Personalised Nutrition for Healthy Living

NCT ID: NCT05951140

Last Updated: 2023-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2022-11-30

Brief Summary

The topic of diet and physical activity are of great importance in the treatment of T2D. In the daily routine of a practice or clinic, a doctor has an average of eight minutes per patient, leaving little time for lifestyle issues (Irving et al. 2017). An individualised procedure requires more time and therefore more resources. Currently, an app can be programmed with evidence-based information so that it provides appropriate personalised behavioural recommendations via machine learning. The user gets direct feedback and can make a behavioural change himself. On the one hand, this approach allows better use of doctor-patient time and, on the other hand, the patient learns through positive reinforcement in such a way that his or her behaviour change is supported and reinforced in the longer term and potentially sustainably.

The aim of this intervention pilot study within the scope of the EU-Horizon 2020 project is to investigate lifestyle support through a mobile app and wearables to improve lifestyle (personalised nutrition) and important metabolic outcomes in patients with type 2 diabetes or prediabetes. In addition, exploratory genetic and microbiome data will be explored to answer the question of personalisation of the recommendations.

Detailed Description

An inadequate diet and increasing sedentary lifestyle are major contributors to the rise of non-communicable diseases. Individualized recommendations can lead to a healthier lifestyle. The scientific evidence of the effectiveness of health apps offering personalized recommendations is limited.

The aim of this intervention pilot study within the scope of the EU-Horizon 2020 project is to investigate lifestyle support through a mobile app and wearables to improve lifestyle (personalised nutrition) and important metabolic outcomes in patients with type 2 diabetes or prediabetes. The Investigators want to asess whether the use of this mobile application that incorporates information of wearables (continuous glucose monitoring and fitness tracker), improves lifestyle and metabolic outcomes in patients with type 2 diabetes (T2D) or prediabetes. Our primary outcome is to improve time in range (TIR) by 5%.

It is a prospective randomized control pilot trial with an intervention period of 12 weeks. Participants will use the Protein app, a continuous glucose monitoring system (CGM) and an activity tracker to collect real world data to enable personalisation.

In order to identify the effect of the PROTEIN-Application, 300 participants with T2DM or prediabetes will be randomly allocated into two groups: the (1) start-group or the (2) wait-group. The start-group will use an activity tracker, a CGM and the PROTEIN app for 12 weeks followed by a six-week period without the app, but they will use the wearables. The wait-group will use an activity tracker and a CGM, but not the PROTEIN app for six weeks followed by a period of 12 weeks using the PROTEIN app. This study design allowed us to have a control group within the whole cohort and clearly see the influence of the PROTEIN app.

Conditions

Diabetes Mellitus, Type 2; PreDiabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Start-Group

The Start-Group starts with the Protein-Application and wereables for 3 Months and afterwards uses only wereables for 6 Weeks.

Group Type: EXPERIMENTAL

Usage of the PROTEIN-Application

Intervention Type: OTHER

Participants were randomly distributed into 2 groups: (1) Start-Group used the developed Application and wereables to investigate the effect of this support. Participants used the devices and the App for 3 Months followed by a 6-Weeks time of only using wereables and no app, to be able to compare the effects of the Application. (2) The Wait-Group used wereables for 6 Weeks before adding the Protein-App for also 3 Months.

Wait-Group

The Wait-Group starts with 6 Weeks of using only wereables and afterwards adds the usage of the Protein-Application.

Group Type: EXPERIMENTAL

Usage of the PROTEIN-Application

Intervention Type: OTHER

Participants were randomly distributed into 2 groups: (1) Start-Group used the developed Application and wereables to investigate the effect of this support. Participants used the devices and the App for 3 Months followed by a 6-Weeks time of only using wereables and no app, to be able to compare the effects of the Application. (2) The Wait-Group used wereables for 6 Weeks before adding the Protein-App for also 3 Months.

Interventions

Usage of the PROTEIN-Application

Participants were randomly distributed into 2 groups: (1) Start-Group used the developed Application and wereables to investigate the effect of this support. Participants used the devices and the App for 3 Months followed by a 6-Weeks time of only using wereables and no app, to be able to compare the effects of the Application. (2) The Wait-Group used wereables for 6 Weeks before adding the Protein-App for also 3 Months.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• ≥ 18 years of age
• Diabetes Type 2 or Prediabetes
• BMI: 20-kg kg/m2
• Android Smart Phone/ Tablet use
• In good physical health
• Able to provide written informed consent

Exclusion Criteria

• Severe endocrine, gastrointestinal, metabolic, cardiovascular, pulmonary, inflammatory or psychiatric disorder
• Active or recent relevant cancer
• Currently receiving treatment with Insulin
• People with disordered eating (such as anorexia nervosa etc.)
• Those who are not be able to provide written consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Union

OTHER

Sponsor Role: collaborator

Prof. Dr. med. Andreas F. H. Pfeiffer

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. med. Andreas F. H. Pfeiffer

Principal Investigator, Univ. Prof. Dr. med.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Lazaros Gymnopoulos, Dr

Role: STUDY_DIRECTOR

Information Technologies Institute, Centre for Research and Technology Hellas

Locations

Charité Univesitätsmedizin Berlin

Berlin, , Germany

Countries

Germany

Other Identifiers

PROTEIN

Identifier Type: -

Identifier Source: org_study_id