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| Name | Class |
|---|---|
| European Commission | OTHER |
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This pilot study will focus on men and women aged ≥60 years for a period of 3 months during which each participant will use the HLRS. The primary purpose is to study whether the HLRS, reflecting a multi-component intervention, is well accepted by the participant, has a decent adherence (i.e., user time of the app). In addition, investigators will study the feasibility of the design, i.e. whether the overall design is well suited to the participants, in order to improve their lifestyle, e.g., dietary habits and PA, among others. Secondary outcomes related to the feasibility approach include dietary habits, PA patterns, and selected plasma and urinary endpoints. This pilot study will be of longitudinal design without a control group. A later trial that is planned for the following year will focus further on biological endpoints and will be randomized. In this present pilot study, investigators aim to assess mainly the user-friendliness of the HLRS, and gather first evidence that the intervention can indeed produce healthier lifestyle patterns.
The study's primary objective is to determine whether the developed HLRS can be successfully applied to the target population (men and women aged ≥60 years) and whether they use it frequently during the study and are satisfied with the HLRS.
Secondly, investigators will study whether the assessment of endpoints required for the later and separately planned ensuing long-term study can be well assessed within the study and if, despite the limited time of the intervention duration, the intervention will be able to preliminary improve specific markers related to the risk of obesity and associated comorbidities. This will entail anthropometric measures to assess changes in body mass and body fat in addition to the primary and secondary objectives.
The number of people struggling with overweight and obesity continues to grow in most countries worldwide, despite varied measures trying to limit the further progress of this pandemic. In Luxembourg, at present, about 26% of the adult population is considered as having obesity(BMI>30 kg/m²), and the associated health costs have been estimated at 1.4% of the GDP or about 930 Mio. USD for Luxembourg. Similar numbers are prevalent in other European countries.
The ongoing problem of high obesity rates has resulted in the creation of a pan-European project HealthyW8 (www.healthyw8.eu), funded by the European Union and in which the Luxembourg Institute of Health (LIH) is the coordinator.
The study described in this application is therefore motivated by the project's main objectives, which entails, among other, a total of 22 pilot trials in various European countries to be conducted. This application concerns only the activities planned in Luxembourg.
With the HealthyW8_65+ Pilot project, investigators have focused on population groups at risk of developing obesity, due to undergoing transitions in their lifestyle. Among the populations at risk are older adults as, categorized as having an age of equal to or above 65 years. As emphasized in the literature, older adults constitute a growing fraction of our society, with likely high associated healthcare costs, whose change to a more sedentary lifestyle upon retirement adds an additional risk factor, especially for sarcopenic obesity and related comorbidities, i.e., low muscle mass and consequences.
As innovative solutions to combat the trend toward increasing overweight and obesity in our society are much in need, the present study aims to employ the developed healthy lifestyle recommender solution (HLRS), which is at the center of a digital application for mobile phones. This HLRS intends to address various factors known to constitute main risks for developing obesity, including dietary patterns, physical activity (PA), and psychological/behavioral ones, among other lifestyle factors, such as sleep patterns, while also considering socio-demographic aspects. Our approach addresses several of the shortcomings of existing apps by catering to individuals with low interest in healthy lifestyles and try to motivate them via nudges and gamifications and organized information sessions to participate.
The pilot study will primarily focus on usability and user experience of the HLRS. An accurate assessment of food intake will be ensured through validated semi-quantitative FFQs and user feedback from the HLRS regarding meals that have been consumed. It is important to note, however, that there will be a secondary outcome, i.e. to test the operational feasibility of the study. This includes collecting biological samples, their measuring and shipment to partners outside Luxembourg. This is important, as this pilot study will be followed by a long term study, i.e. employing the same developed HLRS, but then targeting rather metabolic changes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participant from the general population living in Luxembourg free of manifest diagnosed diseases | Experimental | The following clinical visits and data collection points will be set up within the study:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigators will evaluate the acceptance and adherence to a healthy lifestyle recommender solution (HLRS), a digital app, among participants | Other | The intervention will include collecting blood, stool, urinary samples as well as measuring anthropometrics and collecting data (socio-demographics, general health, well-being, PA, and eating patterns, among others) via questionnaires completed in part from a mobile application. |
| Measure | Description | Time Frame |
|---|---|---|
| Health Lifestyle Recommender System adherence time | Adherence time (daily and weekly usage time in minutes) will be measured by tracking through user log-data, with analysis of any significant changes in usage comparing baseline with final measurement. | 3 month intervention period from baseline (Day 1) to final measurement (Day 90) |
| Health Lifestyle Recommender system user experience | User experience corresponds to the points achieved in the User Experience Questionnaire (UEQ+, 26 items). This questionnaire analyses the attractiveness, perspicuity, efficiency, dependability, stimulation and novelty of a new product (in this case HLRS). The UEQ contains 26 items. Each item is evaluated with a 7-point Likert scale (-3 to 3 points). Then the product is classified as excellent (3 points) or bad (-3 points). | 3 month intervention period from baseline (Day 1) to final measurement (Day 90) |
| Measure | Description | Time Frame |
|---|---|---|
| Anthropometric measurements (1/4) | Body mass index (kg/m^2) will be calculated with weight (kg) and height (m). | 3 month intervention period from baseline (Day 1) to final measurement (Day 90) |
| Anthropometric measurements (2/4) |
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Inclusion Criteria:
Individuals aged 60 or older:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Torsten Bohn PhD, Adjunct Associate Professor | Contact | 621763805 | +352 | Torsten.Bohn@lih.lu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical and Epidemiological Investigation Center CIEC- LCTR | Recruiting | Luxembourg | L-1445 | Luxembourg |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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The project is a pilot study. It is a single-group study where participants will be their own control (i.e. outcome measures at the end of study will be compared to baseline). 30 participants will be included. It consists of samples and data collection, together with a mobile application that allows dispensing an intervention that will last 3 months.
This pilot study will be longitudinal design without a control group. A later trial that is planned for the following year will focus further on biological endpoints and will be randomized. In this present pilot study, investigators aim to assess mainly the user-friendliness of the HLRS, and gather first evidence that the intervention can indeed produce healthier lifestyle patterns. Should the participants complete the study, the individual duration will be 3 months. Investigators foresee that, in total, given the various enrolments of the participants, up to 6 months may be necessary for all participants to complete the entire study.
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Waist and hip circumference (cm) measure and thigh circumference (cm) obtained with a tape
| 3 month intervention period from baseline (Day 1) to final measurement (Day 90) |
| Anthropometric measurements (3/4) | Body fat percentage determined by a bioelectrical impedance scale (Tanita) | 3 month intervention period from baseline (Day 1) to final measurement (Day 90) |
| Anthropometric measurements (4/4) | Visceral body fat (cm2) determined by anthropometric measurements including weight, height, waist circumference and thigh circumference (https://www.lih.lu/en/visceral-fat-calculator/). | 3 month intervention period from baseline (Day 1) to final measurement (Day 90) |
| Physical activity and fitness (1/4) | 24-hour movement obtained by accelerometer to calculate metabolic equivalent of task (METs) | 3 month intervention period from baseline (Day 1) to final measurement (Day 90) |
| Physical activity and fitness (2/4) | International Physical Activity Questionnaire to obtain METS and minutes per week of physical activity. The higher the METs the higher the physical activity intensity. | 3 month intervention period from baseline (Day 1) to final measurement (Day 90) |
| Physical activity and fitness (3/4) | Hand-grip strength (kg) to assess the cardio-physiological fitness. | 3 month intervention period from baseline (Day 1) to final measurement (Day 90) |
| Physical activity and fitness (4/4) | Quick step-up test (number of step-ups achieved) to assess the cardio-physiological fitness. | 3 month intervention period from baseline (Day 1) to final measurement (Day 90) |
| Clinical measurements | Blood pressure is going to be measure with a baumanometer. During the measurement it is obtained two number, the first number is the systolic pressure (mmHg) and the second one is the diastolic pressure (mmHg) | 3 month intervention period from baseline (Day 1) to final measurement (Day 90) |
| Biochemical analysis (1/12) | Biochemical analysis such as the lipid profile including total-cholesterol, LDL-C, HDL-C, and triglycerides (mg/dL); glucose metabolism including fasting blood glucose (mg/dL); vitamin E (mg/dL), CRP (mg/dL), hemoglobin (mg/dL) | 3 month intervention period from baseline (Day 1) to final measurement (Day 90) |
| Biochemical analysis (2/12) | It will be analyzed nutrition related parameters such as albumin (g/dL) and prealbumin (g/dL) | 3 month intervention period from baseline (Day 1) to final measurement (Day 90) |
| Biochemical analysis (3/12) | Hormones including ghrelin (pg/mL) and inflammation biomarkers such as IL-6 (pg/mL) and TNF-α (pg/mL) will be analyzed | 3 month intervention period from baseline (Day 1) to final measurement (Day 90) |
| Biochemical analysis (4/12) | Glucose metabolism will be analysed by glycated haemoglobin (HbA1c, %) | 3 month intervention period from baseline (Day 1) to final measurement (Day 90) |
| Biochemical analysis (5/12) | Insulin resistance will be analysed with Homeostatic Model Assessment for Insulin Resistance) HOMA-IR (no units) | 3 month intervention period from baseline (Day 1) to final measurement (Day 90) |
| Biochemical analysis (6/12) | Total carotenoids (µmol/L) | 3 month intervention period from baseline (Day 1) to final measurement (Day 90) |
| Biochemical analysis (7/12) | Hormones such as leptin (ng/mL) and oxidative stress biomarkers like F2-isoprostanes (ng/mL) | 3 month intervention period from baseline (Day 1) to final measurement (Day 90) |
| Biochemical analysis (8/12) | Adiponectin (µg/mL) | 3 month intervention period from baseline (Day 1) to final measurement (Day 90) |
| Biochemical analysis (9/12) | Malondialdehyde (nmol/L) | 3 month intervention period from baseline (Day 1) to final measurement (Day 90) |
| Biochemical analysis (10/12) | DNA/RNA breakdown products (µg/L) | 3 month intervention period from baseline (Day 1) to final measurement (Day 90) |
| Biochemical analysis (11/12) | Antioxidant capacity FRAP (µmol/L) | 3 month intervention period from baseline (Day 1) to final measurement (Day 90) |
| Biochemical analysis (12/12) | ABTS (mg/L) | 3 month intervention period from baseline (Day 1) to final measurement (Day 90) |
| Diet analysis (1/3) | The healthiness of the diet will be assessed using the Healthy Eating Index (HEI). The HEI employs a scoring system to evaluate a set of foods, with scores ranging from 0 to 100. An ideal overall HEI score of 100 indicates that the set of foods aligns with key dietary recommendations and dietary patterns. | 3 month intervention period from baseline (Day 1) to final measurement (Day 90) |
| Diet analysis (2/3) | Food frequency questionnaire (FFQ) comprises 151 items designed to gather information on food intake frequencies including daily, weekly and monthly consumption. The 24-hour recall method obtains the intake from the past 24 hours. After analyzing the data, the total kilocalories and grams of carbohydrates, protein and lipids consumed during that specific period are determined. | 3 month intervention period from baseline (Day 1) to final measurement (Day 90) |
| Diet analysis (3/3) | Chrononutrition questionnaire will be administered to determine the times of the day participants consume their meals and frequency (days per week) in which they eat breakfast, lunch, dinner and snacks. This tool provides a qualitative analysis of dietary habits. Therefore, it does not provide a numerical score or points. | 3 month intervention period from baseline (Day 1) to final measurement (Day 90) |
| Lifestyle measurements(1/9) | Depression will be assessed using the Patient Health Questionnaire-9 (PHQ-9), a validated tool measuring the severity of depression. The PHQ-9 consists of 9 items, each scored on a scale from 0 to 3, based on the frequency of symptoms experienced over the past two weeks. The total score ranges from 0 to 27, with higher scores indicating greater severity of depression. A score between 20 and 27 suggests severe depression. | 3 month intervention period from baseline (Day 1) to final measurement (Day 90) |
| Lifestyle measurements (2/9) | Mood and emotion will be assessed using the Positive and Negative Affect Schedule (PANAS). This instrument consists of 20 items, divided into two subscales: Positive Affect (PA) and Negative Affect (NA). Each item is rated on a 5-point Likert scale, ranging from 1 (very slightly or not at all) to 5 (extremely). To calculate the scores, sum the ratings for the items in each subscale separately. Higher scores indicate greater levels of the corresponding affect. For example, a higher PA score reflects higher levels of positive affect, while a higher NA score indicates higher levels of negative affect. | 3 month intervention period from baseline (Day 1) to final measurement (Day 90) |
| Lifestyle measurements (3/9) | Psychological hardiness, encompassing aspects of commitment, control, and challenge, will be assessed using the Dispositional Resilience Scale (DRS-15). This 15-item self-report instrument measures an individual's resilience and ability to cope with stress. Each item is rated on a 4-point Likert scale, ranging from 0 ("not at all true") to 3 ("completely true"). The DRS-15 provides a total hardiness score, with higher scores indicating greater psychological hardiness. | 3 month intervention period from baseline (Day 1) to final measurement (Day 90) |
| Lifestyle measurements (4/9) | Sleep disturbances will be assessed using the Pittsburgh Sleep Quality Index (PSQI). This instrument consists of 19 self-rated questions. Each component is scored on a scale from 0 to 3, with higher scores indicating more severe sleep disturbances. The component scores are then summed to produce a global score ranging from 0 to 21; higher global scores denote poorer sleep quality. | 3 month intervention period from baseline (Day 1) to final measurement (Day 90) |
| Lifestyle measurements (5/9) | Mediterranean eating patterns will be assessed by administrating the Mediterranean Diet Adherence Screener (MEDAS-14). This is a 14 item questionnaire of food consumptions to evaluate the amount of 12 main components consumed and two food habits related to the MD. Each of the 14 item is scored with 1 point or 0 points (total score of 14 points), depending on whether participants are adherent to each of the MD (1 point) or not (0 points). The higher the score the higher the adherence to the Mediterranean diet. | 3 month intervention period from baseline (Day 1) to final measurement (Day 90) |
| Lifestyle measurements (6/9) | To evaluate participants' subjective experiences related to a specific activity, the Intrinsic Motivation Inventory (IMI) will be administered. The IMI comprises multiple sections, each containing various statements. Participants will respond to each statement using a 5-point Likert scale. To score the IMI, calculate the subscale scores by averaging the item scores within each subscale. A higher score indicates a greater presence of the concept described by the subscale name. For instance, a higher score on the Pressure/Tension subscale suggests that the individual felt more pressured and tense. | 3 month intervention period from baseline (Day 1) to final measurement (Day 90) |
| Lifestyle measurements (6/9) | Smoking behavior will be assessed using the Fagerström Test for Nicotine Dependence. This instrument consists of six questions designed to evaluate the intensity of physical addiction to nicotine. Each question is scored on a scale from 0 to 1 or 0 to 3, depending on the response options. The total score is calculated by summing the individual item scores, resulting in a range from 0 to 10. Lower total scores indicate less nicotine dependence, while higher scores reflect greater dependence. | 3 month intervention period from baseline (Day 1) to final measurement (Day 90) |
| Lifestyle measurements (7/9) | Alcohol consumption, drinking behaviors, and alcohol-related problems will be assessed by administrating the Alcohol Use Disorders Identification Test (AUDIT). This instrument is a 10-item screening tool. The range of possible scores is from 0 to 40 where 0 indicates an abstainer who has never had any problems from alcohol. | 3 month intervention period from baseline (Day 1) to final measurement (Day 90) |
| Lifestyle measurements (9/9) | Personal traits will be assessed by administrating the Big Five Inventory (BFI) with 10 items. The BFI-10 is a scale measuring the Big Five personality traits Extraversion, Agreeableness, Conscientiousness, Emotional Stability, and Openness. To score the BFI-10, sum the responses for each trait, ensuring that reverse-scored items are appropriately adjusted. Higher scores indicate a greater association with that particular trait. | 3 month intervention period from baseline (Day 1) to final measurement (Day 90) |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |