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.
- Conditions
- type 2 diabetes10018424
- Registration Number
- NL-OMON56477
- Lead Sponsor
- TNO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 50
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
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 (<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 GLI or weight loss program
13. On GLP-1 analogues to stimulate weight loss
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method