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The effect of extended personalisation components to a combined lifestyle intervention program.

The effect of extended personalisation components to a combined lifestyle intervention program. - Personalised combined lifestyle intervention (Slimmer-Personalised)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON51873
Enrollment
120
Registered
2020-12-07
Start date
2021-02-18
Completion date
Unknown
Last updated
2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

overgewicht en obesitas fatness obesity

Interventions

Intervention: All participants will be followed during the first 6 months of the SLIMMER program. In participants in the control group, fasting blood will be drawn at the beginning and end of the st

Sponsors

TNO
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: • 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).

Exclusion criteria

Exclusion criteria: 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 21 units/week • Recent blood donation (

Design outcomes

Primary

MeasureTime frame
Main study parameters/endpoints: To examine the effects on of extended personalization to a lifestyle intervention program difference on compliance and physiological responses. The main objective of this study is to achieve better compliance to the lifestyle intervention program, measured by subjective compliance (participants score their degree of compliance with the given lifestyle advice every 3 months and grade the effort, maintenance and appreciation of the intervention program) and objective compliance (based on the *Eetscore* and amount of physical activity, and presence at sessions).

Secondary

MeasureTime frame
The PhenFlex test will be used as a metabolic stress test to examine changes in inflammatory status due to a lifestyle intervention program. With a health patch some physical variables will be measured (ECG, bio-impedance and accelerometry).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jul 23, 2026