(Cardio)vascular disease, osteoarthritis with or without total hip or knee arthroplasty Other
Conditions
Interventions
Randomization:
Randomization occurs separately for both trials and patients will be randomly allocated to receive the LOFIT intervention or usual care in a 1:1 ratio. A computerized random number gene
Sponsors
Amsterdam UMC Location VUmc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with an increased risk for cardiovascular disorders (i.e. cardiovascular disease, hypertension, high cholesterol, diabetes mellitus I and II) or with musculoskeletal disorders (i.e. osteoarthritis, total knee or hip arthroplasty) 2. Visiting the participating outpatient clinics of Amsterdam UMC, UMC Groningen (UMCG) or Ommelander Ziekenhuis Groningen (OZG) 3. Aged =18 years 4. Body Mass Index (BMI) of =25 kg/m² and /or patients who smoke
Exclusion criteria
Exclusion criteria: 1. Not able to walk at least 100 meters safely (e.g. wheelchair bound) 2. Pregnant 3. Cognitively unable to comply with a healthy lifestyle intervention referral or to complete study measurements 4. Not able to communicate in the Dutch or English language
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The adapted-Fuster-BEWAT score is a composite health risk and lifestyle score which consists of six components measured at baseline and 12 months: 1. Resting blood pressure (mmHg) measured with blood pressure monitor 2. Objectively measured physical activity (steps/24h) using activPAL 3. Objectively measured sitting time (time/24 h) using activPAL 4. Body mass index (BMI) based on weight and height measure 5. Fruit and vegetable consumption (servings 24/h) measured with questionnaire 6. Smoking (units/24 h) measured with questionnaire | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Cardiometabolic markers: fasting plasma glucose, lipids (triglycerides, total cholesterol, high density lipoprotein cholesterol (HDL) and low density lipoprotein cholesterol (LDL)), insulin, Hemoglobin A1C (HbA1C), liver function (Gamma-Glutamyl Transferase (GGT), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST)), kidney function (creatinine). measured at baseline and 12 months 2. Anthropometric measurements (body height (stadiometer), body weight (scale), waist circumference (tape measure), neck circumference (tape measure), resting blood pressure [systolic, diastolic]) (OMRON M6 bloodpressure monitor) at baseline and 12 months 3. Behaviour measured at baseline and 12 months: 3.1. Sitting time, upright time, step count measured using activPAL 3.2. Dietary quality measured with 18 items from the Dutch Food Frequency questionnaire 3.3 alcohol intake measured using Alcohol Use Disorders Identification Test (AUDIT) questionnaire 3.4. Sedentary behaviour measured using Marshall questionnaire 3.5. Physical activity measured using International Physical Activity Questionnaire – Short Form (IPAQ-SF) questionnaire 3.6. Fitness measured using FitMax questionnaire 3.7. Sleep insomnia measured using Insomnia Severity Index (ISI) questionnaire 3.8. Sleep quality measured using Brief Pittsburg Sleep Quality Index (B-PSQI) questionnaire 3.9. Obstructive sleep apnea syndrome (OSAS) measured with the STOP BANG Sleep Apnea questionnaire 3.10. Smoking status measured using Fagerström Test for Nicotine Dependence (FTND) questionnaire 4. Psychological outcomes measured at baseline and 12 months: 4.1. Wellbeing measured using Cantril ladder questionnaire 4.2. Health-related quality of life measured using EQ-5D-5L questionnaire 4.3. Resilience is measured using Brief Resilience Scale (BRS) questionnaire 4.4. General self-efficacy is measured using the General self-efficacy scale (GSES) questionnaire 4.5. Stage of Change is measured in a questionnaire based on transthe | — |
Countries
Netherlands
Contacts
Public ContactJudith Jelsma
Outcome results
None listed