Dietary Protein IntakeAPPROACHNCT07415408
App-based Protein Support for Older Adults; Coaching Towards Healthy Ageing
A study testing Nutritional coaching via an app and Exercise recommendations in people with Dietary Protein Intake, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dietary Protein Intake
- What is being tested?
- Nutritional coaching via an app and Exercise recommendations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteNetherlands
- Study dates
- 12 Jan 2026to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Dietary Protein Intake
- Being tested
- Nutritional coaching via an app, Exercise recommendations
- Keywords
- dietary protein, ehealth, app, nutrition, older adults, elderly, strength exercise, whole foods
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional coaching via an appBehavioural
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 recommendationsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Nutritional coaching via an app; Behavioral: Exercise recommendations |
| 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. Receives: Behavioral: Exercise recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
protein intake
Δprotein intake relative to bodyweight (g/kg/d)
Measured: baseline (0 months), post-intervention (3 months) and follow-up (6 months)
Secondary outcomes (7)
muscle mass
muscle mass (kg) (Body Impedance Analysis BIA)
Measured: 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.
Measured: [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).
Measured: [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).
Measured: [Time Frame: baseline (0 months), post-intervention (3 months) and follow-up (6 months)]
Functional leg muscle strength
timed Chair-Stand (s)
Measured: [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.
Measured: 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.
Measured: post-intervention (3 months after the start)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start12 Jan 2026
- Primary completionJul 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary Protein IntakeStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Amsterdam University of Applied Sciences, FrieslandCampina
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07415408
- Sponsor's protocol ID
- APPROACH25
- Other IDs
- NL-010298
- Acronym
- APPROACH
- Status last verified
- Oct 2025
- First submitted
- 14 Nov 2025
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- App-based Protein Support for Older Adults; Coaching Towards Healthy Ageing
- ClinicalTrials.gov ID
- NCT07415408
- Acronym / sponsor ID
- APPROACH / APPROACH25
- Conditions
- Dietary Protein Intake
- Keywords
- dietary protein, ehealth, app, nutrition, older adults, elderly, strength exercise, whole foods
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Amsterdam University of Applied Sciences, FrieslandCampina
- Study start
- 12 Jan 2026 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Protein and exercise | Experimental | Behavioral: Nutritional coaching via an app, Behavioral: Exercise recommendationsOnly 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. |
| Exercise | Active comparator | Behavioral: Exercise recommendationsParticipants 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional coaching via an appCoaching 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. | Behavioural | Protein and exercise |
| Exercise recommendationsThe 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. | Behavioural | Exercise, Protein and exercise |
Primary outcome
protein intake
Time frame: baseline (0 months), post-intervention (3 months) and follow-up (6 months)
Δprotein intake relative to bodyweight (g/kg/d)
7 secondary outcomes
muscle mass
Time frame: baseline (0 months), post-intervention (3 months) and follow-up (6 months)
Leg muscle strength
Time frame: [Time Frame: baseline (0 months), post-intervention (3 months) and follow-up (6 months)]
Attitude towards physical activity
Time frame: [Time Frame: baseline (0 months), post-intervention (3 months) and follow-up (6 months)]
Attitude towards a healthy diet
Time frame: [Time Frame: baseline (0 months), post-intervention (3 months) and follow-up (6 months)]
Functional leg muscle strength
Time frame: [Time Frame: baseline (0 months), post-intervention (3 months) and follow-up (6 months)]
user-friendliness of the eHealth application
Time frame: post-intervention (3 months after the start)
usability of the eHealth application
Time frame: post-intervention (3 months after the start)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional coaching via an app and Exercise recommendations in people with Dietary Protein Intake, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
protein intake (time frame: baseline (0 months), post-intervention (3 months) and follow-up (6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.