The effect of timing of lifestyle factors in addition to a regular lifestyle interventio

Not Applicable

• Conditions: Either 1) obesity (BMI>30 kg/m2); or 2) overweight (BMI >25 and <30 kg/m2) with at least one comorbidity of sleep apnea, vascular diseases, type 2 diabetes, arthrosis, or increased waist circumference (men >102cm; women >88cm); Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN14642827
• Lead Sponsor: Amsterdam UMC Location VUmc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-12-07
• Last Update Posted: 4 March 2024
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 100

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 <30 kg/m2) with at least one comorbidity:
1.1. Sleep apnea
1.2. Vascular diseases
1.3. T2D
1.4. Arthrosis
1.5. Increased waist circumference (men >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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The following primary outcome measures are assessed at baseline and after 3 and 9 months:<br>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.<br>2. BMI calculated using the self-reported height and weight measured with standard methods

Secondary Outcome Measures

Name	Time	Method
1. Health-Related Quality of Life measured using the Dutch PROMIS scale V1.2 - Global Health<br>2. HbA1c measured using the Contour Plus Blue glucose monitor and HPLC assay<br>3. Waist circumference self-reported