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A feasibility study for an e-health blended personalised lifestyle intervention to change lifestyle behaviour and reverse the risk for type 2 diabetes in people with prediabetes.

A feasibility study for an e-health blended personalised lifestyle intervention to change lifestyle behaviour and reverse the risk for type 2 diabetes in people with prediabetes. - ELFI Health (Empowerment by Lifestyle, Food advice and Interaction)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON56477
Enrollment
50
Registered
2024-01-05
Start date
2024-02-07
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

type 2 diabetes

Interventions

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 pr

Sponsors

TNO
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: To be eligible to participate in this study, a subject must meet all the following criteria: 1. During the information session, health is assessed by the: a. Screening questionnaire (P9885 F02; in Dutch) 2. During the health check, blood measurements are assessed by the point-of-care tool: a. 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

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: 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 (

Design outcomes

Primary

MeasureTime frame
HbA1c as marker for prediabetes risk

Secondary

MeasureTime frame
blood lipids (HDL, LDL, total cholesterol) Blood pressure anthropometrics body composition habitual food intake compliance

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)