Empowering wholesome way of life behaviour by means of personalised intervention portfolios utilizing a wholesome way of life recommender system to stop and management weight problems in older adults: pilot examine protocols from the HealthyW8 undertaking

Recruitment

Recruitment at some websites began in early 2025. However, the initiation of recruitment differed throughout pilot research as a result of variations within the timing of moral approvals. If the recruitment window is inadequate to satisfy the goal enrolment or if the dropout charge is excessive, the interval could also be prolonged till the focused variety of individuals is reached. The completely different recruitment strategies are described in table 1. Interested candidates can register by telephone, electronic mail or common mail. Study workers will contact the registered candidates to offer a quick overview of the undertaking, schedule an appointment for an info session and ship a replica of the ‘participants’ info sheet’. This will permit candidates to evaluation the examine particulars and experimental procedures earlier than signing the knowledgeable consent. The Luxembourg Institute of Health’s (LIH) knowledgeable consent was added in online supplemental material (Ethical Information Notice). Participants will obtain a replica of their signed knowledgeable consent and the examine protocol.

Participants, inclusion and exclusion standards

Participants should meet the next inclusion standards: older adults (≥65 years), being male or feminine, residing within the areas the place trials might be carried out, having chubby (BMI 25.0–29.9 kg/m²), willingness to take part within the examine, and proudly owning a smartphone and primary talents to make use of cell functions. In distinction, exclusion standards will embrace persistent ailments equivalent to most cancers and Parkinson’s illness in addition to different circumstances requiring particular therapies or considerably altering regular physiology (eg, metabolism). Also, people with cognitive ailments, equivalent to Alzheimer’s, or these unable to reside independently, might be excluded, as they might wrestle to deal with the HLRS instruments and functions. Individuals on a selected food plan (eg, a vegan or low-carbohydrate food plan) is not going to be eligible for the examine as a result of potential incompatibility with the examine’s dietary suggestions. Populations with compromised skill to offer voluntary knowledgeable consent, together with prisoners and people with extreme psychological disabilities, will likewise be excluded. Besides, to make sure the feasibility of the intervention duties, individuals with vital mobility impairments or circumstances that preclude participation in reasonable PA (eg, extreme arthritis, latest fractures) might be excluded.

However, people being handled for kind 2 diabetes, hypertension or elevated blood lipids (triglycerides, ldl cholesterol) might be included. This is to make sure real looking recruitment feasibility, as a big proportion of older adults expertise these issues and are handled for them.

Withdrawal/discontinuation of individuals

Participants might withdraw from the examine at any time with out offering a purpose or dealing with adverse penalties. Additional causes for withdrawing might embrace:

1. Ineligibility: individuals who now not meet the inclusion standards or develop well being circumstances (eg, acute sickness).

2. Adverse occasions: occasions compromising individuals’ well being, as decided by the (medical) principal investigator (PI); we’ll proceed to watch for any antagonistic occasions and individuals will have the ability to report such occasions always through the examine.

3. Non-compliance: constant failure to stick to check protocols or procedures.

4. Lost to follow-up: lack of ability to contact individuals or repeated failure to attend scheduled visits.

5. Medical PI or (if not required in trial) PI choice: withdrawal primarily based on security considerations, protocol violations or different issues determined by the (medical) PI. In addition, a medical skilled or institutional medical providers might be consulted to handle any antagonistic impact or medical emergency. These selections might be taken after evaluating baseline or mid-point knowledge.

Data from individuals who withdraw or discontinue the examine might be included within the evaluation, as their causes for discontinuation might present helpful insights into whether or not the trigger was associated to the HLRS or different elements.

If the dropout or discontinuation charge exceeds 10%, extra individuals might be recruited to make sure that no less than 15–25 individuals full the examine, relying on the nation.

Assessments

The pilot research can embrace 4 phases (table 3): enrolment (day-x), baseline (day 0), mid-point (day 45 for a 3-month intervention) and ultimate visits (day 90 for a 3-month intervention), as illustrated in figure 1. Germany and Spain (Zaragoza) will conduct enrolment, baseline and ultimate measurements, whereas Bulgaria (Sofia and Varna), Luxembourg and Spain (Mallorca) will embrace all 4 phases, together with the mid-term visits.

Figure 1

Overview of the trial design and knowledge and pattern assortment—instance for Luxembourg. ^aUniversity of the Balearic Islands (IDISBA) is not going to acquire this pattern. ^bBIPS and CITA can have intermediate conferences with individuals on a 1 or 2 week foundation to enhance adherence to the HLRS and to cut back the opportunity of any malfunctions of the HLRS. *Not collected by all companions. BMI, physique mass index; BIPS, Bremer Institute for Prevention Research; CITA, Agro-Food Technological Center of Aragon; HLRS, Healthy Lifestyle Recommender System; IDISBA, Health Research Institute of the Balearic Islands; PA, bodily exercise.

The examine phases are described as follows:

1. Enrolment go to (day-x): individuals will obtain written and oral details about the examine’s aims, dangers and advantages earlier than signing the knowledgeable consent and knowledge discover type. Participant eligibility might be evaluated primarily based on anthropometric measurements (moreover in Luxembourg: urine spot take a look at (eg, Kosmetex Urine Test Strips)) mixed with a basic well being and way of life questionnaire. Participants who meet the inclusion and exclusion standards will obtain additional details about the examine’s procedures.

2. Baseline go to (day 0). During this go to, individuals will full a number of questionnaires (outlined in Table 4, with the help of examine workers (particularly in these assessing food plan). Trained personnel will acquire anthropometric knowledge, and a nurse will receive organic samples (blood, urine, saliva and stool). Stool samples could also be supplied through the go to or shipped later. Additionally, international locations (aside from BIPS and CITA) will present an accelerometer (ActiGraph GT3X+, Pensacola, Florida, USA) for use through the first week of the intervention. Participants may also obtain directions on utilizing the developed HLRS.

3. Intermediate follow-up (day 45): it will contain a quick telephone interview or an in-person assembly, relying on the participant’s desire, to finish particular questionnaires.

4. Final go to (day 90): the identical measurements and questionnaires from the baseline go to might be repeated.

Outcomes

Primary outcomes are feasibility, utilization patterns (adherence) and person satisfaction. Feasibility might be interpreted with respect to drop-outs, skill to gather all focused knowledge from questionnaires, anthropometric knowledge and in addition organic samples. Adherence might be assessed by means of adherence metrics, such because the frequency of use (measured as time per day and week) or variety of logins. Satisfaction with the general design and user-friendliness might be assessed by the User Experience Questionnaire (UEQ+, 26 gadgets) and the usability take a look at (Short Questionnaire for gathering suggestions on the HealthyW8 intervention methods and instruments functionalities), which might be included at mid-term or ultimate go to to guage the probability of sustained HLRS use. This will assist assess the potential for long-term adoption past the examine interval.

Secondary outcomes goal the examination of obesity-related adjustments through the 3-month intervention, as detailed in table 4. The collected knowledge will present insights into the feasibility of amassing and implementing these measures in deliberate long-term research to evaluate more healthy way of life patterns. Furthermore, the examine will study whether or not the general design is appropriate for the individuals, with the intention of fostering enhancements of their life.

Data assortment

Case report types

An digital Case Report Form (eCRF) has been designed and developed utilizing REDCap (Research Electronic Data Capture, Vanderbilt University, USA) to gather examine knowledge and guarantee knowledge high quality, integrity and safety. The eCRF will permit knowledge to be saved throughout companions in a central database situated on the LIH. All eCRF gadgets might be accomplished by designated, educated workers on website. eCRFs might be reviewed and electronically locked by the medical Principal Investigators (PIs) or delegates. All eCRF knowledge might be pseudonymised (identification numbers solely), and the correspondence tables might be maintained by workers enrolling individuals on website, bodily separated from the eCRF scientific knowledge in REDCap.

The eCRF scientific knowledge might be electronically accomplished by every companion’s website, and questionnaires/surveys might be entered by individuals within the REDCap system, both remotely or along with educated personnel. All REDCap knowledge (from eCRF, questionnaires and organic pattern analyses) might be saved on safe LIH servers, and LIH’s Department of Medical Informatics will handle entry to the information. In the occasion of an antagonistic occasion, solely the workers on website enrolling sufferers will have the ability to entry individuals’ knowledge in non-pseudonymised type, along with the (medical) PI. In case of a desire for conventional paper-based surveys, knowledge could also be collected from individuals and later transferred to the RedCap system.

Sample dimension

An correct pattern dimension estimation for feasibility research, particularly when quite qualitative outcomes are measured as on this examine, is probably not possible; as an alternative, a latest steering doc58 has urged that pattern ‘size should be based on practical considerations including participant flow, budgetary constraints and the number of participants needed to evaluate feasibility goals reasonably’, additionally emphasising that 30 or much less may very well be a significant objective for qualitative work. In the current examine, we goal a pattern dimension of 30, with an anticipated most dropout charge of 33%. Approximately equal numbers of women and men might be recruited to allow the generalisability of outcomes throughout genders.

Assuring adherence to the intervention

The mHealth answer, that’s, the HLRS, was developed with nudging and gamification components to foster adherence. These adherence-promoting options embrace personalised reminders, adaptive objective setting, real-time suggestions, motivational prompts and gamification components equivalent to scoreboards, amongst others. These mechanisms are designed to strengthen engagement and help sustained behaviour change. Participants might be contacted by electronic mail or phone when a participant has not initiated use of the app, with a view to handle potential technical points or to offer login credentials if needed. Participants may also obtain, if they want, on the finish of the research, a quick evaluation interpretation of their well being situation. Participants may also have the ability to proceed the HLRS (with a brand new account) and should hold the smartwatch.

Strategies for attaining sufficient participant enrolment

Each nation coordinator has ample expertise conducting human trials and can promote regionally by means of their networks, together with web sites, flyers and commercials at physicians’ places of work. Should the recruitment charge stay low regardless of all efforts, BMI might be prolonged to regular weight (18.50–24.99 kg/m²), and the age class might be prolonged to incorporate anybody 55 years of age or older. Such adjustments, as every other main adjustments to the examine design, could also be subjected to moral evaluation, relying on the native moral evaluation board’s guidelines.

Missing knowledge and dropouts

Missing knowledge is not going to be imputed in these research. Participants who drop out might be excluded from analyses past their final obtainable knowledge level. To protect the examine’s pattern dimension, individuals who go away might be changed till no less than 20 individuals have finalised the examine. This will guarantee sufficient publicity to the intervention and to check operational procedures, to not estimate intervention results.

All dropouts and replacements might be absolutely documented, together with timing and causes for withdrawal. Feasibility outcomes (eg, recruitment and retention) might be reported primarily based on the unique enrolled cohort, with alternative individuals analysed individually. Participants who withdraw will stay categorised as dropouts for all feasibility outcomes, making certain retention and adherence replicate true acceptability. Replacement will happen solely when a dropout occurs early earlier than finishing key examine visits or minimal intervention publicity and solely to safe sufficient completers for secondary outcomes. Replacement instances is not going to be included in feasibility indicators. This method preserves feasibility validity whereas sustaining sufficient pattern dimension for secondary analyses.

Methods for minimising bias

Explicit inclusion and exclusion standards are established to make sure minimising the danger of together with individuals who may introduce bias. Strategies to minimise attrition embrace sustaining common contact with individuals through telephone and addressing boundaries to participation to protect the integrity of the examine pattern. For instance, at LIH, examine nurses will contact individuals by electronic mail or phone when it’s recognized {that a} participant has not initiated use of the app, to unravel any potential technical points or together with password credentials.

Data monitoring and high quality assurance procedures are applied to make sure the accuracy and reliability of the collected knowledge. While the examine lacks a management group, efforts are made to cut back bias by considerate examine design and clear reporting.

Analyses

Descriptive statistics will summarise baseline traits and supply an outline of the preliminary distributions of variables. Normality of steady knowledge might be assessed utilizing Q-Q plots and the Kolmogorov-Smirnov take a look at. If the information aren’t usually distributed, non-parametric evaluation (Friedman assessments adopted by t-tests) might be carried out, with log-transformations as wanted.

For the first outcomes, we’ll evaluate feasibility, adherence and person satisfaction as defined within the chapter ‘outcomes’ over time or through the time of information assortment (baseline, mid and endpoint). To this finish, linear blended fashions might be arrange, with adherence and person satisfaction associated as dependent variables and participant and time as impartial fastened elements. Potentially, different related variables, equivalent to BMI, age and gender, might be included in additional refined fashions. In addition, a extra qualitative questionnaire developed by the consortium might be accomplished after 6 weeks of use to evaluate usability options. P values under 0.05 (two-sided) might be thought of statistically vital. All analyses might be carried out utilizing IBM SPSS (Statistical Package for the Social Sciences) Statistics, V.29.0 (IBM, Armonk, New York) and R (V.4.4.1) for blended results fashions. For theory-driven path analyses, we’ll use partial least squares structural equation modelling (PLS SEM) to look at hypothesised relationships amongst psychosocial constructs and adherence/usability outcomes; this might be applied with SmartPLS 4 or equal PLS SEM software program (eg, seminr/ plspm in R). Primary analyses may also be carried out on a pooled particular person participant dataset, with nation/website included as an element (fastened impact) and participant as a random impact in linear or generalised linear blended results fashions to account for clustering and to quantify heterogeneity (website×time interactions). Each website will generate native descriptive summaries and carry out predefined Quality Control checks; pooled modelling and PLS SEM might be run centrally.

Secondary analyses

Secondary outcomes embrace anthropometric measurements, a number of biomarkers, questionnaires to evaluate way of life high quality, dietary patterns, emotional well-being and PA, partially assessed by wearable units (a smartwatch and an accelerometer) to trace 24-hour exercise patterns. These analyses will embrace regression fashions and are anticipated to supply estimates that might be used to arrange ensuing larger-scale trials within the close to future. Advanced statistical methods equivalent to propensity rating matching or instrumental variable evaluation could also be employed to handle confounding and potential biases.

Exploratory analyses

To guarantee a complete evaluation of transcriptomics (miRNA) and faecal 16S rRNA knowledge within the context of the weight problems intervention, the information will first bear preprocessing to deal with lacking values and outliers and bear normalisation to make sure knowledge high quality and comparability. Subsequently, exploratory knowledge evaluation methods are employed to achieve insights into the information’s traits and to determine patterns and relationships. Statistical assessments are then utilized to every dataset: in transcriptomics, differential expression evaluation methods equivalent to DESeq2 or edgeR can determine dysregulated microRNAs related to weight problems, and in faecal 16S rRNA, alpha or beta variety indices and statistical assessments equivalent to t-tests or evaluation of variance (ANOVA) can quantify and evaluate variety ranges. Multiple testing correction strategies are employed to manage false positives.