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

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 Overview

• Status: Enrolling by invitation
• Conditions: Dietary Protein Intake
• Intervention / Treatment: Behavioral: Nutritional coaching via an app; Behavioral: Exercise recommendations

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Nijmegen, Netherlands, 6525 GC
    • Radboudumc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Protein and exercise; 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.	Behavioral: Nutritional coaching via an app; 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.; Behavioral: Exercise recommendations; 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.
Active Comparator: Exercise; 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.	Behavioral: Exercise recommendations; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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.	[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)

Other Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Collaborators: FrieslandCampina; Amsterdam University of Applied Sciences

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: February 16, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 16, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: older adults; nutrition; elderly; app; ehealth; dietary protein; strength exercise; whole foods
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Alzheimer Disease
• Other Study ID Numbers: APPROACH25; NL-010298 (Other Identifier: CCMO)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No