Search / Trial NCT06236334

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

Launched by TNO · Jan 23, 2024

Trial Information

Current as of December 22, 2024

Completed

Keywords

Lifestyle E Health Behavior

ClinConnect Summary

The ELFI Health trial is a study looking at whether an online health program can help people with pre-diabetes improve their lifestyle over three months. Pre-diabetes means that blood sugar levels are higher than normal but not yet high enough to be considered diabetes. The program will provide guidance on diet, exercise, and other healthy habits to empower participants to make positive changes.

To be eligible for this study, participants should be between 18 and 70 years old, have a specific range of blood sugar levels, and a stable body weight. They also need to be able to use digital technology and be willing to follow the study's requirements. If someone has diabetes, is using certain medications, or has specific health conditions, they may not qualify. Those who join can expect to engage with the program online, receive support, and contribute to research that could help others in the future.

Gender

ALL

Eligibility criteria

  • 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

Trial Officials

Suzan Wopereis, PhD

Principal Investigator

TNO

About Tno

TNO, the Netherlands Organization for Applied Scientific Research, is an independent research institute dedicated to advancing knowledge and innovation in various fields, including health, nutrition, and technology. With a strong emphasis on bridging the gap between scientific research and practical applications, TNO collaborates with industry partners, academic institutions, and government entities to drive impactful solutions that enhance public health and well-being. The organization is committed to conducting rigorous clinical trials that adhere to the highest ethical and scientific standards, aiming to accelerate the development of novel therapies and interventions that address pressing health challenges.

Locations

Leiden, Holland, Netherlands

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0