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Pre-diabetesELFINCT06236334

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

A study testing ELFI lifestyle intervention in people with Pre-diabetes, run by TNO at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Pre-diabetes
What is being tested?
ELFI lifestyle intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteNetherlands
Study dates
25 Mar 2024to 8 Nov 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy as assessed with screening questionnaire
  • HbA1c: 39 - 53 mmol/mol (= 5.7 - 7.0%)
  • Age between 18 - 70 years
  • Stable BMI of 25 - 35 kg/m2
  • Informed consent signed
  • Willing to comply with the study procedures during the study
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  • Being able to become more physically active, as assessed by the screening questionnaire (P9885 F02; in Dutch).
  • Being digitally competent
  • 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

Who cannot join

  • Being diagnosed with diabetes type 1 or 2
  • Use of insulin, corticosteroids (systemic), or beta-blockers in past month
  • Use of oral diabetes medication in past year
  • (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
  • Being abroad or on vacation for longer than a week.
  • Alcohol consumption > 21 (women) - 28 (men) units/week
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  • Reported unexplained weight loss or gain of > 2 kg in the month prior to the pre-study screening
  • Recent blood donation (<1 month prior to the start of the study)
  • Not willing to give up blood donation during the study
  • 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.
  • Pregnant or lactating women
  • Involved in another Combined Lifestyle Intervention or weight loss program
  • On GLP-1 analogues to stimulate weight loss

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • TNO

    Leiden, Holland, 2333 BE

Other trials in Netherlands

About this study

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

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

Read the 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.

Conditions
Pre-diabetes
Being tested
ELFI lifestyle intervention
Keywords
lifestyle, e-health, behavior
Medical subject headings
Glucose Intolerance, Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ELFI lifestyle interventionBehavioural

    A (digital) lifestyle support intervention. Based on anthropometrics, food intake and lifestyle preferences, subjects will receive behavioral lifestyle support, especially with the focus on healthy food intake.

Study groups in NCT06236334
Study groupRoleWhat they receive
Lifestyle interventionExperimentalThe intervention will be a twelve week lifestyle intervention (live and online)
Receives: Behavioral: ELFI lifestyle intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diabetes risk based on HbA1c level (mmol/mol)

    Change in HbA1c due to lifestyle intervention (in mmol/mol)

    Measured: three months

Secondary outcomes (6)

  1. Lipid profile (mmol/L)

    change in lipid profile due to lifestyle intervention (mmol/L)

    Measured: three months

  2. body weight (kg)

    change in body weight (kg) due to lifestyle intervention

    Measured: three months

  3. body fat % (%)

    change in body fat % (%) due to lifestyle intervention

    Measured: three months

  4. waist circumference (cm)

    change in waist circumference (cm) due to lifestyle intervention

    Measured: three months

  5. hip circumference (cm)

    change in hip circumference (cm) due to lifestyle intervention

    Measured: three months

  6. Habitual food intake (frequencies, number and grams)

    Changes in habitual food intake (frequencies, number and grams)will be examined with q food intake questionnaire before, during and after the intervention intervention program

    Measured: three months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2024
  2. Study start25 Mar 2024
  3. Primary completion8 Aug 2024
  4. Study completion8 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
People at risk for diabetes will be selected. Screening at HbA1c level will be a selection criterion
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06236334
Sponsor's protocol ID
9885 (TNO)
Other IDs
NL85760.028.23, P2341
Acronym
ELFI
Status last verified
Nov 2024
First submitted
12 Jan 2024
Last updated
22 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Uusitupa M, Khan TA, Viguiliouk E, Kahleova H, Rivellese AA, Hermansen K, Pfeiffer A, Thanopoulou A, Salas-Salvado J, Schwab U, Sievenpiper JL. Prevention of Type 2 Diabetes by Lifestyle Changes: A Systematic Review and Meta-Analysis. Nutrients. 2019 Nov 1;11(11):2611. doi: 10.3390/nu11112611.

    PubMed 31683759

  • Galaviz KI, Weber MB, Suvada K BS, Gujral UP, Wei J, Merchant R, Dharanendra S, Haw JS, Narayan KMV, Ali MK. Interventions for Reversing Prediabetes: A Systematic Review and Meta-Analysis. Am J Prev Med. 2022 Apr;62(4):614-625. doi: 10.1016/j.amepre.2021.10.020. Epub 2022 Feb 10.

    PubMed 35151523

Questions about this trial

What is this clinical trial studying?

A study testing ELFI lifestyle intervention in people with Pre-diabetes, run by TNO at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diabetes risk based on HbA1c level (mmol/mol) (time frame: three months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06236334, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.

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