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JITAIs: Optimization of Effectiveness

Primary Purpose

Eating Behavior, Chronic Disease

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Just-In-Time Adaptive Intervention
Sponsored by
Wageningen University and Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Eating Behavior

Eligibility Criteria

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

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Wageningen University and ResearchRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Test group of app

Arm Description

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.

Outcomes

Primary Outcome Measures

Receptivity
The receptiveness is measured with short questions after each prompt on whether the prompt is opportune.

Secondary Outcome Measures

Movement patterns
Movement patterns are collected within the city of Wageningen using GPS.

Full Information

First Posted
January 12, 2023
Last Updated
March 6, 2023
Sponsor
Wageningen University and Research
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT05773625
Brief Title
JITAIs: Optimization of Effectiveness
Official Title
Measuring, Analyzing and Mapping Environmental Influences on (and Changes in) Spatial Patterns: Evidence for Just-in-time Adaptive Interventions
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wageningen University and Research
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development

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
JITAIs have already been developed in the fields of physical activity, smoking, alcohol use and mental illness. Within these fields, results were promising since JITAIs have proven to be effective in changing behaviour. Until now, no JITAIs have been developed that primarily focus on eating behaviour and it is expected that this type of interventions yields great potential in changing eating behaviour. In this pilot study we test our app with the aim to get insight into what factors influence the receptiveness of people. Receptiveness is the person's ability to receive, process, and use the support provided, which is a prerequisite to achieve behaviour change. In the pilot study we want to investigate when and where the right time is to send notifications to people and for what type of interventions people are most receptive. We want to include the inhabitants of Wageningen in our study who will test our app for 2 weeks. In the first week nothing is expected from the participants, but their movement patterns are collected via GPS; the participants are their own control for the Just-In-Time principle. In the second week the participants receive notifications (i.e., a healthy recipe, a tip for the healthier option at a certain location) based on their selected goal (eating more vegetables, eating less meat, less unhealthy snacking). After receiving the notification, participants are asked to answer several questions. At the end of the day, participants are asked to give us more insight in what they like and dislike to receive, at which locations, at what times, how many times a day, and their reasons behind this. With this data we can further develop the app (co-creation). The results of the study will be analysed within persons to visualize patterns. A second goal is to test if the movement patterns of participants can be used to objectively measure if interventions are effective in the future. The movement patterns will be analysed with the use of different algorithms, to see if and how movement patterns can say anything about the behaviour of people (stopping, standing still, alter routes). The movement patterns can be linked to received interventions, locations and receptivity. Within this pilot study, people are not asked to alter their behaviour. Participants do receive notifications that are focussed on making healthier eating choices, but we do not expect any behavioural changes within one week. The goal of the study is to get better insight into the best way to respond to the Just-In-Time principle. Participants will receive zero to several notifications a day for a period of 1 week.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Behavior, Chronic Disease

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Test group of app
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Just-In-Time Adaptive Intervention
Intervention Description
Participants will be exposed to a new innovative app to test.
Primary Outcome Measure Information:
Title
Receptivity
Description
The receptiveness is measured with short questions after each prompt on whether the prompt is opportune.
Time Frame
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.
Secondary Outcome Measure Information:
Title
Movement patterns
Description
Movement patterns are collected within the city of Wageningen using GPS.
Time Frame
Location is stored every 5 seconds during two weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Winkens, Dr.
Phone
0031653882572
Email
laura.winkens@wur.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Monique Simons, Dr.
Email
monique.simons@wur.nl
Facility Information:
Facility Name
Wageningen University and Research
City
Wageningen
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Winkens, Dr.
Phone
0031653882572
Email
laura.winkens@wur.nl

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

JITAIs: Optimization of Effectiveness

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