Personalised Advice for the Prevention of Metabolic Syndrome

NCT04595669 | Completed

• 1 other identifier: NL61382.028.17
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome, Protection Against

Keywords

personalised dietary advice; metabolic syndrome; dietary behaviour

Outcome Measures

Primary Outcomes (5)

• 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)

• 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)

• 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)

• Consumer experiences

  Questionnaire to evaluate experiences with personalized advice and feedback

  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

  Baseline (week 0) and study end (week 16)

Secondary Outcomes (7)

• Waist circumference

  Baseline (week 0), halfway (week 8) and study end (week 16)

• Body weight

  Baseline (week 0), halfway (week 8) and study end (week 16)

• Blood pressure

  Baseline (week 0), halfway (week 8) and study end (week 16)

• Lipid profile (HDL and LDL cholesterol, triglycerides)

  Baseline (week 0), halfway (week 8) and study end (week 16)

• Glucose

  Baseline (week 0), halfway (week 8) and study end (week 16)

Study Arms (1)

Personalised advice

EXPERIMENTAL

Behavioral: Personalised advise

Interventions

Personalised advise BEHAVIORAL

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

Personalised advice

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wageningen University and Research: lead
• TNO: collaborator
• Philips Healthcare: collaborator
• Friesland Campina: collaborator
• Albert Heijn: collaborator
• Menzis: collaborator
• Smart with food: collaborator
• Vital-10: collaborator
• Dutch Spices: collaborator

Study Sites (1)

Stichting Wageningen Research

Wageningen, Gelderland, 6708 WG, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 34185002 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher, PhD

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: October 20, 2020
• Study Start: September 4, 2017
• Primary Completion: December 21, 2017
• Study Completion: December 21, 2017
• Last Updated: October 23, 2020

Record last verified: 2020-10

Locations

NL (1)