NCT05773625

Brief Summary

The goal of this feasibility study is to get insight into the receptivity of a JITAI aimed at healthy dietary intake in inhabitants of a small city in the Netherlands. The main question it aims to answer is: • what is the right time and the right location to send notifications to people and for what type of interventions are people most receptive? Furthermore, the aim is to get insight into the relevance and usability of the app, the privacy concerns that people have and the perceived effectiveness of the app on dietary intake. Participants will test our app for 2 weeks, of which they will receive prompts during one week.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

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

January 1, 2023

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 12, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 17, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

December 13, 2023

Status Verified

December 1, 2023

Enrollment Period

6 months

First QC Date

January 12, 2023

Last Update Submit

December 5, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Receptivity

    The receptiveness is measured with short questions after each prompt on whether the prompt is opportune. Questions on receptiveness are send after every prompt during one week (second week of the study). Dependent on how many locations people visit at which they receive a prompt.

    Receptivity is measured during one week, after every prompt

Secondary Outcomes (1)

  • Movement patterns

    Location is stored every 5 seconds during two weeks.

Study Arms (1)

Test group of app

OTHER

All participants will first use the app one week without receiving just-in-time notifications. Their movement patterns are collected through GPS. In the second week, they will receive just-in-time notifications based on their chosen goal. Participants will act as their own control group.

Device: Just-In-Time Adaptive Intervention

Interventions

Participants will be exposed to a new innovative app to test.

Test group of app

Eligibility Criteria

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

You may qualify if:

  • Open or motivated to improve their eating behaviour (as this is the target group of the final developed app)
  • Older than 18 years old
  • Living in Wageningen
  • Is able to understand and speak Dutch
  • Having an Android phone

You may not qualify if:

  • Does not have a specific goal to improve eating behaviour
  • Is under 18 years old
  • Does not live in Wageningen
  • Does not speak and/or understand Dutch
  • Does not have an android phone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wageningen University and Research

Wageningen, Netherlands

Location

MeSH Terms

Conditions

Feeding BehaviorChronic Disease

Condition Hierarchy (Ancestors)

Behavior, AnimalBehaviorDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher and lecturer

Study Record Dates

First Submitted

January 12, 2023

First Posted

March 17, 2023

Study Start

January 1, 2023

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

December 13, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations