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NCT Number: NCT07415408

App-based Protein Support for Older Adults; Coaching Towards Healthy Ageing

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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Key information

Conditions

Dietary Protein Intake Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radboudumc

Nijmegen, 6525 GC, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Able to use a smartphone;
  • Open to make use of an application;
  • Open to alter their diet;
  • Able to understand and perform the study procedures;
  • Sufficient command of the Dutch language.

Exclusion criteria

  • Comorbidities where physical activity and/or a certain intake may be dangerous (e.g., diagnosed kidney failure);
  • Pre-scribed diet (e.g. low sodium or low potassium diet) or plant-based diet;
  • Use of nutritional shakes (such as meal replacements or protein shakes) during the study period. The use of nutritional supplements (such as iron or vitamin D tablets) is permitted and will be requested.

Treatment and study plan

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.

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.

Primary outcomes

  1. protein intake

    Time frame: baseline (0 months), post-intervention (3 months) and follow-up (6 months)

    Δprotein intake relative to bodyweight (g/kg/d)

Secondary outcomes

  1. muscle mass

    Time frame: baseline (0 months), post-intervention (3 months) and follow-up (6 months)

    muscle mass (kg) (Body Impedance Analysis BIA)

  2. Leg muscle strength

    Time frame: [Time Frame: baseline (0 months), post-intervention (3 months) and follow-up (6 months)]

    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.

  3. Attitude towards physical activity

    Time frame: [Time Frame: baseline (0 months), post-intervention (3 months) and follow-up (6 months)]

    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).

  4. Attitude towards a healthy diet

    Time frame: [Time Frame: baseline (0 months), post-intervention (3 months) and follow-up (6 months)]

    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).

  5. Functional leg muscle strength

    Time frame: [Time Frame: baseline (0 months), post-intervention (3 months) and follow-up (6 months)]

    timed Chair-Stand (s)

  6. user-friendliness of the eHealth application

    Time frame: post-intervention (3 months after the start)

    SUS questionnaire (SUS is a 10-item questionnaire with 5 response options (based on the Likert scale)). A higher score means a higher usability.

  7. usability of the eHealth application

    Time frame: post-intervention (3 months after the start)

    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.

Other outcomes

  1. Muscle strengthening activity and frequency

    Time frame: [Time Frame: baseline (0 months), post-intervention (3 months) and follow-up (6 months)]

    Frequency of muscle strenghtening activities through Muscle-strengthening Exercise Questionnaire (MSEQ)

  2. Muscle strengthening activity duration

    Time frame: [Time Frame: baseline (0 months), post-intervention (3 months) and follow-up (6 months)]

    Duration of muscle strenghtening activities through Muscle-strengthening Exercise Questionnaire (MSEQ)

  3. Muscle strengthening activity types

    Time frame: [Time Frame: baseline (0 months), post-intervention (3 months) and follow-up (6 months)]

    Types of muscle strenghtening activities through Muscle-strengthening Exercise Questionnaire (MSEQ)

  4. Muscle strengthening activity intensity

    Time frame: [Time Frame: baseline (0 months), post-intervention (3 months) and follow-up (6 months)]

    Intensity of muscle strenghtening activities through Muscle-strengthening Exercise Questionnaire (MSEQ)

  5. Intervention adherence: Number of App Content Items Marked as Read

    Time frame: Throughout intervention period (3 months)

    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).

  6. protein knowledge

    Time frame: [Time Frame: baseline (0 months), post-intervention (3 months) and follow-up (6 months)]

    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).

  7. step count (n/d)

    Time frame: baseline (0 months)

    through accelerometer (Axivity) worn on the thigh for 8 consecutive days

  8. sedentary behaviour (h/d)

    Time frame: baseline (0 months)

    through accelerometer (Axivity) worn on the thigh for 8 consecutive days

  9. Light-intensity physical activity (LIPA, h/d)

    Time frame: baseline (0 months)

    through accelerometer (Axivity) worn on the thigh for 8 consecutive days

  10. Moderate-to-Vigorous Physical Activity (MVPA, h/d)

    Time frame: baseline (0 months)

    through accelerometer (Axivity) worn on the thigh for 8 consecutive days

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Amsterdam University of Applied Sciences
  • FrieslandCampina

Registry information

Acronym: APPROACH

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 17, 2026
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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