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

Overview

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.

Interventions

• 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 bal

Primary outcome measures

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

Secondary outcome measures (7)

• 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)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

Netherlands · 1 center

• Radboudumc — Nijmegen

Identifiers

NCT: NCT07415408 · APPROACH25 · NL-010298

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗