Obesity
Conditions
Interventions
The study will be designed as a, parallel, open label, intervention study. The intervention in this study consists of two arms: one intervention group and one control group. Participating practices wi
Sponsors
TNO in collaboration with GGD-NOG (owner of SLIMMER)
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria: • Exclusion criteria from the SLIMMER programme: 1) Behavioural problems that obstruct group sessions 2) Cognitive impairment (IQ 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compliance/adherence. Evaluated by: •User experiences (qualitative aspects including effort, maintenance, and appreciation) at the end of the intervention (month 6); •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). | — |
Secondary
| Measure | Time frame |
|---|---|
| • What is the effect of extended personalization to a combined lifestyle intervention program on health status? Measured by: o Well-being (subjective, using the EQ-5 questionnaire at month: t=-1 (before start intervention), t=3 (halfway intervention), and t=6 (end of the intervention) o Anthropometrics (weight, BMI, waist circumference, etc.) before and after the intervention (t=-1 month and t=6 months) o Metabolic resilience before the intervention (month -1 (one month before the start)) (calculate a composite marker in response to the PhenFlex test based on dynamic measurements of glucose, insulin, NEFA, TG, and cholesterol) of blood collected at t=0, 30, 60 120, and 240 minutes after start consumption of PhenFlex drink and after the six months intervention (t=6 months) o HbA1C (fasting) before and after the intervention (t=-1 month and t=6 months) o IFN-?, leptin, high-sensitive C-reactive protein (hsCRP), adiponectin, IL-6, MPO, and IP-10 to calculate an inflammatory score of blood collected at t=0, 30, 60 120, and 240 minutes after start consumption of PhenFlex drink before and after the intervention (t=-1 month and t=6 months). | — |
Contacts
Public ContactWilrike Pasman
TNO
Outcome results
None listed