Eating BehaviorNCT04510883
Usage and Health Effects of Embodied Conversational Agents Among Older Adults
A study testing PACO and Waiting list + PACO in people with Eating Behavior and Loneliness, run by Wageningen University and Research at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Eating Behavior, Loneliness, Technology Use
- What is being tested?
- PACO and Waiting list + PACO
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteNetherlands
- Study dates
- 13 Jul 2020to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- Not willing to provide inform consent
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Wageningen University & Research
Wageningen, Gelderland, 6706 KN
About this study
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
Read more
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.
- Conditions
- Eating Behavior, Loneliness, Technology Use
- Being tested
- PACO, Waiting list + PACO
- Keywords
- eHealth, Embodied Conversational Agent, Technology use
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PACOBehavioural
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.
Waiting list + PACOBehavioural
Waiting list + PACO
| Study group | Role | What they receive |
|---|---|---|
| PACO | Experimental | Participants are asked to use the intervention for eight weeks. Receives: Behavioral: PACO |
| Waiting list + PACO | Other | Participants receive the same intervention, but only after a waiting period of four weeks. Receives: Behavioral: Waiting list + PACO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Logdata on use application
Amount of time spend on the application during the 8 weeks intervention period
Measured: 8 weeks
Change in De Jong Gierveld Loneliness Scale
Score from 1-5, higher score means a better outcome.
Measured: Four weeks before intervention to eight weeks
Change in eating behaviour based on 24 hours recall
Measured: Four weeks before intervention to eight weeks
Secondary outcomes (9)
Enjoyment via affect scale
Pleasure in using the application. Score from 1-5, higher score means a better outcome.
Measured: Eight weeks after intervention
Classic aesthetics Scale
The design of the application. Score from 1-7, higher score means a better outcome.
Measured: Eight weeks after intervention
Concern for privacy scale
Concerns about sharing personal data, e.g.name and date of birth. Score from 1-7, higher score means a better outcome.
Measured: Four and eight weeks after intervention
Active control scale
Control over the system, as perceived by the user. Score from 1-7, higher score means a better outcome.
Measured: Eight weeks after intervention
System Usability Scale
Whether PACO is easy to use. Score from 1-5, higher score means a better outcome.
Measured: Eight weeks after intervention
Perceived usefulness scale
Score from 1-5, higher score means a better outcome.
Measured: Eight weeks after intervention
Rapport scale
Relationship with the embodied conversational agent. Score from 1-5, higher score means a better outcome.
Measured: Four weeks before intervention to eight weeks
Brief Older People's Quality of Life Scake
Score from 1-5, higher score means a better outcome.
Measured: Four weeks before intervention to eight weeks
Change in Basic Psychological Need Satisfaction and Frustration Scales
Score from 1-5, higher score means a better outcome.
Measured: Four weeks before intervention to eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start13 Jul 2020
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Eating BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University and Research
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, WAAG, Roessingh Research and Development, National Foundation for the Elderly
- Responsible party
- Principal investigator, Lean Kramer, Wageningen University and Research
- Investigators
- Emely de Vet, PhD, Principal investigator, Wageningen University & Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04510883
- Sponsor's protocol ID
- 40-44300-98-110
- Status last verified
- Apr 2021
- First submitted
- 13 Jul 2020
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In accordance with the Data Management Plan, part of the data will be anonymized and made available in DANS-EASY with restricted access.
Publications
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.
PubMed 35404255Kramer 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.
PubMed 33404513
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usage and Health Effects of Embodied Conversational Agents Among Older Adults
- ClinicalTrials.gov ID
- NCT04510883
- Acronym / sponsor ID
- 40-44300-98-110
- Conditions
- Eating Behavior, Loneliness, Technology Use
- Keywords
- eHealth, Embodied Conversational Agent, Technology use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Wageningen University and ResearchUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, WAAG, Roessingh Research and Development, National Foundation for the Elderly
- Study start
- 13 Jul 2020 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 12 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| PACO | Experimental | Behavioral: PACOParticipants are asked to use the intervention for eight weeks. |
| Waiting list + PACO | Other | Behavioral: Waiting list + PACOParticipants receive the same intervention, but only after a waiting period of four weeks. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Not willing to provide inform consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PACOThe 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. | Behavioural | PACO |
| Waiting list + PACOWaiting list + PACO | Behavioural | Waiting list + PACO |
Primary outcome
Logdata on use application
Time frame: 8 weeks
Amount of time spend on the application during the 8 weeks intervention period
Change in De Jong Gierveld Loneliness Scale
Time frame: Four weeks before intervention to eight weeks
Score from 1-5, higher score means a better outcome.
Change in eating behaviour based on 24 hours recall
Time frame: Four weeks before intervention to eight weeks
9 secondary outcomes
Enjoyment via affect scale
Time frame: Eight weeks after intervention
Classic aesthetics Scale
Time frame: Eight weeks after intervention
Concern for privacy scale
Time frame: Four and eight weeks after intervention
Active control scale
Time frame: Eight weeks after intervention
System Usability Scale
Time frame: Eight weeks after intervention
Perceived usefulness scale
Time frame: Eight weeks after intervention
Rapport scale
Time frame: Four weeks before intervention to eight weeks
Brief Older People's Quality of Life Scake
Time frame: Four weeks before intervention to eight weeks
Change in Basic Psychological Need Satisfaction and Frustration Scales
Time frame: Four weeks before intervention to eight weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Derived from this study: PubMed 35404255Kramer 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.
- Derived from this study: PubMed 33404513Kramer 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.
- Individual participant dataSharing planned: Yes. In accordance with the Data Management Plan, part of the data will be anonymized and made available in DANS-EASY with restricted access.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emely de Vet, PhD principal investigator
Wageningen University & Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PACO and Waiting list + PACO in people with Eating Behavior and Loneliness, run by Wageningen University and Research at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Logdata on use application (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04510883, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.