The effect of extended personalisation components to a combined lifestyle intervention program.
- Conditions
- overgewicht en obesitasfatnessobesity
- Registration Number
- NL-OMON51873
- Lead Sponsor
- TNO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
• Men and women aged 18-70 years
• BMI > 30 kg/m2, or
• BMI > 25 kg/m2 with an increased risk of cardiovascular diseases and/or type
2 diabetes, based on the Dutch primary care guidelines cardiovascular risk
management (CVRM), obesity and diabetes.
• Increased waist circumference (women > 80 cm and men > 92 cm);
• Little physical activity and suboptimal diet (room for improvement);
• Physically able to participate in a lifestyle intervention program;
• Motivated to join lifestyle program.
• Able to use online technology on a tablet and a PC/laptop which has good
access to the internet;
• In possession of a Smartphone running on a recent version of iOS or Android;
• Willing to comply with all study procedures;
• Proficient in the Dutch language (speaking and reading).
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
• Exclusion criteria from the SLIMMER program:
1) Behavioural problems that obstruct group sessions
2) Cognitive impairment (IQ < 80);
3) Psychopathology, that requires a different treatment
4) Having an underlying cause of obesity that can be treated;
5) incompetent to act for oneself, without consent of the legal representative.
• Participation in another regular vigorous exercise program (sporting at least
3 times a week) and/or diet program
• Participation in any clinical trial including administration of substances up
to 90 days before Day 01 of this study
• Severe cardiovascular disease (this also includes the history of cardiac
dysrhythmia), unless GP gives agreement
• Not being able to attend 80% of the planned group- and individual sessions;
• Planned surgery during the entire study period
• Pregnant or lactating women
• Preferably not use anti-inflammatory drugs (NSAID*s), corticosteroids
(including topical and inhalation corticosteroids), TNF-alpha blockers on a
regular base
• Other bowel diseases, including Chron*s disease and Colitis Ulcerosa.
• Alcohol consumption > 21 units/week
• Recent blood donation (<1 month before the start of the study)
• Not willing to give up blood donation during the study
• Personnel of TNO Healthy Living, their partner and their first and
second-degree relatives
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Main study parameters/endpoints: To examine the effects on of extended<br /><br>personalization to a lifestyle intervention program difference on compliance<br /><br>and physiological responses. The main objective of this study is to achieve<br /><br>better compliance to the lifestyle intervention program, measured by subjective<br /><br>compliance (participants score their degree of compliance with the given<br /><br>lifestyle advice every 3 months and grade the effort, maintenance and<br /><br>appreciation of the intervention program) and objective compliance (based on<br /><br>the *Eetscore* and amount of physical activity, and presence at sessions). </p><br>
- Secondary Outcome Measures
Name Time Method <p>The PhenFlex test will be used as a metabolic stress test to examine changes in<br /><br>inflammatory status due to a lifestyle intervention program.<br /><br>With a health patch some physical variables will be measured (ECG,<br /><br>bio-impedance and accelerometry).</p><br>