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…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
HbA1c as marker for prediabetes risk
Secondary outcome
blood lipids (HDL, LDL, total cholesterol)
Blood pressure
anthropometrics
body composition
habitual food intake
compliance
Background summary
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.
Study objective
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.
Study design
This 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.
Intervention
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 other peers. Besides, participants have three appointments
during the intervention period with a dietician to discuss their personalised
program.
Study burden and risks
Participants are asked to visit the general practitioners office 7 times in
three months for measurements and appointments. In total, these 7 visits will
take up around 3 hours. At the start and after 3 months, HbA1c and a complete
blood lipid profile are determined. At the start, after 1 and 3 months, body
composition, waist and hip circumferences, and blood pressure are measured, and
food intake is assessed. Since part of the intervention is digital, it is
expected that the lifestyle intervention is less burdensome.
We do not foresee any serious health risks. The risks involved may be related
to physical injuries when participants may start to become physically (more)
active. However, due to coaching and monitoring by the general practitioner
assistant (GPA) and dietician no serious health risks are expected when
participants start to live a healthier lifestyle (eat heathier, become more
physically active, sleep more, and stress less).
People with prediabetes are chosen for this study, because a healthy lifestyle
is known to be effective for prevention or delay of (further development of)
chronic diseases, like type 2 diabetes. Because prediabetes is a serious health
risk to develop type 2 diabetes, people should be empowered to learn what they
can do themselves with respect to lifestyle to prevent further worsening.
Sylviusweg 71
Leiden 2333 BE
NL
Sylviusweg 71
Leiden 2333 BE
NL
Listed location countries
Age
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
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL85760.028.23 |