of 50 individuals. For Aim 
1b, we anticipate recruiting 75 individuals for a target of 60 individuals. Conservative estimates suggest that 14 
individuals need to be recruited to allow for 16 individuals for Aim 2 at study conclusion. For Aim 3, our target is 
40 individuals. We anticipate recruiting 53 individuals. We believe that these targets are feasible with our local 
population. We anticipate recruiting individuals in one wave for Aim 1, two waves for Aim 2, and in 4 waves for 
Aim 3 to reach target enrollment and completion. Should we exceed target enrollment and completion, we will 
continue gathering measurements on all individuals. With the new arm (MOWI-P), we anticipate recruiting an 
additional 16 subjects. For Aim 4 (Weight Maintenance), we anticipate recruiting 60% of each of the original 
sample for Aim 2 (ie: 4 waves @ 8 = 32 x 0.6 = approximately 19 subjects).  
 

PROTECTION OF HUMAN SUBJECTS – AMENDED  
This Human Subjects Research meets the definition of a clinical trial. The Dartmouth Committee for the 
Protection of Human Subjects (CPHS) has approved the study, CPHS#28905 (see Appendix) and includes a 
partial waiver of HIPAA authorization to collect the minimum information required to identify, contact and recruit 
eligible patients. This proposal has been discussed with Dr. William Nelson, Geisel School of Medicine at 
Dartmouth health care ethicist, and Dr. David Kotz, our technology information security expert and Chair of the 
Department of Computer Science, who will both serve as advisors to guide the development of the responsible 
conduct for research.  
 
Human Subjects Involvement, Characteristics and Design: 
Justification of Use of Human Individuals 
The proposed intervention requires human involvement to develop a mobile health Obesity Wellness 
Intervention (MOWI). MOWI consists of a 3x/week in-person intervention at the Dartmouth Center for Health 
and Aging, comprising of three components: an individual weekly nutritional counseling session led by a 
dietician, 2x/week group exercise visits led by a clinical physical therapist, and a patient-self-monitoring 
mHealth device capable of remote sensing (Amulet). The intervention is based on previous studies 
demonstrating the importance of intensive behavioral therapy and caloric restriction16,19,21,80-82 and the 
emerging evidence of the importance of group meetings161. We will also use focus groups and semi-structured 
interviews to obtain input into the utility, acceptability and perceived value of Telehealth modalities (Aim 1a); 
adapt Amulet in older adults to assess geriatric functional measures (Aim 1b); develop, refine, and tailor MOWI 
to evaluate its effectiveness (Aim 2); and conduct and assess the feasibility, acceptability and preliminary 
effectiveness of a video-delivered home-based program (Aim 3). It is impossible to assess study feasibility, 
acceptability or effectiveness without human involvement. The MOWI-P arm will consist of an additional 16 
participants 
 
Characteristics of the Subject Population 
 
We will recruit older motivated adults with obesity (aged ≥65years) to participate in the three separate 
aims of this study. Aim 1a will recruit up to 50 individuals, Aim 1b will recruit 100 individuals (pre-validation and 
validation), Aim 2 aims to recruit and retain 10 individuals, and Aim 3 aims to recruit and retain 40 individuals. 
No special or vulnerable populations, including older adults with cognitive impairment, will be included in this 
study. No assignment to study group will occur. For Aim 1b (pre-validation) on younger local 
personnel/students, we approximate ~30-50 individuals to participate and 10-20 older adults as well. MOWI-P 
will consist of an additional 16 participants 
 
Sources of Materials 
Sources of information 
Data from this study includes clinical characteristics abstracted from the medical record (age, race, 
ethnicity, employment status, ability to communicate in English, marital status, education level, number and 
names of medications, co-morbidities, smoking status, admissions to the nursing home or hospital, BMI, 
documented dementia, weight loss of >5% in the past year, recent angina/coronary events, bariatric surgery). 
Self-reported data from questionnaires will be obtained including Katz86 and Lawton87 activities of daily living 
scales, PAM137, PROMIS139, CHAMPS144, Social Support with Exercise145 , Social Support and Eating Habits, 
Readiness to Change, and number of household members. Objective outcome measures will be assessed 
including grip strength127, Five Times Sit-to-Stand106, Six Minute Walk Test130, gait speed135, weight, and waist 
circumference. Field notes from the physical therapist and the dietician (detailing the experience of the 
intervention, reactions from the participants, aspects that work well or need improving upon, insights etc.), and 
questions regarding patient satisfaction will be assessed.  
All qualitative data from focus groups or semi-structured interviews will be recorded, transcribed and/or 
videotaped by the RA. Satisfaction questionnaires will be completed by participants. This information will 
subsequently be imported for analysis and review using Dedoose and STATA, R or SAS.  
All questionnaire data will be either in paper format, or populated by individuals using the RedCAP 
(Research Electronic Data Capture)  software. Study data will be collected and managed using REDCap 
electronic data capture tools managed at Dartmouth College through the license from the Clinical and 
Translational Science Institute (SYNERGY)146. REDCap is a secure, web-based application designed to 
support data capture for research studies, providing 1) an intuitive interface for validated data entry; 2) audit 

trails for tracking data manipulation and export procedures; 3) automated export procedures for seamless data 
downloads to common statistical packages; and 4) procedures for importing data from external sources.  
 
Study Personnel with Access to Identifiable Data 
The PI and RA will have access to all data. All data would be considered protected health information 
(PHI) subject to HIPAA and D-H regulations. Only the PI and the RA will have access to this individual-level 
data and to the electronic medical record (eDH) which has pertinent PHI and laboratory assessments obtained. 
Drs. Kotz & Pletcher and their teams will also have access to technology-related data that will be 
communicated to the RA and study team. This is necessary in the capacity of the RA to serve as a health 
coach102 to be aware of such information. All other data communicated to other study personnel will be de-
identified and communicated only in aggregate. 
 
 
The MOWI comprises of a multidisciplinary treatment strategy, including nutritional, behavioral, and 
physical interventions, augmented by Telehealth modalities (telemedicine, mHealth and remote sensing). The 
confidentiality of focus group or individual data cannot be guaranteed. We will encourage and ask our study 
participants not to share the information discussed within the session. 
 
 
Strategies for Protecting Personal Information 
All investigators will have completed the requisite Human Individuals protection training, CITI, or 
training as required by local institutional standards. All Dartmouth investigators would abide by HIPAA policies, 
and as such, would have full understanding of privacy rules. Access to medical records would be from private 
D-H work computers accessed using a unique electronic portal identifier. A password-protected datafile on 
password-protected computers of the PI will contain linking data with identifiers. All written material will be 
coded using a unique identifier and not by participant name. All questionnaires or other study-related 
documents will be kept in the PI’s locked office. All consent forms (paper or electronic) will be kept separately 
in the PI’s locked office (or in a secure electronic location). All data will be accessible by the PI and 
downloaded to a D-H password protected computer. Data from audio recordings will be transcribed by the RA, 
other study personnel or by an official transcription service (ie: rev.com). A non-disclosure agreement will be 
signed by the PI.  
Data from the Amulet will be transmitted to a Wi-Fi- secure cloud-based repository via HTTP post, 
decrypted and stored on an Amazon virtual machine running a MySQL database. The data can be downloaded 
by the RA. Individual data in Aim 1b and 2 will be kept confidential, although sharing of information that is 
communicated in group exercise sessions cannot be kept confidential to other participants. 
Survey data will be performed on RedCAP software and be encrypted per institutional policies. The 
Department of Bioinformatics through the Center for Translational Science Activities will facilitate this process. 
Additionally, any video-conferencing will be performed through the Vidyo or Zoom software platforms are 
encoded to transmit securely between participant and study staff. At the conclusion of each wave, any software 
and tablets will be erased and data will be expunged per IT policies.  
Data from the fitness devices and their applications will be password protected, and only study 
personnel would have access to the complete data. All data from the EHR will be HIPAA-compliant. No PHI 
information will be relayed during any of these sessions. The investigators will discuss this with the eligible 
subjects and ensure they are fully aware of these minimal, but possible risks. The risk of a contact allergy with 
the fitness device is possible, although we anticipate this risk being quite low, and if indeed this does occur, a 
communication with the patient’s primary care provider will be made. Should the contact allergy be significant, 
the patient will be treated symptomatically or withdrawn from the study. 
 
Potential Physical and Psychological Risks to Individuals (including possible alternative treatments) 
and Mitigation of Such Risks.  
 
The MOWI comprises of a multidisciplinary treatment strategy, including nutritional, behavioral, and 
physical interventions, augmented by Telehealth modalities (telemedicine, mHealth and remote sensing). The 
confidentiality of focus group or individual data cannot be guaranteed. We will encourage and ask our study 
participants not to share the information discussed within the session. 
Physical activity interventions may lead to mild muscular fatigue or soreness but will be monitored in a 
setting by trained professionals. Risk of falling is elevated in older adults178 and will need to be supervised. 
Physical activity is recommended, even in sedentary individuals who may be at risk for cardiovascular 

events179,180 . As such, primary care clinicians need to provide medical clearance for individuals to participate in 
this program. Injuries may occur while engaging in the physical therapy program which will be allayed by a 
graded approach to activity. As with all functional measures there are safety issues.  Physicians are on site at 
the Dartmouth Center for Health and Aging at the time of these sessions all of whom are certified in cardiac life 
support. If at any time during the study, the patient expresses any unexplained physical symptoms, the RA or 
clinical staff will share this information with the PI, who in turn will contact the participant’s primary care 
provider to ensure prompt evaluation. Should the primary care provider not be available, the participants will be 
transported, if deemed medically necessary, to the closest Emergency Department. A member of the study 
staff will remain with the participant until there is a safe transfer of care. For Aim 3, additional safety measures 
have been established to ensure the safety of participants while participating in at home exercise classes 
where an RA or physical therapist will not have direct contact with them at the time a physical symptom may 
arise. (See attached safety flowchart) Lastly, rarely during focus groups or semi-structured interviews would 
individuals become uncomfortable; however, they will be reminded that they are participating voluntarily and 
may leave the group at any time. Our Institution Review Board expects notification of any incidental findings, 
as well as about any unanticipated problems involving risk to subjects. Any newly identified psychiatric disorder 
will be referred to the primary care provider for assessment and treatment.  
Data from the Amulet and its applications will be password protected, and only study personnel would 
have access to the complete data. All data will be HIPAA-compliant. Additionally, we deliberately chose Vidyo 
as this is a software platform that has been used by the Center for Telehealth and this software is HIPAA-
compliant. The investigators will discuss this with the eligible subjects and ensure they are fully aware of these 
minimal, but possible risks. The risk of a contact allergy with Amulet is possible, although we anticipate this risk 
being quite low, and if indeed this does occur, a communication with the patient’s primary care provider will be 
made. Should the contact allergy be significant, the patient will be treated symptomatically or withdrawn from 
the study. 
Venipuncture will be considered in all participants in Aim 2 – this will be performed at the Dartmouth-
Hitchcock laboratory under standard clinical conditions. We expect minimal risk from this procedure. Volume of 
bloodwork will be <500cc in this population. Bloodwork will be obtained at baseline and again at 12 weeks.  
 
 
  
Adequacy of Protection Against Risks 
Description of Informed Consent Procedures 
Please refer to the above section regarding the HIPAA waiver to allow for identification of subjects in 
the electronic medical record. Competence to provide informed consent will be assured by a review of personal 
history/medical record (all Aims for subjects) and the Callahan Cognitive screener score ≥4 prior to informed 
consent evaluation for Aims 2 & 3 (Appendix). No chart review will be performed for clinicians/leaders in Aim 
1a or the pre-validation in Aim 1b.  
After the study participant expresses interest and is eligible based on inclusion/exclusion criteria (see 
Recruitment & Retention Strategies above), they will be presented with a written consent form (paper or 
electronic form) and initiation of the informed consent discussion will occur by either the PI or RA or member of 
the study staff. Participants will be encouraged to ask questions about the study or research process. If the 
participants need more time to consider enrolling, a follow-up telephone call to continue this consent process 
will occur according to IRB-approved procedures for telephone consent by the PI/RA with contact telephone 
numbers if they have additional questions. Participants will be encouraged to ask questions about the study or 
research process and be given ample time to review the informed consent form. A telephone script will be 
available which will encourage questions and clarification of the study procedures as needed. All individuals 
agreeing will be asked to sign an informed consent document (paper or electronic), or if done by telephone, a 
return postage envelope will be used to return the consent form. The individual who agrees by phone will not 
commence the study until this form is received. The form will be scanned into the Dartmouth-Hitchcock 
Electronic Medical Record and the encounter will be documented. Once targeted enrollment for a given 
iteration occurs, the PI/RA will arrange and notify the patient the time and date of the first session. Primary 
care provider permission will be necessary prior to commencing this study for Aims 2 and 3.  
All consent processes will be performed at the Dartmouth Centers for Health and Aging, the Amulet 
laboratory on campus, or a mutually convenient location as designated by the participant/PI. The overall 
purpose of the research will be presented to the participant and the specific component they will be recruited 
for will be discussed. The reason why the individual was asked to be involved will be provided.  The anticipated 
outcome will be explained to the individuals. We shall emphasize to the prospective subject that their 

involvement is entirely voluntary and will not influence nor impact their care at Dartmouth-Hitchcock. 
Individuals will be encouraged to discuss the study with their family and friends and take their time to make 
such a decision. We will emphasize that their participation in all aims is based on their willingness to engage in 
the requisite technology. 
The time commitment for the research project will be described and the anticipated discomforts and 
risks (both physical and nonphysical). The potential benefits to the participant and the potential benefits to 
others will be provided (see below). A description of their confidentiality will be provided, including how their 
information will be treated, stored, maintained (and for what duration) and how the materials will be disposed 
of.  They will be provided with the freedom to participate in research and/or withdrawal of the research 
permission at any time and the institutional processes for doing so. The sources of information that data can be 
collected will be given, along with the contact information for questions or concerns will be provided along with 
the PI’s name, address, phone number. Any costs or description for compensation for injury will be described. 
The grantor for this research will be given as well and any potential conflicts of interest that the investigators 
may have.  
 
A separate consent form will be provided for Aim 4. 
For Aim 1a: Qualitative Assessment (Focus Groups/Semi-Structured Interviews) Subjects: The 
Dartmouth CPHS considers this type of research minimal risk. An information page and consent form (paper or 
electronic) will be provided to each participant. The RA will explain the purpose of this component of the study 
and answer any questions that any of the participants may have. Each individual will have the opportunity to 
answer questions in the group (or individually for the semi-structured interview), in a non-pressured manner. 
Should the participant, following discussion of the study purpose and consent not be willing to participate, the 
subject shall be thanked for their time but not included in the group. None of their information shall be used and 
any information to date will be destroyed.    
 
For Aim 1a: Qualitative Assessment (Clinician & Community Leader Semi-Structured Interviews): The 
Dartmouth CPHS considers this type of research minimal risk. An information page and consent form will be 
provided to each participant (paper or electronic). The RA will explain the purpose of this component of the 
study and answer any questions that any of the participants may have. Each individual will have the 
opportunity to answer questions in a non-pressured manner. Should the participant, following discussion of the 
study purpose and consent not be willing to participate, the subject shall be thanked for their time but not 
included in the study. None of their information shall be used and any information to date will be destroyed.    
 
For Aim 1b: Prevalidation of Amulet Information: As per CPHS discussion of 7/6/2016, an information 
sheet will be provided (either paper/electronic) to the participants.  
 
For Aims 1b (Adapt Amulet), Prevalidation Aim 2, Aim 2  (Define/refine MOWI) & Aim 3 (Home-based 
MOWI): The RA will review the respective aim study with the patient, answer any questions, and assess the 
patient’s eligibility. Description of the intervention and the possible risks, benefits and alternatives will be 
presented. Much of the eligibility criteria will have been screened in advance (see above). The RA will present 
the information sheet (Aim 1b), consent form (Aim 2+3 - paper or electronic) and initiate the informed consent 
discussion (as described above). Should the participant, following discussion of the study purpose and consent 
not be willing to participate, the subject shall be thanked for their time but not included in the group. None of 
their information shall be used and any information to date will be destroyed.    
 
The completed form will be scanned into the Dartmouth-Hitchcock Electronic Medical Record (Aims 2+3) and 
the encounter will be documented for study subjects. For community leaders, clinicians and pre-validation 
subjects, the consent forms (paper or electronic) will be kept in the PI’s locked office. 
 
Adequacy of Protection Against Risks 
Participants are informed that information obtained through research interviews and assessments are 
confidential. Talking about life experiences may cause discomfort. If participants feel uncomfortable they are 
encouraged to take a break and continue again later or are offered to stop the interview or assessment. 
Participants may also choose not to answer certain questions. The interviewer also may offer to call the 

participant’s family, a program staff member, or concerned others (such as a close friend) to make sure he or 
she has someone to talk with about the program.  
The team will also encourage continual communication with the primary care provider if any medical concerns 
are raised by participants. Should any participant endorse any symptoms, we will immediately contact the 
nursing staff of the patient’s primary care physician at Dartmouth-Hitchcock or to the individual’s local 
community provider to communicate this risk. On site, there will be individuals and other members that are 
certified in Basic Life Support by the American Heart Association as required by Institutional Policies. Urgent 
care can be provided in the event of an emergency prior to calling 9-1-1 for an ambulance to arrive.  
Any other medically-related questions will be referred to the patient’s primary care provider during normal 
business hours (Monday to Friday 8am-5pm) and after-hours on-call coverage is available through the Family 
Medicine/General Internal Medicine practices or to the local community practice. All study activities will be 
performed during normal clinic hours (8am to 5pm) and hence access to participant’s primary care team is 
possible. Study-related questions can be communicated to the Principal Investigator at 603-653-9500 or by e-
mail at John.A.Batsis@dartmouth.edu. Additionally, the patient’s emergency contact will be contacted as 
indicated in the consent form. Our team intends on collaborating with each participant’s primary care provider 
to determine an appropriate action plan to minimize any risk. 
 
Potential Benefits of Proposed Research 
 
Research participants have an opportunity to engage in a medically supervised Obesity Wellness 
Intervention using novel technologies and would benefit from the discussions with other participants in similar 
situations. For the intervention development, participants will participate in this program which has the potential 
to improve their overall function, aerobic and resistance activity and wellness. Approximately 150minutes 
weekly of aerobic physical activity is recommended166,167. While our program focuses primarily on resistance 
training, we will encourage individuals to achieve the aerobic objective on their own. Individuals will obtain data 
that could potentially be used in clinical settings. The monetary appreciation is another benefit of this proposed 
research that will offset travel costs.  The overall risks of this study are quite minimal, yet in line with 
recommendations from major medical societies. Obesity interventions are recommended even in older 
adults168, yet we believe that any benefits received from this intervention far exceed those risks. The 
components of the obesity intervention would be considered medically necessary for older adults with obesity.  
 
Importance of the Knowledge to be Gained 
The information gained in this study will allow the investigators to ascertain the benefits from a 
technology-based wellness program and anticipate furthering our understanding of the implications of this 
program on functional and biological biomarkers. Understanding these relationships in a clinical setting will 
allow further refinement into a wellness program for obese older adults with the goal of limiting the acceleration 
of sarcopenia and improving function. The program engages and empowers patients in altering their lifestyle, 
thereby promoting healthy living, proper nutrition, physical activity, and maintenance of function. The risks of 
the study are minimal to individuals in relation to the potential benefits they may receive.  
Additionally, the Amulet is intended on becoming a commercially available device intended on 
improving physical health and wellness. The device has been granted a Non-Significant Risk exemption (NSR) 
according to published intent of Amulet100 and review of the protocol by the Committee for the Protection of 
Human Subjects at Dartmouth, dated 7/23/2015 based on 21 CFR 812.2(b)(ii) (Appendix). 
 
Confidentiality and Data Integrity:  
Confidentiality protections include confidentiality training for all new employees and refresher seminars 
annually for all employees; coding subjects by number; filing code sheets separately from data; removing or 
obscuring names from data forms; using an acronym in return addresses on correspondence to subjects; 
storing all data in locked file cabinets; and password-protected computer databases.  
All data collected by Amulet will be recorded to an internal memory card (standard MicroSD card) but 
can only be accessed by removing it from the Amulet (by unscrewing the back cover) and then read by any 
device with an SD-card adapter. This approach provides a secure and reliable means of collecting data and 
transferring it to the researcher’s computer when the subject returns the Amulet at the end of the study. There 
will be automated upload of live data via standard Bluetooth wireless protocols to a computer server in the Kotz 
lab (or virtual server in the Amazon Cloud). This transfer of data will be conducted over authenticated and 
confidential channels using standard protocols (https – which is used by all common e-commerce and banking 
websites). Fitbit data will be collected through the application or through a 3rd party vendor (Fitabase).  

 

 
Table 6:  Timeline & Benchmarks for Success for Research Strategy for K23 
Year 1 
Year 2 
Year 3 
Year 4 
Year 5 
Quarter Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 
Training 
Aim1 
Aim 2 
Aim 3 
Recruitment 
Aim 1 
Aim 2 
Aim 3 
Study Waves 
Aim 1a,b 
Aim 2 
Aim 3 
Analysis/Manual 
Aim 1 
Aim2 
Aim 3 
R01/Manuscripts 
 
 
All Aims 

STATISTICAL DESIGN AND POWER 
Aim 1 (Qualitative assessment) will use mixed-methods to adapt Amulet and MOWI for use in rural 
older obese adults. Aim 2 (Develop/refine MOWI) and Aim 3 (Evaluate home-based MOWI) will explore 
feasibility/acceptability, and preliminary effectiveness of the above outcomes. Data will be analyzed as 
follows:  
Aim 1a (Qualitative assessment): Determine the acceptability, utility and perceived value of mHealth: 
Qualitative data will be managed and analyzed using Dedoose informed by the ‘grounded theory’ approach. 
Two researchers will read data and will develop codebook operational definitions from transcript coding, a 
validated approach on rigor in this type of research which allows for multiple perspectives. Codes will be 
assigned to text, grouped, and checked for themes. The codebook will consist of a priori researcher-driven 
codes, derived from interview and focus groups and inductively derived codes from qualitative data. The 
iterative process involves labeling segments reflecting experiences with the pilot. The query tool will retrieve 
text by code and group. Analyses will assess within group consensus or disagreement. Themes, including 
patient-engagement, allow for refining the manual and determining feasibility/acceptability.  
 

Y

CONSENT TO TAKE PART IN RESEARCH
Dartmouth-Hitchcock Medical Center and Dartmouth College 
Study title:    Mobile Health Obesity Wellness Intervention in Rural Older Adults
Aim #1a – clinicians/leaders
Principal Investigator: John A. Batsis, MD
You are being asked to take part in a research study.  Taking part in research is voluntary.  
Your decision whether or not to take part will have no effect on the quality of your academic 
standing or job status. Please ask questions if there is anything about this study you do not 
understand.
What is the purpose of this study?
The purpose of the study is to obtain information to see whether incorporating technology into 
a wellness program is valid, effective and can improve one’s care from a clinician/community 
leader standpoint.  
Will you benefit from taking part in this study?
You may or may not personally benefit from being in this research study. We hope that the 
information we gather will be helpful in advancing our research to help older adults who need 
to lose weight in the future.
What does this study involve?
Your participation in this study will last one session.  You will be requested to participate in 
one 60-minute semi-structured interview to gather your input about obesity and what 
components of a program would be desirable for patients.The interview is to collect the voice 
of the clinician or community leader in regards to how patients may feel about their weight 
and various components that are being considered in designing a wellness program. Data will 
be available and analyzed only by the investigators or their team. We shall audio-record the 
sessions, transcribe them and subsequently analyze them. Data on your age, sex, role, and 
years of experience will be obtained. 
What are the options if you do not want to take part in this study?
You do not have to take part in this study if you do not wish to.  
If you take part in this study, what activities will be done only for research purposes?
Semi-structured interviews will be conducted as an open conversation under the guidance of 
an interviewer. Conversations will revolve around topics related to the development of an 
obesity program. They will be audio recorded and a transcriber will take written notes of the 
conversation. Verbal and written material from each session will be analyzed. 
What are the risks involved with being enrolled in this study? 
CPHS Approval Expires 7/24/2019
CPHS Approval Date 7/3/2018          
          STUDY00028905

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
Audio recording of the conversation will help the researchers with accuracy of data. No 
potential physical, psychological, social, legal or medical risks are expected from this 
interview.  All information will be kept confidential by the investigators per research 
guidelines. The investigators have no control over divulging of data from other participants, 
though. 
Other important items you should know: 
• Leaving the study: 
You may choose to stop taking part in this study at any time for any reason. If you decide to 
stop taking part, it will have no effect on your academic standing or job standing at 
Dartmouth-Hitchcock Medical Center or Dartmouth College. The investigator reserves the 
right to stop the study participant from continuing without participant consent. 
• New Information: New information related to this research will be made known to you 
when it becomes available.  This may affect your decision to stay in this study. 
• Number of people in this study:  We expect 50 people to enroll in this study here.
• Funding:  The National Institutes on Aging and the Department of Medicine provides 
funding to Dartmouth College for this research. 
How will your privacy be protected?
The information collected as data for this study includes: 
Audio recording of the conversation and written notes. No electronic medical record data will 
be collected for this part of the study. Study data will be maintained for a period of six (6) 
years or longer if needed for other purposes. At that time, data will be deleted from computer 
hardware or shredded on the DHMC campus. 
 
We are careful to protect the identities of the people in this study.  We also keep the 
information collected for this study secure and confidential.  All data will be kept in a locked 
office, and all computer data will be on a password protected encrypted computer or server as 
outlined by the Committee of Protection of Human Subjects. 
The information collected for this study will be used only for the purposes of research as stated 
earlier in this form.  
What about the costs of this study? 
There are no costs charged to the participant. 
Will you be paid to take part in this study?
There will be no payments for this part of the study. 
Whom should you call with questions about this study?
CPHS Approval Expires 7/24/2019
CPHS Approval Date 7/3/2018          
          STUDY00028905

Y

If you have questions about this study, you can call your doctor or the research director for 
this study: Dr. John A. Batsis, MD, (603) 653-9500 normal business hours.  
If you have questions, concerns, complaints, or suggestions about human research at 
Dartmouth, you may call the Office of the Committee for the Protection of Human Subjects at 
Dartmouth College (603) 646-6482 during normal business hours.
CONSENT
I have read the above information about: 
Mobile Health Obesity Wellness Intervention in Rural Older Adults
and have been given time to ask questions.  I agree to take part in this study and I have been 
given a copy of this signed consent form.
Participant's Signature and Date
/ 
PRINTED NAME 
Researcher or Designee Signature and Date
PRINTED NAME 
CPHS Approval Expires 7/24/2019
CPHS Approval Date 7/3/2018          
          STUDY00028905

9

CONSENT TO TAKE PART IN RESEARCH
Dartmouth-Hitchcock Medical Center and Dartmouth College 
Study title:    Mobile Health Obesity Wellness Intervention in Rural Older Adults
Aim #1a - Subjects
Principal Investigator: John A. Batsis, MD
You are being asked to take part in a research study.  Taking part in research is voluntary.  
Your decision whether or not to take part will have no effect on the quality of your medical care. 
Please ask questions if there is anything about this study you do not understand.
What is the purpose of this study?
The purpose of the study is to obtain information to see whether incorporating technology into 
a wellness program is valid, effective and can improve one’s care.  
Will you benefit from taking part in this study?
You may or may not personally benefit from being in this research study. We hope that the 
information we gather will be helpful in advancing our research to help older adults who need 
to lose weight in the future.
What does this study involve?
Your participation in this study will last one session.  You will be requested to participate in 
total of either one (1) focus group session (~90 minutes) and/or one 60-minute semi-structured 
interview to gather your input about obesity and what components of a program would be 
desirable for patients.The focus group/semi-structured interview is to collect the voice of the 
patient in regards to how they feel about their weight and various components that are being 
considered in designing a wellness program. Socioeconomic data of participants will be 
obtained through a self-administered paper questionnaire at the start of the session. Data will 
be available and analyzed only by the study team. We shall audio-record the sessions, 
transcribe them and subsequently analyze them. Basic information that we will ask include: 
Age, sex, employment status, education
What are the options if you do not want to take part in this study?
You do not have to take part in this study if you do not wish to nor do you need to take part in 
this study to receive medical care or treatment.  
If you take part in this study, what activities will be done only for research purposes?
Focus groups will be conducted as an open conversation under the guidance of a moderator. 
Semi-structured interviews will take place by an individual. Conversations will revolve 
around topics related to the development of an obesity program. They will be audio recorded 
and a transcriber will take written notes of the conversation. Verbal and written material from 
each session will be analyzed. 
CPHS Approval Expires 7/24/2019
CPHS Approval Date 7/3/2018          
          STUDY00028905

9

What are the risks involved with being enrolled in this study? 
Audio recording of the conversation will help the researchers with accuracy of data. No 
potential physical, psychological, social, legal or medical risks are expected from this group.  
All information will be kept confidential by the principal investigator per research guidelines. 
The investigators have no control over divulging of data from other participants, though. 
Other important items you should know: 
• Leaving the study: 
You may choose to stop taking part in this study at any time for any reason. If you decide to 
stop taking part, it will have no effect on the quality of medical care you receive at Dartmouth-
Hitchcock Medical Center. Any equipment must be returned to the study director. The 
investigator reserves the right to stop the study participant from continuing without 
participant consent. 
• New Information: New information related to this research will be made known to you 
when it becomes available.  This may affect your decision to stay in this study. 
• Number of people in this study:  We expect 50 people to enroll in this study here.
• Funding:  The National Institutes on Aging and the Department of Medicine provides 
funding to Dartmouth College for this research. 
How will your privacy be protected?
The information collected as data for this study includes: 
Data that is available in the Dartmouth-Hitchcock electronic medical record and audiotaped 
data as outlined above.  Study data will be maintained for a period of six (6) years or longer if 
needed for other purposes. At that time, data will be deleted from computer hardware or 
shredded on the DHMC campus. 
We are careful to protect the identities of the people in this study.  We also keep the 
information collected for this study secure and confidential.  All data will be kept in a locked 
office, and all computer data will be on a password protected encrypted computer or server as 
outlined by the Committee of Protection of Human Subjects. 
The information collected for this study will be used only for the purposes of research as stated 
earlier in this form.  
Who may use or see your health information?
By signing this form, you allow the research team to use your health information and give it to 
others involved in the research.  The research team includes the study director plus others 
working on this study at Dartmouth-Hitchcock Medical Center and elsewhere.  
CPHS Approval Expires 7/24/2019
CPHS Approval Date 7/3/2018          
          STUDY00028905

9

The information collected for this study may be used by researchers or officials of the 
following institutions.
•
Dartmouth College
•
Mary Hitchcock Memorial Hospital
•
Dartmouth-Hitchcock Clinic
•
Dartmouth-Hitchcock Medical Center
•
Mayo Clinic Rochester
•
University of New Hampshire, Durham
•
The Committee for the Protection of Human Subjects (CPHS) at Dartmouth College 
Some of the information used in this study, called Protected Health Information ("PHI"), is 
protected by federal privacy laws.  By signing this consent form, you give your permission to 
have your PHI collected, used and disclosed for purposes of this study.  After the study staff 
or study doctor discloses your PHI to others, it could be re-disclosed and no longer protected 
by federal privacy laws.
Your permission to use your health information for this study will not end until the study is 
completed. During this study, you and others who take part in the study may not have access 
to the study data.  You may ask for study data once the study is over.  You have a right to 
receive a copy of the information in your medical record at any time.
It is possible for a court or government official to order the release of study data including 
information about you. 
What if you decide not to give permission to use and share your personal health 
information?
If you do not allow use of your health information for this study, you may not take part in this 
study. If you choose to stop taking part in this study, you may cancel permission for the use of 
your health information.  You should let the researcher know if you want to cancel your 
permission. The study team will assist you in putting your wishes in writing. Information 
collected for the study before your permission is cancelled will continue to be used in the 
research.
What about the costs of this study? 
There are no costs charged to the participant 
Will you be paid to take part in this study?
Complementary beverages and snacks will be provided. As a token for completing this 
session, you will be provided with $10 for focus group participation and/or $25 for the semi-
structured interview in the form of a gift card or equivalent. 
CPHS Approval Expires 7/24/2019
CPHS Approval Date 7/3/2018          
          STUDY00028905

9

If you take part in this study, the sessions will be done only for research purposes and paid for 
by the sponsor. Insurance plans will not be billed as part of this project. All medical issues 
resulting from this study would need to be covered through your regular healthcare insurance. 
You or your insurance plan will be expected to pay for the costs of this usual medical care. For 
assistance in determining your coverage, please call the billing specialist in DHMC Patient 
Financial Services at 603-653-1047 or 800-368-4783.  
Whom should you call with questions about this study?
If you have questions about this study or need to report a study related injury, you can call 
your doctor or the research director for this study: Dr. John A. Batsis, MD, (603) 653-9500 
normal business hours.  If Dr. Batsis is not available, all concerns should be addressed by your 
primary care provider’s office who will be available to answer your questions during normal 
business hours. An emergency contact number is (603) 650-5000, the main hospital number. 
If you have questions, concerns, complaints, or suggestions about human research at 
Dartmouth, you may call the Office of the Committee for the Protection of Human Subjects at 
Dartmouth College (603) 646-6482 during normal business hours.
CONSENT
I have read the above information about: 
Mobile Health Obesity Wellness Intervention in Rural Older Adults
and have been given time to ask questions.  I agree to take part in this study and I have been 
given a copy of this signed consent form.
Participant's Signature and Date
/ 
PRINTED NAME 
Researcher or Designee Signature and Date
PRINTED NAME 
CPHS Approval Expires 7/24/2019
CPHS Approval Date 7/3/2018          
          STUDY00028905