Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2025-12-26 @ 6:18 AM
Study NCT ID:
NCT06236334
Status:
COMPLETED
Last Update Posted:
2024-11-22
First Post:
2024-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ELFI Health (e-Health for Empowerment by Lifestyle, Food Advice and Interaction)
Sponsor:
TNO
Organization:
Study Overview
Official Title:
The Validation of a Proof-of-concept Study of People at Risk for Diabetes With Personalised Lifestyle Interventions and E-health to Change Lifestyle Behaviour and Reverse the Risk for Diabetes
Status:
COMPLETED
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ELFI
Brief Summary:
In the present study the investigators will examine whether people living with prediabetes benefit from an e-health lifestyle intervention of three months.
Detailed Description:
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.
Therefore, 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.
The 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.
The participants are newly diagnosed adults with prediabetes, aged 18-70 years. Prediabetes is defined as people with disturbed glucose values based on HbA1c levels of 39 - 53 mmol/mol (= 5.7 - 7.0%).
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 peers. Besides, participants have three appointments during the intervention period with a dietician to discuss their personalised program.
The main study outcome is the feasibility of the ELFI Health lifestyle intervention for three months in people with prediabetes in primary care. Key question is whether the intervention is appreciated by the subjects and working sufficiently to motivate participants in maintaining a healthier lifestyle. The feasibility will be evaluated by examination of the HbA1c level and subsequent prediabetes risk.
Therefore, 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.
The 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.
The participants are newly diagnosed adults with prediabetes, aged 18-70 years. Prediabetes is defined as people with disturbed glucose values based on HbA1c levels of 39 - 53 mmol/mol (= 5.7 - 7.0%).
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 peers. Besides, participants have three appointments during the intervention period with a dietician to discuss their personalised program.
The main study outcome is the feasibility of the ELFI Health lifestyle intervention for three months in people with prediabetes in primary care. Key question is whether the intervention is appreciated by the subjects and working sufficiently to motivate participants in maintaining a healthier lifestyle. The feasibility will be evaluated by examination of the HbA1c level and subsequent prediabetes risk.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: