Table 6

Intervention description using the Template for Intervention Description and Replication (TIDieR) checklist

1. Brief nameStudy namePreventIT (Early risk detection and prevention in ageing people by self-administered ICT-supported assessment and a behavioural change intervention, delivered by use of smartphones and smartwatches)
Intervention groupsThe aLiFE programme
(experimental group 1)		The eLiFE programme
(experimental group 2)		WHO guidelines
(control group)
2. WhyA rapidly ageing population will place increasing stress on our healthcare systems. The focus needs to shift from treatment towards health promotion for active and healthy ageing and prevention of age-related diseases. The PreventIT project has adapted a Lifestyle-integrated Exercise (LiFE) programme (to suit healthy young older adults at risk for future accelerated functional decline into two interventions: one delivered by instructors and use of paper manuals (aLiFE), and one delivered via mobile phone (smartphone) with a virtual instructor (eLiFE). The aim is to develop and test a personalised behaviour change intervention on physical activity aimed at young older adults that has the potential to prevent accelerated functional decline at older age.
3. What materialsAll participants received a detailed risk and baseline assessment at their respective study sites, assessing medical history, physical and cognitive functions and quality of life. All participants had their PA levels recorded for 7 consecutive days using activity monitors. In all three groups, participants completed motivational questionnaires prior to beginning the intervention.
Paper manual
The aLiFE manual included descriptions and instructions of the activities selectable within the programme (strength and balance exercises), an activity planner (weekly use) and activity counter (daily use), safety instructions and further information about increasing physical activity and reducing sedentariness.		PreventIT mHealth system on smartphone and smartwatch
eLiFE was delivered via the PreventIT mHealth system. Participants received instructions by use of video clips, pictures and text/verbal instructions on the PreventIT smartphone for the activities. The architecture of the eLiFE application system is shown in figure 1. Activity planning, reporting and feedback is provided entirely through the smartphone application. Participants receive one troubleshooting document to aid with technological problems they may encounter. Instructors are available to help participants use the smartphone during home visits.		One-page WHO guidelines regarding recommended PA levels per week for the target group
4. What procedureAll participants receive a risk screening and medical assessment to ensure study eligibility and rule out contraindications to an exercise intervention. A detailed baseline assessment at a clinical site and a 7-day PA monitoring is completed. Participants are informed of their group allocation after their 7 days of PA monitoring is completed.
Intervention groups
Receive direct support through a trained staff member to implement the aLiFE/eLiFE programme into their daily life and understand the concept of the programme. Assistance is provided on how to select, upgrade and identify additional daily situations to integrate activities. Participants receive home visits as well as support phone calls during the 6-month active intervention period as part of the ongoing active intervention.		Control group
During a single home visit the written WHO guidelines are provided to participants with guidance on the dose–response relationship between the frequency, duration, intensity, type and total amount of physical activity recommended per week.
5. Who providedAssessmentAll assessments completed at the clinical sites are completed by blinded research staff with tertiary qualification as physiotherapists or exercise scientists. Assessments are completed at baseline (T1), 6 months after randomisation (T2) and 12 months after randomisation (T3).
InterventionFollowing randomisation, participants receive the relevant intervention delivered in their home, provided by physiotherapists or exercise scientists. All staff had undergone a 3-day workshop to ensure standardised intervention delivery across all three clinical sites.
6. HowInvitation to participatePersons born between 1947 and 1956 (61–70 years of age at the time of inclusion) were invited via mail-out to participate. Three respective local registries randomly selected persons within the target group. Participants were required to contact their respective site actively if they were interested.
Telephone screeningA telephone screening determined eligibility to attend the risk screening of potential participants.
Risk screening and medical screeningThe risk screening is completed by trained researchers and a medical screening is completed by medical doctors at each site. The multistep process ensures participants meet inclusion/exclusion criteria, and that an exercise programme is deemed safe from a medical perspective.
T1, T2, T3 assessmentThe assessments are completed by blinded research staff at the three clinical sites.
The interventions (aLiFE and eLiFE) are delivered in the participants’ home, the types of activities and difficulty levels are dependent on the individual’s ability and preference. Home visits and follow-up phone calls are completed according to a predefined schedule. Participants are permitted to attend further exercises groups, undertake other activities or seek further healthcare during the duration of the trial which are beyond the scope of the RCT. Details are recorded during assessments (T2, T3) but no additional assistance is provided by the research staff.The control group receives a single home visit and is provided with written information about PA recommendations only.
Participants are permitted to attend exercise groups, undertake other activities or seek healthcare during the duration of the trial which are beyond the scope of the control group intervention. Details are recorded during assessments (T2, T3) but no additional assistance is provided by the research staff.
7. WhereThe RCT is conducted as part of the PreventIT project, a European Horizon 2020 ICT and personal health project (project number 689238). The three participating clinical centres are Trondheim, Norway; Amsterdam, The Netherlands; and Stuttgart, Germany.
8. When and how muchThe aLiFE programme
(experimental group 1)		The eLiFE programme
(experimental group 2)		WHO guidelines
(control group)
Home visits, phone calls6 home visits
3 phone calls		4 home visits
3 phone calls		1 home visit
Active intervention period6 months6 monthsNA
Passive follow-up period6 months6 months12 months
Instructor main roleTeach the programmeTeach how to use the PreventIT mHealth systemNA
ActivitiesParticipants choose activities from the strength, balance and/or PA domain to integrate into their daily activities. The number of activities is individual and an activity planner and counter is used for documentation purposes.The PreventIT mHealth system suggests a list of activities to participants ranked according to the expected level of benefit. Participants select their preferred activities from this list. The number of activities chosen is determined by the individual.NA
Training goalsDecided by the participants with help of a prespecified list of possible goalsParticipants select goals from a prespecified list within the applicationNA
Phenotyping toolNot used in aLiFEResults from assessments (T1) are included in the PreventIT mHealth system for each participant individually prior to the first home visit to decide what to prioritise among the activities (balance, strength or physical activity).NA
MotivationProvided by the instructor-based individual progress (eg, reviewing the activity planner during home visits)Personalised motivational messages are displayed on the phone based on chosen activities and the reported adherenceNA
Social interaction/chatNAParticipants can use the platform ‘Slack’ for group chat to communicate anonymously with other eLiFE participants at their clinical site.NA
9. TailoringaLiFE assessment tool (LAT)The LAT is performed at the first home visit so the instructor can set the initial difficulty level on the balance and strength activities.The LAT is performed at the first home visit, instructors manually add the results to the PreventIT mHealth system and the system sets the initial difficulty level on the balance and strength activities.NA
ProgressionThe instructor teaches the participants when to upgrade the number of activities and situations during the subsequent home visitsParticipants can independently progress their activities based on the rule that the user has performed the activity each day for the last 7 days for at least 50% of the goal on average and at least 50% of the goal on each of the last 3 days.
The progression is not compulsory when a higher level becomes accessible.
FeedbackFeedback is provided by the instructor based on individual progress (reviewing the activity planner and counter) during home visits.Participants receive feedback on their PreventIT mHealth system:
1. Based on physical behaviour monitored by the smartphone and the smartwatch (time of PA and amount of sedentariness).
2. Depending on the amount (type and dose) of strength and balance activities completed (in-app adherence reporting) in relation to the intended type/dose.		NA
10. ModificationSuper-userParticipants are recommended to select activities that are challenging and relevant to the individual as identified using the LAT. As some participants reached level 4 (highest level) on certain activities (mainly strength exercises), further ‘upgrades’ to the activities were offered. This ‘super-user’ concept aims to further increase the task challenge (beyond level 4) in order to ensure a training intensity which induces motor adaptations and clinically relevant improvements in functional performances. It includes elements of peak strain, slow motion (extended muscle loading), increased number of repetitions, differential training (learning through change/differences in movement variables, eg, joint angle/position), combining strength and balance activities, decreasing base of support and more complex sensorimotor tasks.
Participants are able to access the ‘super-user’ function for a specific activity after having performed the particular activity at 100% for 14 consecutive days.		NA
11. How well plannedParticipant daily adherenceDaily adherence can be reported using the activity counters, with responses being dichotomous (completed, not completed).Daily adherence is reported on the PreventIT mHealth system that specifically asks about the planned/intended activities as previously defined by the participant.NA
Participant monthly adherenceMonthly adherence data are obtained via a weblink or via a postal question. Participants are asked if they completed all their activities/PA as intended in the last 7 days. The responses are: (1) yes, more than intended; (2) yes, as much as intended; (3) yes, but not as much as intended; (4) no, did not feel well; (5) no, forgot; (6) no, no time; (7) no, dislike of planned activity.
Instructor fidelityTraining is delivered independently in each of the three clinical sites. All instructors adhere to a single training protocol to ensure standardised delivery of the programme across sites. Training delivery was taught during a 3-day workshop with subsequent exam.

  • aLiFE, adapted LiFE; eLiFE, enhanced LiFE; ICT, Information and Communication Technology; NA, not applicable (this intervention component is not available in this intervention arm/control group); PA, physical activity; RCT, randomised controlled trial; T1, baseline assessment; T2, assessment 6 months after randomisation±2 weeks; T3, assessment 12 months after randomisation±4 weeks.