A 12-week Intervention With Motivational Interviewing and Physical Activity Monitoring, to Enhance the Daily Amount of Physical Activity in Community Dwelling Older Adults - a Randomized Controlled Trial
Phase: NA
Conditions: Aging, Physical Activity, Older Adults
Sponsor: University of Copenhagen

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Title page 
Citation 
Rasmus Tolstrup Larsen 1, PT, MSc (rala@sund.ku.dk)  
Christoffer Brun Korfitsen 1, PT (korfitsen@sund.ku.dk)   
Carsten Bogh Juhl 4, PT, MPH, PhD (cjuhl@health.sdu.dk) 
Henning Boje Andersen 3, PhD, Professor (hebq@dtu.dk)  
Jan Christensen 2, 5 PT, MSc, PhD (fysjan@gmail.com) 
Henning Langberg 1, PhD, Professor (henninglangberg@gmail.com)  
 
Affiliation 
1: CopenRehab 
University of Copenhagen, Department of Public Health, Section of Social Medicine 
Gothersgade 160, 3rd floor 
1123 Copenhagen K 
2: Department of Occupational- and Physiotherapy, Copenhagen University Hospital, Rigshospitalet, Copenhagen, 
Denmark. 
3: Technical University of Denmark, DTU Management Engineering Inst. 
4: Research Unit of Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical 
Biomechanics, Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark. 
Department of Physiotherapy and Occupational Therapy, Copenhagen University Hospital, Herlev and Gentofte, 
Denmark 
5: National Centre for Rehabilitation and Palliative Care, University of Southern Denmark and Odense University 
Hospital, Denmark. 
 
 
 
 

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Table of contents 
1.Title 
4 
2. Trial registration 
4 
3. Protocol version 
4 
4. Funding 
4 
5. Roles and responsibilities 
5 
INTRODUCTION 
6 
6. Background and rationale 
6 
7. Objectives 
7 
8. Trial design 
8 
METHODS: PARTICIPANTS, INTERVENTIONS, AND OUTCOMES 
9 
9. Study setting 
9 
10. Eligibility criteria 
9 
11. Interventions 
10 
12. Outcomes 
13 
13. Participant timeline 
18 
14. Sample size 
19 
15. Recruitment 
19 
METHODS: ASSIGNMENT OF INTERVENTIONS 
20 
16. Allocation 
20 
16.c Implementation 
20 
17. Blinding (masking) 
20 
17. a 
20 
17b. 
20 
METHODS: DATA COLLECTION, MANAGEMENT, AND ANALYSIS 
21 

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18. Data collection methods 
21 
18a. Plans for assessment and collection of outcomes 
21 
18b. Plans to promote participant retention and complete follow-up. 
21 
19. Data management 
22 
20. Statistical methods 
22 
METHODS: MONITORING 
24 
21. Data monitoring 
24 
22. Harms 
24 
23. Auditing 
24 
ETHICS AND DISSEMINATION 
25 
24. Research ethics approval 
25 
25. Protocol amendments 
25 
26. Consent or assent 
25 
27. Confidentiality 
25 
28. Declaration of interests 
25 
29. Access to data 
27 
30. Ancillary and post-trial care 
27 
31. Dissemination policy 
27 
REFERENCES 
28 
APPENDIX 
32 
32. Informed consent materials 
32 
PARTICIPANT INFORMATION ON PARTICIPATION IN A RESEARCH PROJECT 
32 

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1.Title 
The MIPAM trial: A 12-week intervention with motivational interviewing and physical activity 
monitoring, to enhance the daily amount of physical activity in community dwelling older adults – a 
randomized controlled trial 
 
2. Trial registration 
ClinicalTrials.gov Identifier: NCT03906162 
 
3. Protocol version 
Version 3.0 
 
4. Funding 
The content presented within this paper was produced as part of the project REACH: this project 
has received funding from the European Union’s Horizon 2020 research and innovation program 
under grant agreement No. 690425 [1]. 
 
 
 
 

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5. Roles and responsibilities  
Names, affiliations, and roles of protocol contributors 
 
The affiliations of Rasmus Tolstrup Larsen (RTL), Christoffer Bruun Korfitsen (CBK), Carsten 
Bogh Juhl (CJ), Henning Boje Andersen (HBA), Jan Christensen (JC) and Henning Langberg (HL) 
is reported on the title page.  
 
All authors did actively contribute to the design of this intervention study. The intervention content 
was developed by RTL and CBK. The outcome measures were chosen and evaluated by RTL, 
CBK, CJ, JC and HL. Besides being actively contributing to the design, HBA served as the primary 
technology expert and CJ served as the methodological expert as well as proving statistical 
counselling. The study was originally initiated by HL and HBA. RTL was the primary author of this 
protocol, but all authors contributed to its content.   
  
The funder (Horizon 2020) have not contributed to any work regarding this study protocol.   
 
Fitrockr (https://www.fitrockr.com/#!/welcome), will serve as the data management team 
responsible for handling the data export from the PAMs and exporting the data to the research and 
intervention team. Data processor agreement forms have been completed prior to registration and 
beginning of this RCT, in accordance with approval from the Danish Data Protection Agency.  

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Introduction 
6. Background and rationale 
Twenty-seven percent of older adults in Denmark (65-74) and 39-46% of very old adults (75+) do 
not meet the WHO recommendations for minimum PA [2] and the motivation for increasing PA 
levels is lowest for these two age groups [3] possibly due to the many barriers known to this age 
group [4–14]. The identification of reliable predictors of exercise adherence will allow healthcare 
providers to effectively intervene and change patterns of physical activity in sedentary elderly.  
Evidence suggest that behavioral (walking, exercise) and cognitive (counselling and 
motivational interviews) interventions are effective for short-term physical activity increase in older 
people [14]. In order to maintain long-term participation in PA, individualized interventions modelled 
using behavioral theories may be required [14]. Social support may be especially important for 
increasing PA in older adults as social support, strain, and social networks influence health behaviors 
and outcomes [15]. Another reason for lack of motivation for exercise in older adults can be by low 
self-efficacy or outcome expectancy for exercise beliefs, which is often closely related to PA levels 
in older people [16].  
The lack of PA cannot be attributed solely to personal motivation and the complexity of 
physical activity interventions has been recognized by stakeholders who increasingly are electing to 
employ multi-component approaches in increasing a population’s PA [12, 17, 18]. Multi-component 
community wide interventions however fail to effectively increase PA in populations however 
making access to exercise facilities does show to be feasible to increase PA in some studies [12, 19].  
To increase long-term participation in PA in older adults interventions should include 
delivered materials about health recommendations, behavior and cognitive strategies which are 
theory- and motivational based [20]. The content and positive framing of recommendations and 
feedback is important to consider when examining the promotion of PA in older adults [21] and a 
focus on action planning, identifying environmental or contextual barriers may be needed to have an 
impact and to motivate behavior change in sedentary older adults [15].  
 
Walking programs with elderly are effective in increasing physical activity on a short term, 
but the programs should be individualized to maintain long term participation [14]. Walking 
interventions based on activity monitoring are becoming more frequent and hence, an increasing 
number of scientific results suggest that the monitors can facilitate motivational behavioral change 
and increase the average number of daily steps in older adults [22].  

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An intervention strategy including PAMs, facilitating goal setting [23] and using Motivational 
Interviewing (MI) have shown to promote maintenance of increased physical activity behavior at six 
months [24]. Incorporating techniques such as MI may increase motivation and self-efficacy [25]. MI 
addresses the behavioral and psychological aspects of why people maintain current health habits [26] 
and shows potential for exercise behavior change (23,26,27). When health professionals set out to 
assist clients with changing a health behavior such as PA, they usually begin by giving their clients 
advice using a direct communication approach. The expectation is that the client will make a 
favorable health related decision because the advice is sensible. Advice often has little or no impact 
on health behaviors because often times the information is too complex for the client, is of no concern 
to the client, or is too overwhelming in its amount or content and is, therefore, not heard [27]. In using 
MI, Rollnick and colleagues [27] suggest that health professionals not dispense advice or instructions 
on how a client should change a behavior because of the natural human behavior to resist being told 
what to do. This resistance creates ambivalence about the change [27]. Combining resistance with 
perceived barriers to PA only adds to the problem. The client envisions how one "should exercise", 
imagines the difficulty in doing it, and eventually quits thinking about it all together [27]. In MI, 
ambivalence to change is viewed as part of normal human behavior [27]. Health professionals who 
understand this are better able to help their clients move through a process of change that is consistent 
with their goals and values [27]. This is accomplished by employing empathy, one of the core 
principles in MI [27]. The goal of MI is to attain an initiation and commitment for change that is 
collaborative, evocative, honoring of client autonomy and sought by both the client and the 
practitioner [26, 27]. The 'objective is to have the client verbally express the reasons to change to a 
more physically active lifestyle and then in combination with hearing those reasons as they are said, 
the progress towards improved physically active behavior is strengthened [28]. Future research has 
been previously recommended to determine if there is a minimum amount and length of MI 
interventions needed that should be delivered to produce consistent long term results [26]. 
 
7. Objectives  
The objective of this randomized controlled trial is to investigate if motivational interviewing 
provided as an add-on intervention to a physical activity intervention will increase the average daily 
step count in community-dwelling participants above the age of 70.   
 

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1. It is hypothesized that motivational interviewing, will enhance the average daily step count 
among participants. 
2. It is hypothesized that motivational interviewing, will affect self-reported physical activity 
and quality of life. 
3. It is hypothesized that self-efficacy and outcome expectancy for exercise, will mediate the 
effect and explain heterogeneity in the results.  
 
8. Trial design  
Study Type: Interventional 
Estimated Enrollment: 154 participants 
Allocation: Randomized 
Intervention Model: Parallel Assignment 
12-week intervention with two groups in a parallel design 
Masking: Double (Investigator, Outcomes Assessor) 
Primary investigator will be blinded for allocation before making the final 
analyses. No outcome assessments will be made by an assessor. Only 
objectively measured steps per day and participant reported outcome 
measures will be used for this study. 
Primary Purpose: Prevention 
The primary hypothesis till be investigated with a superiority analysis.  
 
 

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Methods: Participants, interventions, and outcomes 
 
9. Study setting 
Description of study settings (e.g., community clinic, academic hospital) and list of countries where 
data will be collected. Reference to where list of study sites can be obtained’. 
 
This RCT will be conducted in Denmark. Participants eligible for inclusion will receive the content 
necessary for participation by mail. The participants will only have contact with the research team 
via phone or e-mail correspondence.  
 
10. Eligibility criteria 
Participants will be considered eligible for inclusion if they; 1) are retired and community-dwelling, 
2) at least 70 years of age by the day of enrolling the trial, 3) own a smartphone or tablet able to install 
the Garmin Connect application, 4) have an email address and are able to correspond and complete 
the study survey on a computer and 5) have hearing abilities sufficient to receive a telephone 
interview. 
 
Participants will not be considered eligible for inclusion, and hence excluded, if; 1) they have 
cognitive impairment from moderate to severe dementia or Alzheimer’s disease, 2) they are 
undergoing active chemotherapy or palliative care from cancer, 3) have a major mobility impairment 
(e.g. from paralysis, amputations, severe arthrosis or arthritis, Sclerosis or Parkinson’s disease).  
 
 
 

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11. Interventions 
Experimental: 
Motivational 
interviewing 
Experimental 
content + base 
intervention 
Behavioral: Motivational interviews  
During the 12-week intervention, the participants will receive seven 
telephone calls from a physical therapist (PT). Using an intervention 
schedule inspired by the work of King et al. to facilitate initiation and 
maintenance of behavior change, calls are delivered in week 1, 2, 3,5,7,9, 
and 12 [29]. 
The telephone call will consist of a motivational interview (MI) focused 
on enhancing the daily level of physical activity in the participants. 
MI is a form of counselling aiming at prompting increases in self-
efficacy, which may leave people more open to and invested in changing 
their behaviors and shows potential for significant effects for exercise 
behavior change. In this person-centered intervention model, participants 
are guided through self-reflective counseling. They receive feedback on 
these health behaviors in relation to national recommendations; 
consistent with a MI approach [27], this feedback also highlights the 
discrepancy between their health goals and their current health behaviors; 
they set collaborative goals for physical activity change with their PT, 
with the participant encouraged to begin with the target area in which 
she/he is most motivated to change; all of this is incorporated into a 
behaviorally-specific plan that specifies exactly what is to be done and 
when; barriers and supports are identified; confidence is assessed and 
problem-solving is discussed as necessary. These steps are repeated 
during intervention contacts, with goals being adjusted as necessary. 
During the maintenance face (week 5-12) increasing emphasis is placed 
on identification of multi-level supports for health behavior change. 
Participants are encouraged to use a variety of supports including family 
and friends, as well as neighborhood and community supports. In 
collaboration with local community partners, a community reference 

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guide is compiled that enabled the counselor to refer participants to 
specific community resources (e.g., walking groups). 
In addition to the telephone based motivational interviews, the 
experimental group will also receive the "base intervention" which is 
described in detail under the "control intervention paragraph". 
Behavioral: Base intervention  
The "base intervention" consists of a physical activity monitor (PAM) for 
everyday use in the intervention period and a pamphlet with information 
about Danish recommendations on physical activity in aging populations. 
The PAM will be the Garmin Vivofit 3 monitor linked to a pre-specified 
Garmin Connect account. The participants will be asked to install the 
Garmin Connect application on their smartphone and use the given 
ID/password in the app. The participants will be asked to wear the 
monitor 24-hours a day for the 12-week intervention period. The 
participants can use the PAM as they like but they will be asked to try to 
use the PAM and the application to enhance their daily level of physical 
activity. 
Active 
Comparator: 
Control 
intervention 
Base intervention 
Behavioral: Base intervention  
The "base intervention" consists of a physical activity monitor (PAM) for 
everyday use in the intervention period and a pamphlet with information 
about Danish recommendations on physical activity in aging populations. 
The PAM will be the Garmin Vivofit 3 monitor linked to a pre-specified 
Garmin Connect account. The participants will be asked to install the 
Garmin Connect application on their smartphone and use the given 
ID/password in the app. The participants will be asked to wear the 
monitor 24-hours a day for the 12-week intervention period. The 
participants can use the PAM as they like but they will be asked to try to 

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use the PAM and the application to enhance their daily level of physical 
activity. 

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11.b, Fidelity 
The intervention (and the actual content of the motivational interviews) will be tailored to the 
individual participant, but the number of calls will not be adjusted.  
The project telephone counselor has a masters degree in physiotherapy and additional training in the 
MI approach to telephone health behavior counseling. Training involved a four-day course, reading 
study materials, discussions with previous study investigators, viewing of MI recording, and roll 
plays. Prior to this study the counselor has also conducted more than 200 interviews with older adults 
and staff in the community to familiarize with the community culture and local resources.  
During the study, with participants' verbal consent, telephone MI (and control) sessions is audiotaped 
on a regular basis to ensure fidelity of intervention delivery and to provide counselor feedback. Based 
on a review of these recordings the fidelity monitoring is conducted by two experienced independent 
MI coders who are blinded to treatment assignment using the Motivational Interviewing Treatment 
Integrity (MITI) Scale, a tool developed to measure MI treatment adherence [30]. 
 
12. Outcomes 
Primary Outcome Measure: 
1. Individual intervention period average steps per day, recorded every day by the PAM. The 
average number of steps per day throughout the 12 weeks will be the primary outcome for 
the individual participant.  
Time frame: A daily average of the 12 weeks of intervention 
 
The Garmin Vivofit 3 will serve as the PAM and thus, measure the primary outcome. Garmin 
Vivofit 3 has to our knowledge only been validated in older adults by our own research group 
(manuscript being prepared for submission).  
Four physical activity monitors were included in the validation study; Misfit Shine, Nokia GO, 
Jawbone UP and Garmin Vivofit 3. The aim of the study was to compare different PAMs on 
different body locations. All hip-worn PAMs fulfilled the a priori hypothesized moderate criterion 
validity, when evaluating all participants. The hip-worn Garmin Vivofit 3 fulfilled the a priori 

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hypothesized criterion validity evaluating all participants, participants with rollator and participants 
without rollators and it was evaluated as the best performing device in older adults in general.  
The validation study is currently being finalized for submission.  
 
Secondary Outcome Measures: 
1. International Physical Activity Questionnaire [Time Frame: Baseline + end point at 12 
weeks + follow up at 6 months and 12 months] 
2. Nordic Physical Activity Questionnaire [Time Frame: Baseline + end point at 12 weeks + 
follow up at 6 months and 12 months] 
3. EQ5D Quality of life questionnaire [Time Frame: Baseline + end point at 12 weeks + follow 
up at 6 months and 12 months] 
4. UCLA Loneliness Scale [Time Frame: Baseline + end point at 12 weeks + follow up at 6 
months and 12 months]  
5. Self-Efficacy for Exercise [Time Frame: Baseline + end point at 12 weeks + follow up at 6 
months and 12 months] 
6. Outcome expectancy for  Exercise-2 [Time Frame: Baseline + end point at 12 weeks + 
follow up at 6 months and 12 months] 
7. Copenhagen Social Relations Questionnaire [Time Frame: Baseline + end point at 12 weeks 
+ follow up at 6 months and 12 months] 
Secondary outcome measures include participant reported outcomes administered by online 
questionnaires. The baseline measurement will be undertaken before the intervention group receives 
the first motivational interview and the end point measurement will be undertaken in the days after 
the last motivational interview.  
 
International Physical Activity Questionnaire short form (IPAQ-SF) 
The seven-item IPAQ-SF measure assesses the types of intensity of physical activity and sitting time 
that people has done the past seven days as part of their daily lives are considered to estimate total 
physical activity in MET-min/week and time spent sitting [31]. The score is categorized to three 
levels of (categories) of PA; low, moderate and high [32]. In a review of 16 international studies of 

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the measurement properties IPAQ-SF showed acceptable reliability (Spearman’s rho: 0,32-0,88) [31] 
and low to moderate concurrent validity against accelerometer had a pooled correlation coefficient of 
0.30 (Spearman’s rho range: 0,09-0,38) [33]. The Danish version have been used in a Danish 
population of older adults [34]. 
 
Nordic Physical Activity Questionnaire short (NPAQ-short) 
The two-item NPAQ-short [35] is a short revised version of the original NPAQ, a survey tool based 
on telephone interviews designed for assessment of Moderate and Vigorous Physical Activity 
(MVPA). It is developed to monitor compliance with the WHO recommendations on PA [36] and 
has showed moderate correlation with objectively measured MVPA (Spearman’s rho: 0.33) in a 
Danish population with an average age of 43 (range: 17-85) [35].  
 
The 5-level EuroQol-5 Domain (EQ-5D-5L) Quality of life questionnaire 
The EQ-5D-5L is a generic health-related quality of life (HRQoL) measure developed as a non-
disease-specific instrument for describing and valuing health states [37] and comprises five 
dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression), each of 
which has three levels (no problems, moderate problems and extreme problems) and a visual analogue 
scale (EQ VAS). The score for the five dimensions can be combined into a five-digit number that 
describes the patient’s health state. The EQ VAS records the patient’s self-rated health on a vertical 
visual analogue scale, where the endpoints are labelled ‘The best health you can imagine’ and ‘The 
worst health you can imagine’. The EQ-5D-5L has shown general feasibility for measuring HRQoL 
in a geriatric population sample [38] as well as acceptable reliability and validity [39]. The EQ-5D-
5L is adapted to Danish [40] and in the national sample of Danish 70-79 year-olds, the mean EQ-5D-
5L index score was 0.83 (SD: 0,19) [41].  
 
UCLA Loneliness Scale 
The 20-item UCLA loneliness scale (third version) is a self-report measure of loneliness and social 
isolation [42]. The scale consists of 11 positive and nine negative items and the total score is 
calculated by finding the sum of 20 items (0-60), with a higher score indicating more loneliness. Items 
one, five, six, nine, 10, 15, 19 and 20 are all reverse scored. The scale is adapted to Danish and this 
version has shown high internal consistency (Cronbach’s Alpha: 0.92) and has shown evidence of 

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convergent validity as a moderate to high correlation with other measures of emotional loneliness (r: 
0.69) and social loneliness (r: 0.73). In addition, the scale shows evidence of discriminant validity by 
its relations to self-esteem (r: -0.58), depression (r: 0,59), extraversion (r: 0.57) and neuroticism (r: 
0,58). in a population of Danish 8th grade students that are comparable to the original scale [43]. The 
scale has showed acceptable model fit as a unidimensional structure [43]. 
 
Self-Efficacy for Exercise (SEE-DK) 
The nine-item SEE-DK addresses confidence to engage in regular exercise [44], when challenged by 
known barriers to exercise [4]. The scale was developed initially for sedentary adults in the 
community who participated in an outpatient exercise program [45] and was revised to older adults 
[44]. It is designed to be administered using face-to-face interview. Response categories range from 
0 (no confidence) to 10 (very confident) [44]. Item scores are used to calculate a total score (0-90), 
with higher scores indicating higher confidence, or self-efficacy, related to exercise. The SEE-DK is 
adapted to Danish older adults with acceptable face and content validity, construct validity by  
acceptable model fit as a unidimensional scale, and test-retest reliability [46]. 
 
Outcome Expectancy for Exercise-2 (OEE2-DK) 
The 13-item OEE-2 scale was developed from the original 9-item Outcome Expectations for Exercise 
scale (OEE) that specifically focused on measuring the positive outcome expectations for exercise 
(POEE). Based 1n qualitative findings [4, 47], the original OEE was revised to include four items 
that focused on negative outcome expectations for exercise (NOEE) [48]. It was initially developed 
for older adults [49, 50]. To complete the OEE2-DK scale the participants are asked, using a Likert 
scale, to strongly agree, agree, neither agree nor disagree, disagree, or strongly disagree with the 
stated outcomes to each statement of exercising. The POEE and NOEE subscales are scored by 
calculating the average score on each scale (1-5) and the items three, six, nine and 12 (NOEE 
subscale) are reverse-scored [48]. The OEE2-DK is adapted to Danish older adults with acceptable 
face and content validity, construct validity by  acceptable model fit as a two-dimensional scale, and 
test-retest reliability [46]. 
 
Copenhagen Social Relations Questionnaire (CSRQ) 

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The 42-items questionnaire was developed originally in Danish in 1999 [51] and measures the 
structural aspect of social relations, with focus on contact frequency and diversity, and functional 
aspects with focus on perceived social support. CSRQ has been used in several Danish population-
based surveys including in the Copenhagen Aging and Midlife Biobank (CAMB) [52]. In a sample 
of 38-69 old adults the CSRQ showed acceptable face and content validity and good test-retest 
reliability by 41% of the items had substantial to almost perfect agreement (kappa: 0.65-0.97) and the 
rest showed moderate agreement (kappa: 0.41-0.60) [53].  
The secondary outcomes will also serve as follow up measurements six and 12 months after ending 
the intervention. They will also be conducted with online surveys.  
 

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13. Participant timeline 
Time schedule of enrolment, interventions (including any run-ins and washouts), assessments, and 
visits for participants. A schematic diagram is highly recommended (see Figure). 
 
 
Figure 1.  SPIRIT participant timeline. 
The participant is allocated to the intervention group and 
will wear the monitor throughout the intervention period. 
The participant receives a telephone call with the first 
motivational interview (20 minutes).
The participant receives a telephone call with oral explanation of study including possible benefits and harms. They 
are also assessed for eligibility regarding the inclusion criteria 
The participant receive the physical activity monitor, the pamphlet about physical activity and written information 
about the study by mail.
The participant is monitored for one week with their physical activity monitor. The participant completes the online 
survey with  informed consent and the baseline assessment.
The participant confirms willingness to continue participation
The participant is randomized to intervention or control intervention group
The participant accepts the invitation to participate in the study
Excluded: no informed consent
Excluded: excluded  for 
not fulfilling the 
inclusion criteria og due 
to exclusion criteria
The participant is allocated to the control group and 
will not receive any motivational interviews, but will 
only wear the physical activity monitor throughout 
the intervention period. 
Week
0
0
1
1
1
2
3
4
6
8
10
13
The participant receives a telephone call with the 
second motivational interview (20 minutes).
The participant receives a telephone call with the 
third motivational interview (20 minutes).
The participant receives a telephone call with the 
fourth motivational interview (20 minutes).
The participant receives a telephone call with the 
fifth motivational interview (20 minutes).
The participant receives a telephone call with the 
sixth motivational interview (20 minutes).
The participant receives a telephone call with the last 
motivational interview (20 minutes).
Participants return the monitors with mail and complete the end-point questionnaire
Participants complete the six month follow up questionnaire
Participants complete the twelve month follow up questionnaire
14
40
66
Lost to follow up
Lost to follow up

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14. Sample size 
Estimated number of participants needed to achieve study objectives is 128 participants. The number 
will be enough to show a 0.5 standard deviation difference between groups, equal to a moderate effect 
size. The number of participants will yield a power on 80% with a significance level on 0.05. To 
account for attrition this study will include 20% more participants than the above mentioned, and 
hence terminate the inclusion of participants when 154 participants in total and 77 in each group have 
been enrolled.  
 
15. Recruitment 
We will recruit participants through online advertisements on social media and in non-profit 
organizations working with older adults. We will also try to recruit participants at activity centers and 
other communities of older adults.  
 
 

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Methods: Assignment of interventions 
16. Allocation 
16.a. Sequence generation 
Participants will be randomly assigned to either the intervention or the control group, with a 1:1 
allocation. Eligible participants who have completed the baseline step count, will be randomized in 
blocks of four participants or more, stratified on sex (M/F) and average baseline step count for the 
extracted days prior to the allocation. Randomization of participants will happen every week, except 
weeks with less than four new participants. 
 
16.b Allocation concealment mechanism 
Participants will be randomized using STATA, which is a statistical software package. Allocation 
concealment will be ensured, as the allocation will not be available until the patient has been recruited 
into the trial, which takes place after the baseline step count measurements have been completed. 
 
16.c Implementation 
One investigator will be in charge of the randomization. That investigator will receive a list of 
participant IDs every week and randomize the participants according to the above. That one 
investigator will not have anything do to with recruitment nor statistical analyses.  
 
17. Blinding (masking) 
17. a 
Outcome assessors and data-analysists will be blinded for participant allocation.  
 
17b.  
Due to the nature of the intervention neither participants nor staff conducting the motivational 
interview in the intervention group can be blinded to allocation but are strongly inculcated not to 
disclose the allocation status of the participants with the principal investigator who will conduct the 
analyses. The group names of the intervention and the control group will be anonymized before the 
data will be analyzed to ensure blinding of the principal investigator.  
 
 

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Methods: Data collection, management, and analysis 
 
18. Data collection methods 
18a. Plans for assessment and collection of outcomes 
Primary outcome 
The primary outcome (average steps per day in the 12-week intervention period) will be extracted 
from the data management software Fitrockr. Participants will be asked to synchronize their PAMs 
and their Garmin Connect application daily, ensuring daily storage of the step counts. The PAMs 
have a 30-day storage for daily totals so data will not be lost, even if the participants forget to 
synchronize their PAMs for longer periods of time. Fitrockr will extract the data from Garmin 
Connect and make daily step counts available for export through their service. When the participant 
has completed the 12-week intervention, the daily totals will be extracted as 84 variables (12*7). 
After the data extraction, the average daily step count will be calculated.  
 
Secondary outcomes 
The secondary outcomes are all participant reported and administered through SurveyXact. All 
participants will receive an email with an electronic SurveyXact invitation on the day of 
randomization. On the last day of intervention (day 84), the participants will receive a similar 
SurveyXact invitation with the end-point questionnaire. The six and 12-month follow up assessments 
will be administered in similar ways to the end-point assessment.  
 
Demographic and other baseline items 
Non-outcome variables will be included in the baseline questionnaire.   
 
18b. Plans to promote participant retention and complete follow-up. 
 
If possible, reasons for drop out will be collected from each discontinued participant. The available 
data on the primary outcome will be used to calculate the intervention period average steps per day. 
If the participant fails to synchronize the PAM and a possible drop out is suspected, a person from 
the research team will call the participant to either remind them to synchronize the PAM or try to 
motivate the participant to continue the intervention.  
 

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Lost to follow up with the end-point or follow up questionnaires will be reminded via email 7, 14 
and 21 days after the deadline. 
 
19. Data management 
All outcomes will be handled and stored electronically.  
Steps per day will be stored every time the participant synchronizes the PAM. The data handling 
responsible Fitrockr will extract data from the Garmin applications and store it according to the 
agreements. Every time a participant completes the intervention period, their data will be exported 
from the Fitrockr database and stored securely at the University of Copenhagen server.  
 
During the study, with participants' verbal consent, telephone MI (and control) sessions is audiotaped 
on a regular basis to ensure fidelity of intervention delivery and to provide counselor feedback. 
 
The participant reported outcomes for the secondary outcomes will be administered using 
SurveyXact, securing data every time a survey has been completed. Every time a participant 
completes the intervention period, their data will be exported from the Fitrockr database and stored 
securely at the University of Copenhagen server. 
 
No personal data will be exported from Fitrockr or SurveyXact without pseudonymization. Complete 
anonymization of all data will be done after the last follow up period. Data protection agency approval 
Reference number: 514-0268/18-3000 
 
20. Statistical methods  
The primary outcome will be analyzed as a mixed effects model, where intervention group are 
analyzed fixed and participants are random effects. The analysis will investigate the group difference 
in average daily step count, adjusted for baseline step count and gender. Same analysis will be 
performed on secondary outcomes.  
 
Drop outs with data on the primary outcome for at least one week will have their average daily step 
count based on the available days. All analysis will be performed following the Intention to Treat 
(ITT) principle imputing missing data using a multiple imputation based on age, gender, baseline 
step counts and average daily step count (for missing data on the secondary outcomes). In 

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calculating the average daily step count, days with less than 100 steps will be handled as “days of 
non-wear” and excluded assessing the mean step count. 
 
 

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Methods: Monitoring 
21. Data monitoring 
Not applicable/relevant 
 
22. Harms 
In our study an adverse event will be defined as any untoward medical occurrence in a participant 
without regard to the possibility of a causal relationship with the intervention. Adverse events will be 
collected after the subject has provided consent and enrolled in the study. If a participant experiences 
an adverse event after the electronically administered informed consent has been signed (entry) but 
the subject has not started to receive study intervention, the event will be reported as not related to 
the intervention. All adverse events occurring after entry into the study will be recorded. The 
participants will be asked at the end-point questionnaire if they experienced any adverse events in 
terms of using the PAMs or trying to enhance their daily amount of physical activity.  
 
23. Auditing  
No auditing has been protocolled.  
  
 

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Ethics and dissemination 
24. Research ethics approval 
According to a written correspondence with the Danish Ethics Committee in the Capital Region of 
Denmark, this trial was not subject to the current laws on research ethics in Denmark due to the non-
invasive behavioral change intervention. The study can be conducted without further approval from 
the Danish Ethics Committee in the Capital Region of Denmark (Journal-nr.:18004960). 
 
25. Protocol amendments 
Any modifications to the protocol which may impact on the conduct of the study, potential benefit of 
the participants or may affect safety, including changes of study objectives, study design, sample 
population, sample size, study procedures, or significant administrative aspects will require a formal 
amendment to the protocol that will be revised and re-uploaded to Clinicaltrials.gov.  
 
26. Consent or assent 
Informed consent will be collected electronically via SurveyXact. Prior to agreeing and signing the 
consent survey, the participant will receive written information about the study on email and if the 
participant has any questions the participant might answer or call the study responsible researcher 
(RTL).  
 
27. Confidentiality 
All study-related information and collected data on participants will be stored securely at a server at 
University of Copenhagen. The only possible way to extract any personal information is by having 
access to the secure server.  
 
Any data that will leave the secure server will be anonymized.  
 
28. Declaration of interests 
The content presented within this protocol and the study was produced as part of the project REACH: 
this project has received funding from the European Union’s Horizon 2020 research and innovation 
programme under grant agreement No. 690425.  
 

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Primary investigator: PhD Fellow Rasmus Tolstrup Larsen, MSc 
Section of Social Medicine, Department of Public Health, University of Copenhagen. Has 
received funding from the European Union’s Horizon 2020 research and innovation programme 
under grant agreement No 690425. 
Declare to have no financial ties or non-financial competing interests. 
 
Research assistant Christoffer Bruun Korfitsen, PT 
Section of Social Medicine, Department of Public Health, University of Copenhagen. Has 
received funding from the European Union’s Horizon 2020 research and innovation programme 
under grant agreement No 690425. 
Declare to have no financial ties or non-financial competing interests. 
 
Associate Professor Carsten Juhl, PT, MPH, PhD 
Department of Sports Science and Clinical Biomechanics, University of Southern Denmark and 
Department of Occupational and Physical Therapy, Gentofte and Herlev Hospitals, Copenhagen 
University Hospital, Denmark 
Has received no funding for this project 
Declare to have no financial ties or non-financial competing interests. 
 
Post-doctoral researcher Jan Christensen, PT, MSc, PhD 
Department of Occupational and Physiotherapy, Copenhagen University Hospital, Rigshospitalet, 
Denmark 
Has received no funding for this project 
No financial ties or non-financial competing interests. 
 
Henning Boje Andersen, MA, Professor Emeritus, Senior Researcher 
Technical University of Denmark, Management Department. Has received funding from the European 
Union’s Horizon 2020 research and innovation programme under grant agreement No 690425. 
 No financial ties or non-financial competing interests. 
 
 

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Professor Henning Langberg, PhD, DMSc 
Section of Social Medicine, Department of Public Health, University of Copenhagen. Has received 
funding from the European Union’s Horizon 2020 research and innovation programme under grant 
agreement No 690425. 
Declare to have no financial ties or non-financial competing interests. 
 
 
 
29. Access to data 
To ensure validity of the results, all investigators will have access to the anonymized and cleaned 
data set.  
 
30. Ancillary and post-trial care  
No ancillary and post-trial care have been protocolled.  
 
31. Dissemination policy  
Upon request, every participant can get access to their own results and the summarized study results. 
We plan to publish all results in scientific peer-reviewed journals within the area of physical activity, 
public health, behavioral research or health technology. Furthermore, we plan to communicate 
important knowledge and experiences from the study to healthcare professionals, municipalities and 
other relevant parties.  
 
Authorship of all scientific papers will be submitted to the Vancouver recommendations for defining 
the role of authors and contributors from the International Committee of Medical Journal Editors  
 
Upon reasonable request (to reproduce results or analyses), researchers or other interested external 
persons will be able to access the anonymized and cleaned participant level dataset including the 
analysis code for the statistical software.  
 

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Appendix 
 
32. Informed consent materials 
 
 
Participant information on participation in a research project 
 
Project title: The MIPAM trial: A 12-week intervention with motivational interviewing and physical activity monitoring, 
to enhance the daily amount of physical activity in community dwelling older adults – a randomized controlled trial 
 
This consent form is part of the informed consent process. It is designed to give you an idea of what this research study 
is about and what will happen to you if you choose to be in the study. The research project is conducted by the primary 
investigator and PhD fellow Rasmus Tolstrup Larsen, from University of Copenhagen. You must understand what the 
content and aim of the research project is, before you decide whether you would like to participate in the project. It is 
important that you do a thorough read of this document.  
 
It is possible to receive a telephone call with an oral elaboration of this document. It is also possible to include another 
person (relative or friend) in the telephone call. If you decide to participate, you have to declare it in an electronic 
consent form (the link is available in the email you received with this document). Remember that you have the right to 
consider your decision before you agree to participate. It is completely voluntary to participate in the study and you 
can by any time chose to withdraw from the study.  
 
Aim of the study 
The aim of this randomized controlled trial is to find new and effective ways to enhance the daily amount of physical 
activity in older adults. The study will investigate if motivational interviewing as an add-on intervention will enhance 
the expected effect from physical activity monitors worn daily. All participants will receive a Garmin Vivofit 3 physical 
activity monitor to wear every day in 13 weeks. Half of the participants will be randomized to receive seven telephone 
calls with motivational interviewing.  
 
We aim to include 154 participants for this project.  
 
Trial plan 
 

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You will receive the physical activity monitor by mail. In the second week you will receive the baseline questionnaire via 
e-mail. If you are allocated to receive the motivational interviewing, you will receive seven telephone calls (week 
2,3,4,6,8,10 and 13).  
 
After wearing the physical activity monitor for 13 weeks, you will need to answer the end-point questionnaire and 
return the physical activity monitor via mail.  
 
You will also receive a follow up questionnaire after six and 12 months.  
 
As this study only contains a physical activity monitor and motivational interviewing, we do not expect any side effects 
from the intervention. However, if you suddenly enhance your daily level of physical activity a lot, you may have days 
where you feel more tired and if you have degenerative changes (e.g. arthritis) you may also have some days where 
you feel a bit more pain than you are used to.  
 
After the project, we may ask you to participate in a qualitative interview with one of the investigators. This is also 
completely voluntary.  
 
To be eligible for inclusion in this study: 
- 
You must be retired and above 70 years of age 
- 
You must be able to walk independently without other people assisting you (rollators and canes are allowed) 
- 
You are community dwelling 
- 
You have a Windows- or Google smartphone, an iPhone or an iPad to install the Garmin Connect application 
on. 
Apple: iOS 10.0 or newer. Windows: Windows 10 Mobile version 10586.0 or newer, Windows 10 version 
10586.0 or newer.  
- 
You have access to an email account.  
 
To be eligible for inclusion in this study you cannot: 
- 
Have dementia or Alzheimer’s disease 
- 
Receive active cancer treatment (e.g. chemotherapy) 
- 
Be disabled due to severe diseases or conditions such as Parkinson’s disease, post-stroke paralysis, 
amputations and others. 
 
Financial compensation 
Your participation in this trial is voluntary and you will not be compensated financially.  
 
Personal data management 

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All information about you will be handled according to current Danish data rules and regulations.  
Personal information such as name, address, email and telephone number will only be stored in closed servers at 
University of Copenhagen. The Data Protection board approval number for this trial is 514-0268/18-3000.  
Your data will be anonymized after your participation to use for data analysis in this project and possibly also other 
research projects investigating other related questions. At any time, you will be able to get your own results from this 
study.  
This research project will be published in a scientific peer reviewed journal. Besides the publication, we will disseminate 
our findings to health professionals, municipalities, at health conferences and to other interested bodies.  
 
By reading this document, we hope that you now are adequately informed about the study to make an informed 
decision on whether you would like to participate. We have also included the standard document “the rights of 
participants in health research projects”.  
 
If you would like to know more about the study before deciding, please contact,  
 
Rasmus Tolstrup Larsen 
Gothersgade 160, 3. 
1123 København K 
E-mail: rala@sund.ku.dk 
Tlf.: +4542423007  
Best regards, Rasmus Tolstrup Larsen 
 
 
Videnskabsetisk Komite (projekt nr.: 18004960)  
Version 1, 1. april 201

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