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| ID | Type | Description | Link |
|---|---|---|---|
| NL-010298 | Other Identifier | CCMO |
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| Name | Class |
|---|---|
| Amsterdam University of Applied Sciences | OTHER |
| FrieslandCampina | INDUSTRY |
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Rationale: Sufficient dietary protein intake helps to preserve muscle mass and strength and is a key factor in healthy ageing. Achieving an increased protein intake with regular food products has shown to be a challenge for many older adults. Applying behavioural change techniques may facilitate a more sustained improvement in protein consumption over time.
Objective: To investigate whether a nutritional app intervention can increase the protein intake (with the goal of 1.2 g/kg body weight/day) of older adults, using readily available food products. Secondary and tertiary objective include the effects of the intervention on body composition and muscle strength and long-term effects on protein intake.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Protein and exercise | Experimental | Only the intervention group is coached to sustainable changes in (1) the amount of protein intake (goal: 1.2 g/kg body weight/d) and (2) the efficiency of protein intake with a focus on high-quality proteins, variety in protein sources, and timing of intake. To increase applicability in daily life, we aim to achieve these goals using readily available protein products. Participants in both groups have access to the application that contains a wide range of muscle and bone-strengthening activities, as well as balance exercises that can be performed independently at home. |
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| Exercise | Active Comparator | Participants have only access to the application that contains a wide range of muscle and bone-strengthening activities, as well as balance exercises that can be performed independently at home. Participants do not receive nutritional recommendations. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutritional coaching via an app | Behavioral | Coaching involves e-coaching via an app, supported by one telephone consultation. Within the SO-NUTS (preventing obesity, sarcopenia, and Sarcopenic Obesity in retirement through digital, personalised interventions for healthy NUTrition and physical activity for Seniors) project, BCTs are investigated that fit the older adult population. Insights gained from systematic review and focus group interviews are applied to the Eifit application. |
| Measure | Description | Time Frame |
|---|---|---|
| protein intake | Δprotein intake relative to bodyweight (g/kg/d) | baseline (0 months), post-intervention (3 months) and follow-up (6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| muscle mass | muscle mass (kg) (Body Impedance Analysis BIA) | baseline (0 months), post-intervention (3 months) and follow-up (6 months) |
| Leg muscle strength | 1RM leg press (kg). A submaximal protocol will be used of around 8-10 repetitions. The Bryzcki formula (Jacobsen F, Holten O, Faugli H, Leirvik R. Medical exercise therapy. Manual therapy in Norway. 1992;7:19-22.): 1RM = weight (kg) / (1,0278 - (0,0278 x number of repetitions)) will be used to determine the 1RM. |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle strengthening activity and frequency | Frequency of muscle strenghtening activities through Muscle-strengthening Exercise Questionnaire (MSEQ) | [Time Frame: baseline (0 months), post-intervention (3 months) and follow-up (6 months)] |
| Muscle strengthening activity duration |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboudumc | Nijmegen | 6525 GC | Netherlands |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Participants in the exercise (active comparator) group are blinded to the real purpose of the study being 'to improve protein intake' to limit subjects bias. Meaning that the participants in the exercise group will also change their diet including their protein intake.
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| Exercise recommendations | Behavioral | The objective is to adhere to the 2017 physical activity guidelines as set by the Health Council of the Netherlands i.e. "Engage in at least 150 minutes of moderate-intensity physical activity per week, perform muscle- and bone-strengthening activities at least twice a week in combination with balance exercises, and avoid prolonged periods of sitting." Participants in both groups have access to the application that contains a wide range of muscle and bone-strengthening activities, as well as balance exercises that can be performed independently at home. Activities such as walking, cycling, tennis, or swimming can also be added. Participants can monitor their progress themselves, and if desired, push notifications, tips, and reminders can be sent. |
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| [Time Frame: baseline (0 months), post-intervention (3 months) and follow-up (6 months)] |
| Attitude towards physical activity | Behavioural Regulation in Exercise Questionnaire (BREQ). 12 items with a 5-point Likert scale: totally disagree; disagree; neutral; agree; totally agree. The items relate to 6 types of motivation: from amotivation to different types of external motivation to intrinsic motivation. It concerns a continuum from extrinsic to intrinsic motivation, where higher scores indicate more autonomous motivation, such as doing something because you find it important for yourself (integrated regulation). | [Time Frame: baseline (0 months), post-intervention (3 months) and follow-up (6 months)] |
| Attitude towards a healthy diet | Regulation of Eating Behavior Scale (REBS). 12 items with a 5-point Likert scale: totally disagree (1); disagree; neutral; agree; totally agree (5). The items relate to 6 types of motivation: from amotivation to different types of external motivation to intrinsic motivation. It concerns a continuum from extrinsic to intrinsic motivation, where higher scores indicate more autonomous motivation, such as doing something because you find it important for yourself (integrated regulation). | [Time Frame: baseline (0 months), post-intervention (3 months) and follow-up (6 months)] |
| Functional leg muscle strength | timed Chair-Stand (s) | [Time Frame: baseline (0 months), post-intervention (3 months) and follow-up (6 months)] |
| user-friendliness of the eHealth application | SUS questionnaire (SUS is a 10-item questionnaire with 5 response options (based on the Likert scale)). A higher score means a higher usability. | post-intervention (3 months after the start) |
| usability of the eHealth application | Usefulness, Satisfaction, and Ease of use Questionnaire (USE). A 30-item questionnaire with a 5-point Likert scale ranging from: strongly disagree to strongly agree. | post-intervention (3 months after the start) |
Duration of muscle strenghtening activities through Muscle-strengthening Exercise Questionnaire (MSEQ) |
| [Time Frame: baseline (0 months), post-intervention (3 months) and follow-up (6 months)] |
| Muscle strengthening activity types | Types of muscle strenghtening activities through Muscle-strengthening Exercise Questionnaire (MSEQ) | [Time Frame: baseline (0 months), post-intervention (3 months) and follow-up (6 months)] |
| Muscle strengthening activity intensity | Intensity of muscle strenghtening activities through Muscle-strengthening Exercise Questionnaire (MSEQ) | [Time Frame: baseline (0 months), post-intervention (3 months) and follow-up (6 months)] |
| Intervention adherence: Number of App Content Items Marked as Read | Participants receive various content items through the study app (e.g., written information, videos, exercises, recipes). Each item includes a "Marked as Read" button. The outcome is the total number of items marked as read. Scores range from 0 to the maximum number of items provided, with higher scores indicating greater engagement (better adherence). | Throughout intervention period (3 months) |
| protein knowledge | Score 0-9 based on a 9-item Protein knowledge questionnaire with answer options: True, False, or 'I don't know'. A higher score means a higher level of knowledge regarding dietary proteins. A lower protein knowledge is defined as an objective protein knowledge score lower than 5 (median score). | [Time Frame: baseline (0 months), post-intervention (3 months) and follow-up (6 months)] |
| step count (n/d) | through accelerometer (Axivity) worn on the thigh for 8 consecutive days | baseline (0 months) |
| sedentary behaviour (h/d) | through accelerometer (Axivity) worn on the thigh for 8 consecutive days | baseline (0 months) |
| Light-intensity physical activity (LIPA, h/d) | through accelerometer (Axivity) worn on the thigh for 8 consecutive days | baseline (0 months) |
| Moderate-to-Vigorous Physical Activity (MVPA, h/d) | through accelerometer (Axivity) worn on the thigh for 8 consecutive days | baseline (0 months) |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |