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

NCT06236334 | Completed

• 3 other identifiers: 9885 (TNO)NL85760.028.23P2341
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre-diabetes

Keywords

lifestyle; e-health; behavior

Outcome Measures

Primary Outcomes (1)

• Diabetes risk based on HbA1c level (mmol/mol)

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

  three months

Secondary Outcomes (6)

• Lipid profile (mmol/L)

  three months

• body weight (kg)

  three months

• body fat % (%)

  three months

• waist circumference (cm)

  three months

• hip circumference (cm)

  three months

Study Arms (1)

Lifestyle intervention

EXPERIMENTAL

The intervention will be a twelve week lifestyle intervention (live and online)

Behavioral: ELFI lifestyle intervention

Interventions

ELFI lifestyle intervention BEHAVIORAL

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.

Lifestyle intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• TNO: lead
• Roche Diagnostics GmbH: collaborator
• World Data Exchange: collaborator

Study Sites (1)

TNO

Leiden, Holland, 2333 BE, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 31683759 BACKGROUND

• 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.

  PMID: 35151523 BACKGROUND

MeSH Terms

Conditions

Glucose Intolerance; Behavior

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Suzan Wopereis, PhD

  TNO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: All subjects will participate in a blended/hybrid intervention of live and online lifestyle support
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: People at risk for diabetes will be selected. Screening at HbA1c level will be a selection criterion

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: February 1, 2024
• Study Start: March 25, 2024
• Primary Completion: August 8, 2024
• Study Completion: November 8, 2024
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)