Metabolic Syndrome, Protection AgainstNCT04595669
Personalised Advice for the Prevention of Metabolic Syndrome
A study testing Personalised advise in people with Metabolic Syndrome, Protection Against, run by Wageningen University and Research at 1 site in Netherlands.
Trial summary
Rationale: Improving dietary behaviours in view of optimising risk factors of metabolic syndrome requires behaviour change strategies. Tailored dietary advice, i.e. recommendations offered as a guide to action, can support behaviour change. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Protection Against
- What is being tested?
- Personalised advise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteNetherlands
- Study dates
- 4 Sep 2017to 21 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Having given written informed consent
- Aged 40 years or over
- At risk of metabolic syndrome
- Motivated to change behaviour
- Willing to use technology (digital platforms, activity tracker, digital questionnaires, apps)
- Customer of supermarket Albert Heijn (at least 1x per week) and in possession of customer card
- Willing to share food purchase data as registered with the Bonuskaart with the investigators
- In possession of I-phone or mobile phone with android system
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Stichting Wageningen Research
Wageningen, Gelderland, 6708 WG
About this study
Official title: Personalised Dietary Advice for Highly Motivated Consumers at Risk of Metabolic Syndrome - a Pilot Study
Rationale: Improving dietary behaviours in view of optimising risk factors of metabolic syndrome requires behaviour change strategies. Tailored dietary advice, i.e. recommendations offered as a guide to action, can support behaviour change. In the current 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 study we target consumers at risk of metabolic syndrome (MetS) that are highly motivated to change their dietary behaviour in view of improving health.
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 future studies. The secondary objective is to explore potential effects of personalised dietary advice and feedback on subjective health and metabolic health parameters.
Read more
Study design: The study follows a one group pre-test post-test design with a duration of 16 weeks after the first advice is provided to the participants.
Study population: In total 40 adult men and women at risk of metabolic syndrome will be recruited from the consumer databases of Wageningen Food \& Biobased Research. Consumers are eligible for study participation when they are highly motivated to change dietary behaviour, willing to use technology, willing to share food purchase data as registered on a customer card of the supermarket, and in possession of a smart-phone.
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.
Main study parameters/endpoints: 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.
- Conditions
- Metabolic Syndrome, Protection Against
- Being tested
- Personalised advise
- Keywords
- personalised dietary advice, metabolic syndrome, dietary behaviour
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalised adviseBehavioural
personalised dietary advice in combination with feedback on dietary behaviour and health status (i.e. waist circumference, blood pressure, cholesterol, glucose and triglycerides)
| Study group | Role | What they receive |
|---|---|---|
| Personalised advice | Experimental | Not described Receives: Behavioral: Personalised advise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dietary quality at baseline
Dietary quality was assessed by an online version of the Dutch Healthy Diet Index (DHDI) ('Eetscore', Division of Human Nutrition, Wageningen University). The DHDI evaluates adherence to the Dutch dietary guidelines per food category (score 1-10) and a total score (score 8-80).
Measured: Baseline (week 0)
Dietary quality halfway
Dietary quality was assessed by an online version of the Dutch Healthy Diet Index (DHDI) ('Eetscore', Division of Human Nutrition, Wageningen University). The DHDI evaluates adherence to the Dutch dietary guidelines per food category (score 1-10) and a total score (score 8-80).
Measured: halfway (week 8)
Dietary quality at study end
Dietary quality was assessed by an online version of the Dutch Healthy Diet Index (DHDI) ('Eetscore', Division of Human Nutrition, Wageningen University). The DHDI evaluates adherence to the Dutch dietary guidelines per food category (score 1-10) and a total score (score 8-80).
Measured: study end (week 16)
Consumer experiences
Questionnaire to evaluate experiences with personalized advice and feedback
Measured: study end (week 16)
Changes in Self perceived health during study period
questionnaire to evaluate 1-self-perceived health status, 2-healthiness of the diet and 3-satisfaction with actual diet. Items All items were evaluated on a 7-point scale. For items 1 and 2, the scale ranged from 1=very unhealthy up to 7=very healthy. For item 3, the scale ranged from 1=very unsatisfied up to 7=very satisfied
Measured: Baseline (week 0) and study end (week 16)
Secondary outcomes (7)
Waist circumference
in cm
Measured: Baseline (week 0), halfway (week 8) and study end (week 16)
Body weight
measured on a calibrated weighing scale to the nearest 0.1 kg
Measured: Baseline (week 0), halfway (week 8) and study end (week 16)
Blood pressure
in mmHg, measured in finger prick blood by research nurse with the Medisana upper-arm blood pressure monitor
Measured: Baseline (week 0), halfway (week 8) and study end (week 16)
Lipid profile (HDL and LDL cholesterol, triglycerides)
measured in finger prick blood by research nurse by the Mission Cholesterol 3-1 device
Measured: Baseline (week 0), halfway (week 8) and study end (week 16)
Glucose
measured in finger prick blood by research nurse by the Meditouch 2 device
Measured: Baseline (week 0), halfway (week 8) and study end (week 16)
C-peptide
assessed in dried blood spots by high performance liquid chromatography with ultraviolet detection and liquid chromatography mass spectrometry
Measured: Baseline (week 0), halfway (week 8) and study end (week 16)
Carotenoids in blood
assessed in dried blood spots by high performance liquid chromatography with ultraviolet detection and liquid chromatography mass spectrometry
Measured: Baseline (week 0), halfway (week 8) and study end (week 16)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start4 Sep 2017
- Primary completion21 Dec 2017
- Study completion21 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic Syndrome, Protection AgainstStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University and Research
- Sponsor type
- University, hospital or other
- Collaborators
- TNO, Philips Healthcare, FrieslandCampina N.V., Albert Heijn, Menzis, Smart with food, Vital-10, Dutch Spices
- Responsible party
- Principal investigator, Diederik Esser, Wageningen University and Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04595669
- Sponsor's protocol ID
- NL61382.028.17
- Status last verified
- Oct 2020
- First submitted
- 15 Oct 2020
- Last updated
- 23 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
van der Haar S, Hoevenaars FPM, van den Brink WJ, van den Broek T, Timmer M, Boorsma A, Doets EL. Exploring the Potential of Personalized Dietary Advice for Health Improvement in Motivated Individuals With Premetabolic Syndrome: Pretest-Posttest Study. JMIR Form Res. 2021 Jun 24;5(6):e25043. doi: 10.2196/25043.
PubMed 34185002
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalised Dietary Advice for Highly Motivated Consumers at Risk of Metabolic Syndrome - a Pilot Study
- ClinicalTrials.gov ID
- NCT04595669
- Acronym / sponsor ID
- NL61382.028.17
- Conditions
- Metabolic Syndrome, Protection Against
- Keywords
- personalised dietary advice, metabolic syndrome, dietary behaviour
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Wageningen University and ResearchUniversity, hospital or other
- Collaborators
- TNO, Philips Healthcare, FrieslandCampina N.V., Albert Heijn, Menzis, Smart with food, Vital-10, Dutch Spices
- Study start
- 4 Sep 2017 (actual)
- Primary completion
- 21 Dec 2017 (actual)
- Study completion
- 21 Dec 2017 (actual)
- First posted
- 20 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rationale: Improving dietary behaviours in view of optimising risk factors of metabolic syndrome requires behaviour change strategies. Tailored dietary advice, i.e. recommendations offered as a guide to action, can support behaviour change. In the current 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 study we target consumers at risk of metabolic syndrome (MetS) that are highly motivated to change their dietary behaviour in view of improving health.
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 future studies. The secondary objective is to explore potential effects of personalised dietary advice and feedback on subjective health and metabolic health parameters.
Study design: The study follows a one group pre-test post-test design with a duration of 16 weeks after the first advice is provided to the participants.
Study population: In total 40 adult men and women at risk of metabolic syndrome will be recruited from the consumer databases of Wageningen Food \& Biobased Research. Consumers are eligible for study participation when they are highly motivated to change dietary behaviour, willing to use technology, willing to share food purchase data as registered on a customer card of the supermarket, and in possession of a smart-phone.
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.
Main study parameters/endpoints: 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Personalised advice | Experimental | Behavioral: Personalised advise |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Having given written informed consent
- Aged 40 years or over
- At risk of metabolic syndrome
- Motivated to change behaviour
- Willing to use technology (digital platforms, activity tracker, digital questionnaires, apps)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalised advisepersonalised dietary advice in combination with feedback on dietary behaviour and health status (i.e. waist circumference, blood pressure, cholesterol, glucose and triglycerides) | Behavioural | Personalised advice |
Primary outcome
Dietary quality at baseline
Time frame: Baseline (week 0)
Dietary quality was assessed by an online version of the Dutch Healthy Diet Index (DHDI) ('Eetscore', Division of Human Nutrition, Wageningen University). The DHDI evaluates adherence to the Dutch dietary guidelines per food category (score 1-10) and a total score (score 8-80).
Dietary quality halfway
Time frame: halfway (week 8)
Dietary quality was assessed by an online version of the Dutch Healthy Diet Index (DHDI) ('Eetscore', Division of Human Nutrition, Wageningen University). The DHDI evaluates adherence to the Dutch dietary guidelines per food category (score 1-10) and a total score (score 8-80).
Dietary quality at study end
Time frame: study end (week 16)
Dietary quality was assessed by an online version of the Dutch Healthy Diet Index (DHDI) ('Eetscore', Division of Human Nutrition, Wageningen University). The DHDI evaluates adherence to the Dutch dietary guidelines per food category (score 1-10) and a total score (score 8-80).
Consumer experiences
Time frame: study end (week 16)
Questionnaire to evaluate experiences with personalized advice and feedback
Changes in Self perceived health during study period
Time frame: Baseline (week 0) and study end (week 16)
questionnaire to evaluate 1-self-perceived health status, 2-healthiness of the diet and 3-satisfaction with actual diet. Items All items were evaluated on a 7-point scale. For items 1 and 2, the scale ranged from 1=very unhealthy up to 7=very healthy. For item 3, the scale ranged from 1=very unsatisfied up to 7=very satisfied
7 secondary outcomes
Waist circumference
Time frame: Baseline (week 0), halfway (week 8) and study end (week 16)
Body weight
Time frame: Baseline (week 0), halfway (week 8) and study end (week 16)
Blood pressure
Time frame: Baseline (week 0), halfway (week 8) and study end (week 16)
Lipid profile (HDL and LDL cholesterol, triglycerides)
Time frame: Baseline (week 0), halfway (week 8) and study end (week 16)
Glucose
Time frame: Baseline (week 0), halfway (week 8) and study end (week 16)
C-peptide
Time frame: Baseline (week 0), halfway (week 8) and study end (week 16)
Carotenoids in blood
Time frame: Baseline (week 0), halfway (week 8) and study end (week 16)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2020.
- Derived from this study: PubMed 34185002van der Haar S, Hoevenaars FPM, van den Brink WJ, van den Broek T, Timmer M, Boorsma A, Doets EL. Exploring the Potential of Personalized Dietary Advice for Health Improvement in Motivated Individuals With Premetabolic Syndrome: Pretest-Posttest Study. JMIR Form Res. 2021 Jun 24;5(6):e25043. doi: 10.2196/25043.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalised advise in people with Metabolic Syndrome, Protection Against, run by Wageningen University and Research at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dietary quality at baseline (time frame: Baseline (week 0)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04595669, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2020.