This project therefore adopts an urgently needed comprehensive individualized approach. We characterize each participant in a large sample of individuals varying in bodyweight by their own baseline comprehensive profile, including person…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Obesitas, overgewicht
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
At baseline, a comprehensive set of variables will be assessed, all of which
have been associated with overweight and obesity in previous empirical studies.
These include biomedical variables (e.g., ghrelin and leptin), psychological
variables (e.g., depressive symptoms), person characteristics (e.g., age),
environmental variables (e.g., neighbourhood safety) and behavioural variables
(e.g., usual eating habits). It In addition, we will collect time-series data
on (un)healthy eating and physical (in)activity, and predictors of these
behaviours (e.g., emotions) in daily life, both at baseline and after
intervention.
Secondary outcome
Not applicable
Background summary
Overweight is the largest and most prevalent modifiable risk factor for health
problems, and significantly contributes to healthcare costs. Researchers
generally agree that overweight is multifactorially determined, including
biomedical, behavioral, environmental, and psychological mechanisms. There is
empirical support for each of these mechanisms, but often evidence is not
consistent across studies, effect sizes are modest at best, and variability on
outcome-measures across participants in a study is often large. This suggests
that contributing factors to overweight likely differ across people. Similarly,
treatments for overweight are, on average, only modestly effective and
individual variability in weight-loss-response to treatment is large.
Study objective
This project therefore adopts an urgently needed comprehensive individualized
approach. We characterize each participant in a large sample of individuals
varying in bodyweight by their own baseline comprehensive profile, including
person characteristics, biological, psychological, environmental, and
behavioral variables. Next, we investigate how baseline comprehensive
individual profiles cluster in a meaningful way, and relate to bodyweight at
baseline, post-treatment, and follow-up. We also test if results for weight
change are moderated by treatment-condition: Intensive Lifestyle Intervention
(ILI) versus lifestyle-information control group.
Moreover, we investigate how these individual profiles translate to behavior in
daily life. We collect time-series data on (un)healthy eating and physical
(in)activity, and predictors of these behaviors (e.g., emotions, stress) in
daily life during three weeks at baseline and three weeks post-treatment. Based
on these time-series data, we estimate daily lifestyle networks per individual
(baseline/post-treatment), and relate these to the comprehensive individual
profiles. Moreover, we investigate how these daily lifestyle networks relate to
bodyweight, and change over time, dependent on treatment condition. We
hypothesize that*after ILI and mostly with more weight loss*healthy behaviors
increase, and predictors link with healthy behaviors more frequently in these
networks. The proposed research puts the individual center stage, paving the
way for personalized interventions.
Study design
This study, will use an open study design with 3 parallel groups.
Intervention
The participants with overweight and obesity are randomly assigned to either an
intensive lifestyle intervention or a lifestyle-information control group.
Study burden and risks
All participants need to take part in a measurement day at our centre, during
which a BodPod measurement is performed, three blood samples are obtained, and
a physical fitness test is performed. In addition, they will fill out a set of
standardized questionnaires via Qualtrics and will take part in two 3-week
periods of ecological momentary assessment (EMA) via smartphone and wear a
provided activity tracker. The EMA-protocol will prompt participants 8 times a
day to answer questions on their smartphone about variables such as food
craving, emotions and stress.
Universiteitssingel 40
Maastricht 6229 ER
NL
Universiteitssingel 40
Maastricht 6229 ER
NL
Listed location countries
Age
Inclusion criteria
1. Is informed and has been given a minimum of 7 days to consider participation
and has given informed consent in writing; 2. Is male or female and in the age
range between 18 and 65 years (inclusive); 3. Has a body mass index (BMI) in
one of the following ranges - Healthy weight: >=18.5 and <=25.0 kg/m2; -
Overweight: >25.0 and <=30.0 kg/m2; - Obese: >30.0 kg/m2 4. Is a fluent Dutch
speaker. 5. Has been weight stable (±3 kg) for the past three months.
Exclusion criteria
1. Female participant who is pregnant;
2. Is currently in specialized treatment for overweight/obesity;
3. Is currently in specialized treatment for a mental disorder;
4. Has had gastric surgery;
5. Is taking medication for chronic conditions such as diabetes, pulmonary
disease, and heart and vascular disease that interfere with the measurements of
the current study.
6. Is not capable of taking part in all measurements;
7. Is physically disabled.
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 | NL81710.068.23 |