Personalised Advice for the Prevention of Metabolic Syndrome

Metabolic Syndrome, Protection Against Clinical Trial

Official title:

Personalised Dietary Advice for Highly Motivated Consumers at Risk of Metabolic Syndrome - a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04595669
• Other study ID #: NL61382.028.17
• Status: Completed
• Phase: N/A
• Start date: September 4, 2017
• Est. completion date: December 21, 2017

Study information

• Verified date: October 2020
• Source: Wageningen University and Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: December 21, 2017
• Est. primary completion date: December 21, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome, Protection Against
• Syndrome

Intervention

Behavioral:
• Personalised advise
personalised dietary advice in combination with feedback on dietary behaviour and health status (i.e. waist circumference, blood pressure, cholesterol, glucose and triglycerides)

Locations

Country	Name	City	State
Netherlands	Stichting Wageningen Research	Wageningen	Gelderland

Sponsors (9)

Lead Sponsor	Collaborator
Wageningen University and Research	Albert Heijn, Dutch Spices, Friesland Campina, Menzis, Philips Healthcare, Smart with food, TNO, Vital-10

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline (week 0)
Primary	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).	halfway (week 8)
Primary	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).	study end (week 16)
Primary	Consumer experiences	Questionnaire to evaluate experiences with personalized advice and feedback	study end (week 16)
Primary	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	Baseline (week 0) and study end (week 16)
Secondary	Waist circumference	in cm	Baseline (week 0), halfway (week 8) and study end (week 16)
Secondary	Body weight	measured on a calibrated weighing scale to the nearest 0.1 kg	Baseline (week 0), halfway (week 8) and study end (week 16)
Secondary	Blood pressure	in mmHg, measured in finger prick blood by research nurse with the Medisana upper-arm blood pressure monitor	Baseline (week 0), halfway (week 8) and study end (week 16)
Secondary	Lipid profile (HDL and LDL cholesterol, triglycerides)	measured in finger prick blood by research nurse by the Mission Cholesterol 3-1 device	Baseline (week 0), halfway (week 8) and study end (week 16)
Secondary	Glucose	measured in finger prick blood by research nurse by the Meditouch 2 device	Baseline (week 0), halfway (week 8) and study end (week 16)
Secondary	C-peptide	assessed in dried blood spots by high performance liquid chromatography with ultraviolet detection and liquid chromatography mass spectrometry	Baseline (week 0), halfway (week 8) and study end (week 16)
Secondary	Carotenoids in blood	assessed in dried blood spots by high performance liquid chromatography with ultraviolet detection and liquid chromatography mass spectrometry	Baseline (week 0), halfway (week 8) and study end (week 16)