ELFI Health (e-Health for Empowerment by Lifestyle, Food Advice and Interaction) (ELFI)

November 19, 2024 updated by: TNO

The Validation of a Proof-of-concept Study of People at Risk for Diabetes With Personalised Lifestyle Interventions and E-health to Change Lifestyle Behaviour and Reverse the Risk for Diabetes

In the present study the investigators will examine whether people living with prediabetes benefit from an e-health lifestyle intervention of three months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In the Netherlands about 1,2 million people are living with type 2 diabetes. This number increases weekly by an average of 1000 people. Besides, an equal number of people are living in a condition of prediabetes. In this precondition of type 2 diabetes, prevention is still possible for people by changing their lifestyle. Ideally, for every individual a personalised lifestyle intervention, adapted to the individual situation, biology and preferences is advised. A personalised lifestyle intervention is effective in preventing and delaying progression to type 2 diabetes. In this study, it will be investigated whether it is feasible to perform a personalised lifestyle intervention in combination with an online e-health platform. The e-Health for Empowerment by Lifestyle, Food advice and Interaction (ELFI) Health lifestyle intervention aims to improve the lifestyle of people with prediabetes to prevent them from developing type 2 diabetes.

Therefore, the primary objective is to execute a feasibility study of the ELFI Health lifestyle intervention for three months in people with prediabetes in primary care (based on HbA1c). The secondary objectives are assessing the impact of the ELFI health lifestyle intervention after three months on objective outcome parameters, including lipid profile, body composition, waist and hip circumference, blood pressure, and nutritional intake, as well as evaluating the lifestyle intervention and the online e-health platform used by participants and medical professionals.

The study is a feasibility study, studying the ability of a personalised lifestyle intervention and e-health platform to change lifestyle behaviour and decrease the risk for the development of type 2 diabetes in people with prediabetes.

The participants are newly diagnosed adults with prediabetes, aged 18-70 years. Prediabetes is defined as people with disturbed glucose values based on HbA1c levels of 39 - 53 mmol/mol (= 5.7 - 7.0%).

The intervention in this study consists of a personalised lifestyle intervention for three months. After measurements of HbA1c, blood lipids, body composition, waist and hip circumferences, blood pressure, and after assessment of food intake, a personal goal is set and participants start following the personalised lifestyle intervention. This is partly a digital intervention and partly a physical intervention (blended care). The digital part is followed via an online e-health platform, which offers different information modules. The physical part consists of different measurements of the outcome parameters and community events, where participants are in contact with their general practitioner and peers. Besides, participants have three appointments during the intervention period with a dietician to discuss their personalised program.

The main study outcome is the feasibility of the ELFI Health lifestyle intervention for three months in people with prediabetes in primary care. Key question is whether the intervention is appreciated by the subjects and working sufficiently to motivate participants in maintaining a healthier lifestyle. The feasibility will be evaluated by examination of the HbA1c level and subsequent prediabetes risk.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Holland
      • Leiden, Holland, Netherlands, 2333 BE
        • TNO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Healthy as assessed with screening questionnaire
  2. HbA1c: 39 - 53 mmol/mol (= 5.7 - 7.0%)
  3. Age between 18 - 70 years
  4. Stable BMI of 25 - 35 kg/m2
  5. Informed consent signed
  6. Willing to comply with the study procedures during the study
  7. Being able to become more physically active, as assessed by the screening questionnaire (P9885 F02; in Dutch).
  8. Being digitally competent
  9. Willing to accept the use of all nameless data, including publication, and the confidential use and storage of all data for at least 15 years

Exclusion Criteria:

  1. Being diagnosed with diabetes type 1 or 2
  2. Use of insulin, corticosteroids (systemic), or beta-blockers in past month
  3. Use of oral diabetes medication in past year
  4. (Having a history of a) medical condition that might significantly affect the study outcome as judged by the general practitioner and health and lifestyle questionnaire. This includes gastrointestinal dysfunction, diseases related to inflammation or allergy, or a psychiatric disorder
  5. Being abroad or on vacation for longer than a week.
  6. Alcohol consumption > 21 (women) - 28 (men) units/week
  7. Reported unexplained weight loss or gain of > 2 kg in the month prior to the pre-study screening
  8. Recent blood donation (<1 month prior to the start of the study)
  9. Not willing to give up blood donation during the study
  10. Not willing to accept information-transfer concerning participation in the study, or information regarding his health, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from his general practitioner.
  11. Pregnant or lactating women
  12. Involved in another Combined Lifestyle Intervention or weight loss program
  13. On GLP-1 analogues to stimulate weight loss

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lifestyle intervention
The intervention will be a twelve week lifestyle intervention (live and online)
Behavioral: ELFI lifestyle intervention
A (digital) lifestyle support intervention. Based on anthropometrics, food intake and lifestyle preferences, subjects will receive behavioral lifestyle support, especially with the focus on healthy food intake.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diabetes risk based on HbA1c level (mmol/mol)
Time Frame: three months
Change in HbA1c due to lifestyle intervention (in mmol/mol)
three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lipid profile (mmol/L)
Time Frame: three months
change in lipid profile due to lifestyle intervention (mmol/L)
three months
body weight (kg)
Time Frame: three months
change in body weight (kg) due to lifestyle intervention
three months
body fat % (%)
Time Frame: three months
change in body fat % (%) due to lifestyle intervention
three months
waist circumference (cm)
Time Frame: three months
change in waist circumference (cm) due to lifestyle intervention
three months
hip circumference (cm)
Time Frame: three months
change in hip circumference (cm) due to lifestyle intervention
three months
Habitual food intake (frequencies, number and grams)
Time Frame: three months
Changes in habitual food intake (frequencies, number and grams)will be examined with q food intake questionnaire before, during and after the intervention intervention program
three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TNO

Collaborators

World Data Exchange
Roche Diagnostics GmbH

Investigators

  • Principal Investigator: Suzan Wopereis, PhD, TNO

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2024

Primary Completion (Actual)

August 8, 2024

Study Completion (Actual)

November 8, 2024

Study Registration Dates

First Submitted

January 12, 2024

First Submitted That Met QC Criteria

January 23, 2024

First Posted (Actual)

February 1, 2024

Study Record Updates

Last Update Posted (Estimated)

November 22, 2024

Last Update Submitted That Met QC Criteria

November 19, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9885 (TNO)
  • NL85760.028.23 (Registry Identifier: ToetsingOnline The Netherlands)
  • P2341 (Other Identifier: Ethical Review Board Brabant, The Netherlands)

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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