NCT05884489

Brief Summary

The study is a pilot study (phase 2) that includes a usability study (phase 1). The aim of the study is to investigate the feasibility and usability of the healthy nutrition application and the effects on adherence to Modified Mediterranean diet, self-efficacy and nutrition knowledge among patients with cardiovascular disease in a cardiac rehabilitation setting. Furthermore, it studies the overall user experience when using the healthy nutrition application.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 12, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 12, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 1, 2023

Completed
Last Updated

June 1, 2023

Status Verified

May 1, 2023

Enrollment Period

4 months

First QC Date

May 9, 2023

Last Update Submit

May 22, 2023

Conditions

GamificationNutritionBehavior Change

Keywords

GamificationSmartphoneMediterranean dietNutritionCardiovascular diseasesIntervention

Outcome Measures

Primary Outcomes (4)

  • Usability

    The usability questionnaire asks patients to evaluate various components of the application based on perceived usefulness, ease of use and ease of understanding, as well as visual attractiveness and contains various questions specific to each component. The questionnaire includes 109 questions, we use 5-point Likert scale. The higher score means better usability.

    Six week

  • Motivation

    Motivation is measured by Intrinsic Motivation Inventory(IMI), it includes 18 items, we use 5-point Likert scale, the scores range from 18 to 90. Higher score means higher motivation.

    Six week

  • Application visits

    Usability is also measured by the objective index "application visits", the visits to each page/component of the application during the whole six week are recorded in the application.

    During the whole six week

  • Acceptance

    The acceptance is measured by Self-reported habit index(SRHI). It includes 12 items, we use 7-point Likert scale. Scores ranged from 12 to 84. The higher the score, the higher the acceptability.

    Six week

Secondary Outcomes (4)

  • Change from baseline Adherence to Mediterranean diet at 6 weeks

    Baseline and six week

  • Change from Self-efficacy at 6 weeks

    Baseline and Six week

  • Change from Knowledge at 6 weeks

    Baseline and six week

  • Digital health literacy

    Baseline

Study Arms (1)

Intervention group

EXPERIMENTAL
Behavioral: A gamified smartphone app-based eating behaviour intervention

Interventions

A gamified smartphone app-based eating behaviour interventionBEHAVIORAL

All patients gained access to the healthy nutrition application and were encouraged to make full use of its feature, and they were also required to maintain a logbook through the application at home to follow-up on their diet. The intervention last for six weeks.

Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • History of cardiovascular disease with or without intervention (PCI/CABG/conservative/pacemaker implantation/ablation)
  • History of current or past cardiac rehabilitation in Jessa Hospital Hasselt
  • Current treatment must require them to follow the Mediterranean diet plan
  • Age ≥18 years
  • Willing and physically able to follow a application-based healthy nutrition program and other study procedures in a six-week follow-up period
  • Evidence of a personally signed and dated informed consent, indicating that the subject (or a legally-recognized representative) has been informed of all pertinent aspects of the study
  • Possession of and/or able to use an Android based smartphone (version 6 or higher)
  • Possession of internet connectivity
  • Dutch speaking and understanding

You may not qualify if:

  • Pregnant females
  • Combined with diabetes or severe kidney disease
  • Participation in other cardiac rehabilitation program trials, focusing on diet outcome
  • Current or recent participation in other technology-supported programs, even when not directly targeting nutrition
  • Any condition which in the opinion of the investigator would make it unsafe or unsuitable for the patient to participate in this study or a life expectancy of less than six weeks based on investigators judgment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiology Department, Jessa Hospital

Hasselt, Limburg, 3500, Belgium

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2023

First Posted

June 1, 2023

Study Start

June 1, 2022

Primary Completion

October 12, 2022

Study Completion

October 12, 2022

Last Updated

June 1, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)