Either 1) obesity (BMI>30 kg/m2)
Conditions
Interventions
Current interventions as of 27/01/2025:
Participants will be randomly assigned in a 1:1 ratio to one of the two intervention arms using a variable block randomization algorithm (blocks of 2, 4 or 6)
Sponsors
Amsterdam UMC Location VUmc
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Have a CLI indication as described in the MiGuide-CooL CLI for regular care. These inclusion criteria are either obesity (BMI>30 kg/m2) or overweight (BMI >25 and 102cm; women >88cm) 2. Aged 18 years or older 3. Motivated to change lifestyle behaviour 4. Digitally skilled and in the possession of a smartphone 5. Being able to speak and understand the Dutch language
Exclusion criteria
Exclusion criteria: 1. Unable to give written informed consent 2. Serious mental impairment i.e. preventing understanding of the study protocol/aim 3. Pregnant women 4. Working in night shifts or irregular phase shifts 5. Taken sulphonylurea (SU)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The following primary outcome measures are assessed at baseline and after 3 and 9 months: 1. Fasting glucose measured at home using the Contour Plus Blue glucose monitor; 1 drop of blood is deposited from a finger prick on the stick, which is then inserted in the device and a photo will be taken of the measurement. The photo is then sent by email or phone to the researcher. 2. BMI calculated using the self-reported height and weight measured with standard methods | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Health-Related Quality of Life measured using the Dutch PROMIS scale V1.2 - Global Health 2. HbA1c measured using the Contour Plus Blue glucose monitor and HPLC assay 3. Waist circumference self-reported | — |
Countries
Netherlands
Contacts
Public ContactFemke Rutters
Outcome results
None listed