Objective: We aim to assess 1) whether subjects will show better compliance when the lifestyle intervention is more personalised (using TNO tools and techniques) compared to the regular lifestyle intervention, and 2) the effectiveness of the…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
overgewicht en obesitas
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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).
Background summary
Rationale: Obesity and type 2 diabetes have become a global health concern. A
healthier lifestyle can remit or reverse type 2 diabetes, which could be more
effective than medication, e.g. metformin. Furthermore, a healthy lifestyle can
improve low-grade inflammation and improve the composition of the microbiome.
Yet, achieving and containing a healthier lifestyle behaviour is difficult.
Personalization, i.e. tailoring to an individual*s needs and preferences, is an
important factor for achieving sustainable healthy lifestyle habits. The
*SLIMMER* combined dietary and exercise program is one of the effective
interventions in the Netherlands, that has been included in the basic package
of the health care provider.
The extension of the research period corresponds to the duration of the regular
SLIMMER programme. We would like to evaluate the effectiveness of the entire
intervention and therefore also examine the effects in the long term.
Study objective
Objective: We aim to assess 1) whether subjects will show better compliance
when the lifestyle intervention is more personalised (using TNO tools and
techniques) compared to the regular lifestyle intervention, and 2) the
effectiveness of the combined dietary and physical activity intervention on
metabolism and inflammatory status. Furthermore, we aim to explore the possible
effects of a combined lifestyle intervention on mycobiome and microbiome
composition in the intestine. We hypothesize that better compliance may
eventually lead to more effective life style behavior change.
The long-term findings and possible differences in compliance as a result of
the personalisation are also interesting data for publication.
Study design
Study design: The study will be designed as a randomized, parallel, open label,
intervention study. The intervention in this study consists of two arms: one
intervention group (n=60) and one control group (n=60).
tests will be conducted before and after the intensive first six months at
month 0 and month 6.
Data of various questionnaires at 12 and 24 months of the study will be
collected. Physical data of these timepoints will be requested from
thelifestyle coach.
Intervention
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 study. Participants in the
intervention group receive the same care as the control group, but with
personalisation tools on top of it. These items include: more personalized
dietary and exercise advice based on a mixed meal challenge (PhenFlex), 360
degrees diagnosis, self-monitoring, personalized digital behavioural support,
intermediate feedback based on lab values and behaviour, and blended care.
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: Participants follow the SLIMMER program. For
study purposes, at the beginning and at the end of the intervention, subjects
will visit TNO for a test day. Blood samples will be drawn to examine the
metabolic response to the PhenFlex, metabolic stress test. A fecal sample swab
will be collected in the week before each test. During the study some
questionnaires need to be completed. During the combined lifestyle intervention
subjects will participate in multiple group exercise- and coaching sessions and
some individual sessions. Subjects will be monitored continuously by
physiotherapists, dieticians, lifestyle coaches and the general practitioners
(assistant). No risk or real burden is of concern in this study.
Utrechtseweg 48
Zeist 3704 HE
NL
Utrechtseweg 48
Zeist 3704 HE
NL
Listed location countries
Age
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
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL75482.028.20 |
| Other | NL9145 |