Program sustainable vitality

Recruiting

Conditions: Cardiovascular disease
diabetes-2 and overweight
10082206
10018424
10003018

Registration Number: NL-OMON38992

Lead Sponsor: Technische Universiteit Delft

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 104

Inclusion Criteria

*Cardiovascular disease (including previous diagnoses, hypertension (><=140/90) or hypercholesteremia (cholesterol ><= 6,0 mmol/l or LDL ><= 3,4 mmol/l), and/or diabetes-2 (including prediabetes risk: HbA1C ><= 6,0% (><= 42 mmol/mol) and/or being overweight (BMI ><= 25).
*Physically, mentally and socially capable of participating in an intensive lifestyle program.
*Strong motivation to participate (score 4 *strong* or 5 *very strong* on a 5-point scale).

Exclusion Criteria

*Serious comorbidity or treatment side effects that hamper participation.
*Psychiatric problems.
*Risk factor measurement outcomes which require immediate medication changes.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Intervention effects will be measured six weeks after enrollment, on an<br /><br>intention to treat basis. The primary effect outcomes after six weeks are the<br /><br>following physical risk factors: LDL cholesterol and total cholesterol<br /><br>(expected effect sizes: -0,5 mmol/l). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary physical outcomes are: BMI, blood pressure, HbA1C and fasting<br /><br>glucose. Secondary outcomes related to productivity are: self-assessed<br /><br>absenteeism and presenteeism (using the questionnaire of Iverson et al 2010;<br /><br>which will be correlated with work leave registration) and work engagement<br /><br>(using UWES-9).<br /><br><br /><br>Finally, after participants have started in the intervention, as a secondary<br /><br>pre-/post-intervention evaluation, the following data are collected:<br /><br>satisfaction, health behavior scores (as tracked by participants in their<br /><br>eDashboards), smoking cessation and medication changes.</p><br>