Personalised combined lifestyle interventio
- Conditions
- Obesity
- Registration Number
- NL-OMON22186
- Lead Sponsor
- TNO in collaboration with GGD-NOG (owner of SLIMMER)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 120
In order to be eligible to participate in this study, a subject must meet all of the following criteria in addition to the above:
•Physically able to participate in a lifestyle intervention program;
•Motivated to join lifestyle program.
•Able to use online technology on a tablet or 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).
•Exclusion criteria from the SLIMMER programme:
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 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
•Using on a regular base: anti-inflammatory drugs (NSAID’s), corticosteroids (including topical and inhalation corticosteroids), TNF-alpha blockers, and salicylates (e.g. ascal)
•Having a chronic inflammatory disease, including asthma, rheumatic fever, IBD, COPD
•Other bowel diseases, including Chron’s disease and Colitis Ulcerosa.
•Alcohol consumption > 21 units/week
•Recent blood donation (<1 month prior to 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 Compliance/adherence. Evaluated by:<br>•User experiences (qualitative aspects including effort, maintenance, and appreciation) at the end of the intervention (month 6);<br>•Improved lifestyle behavior (subjective compliance as well as actual compliance measured by physical activity and dietary intake) (after the intervention at t=6 months compared to lifestyle behavior before the start of the intervention t=-1 month).<br>
- Secondary Outcome Measures
Name Time Method