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

NCT06236334

CompletedNA

Sponsor: TNO

Conditions: Pre-diabetes

Interventions: ELFI lifestyle intervention

Countries: Netherlands

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

Eligibility overview

Sex: ALL

Age: 18 Years to 70 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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
Locations (1)
  • Leiden, Holland, Netherlands