In the current pilot-study, we will focus on demonstrating whether personalisation improves compliance with advice on diet and physical activity patterns in a population of community-dwelling seniors. This advice will be based on personal preference…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
spiergezondheid
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
On a weekly basis, participants will be asked to score the degree of compliance
with the received advice on a 10 cm unstructured line scale with two anchors on
10% and 90% of the scale (very low and very high). By monitoring the degree of
implementation during the intervention period, both trends within individuals
and between groups can be observed.
Furthermore, the degree of compliance with the advice can be assessed based on
dietary intake data as registered in the 'Eetmeter' (an online food diary
developed by the 'Dutch nutrition centre'), and the results of the activity
tracker.
Secondary outcome
In addition, physical performance, handgrip strength, sedentary behaviour,
quality of life, parameters of metabolic health status, protein and lipid
profiles in responses to a challenge test, parameters of glycaemic control and
patient specific complaints will be measured both at baseline and end.
Background summary
A healthy diet with adequate protein and energy content and regular physical
exercise have been shown to limit and treat age-related declines in muscle
mass, strength, and functional abilities. Improving diet and lifestyle
behaviours in view of optimizing muscle health requires behaviour change
strategies. Previous studies have shown that personalized feedback and advice
are more effective than giving general information for improving dietary
patterns and increasing physical activity.
Study objective
In the current pilot-study, we will focus on demonstrating whether
personalisation improves compliance with advice on diet and physical activity
patterns in a population of community-dwelling seniors. This advice will be
based on personal preference, genotype, phenotype and measures of personal
muscle health status as well as socio-psychological factors. These data will be
combined in decision trees leading to optimal, personalised advice that is
expected to give higher compliance with positive effects on muscle health.
Furthermore, the secondary objective of this pilot-study is to gain insight
into the varation of different parameters of muscle health among
community-dwelling seniors.
Study design
Single-blind randomised intervention study with a duration of 9 weeks
Intervention
Every three weeks, participants will receive advice on diet and physical
activity patterns with personalised content and communicated in personalised
form. Content of the advice will be personalised based on cut-off scores on
personal health measures (i.e. parameters of metabolic health, genetic
variation (SNP), nutrient intake, anthropometry, physical activity, patient
specific complaints, quality of life and vitality) and the form will be
modified based on socio-psychological factors (freedom of choice, self-efficacy
and implementation intentions).
Study burden and risks
The risks associated with participation can be considered negligible and the
burden can be considered minimal. There are no special risks for participation
in this study. The included personal advices are based on personal
possibilities and do not pose any health risks. Subjects will not be supplied
with an investigational product. The non-investigational product used (the
PhenFlex challenge) is only used at baseline and at the end as a test method
and is a safe food product. Therefore subjects are not exposed to additional
risks.
Utrechtseweg 48
Zeist 3704 HE
NL
Utrechtseweg 48
Zeist 3704 HE
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, subjects must meet all of the following criteria:
* They have signed the informed consent
* They are * 60 years old
* They are considered healthy based on the 'Health and Lifestyle questionnaire' (F1_1_screening questionnaire)
* They have a Body Mass Index of 20-30 kg/m2
* They perform sedentary behaviour for at least 10 hours per day
* They are able and willing to use self-monitoring devices
* They have a desktop or laptop with internet access at home
Exclusion criteria
Potential subjects who meet any of the following criteria will be excluded from participation in this study:
* They use medication known for its effects on blood glucose, cholesterol or insulin
* They have a history of medical or surgical events that may significantly affect the study outcome, including physical limitations, cardio-vascular events or cerebro vascular accident as assessed by the 'Health and Lifestyle questionnaire' (F1_1_screening questionnaire)
* They are rehabilitating
* They have a pacemaker
* They are currently suffering from diabetes type I or type II as determined by the general practitioner
* They follow a specific diet (e.g. slimming diet or medically prescribed diet)
* They have physical, mental or practical limitations in using computerized systems
* They have an alcohol consumption > 28 units/week for males and > 21 units (drinks)/week for females
* They experienced unintended weight loss or weight gain of > 2 kg in the three months prior to the screening
* They do not accept that the general practitioner will be informed about participation of the study
* They are away for a longer period of time during the intervention period
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 | NL53218.081.15 |