The primary objective is to investigate the potential of personalised dietary advice and feedback for initiating and maintaining dietary changes by consumers at risk of MetS. In addition we want to evaluate understanding, applicability and personal…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
metabool syndroom
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcomes of the study are the adequacy of intake of fruits, vegetables,
whole grain products, dairy, fish, fats & oils, red meat, processed meat, and
sweetened beverages & fruit juices as estimated by the online tool Eetscore.
Furthermore consumer experiences and individual benefits of the provided
personalised dietary advice are monitored on a weekly basis throughout the
intervention period.
Secondary outcome
* Parameters of metabolic health status measured with do-it-yourself methods or
based on fingerprick blood (t=0, t=8, t=16)
o Body Mass Index (BMI) [kg/m2]
o Waist circumference [cm]
o Blood pressure
o Fasting glucose
o Fasting cholesterol
o Fasting triglycerides
o Fasting insulin
o Fasting c-peptide
* Parameters of metabolic health status measured in venous blood (t=16)
o Fasting glucose
o Fasting cholesterol
o Fasting triglycerides
o Fasting insulin
o Fasting c-peptide
* Vitality (t=0, t=16)
Vitality will be assessed through a short vitality questionnaire (Vita-16)
addressing the core dimensions of vitality: energy, motivation and resilience.
Background summary
Improving dietary behaviours in view of optimising risk factors of metabolic
syndrome (MetS) requires behaviour change strategies. Tailored dietary advice,
i.e. recommendation offered as a guide to action, can support behaviour change.
In the current pilot-study we aim to learn how to better help consumers in
their daily life to make lifestyle choices that better match their personal
health target than their usual choices by providing personalised advice and
feedback. In this pilot-study we target consumers at risk of metabolic syndrome
that are highly motivated to change their dietary behaviour in view of
improving health.
Study objective
The primary objective is to investigate the potential of personalised dietary
advice and feedback for initiating and maintaining dietary changes by consumers
at risk of MetS. In addition we want to evaluate understanding, applicability
and personal benefit of personalised dietary advice and feedback by the target
population to be able to further optimize the personalisation in a future
study. The secondary objective is to explore potential effects of personalised
dietary advice and feedback on subjective health and metabolic health
parameters. Also, we want to validate metabolic health parameters analysed in
fingerprick blood with parameters analysed en in venous blood.
Study design
The pilot-study follows a one group pre-test post-test design with a duration
of 16 weeks after receipt of the first advice.
Intervention
The intervention consists of personalised dietary advice and feedback on actual
behaviour and health status that will be provided to study participants at set
time points throughout the study period. The content of the advice will be
generated partly automated based on dietary intake and parameters of metabolic
health using knowledge rules that are developed for this study. During a
consultation with the dietician, the advice is then translated in a dietary
behaviour change strategy by taking into account individual preferences through
motivational interviewing
Study burden and risks
The risks associated with participation in this pilot-study can be considered
negligible and the burden of the study is in line with the possible gains for
the participants. There are no special risks for participation in this study.
The included personal advices follow national food-based dietary guidelines and
are based on personal possibilities. Although the study includes some invasive
measurements (blood collection through fingerprick method or voluntary venous
puncture), these do not pose any health risks. Subjects will not be supplied
with an investigational medical 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.
Nieuwe Kanaal 9a
Wageningen 6709 PA
NL
Nieuwe Kanaal 9a
Wageningen 6709 PA
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
* Having given written informed consent
* Aged 40 years or over
* At risk of metabolic syndrome (i.e. high waist circumference AND one of the following metabolic abnormalities: Elevated triglycerides, reduced HDL, high blood pressure or elevated fasting glucose
* Motivated to change behaviour as assessed with short questionnaire on intrinsic motivation
* Willing to use technology (digital platforms, activity tracker, digital questionnaires, apps)
* Customer of Albert Heijn (at least 1x per week) and at least 3 months in possession of a registered Bonuskaart
* Willing to share food purchase data registered by the Bonuskaart with the investigators
* In possession of I-phone or mobile phone with android system (because of activity tracker)
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
* Use of medication known for its effects on blood glucose, cholesterol or insulin
* Suffering from diabetes
* Familial hypercholesterolemia
* Following a specific diet
* Having an alcohol consumption > 28 units/week for males and > 21 units (drinks)/week for females
* Does not accept that the general practitioner will be informed about participation of the study
* Having holidays planned for a period of more than two weeks during the intervention period
Design
Recruitment
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL61382.028.17 |