NCT04510883

Brief Summary

Rationale: Embodied Conversational Agents (ECAs), could be a highly effective medium to address health behaviour change among older adults. As compliance to health advice is important for positive health outcomes, successful design of persuasive ECAs can have huge health benefits. However, insights in the mechanisms underlying usage and health behaviour change via ECAs are lacking. Objective: The objective is to unravel the mechanisms behind the use of an ECA intervention, and understand the mechanism behind the observed behaviour change Study design: A randomized staggered-entry waitlist-controlled trial will be carried out. Study population: The study population consist of Dutch-speaking older adults, who live independently, are without partner, are retired, 65+ and possess basic computer skills. Intervention: The application PACO has been created for (and with) older adults with the goal to motivate them to improve their eating behaviour and decrease their feelings of loneliness. Main study parameters/endpoints: The main study parameters are use, loneliness, and eating behaviour. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Subjects are not exposed to any risks, nor have they any costs. They do have to fill in questionnaires and use the application. The duration and data collection moments are needed to gain a fine-grained understanding of the use, relationship development and health change process. For subjects, the main benefit is to gain insight in their health behaviour via the PACO-application. Although this might be experienced as confronting by some. The technology was developed based on sound theories, with input from the target group, so the investigators expect positive experiences and an improvement in participants loneliness and eating behaviour. However, this can only be proven after the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

July 13, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 12, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

April 8, 2021

Status Verified

April 1, 2021

Enrollment Period

6 months

First QC Date

July 13, 2020

Last Update Submit

April 6, 2021

Conditions

Keywords

eHealthEmbodied Conversational AgentTechnology use

Outcome Measures

Primary Outcomes (3)

  • Logdata on use application

    Amount of time spend on the application during the 8 weeks intervention period

    8 weeks

  • Change in De Jong Gierveld Loneliness Scale

    Score from 1-5, higher score means a better outcome.

    Four weeks before intervention to eight weeks

  • Change in eating behaviour based on 24 hours recall

    Four weeks before intervention to eight weeks

Secondary Outcomes (9)

  • Enjoyment via affect scale

    Eight weeks after intervention

  • Classic aesthetics Scale

    Eight weeks after intervention

  • Concern for privacy scale

    Four and eight weeks after intervention

  • Active control scale

    Eight weeks after intervention

  • System Usability Scale

    Eight weeks after intervention

  • +4 more secondary outcomes

Other Outcomes (2)

  • Willingness to pay single questions

    Eight weeks after intervention

  • User experience via self-formulated open question

    Four and eight weeks after intervention

Study Arms (2)

PACO

EXPERIMENTAL

Participants are asked to use the intervention for eight weeks.

Behavioral: PACO

Waiting list + PACO

OTHER

Participants receive the same intervention, but only after a waiting period of four weeks.

Behavioral: Waiting list + PACO

Interventions

PACOBEHAVIORAL

The intervention is a fully-automated web-based eHealth application in which two embodied conversational agents engage in dialogue with older adults in order to motivate them towards dietary behavior change and decrease loneliness. The application consists of five different modules, each one applying different behavior change techniques.

PACO

Waiting list + PACO

Waiting list + PACO

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Living independently at home
  • Living without a partner
  • No paid profession and at least 65 years of age
  • Dutch speaking
  • Able to use a tablet or computer
  • Internet connection at home

You may not qualify if:

  • Not willing to provide inform consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wageningen University & Research

Wageningen, Gelderland, 6706 KN, Netherlands

Location

Related Publications (2)

  • Kramer LL, van Velsen L, Clark JL, Mulder BC, de Vet E. Use and Effect of Embodied Conversational Agents for Improving Eating Behavior and Decreasing Loneliness Among Community-Dwelling Older Adults: Randomized Controlled Trial. JMIR Form Res. 2022 Apr 11;6(4):e33974. doi: 10.2196/33974.

  • Kramer LL, Mulder BC, van Velsen L, de Vet E. Use and Effect of Web-Based Embodied Conversational Agents for Improving Eating Behavior and Decreasing Loneliness Among Community-Dwelling Older Adults: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Jan 6;10(1):e22186. doi: 10.2196/22186.

MeSH Terms

Conditions

Feeding Behavior

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Intervention Hierarchy (Ancestors)

Appointments and SchedulesOrganization and AdministrationHealth Services Administration

Study Officials

  • Emely de Vet, PhD

    Wageningen University & Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Model Details: An unblinded randomized controlled trial. Participants in the first cohort directly receive the intervention for 8 weeks. Participants in the second cohort receive the intervention after a waiting list condition of 4 weeks, serving as a control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

July 13, 2020

First Posted

August 12, 2020

Study Start

July 13, 2020

Primary Completion

December 30, 2020

Study Completion

December 30, 2020

Last Updated

April 8, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will share

In accordance with the Data Management Plan, part of the data will be anonymized and made available in DANS-EASY with restricted access.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
The data will become available within 12 months after the end of the study.

Locations