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Personalised Advice for the Prevention of Metabolic Syndrome

Primary Purpose

Metabolic Syndrome, Protection Against

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Personalised advise
Sponsored by
Wageningen University and Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Metabolic Syndrome, Protection Against focused on measuring personalised dietary advice, metabolic syndrome, dietary behaviour

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Stichting Wageningen Research

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Personalised advice

Arm Description

Outcomes

Primary Outcome Measures

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).
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).
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).
Consumer experiences
Questionnaire to evaluate experiences with personalized advice and feedback
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

Secondary Outcome Measures

Waist circumference
in cm
Body weight
measured on a calibrated weighing scale to the nearest 0.1 kg
Blood pressure
in mmHg, measured in finger prick blood by research nurse with the Medisana upper-arm blood pressure monitor
Lipid profile (HDL and LDL cholesterol, triglycerides)
measured in finger prick blood by research nurse by the Mission Cholesterol 3-1 device
Glucose
measured in finger prick blood by research nurse by the Meditouch 2 device
C-peptide
assessed in dried blood spots by high performance liquid chromatography with ultraviolet detection and liquid chromatography mass spectrometry
Carotenoids in blood
assessed in dried blood spots by high performance liquid chromatography with ultraviolet detection and liquid chromatography mass spectrometry

Full Information

First Posted
October 15, 2020
Last Updated
October 21, 2020
Sponsor
Wageningen University and Research
Collaborators
TNO, Philips Healthcare, Friesland Campina, Albert Heijn, Menzis, Smart with food, Vital-10, Dutch Spices
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1. Study Identification

Unique Protocol Identification Number
NCT04595669
Brief Title
Personalised Advice for the Prevention of Metabolic Syndrome
Official Title
Personalised Dietary Advice for Highly Motivated Consumers at Risk of Metabolic Syndrome - a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
September 4, 2017 (Actual)
Primary Completion Date
December 21, 2017 (Actual)
Study Completion Date
December 21, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wageningen University and Research
Collaborators
TNO, Philips Healthcare, Friesland Campina, Albert Heijn, Menzis, Smart with food, Vital-10, Dutch Spices

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Protection Against
Keywords
personalised dietary advice, metabolic syndrome, dietary behaviour

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Personalised advice
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Personalised advise
Intervention Description
personalised dietary advice in combination with feedback on dietary behaviour and health status (i.e. waist circumference, blood pressure, cholesterol, glucose and triglycerides)
Primary Outcome Measure Information:
Title
Dietary quality at baseline
Description
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).
Time Frame
Baseline (week 0)
Title
Dietary quality halfway
Description
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).
Time Frame
halfway (week 8)
Title
Dietary quality at study end
Description
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).
Time Frame
study end (week 16)
Title
Consumer experiences
Description
Questionnaire to evaluate experiences with personalized advice and feedback
Time Frame
study end (week 16)
Title
Changes in Self perceived health during study period
Description
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
Time Frame
Baseline (week 0) and study end (week 16)
Secondary Outcome Measure Information:
Title
Waist circumference
Description
in cm
Time Frame
Baseline (week 0), halfway (week 8) and study end (week 16)
Title
Body weight
Description
measured on a calibrated weighing scale to the nearest 0.1 kg
Time Frame
Baseline (week 0), halfway (week 8) and study end (week 16)
Title
Blood pressure
Description
in mmHg, measured in finger prick blood by research nurse with the Medisana upper-arm blood pressure monitor
Time Frame
Baseline (week 0), halfway (week 8) and study end (week 16)
Title
Lipid profile (HDL and LDL cholesterol, triglycerides)
Description
measured in finger prick blood by research nurse by the Mission Cholesterol 3-1 device
Time Frame
Baseline (week 0), halfway (week 8) and study end (week 16)
Title
Glucose
Description
measured in finger prick blood by research nurse by the Meditouch 2 device
Time Frame
Baseline (week 0), halfway (week 8) and study end (week 16)
Title
C-peptide
Description
assessed in dried blood spots by high performance liquid chromatography with ultraviolet detection and liquid chromatography mass spectrometry
Time Frame
Baseline (week 0), halfway (week 8) and study end (week 16)
Title
Carotenoids in blood
Description
assessed in dried blood spots by high performance liquid chromatography with ultraviolet detection and liquid chromatography mass spectrometry
Time Frame
Baseline (week 0), halfway (week 8) and study end (week 16)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Stichting Wageningen Research
City
Wageningen
State/Province
Gelderland
ZIP/Postal Code
6708 WG
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
34185002
Citation
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.
Results Reference
derived

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Personalised Advice for the Prevention of Metabolic Syndrome

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