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Cited by 23Social Robot Interaction and HRITechnology Use by Older AdultsDigital Mental Health Interventions

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

Open access
Kramer, Lean L, Mulder, Bob C, van Velsen, Lex, de Vet, Emely·2021·JMIR Research Protocols
DOI 10.2196/22186PMC PMC7817356

Published version of a preprint

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Abstract

Background: An unhealthy eating pattern and loneliness negatively influence quality of life in older age. Embodied conversational agents (ECAs) are a promising way to address these health behaviors in an engaging manner. Objective: We aim to (1) identify whether ECAs can persuade community-dwelling older adults to change their dietary behavior and whether ECA use can decrease loneliness, (2) test these pathways to effects, and (3) understand the use of an ECA. Methods: The web-based eHealth app PACO is a fully automated 8-week intervention in which 2 ECAs engage older adults in dialogue to motivate them to change their dietary behavior and decrease their loneliness. PACO was developed via a human-centered and stakeholder-inclusive design approach and incorporates Self-determination Theory and various behavior change techniques. For this study, an unblinded randomized controlled trial will be performed. There will be 2 cohorts, with 30 participants per cohort. Participants in the first cohort will immediately receive the PACO app for 8 weeks, while participants in the second cohort receive the PACO app after a waiting-list condition of 4 weeks. Participants will be recruited via social media, an online panel, flyers, and advertorials. To be eligible, participants must be at least 65 years of age, must not be in paid employment, and must live alone independently at home. Primary outcomes will be self-assessed via online questionnaires at intake, control, after 4 weeks, and after 8 weeks, and will include eating behavior and loneliness. In addition, the primary outcome—use—will be measured via data logs. Secondary outcomes will be measured at the same junctures, via either validated, self-assessed, online questionnaires or an optional interview. Results: As of July 2020, we have begun recruiting participants. Conclusions: By unraveling the mechanisms behind the use of a web-based intervention with ECAs, we hope to gain a fine-grained understanding of both the effectiveness and the use of ECAs in the health context. Trial Registration: ClinicalTrials.gov NCT04510883; https://clinicaltrials.gov/ct2/show/NCT04510883 International Registered Report Identifier (IRRID): PRR1-10.2196/22186

AI snapshot

Written from the paper’s full text.

TL;DR

This paper is the protocol for an unblinded randomized controlled trial evaluating PACO, a fully automated 8-week web-based app in which two embodied conversational agents (ECAs) dialogue with community-dwelling older adults to improve eating behavior and decrease loneliness. No outcome results are reported; recruitment had begun as of July 2020.

Key findings

  • No effectiveness results are reported: "As of July 2020, we have begun recruiting participants."
  • The trial aims to include 60 participants (30 per cohort), a number based on the 10-times rule for partial least squares structural equation modeling (PLS-SEM), discussed with a statistician.
  • Primary outcomes are use (measured via data logs), eating behavior (three open 24-hour recall questions on fruit, vegetables, and drinks), and loneliness (De Jong Gierveld Loneliness Scale, 6 items).
  • The paper presents two conceptual models to be tested: one explaining ECA use (CEU) and one explaining health effects (CHE), the latter grounded in Self-determination Theory.

Methods

  • Design: unblinded randomized controlled trial with two cohorts of 30. Cohort 1 receives the 8-week PACO app immediately; cohort 2 receives it after a 4-week waiting-list condition and serves as the control group. Questionnaires are administered at control, intake (T0), 4 weeks (T1), and 8 weeks (T2), plus data logs during the intervention and an optional ~30-minute interview.
  • Participants: recruited via an existing online panel (Ouderenpanel), flyers, advertorials in local/community newspapers and social media, and participant referrals. Eligibility: aged ≥65 years, not in paid employment, living alone independently at home, Dutch-speaking, able to use a tablet/computer, and with home wireless internet. No exclusion criteria apart from willingness to provide informed consent.
  • Analysis: descriptive statistics for demographics, data logs, and willingness-to-pay; within-subject t tests comparing control, T0, T1, and T2; PLS-SEM in two phases (measurement model validation, then causal model testing) for the two conceptual models; thematic analysis (deductive and inductive) of interviews and open-ended user-experience questions. Participants with no PACO interaction for 14 consecutive days are treated as dropouts. Analyses in SPSS v24 and SmartPLS v3.
  • Intervention: PACO has five modules applying behavior change techniques — food diary (self-monitoring), goals (action planning), recipes (tailoring and self-efficacy, >280 recipes), stories (social learning), and chat via WhatsApp groups (social facilitation). Two ECAs: Herman (the cook, nutritional advice) and Ellen (the peer, social advice).

Limitations

  • Stated: the recruitment strategy is expected to include more women than men, though the authors note this reflects the greater number of single older women in the Netherlands; encouraging participants to invite relatives risks contamination, which will be monitored.
  • Stated: use of the ECA intervention may be influenced by the study itself, since participants know they must complete multiple questionnaires and are phoned if they do not use the app for 7 days, potentially increasing use relative to a non-trial setting.
  • Evident from the text: as a protocol, no effectiveness or use data are yet available, so all claims about ECA effects remain to be tested; the sample size (60) is small and justified by the 10-times rule and the study's explorative nature rather than a formal power calculation.

Model-written summary. Check it against the paper before relying on it.

Integrity signals

Registry

Crossref · 10.2196/22186

Cites

58 of 58 references verified0 citation errors · 0 not checkable

Statistics

Nothing to recompute.

Claims the paper makes

0 of 45 cited sources checked · 0 supported · 0 flagged

  • Premisecitation

    Loneliness is a significant predictor of malnutrition.

    “and is a significant predictor of malnutrition [6]”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [6] Ramic, E, 2011, Med. Arh

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  • Premisecitation

    Loneliness is associated with a loss of pleasure in eating and cooking.

    “As eating is regarded as a social activity, loneliness is associated with a loss of pleasure in eating and cooking [5]”
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    • cites [5] source

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  • Premisecitation

    The expected increase in single, community-dwelling older adults in the coming years will exacerbate the loneliness problem.

    “The expected increase in the coming years [9] in this group of single, community-dwelling older adults will exacerbate this problem.”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [9] van Duin, C, 2016, Huishoudensprognose 2015–2060: jongeren en ouderen langer thuis

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  • Premisecitation

    In the Netherlands, there are more single women than men in older age groups.

    “given that there are more single women than men in older age groups in the Netherlands [61]”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [61] CBSBevolking; geslacht, leeftijd en burgerlijke staat,Statline202009072020-12-23Den HaagCBShttps://opendata.cbs.nl/statline/#/CBS/nl/dataset/7461bev/table?ts=1565696300750

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  • Premisecitation

    Self-monitoring and self-efficacy are associated with increased autonomy.

    “Self-monitoring and self-efficacy are associated with increased autonomy [30].”
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    Premisecitation

    In the Netherlands, over 50% of older adults indicate experiencing loneliness, and this percentage is higher among people without a partner.

    “In the Netherlands, over 50% of older adults indicate that they experience loneliness, a percentage that is even higher among people without a partner [8].”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [8] GGDCBSRIVMGezondheidsmonitor Volwassenen en Ouderen201807052020-12-23https://www.volksgezondheidenzorg.info/onderwerp/eenzaamheid/cijfers-context/huidige-situatie#node-eenzaamheid-naar-leeftijd

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    Premisecitation

    Unhealthy eating and loneliness negatively influence quality of life in older age.

    “Unhealthy eating and loneliness negatively influence quality of life (QoL) in older age [1,2].”
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    Premisecitation

    Embodied conversational agents have been proposed as a promising technological tool to persuasively address health behaviors by changing users' attitudes or behaviors through persuasion and social influence rather than coercion.

    “Embodied conversational agents (ECAs) have been proposed as a promising technological tool to persuasively address these health behaviors, with the aim of changing users’ attitudes or behaviors through persuasion and social influence rather than through coercion [10].”
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    • cites [10] source

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    Study design and conductcitation

    The target sample size of 60 participants (30 per cohort) is based on the 10-times rule for PLS-SEM, discussed with a statistician, and considering current practices, the explorative nature of the study, and available staff.

    “We aim to include a total of 60 participants: 30 in cohort 1 and 30 in cohort 2.”
    • Also stated in: § Participants · plain
      “The number of participants is based on the 10-times rule, a widely used minimum-sample-size estimation method for partial least squares structural equation modeling (PLS-SEM) [32]. This method was discussed with a statistician.”
    • Also stated in: § Participants · plain
      “In addition, we considered the current practices in the field [12], the explorative nature of this study, and the staff available to provide support.”
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    • cites [32] source

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  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    The study has been registered at ClinicalTrials.gov before the enrolment of participants (identifier NCT04510883).

    “The study has been approved by the medical ethical committee of Wageningen University (number NL73121.081.20) and has been registered at ClinicalTrials.gov before the enrolment of participants (identifier NCT04510883).”
    Quote in the paperNot a substantial claim

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    Study design and conductnone given

    In phase 1, the measurement model will be validated by testing the constructs separately to determine internal validity using SEM-oriented criteria and a traditional Cronbach alpha.

    “In phase 1, the measurement model will be validated by testing the constructs separately to determine internal validity [using structural equation modeling (SEM)-oriented criteria and a traditional Cronbach alpha].”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    The study has been approved by the medical ethical committee of Wageningen University (number NL73121.081.20).

    “The study has been approved by the medical ethical committee of Wageningen University (number NL73121.081.20) and has been registered at ClinicalTrials.gov before the enrolment of participants (identifier NCT04510883).”
    Quote in the paperNot a substantial claim

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    Study design and conductnone given

    The randomized controlled trial will be unblinded.

    “An unblinded randomized controlled trial will be carried out.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductnone given

    The intervention was developed via a human-centered and stakeholder-inclusive design approach, incorporating theory and various BCTs.

    “The intervention was developed via a human-centered and stakeholder-inclusive design approach, incorporating theory and various BCTs.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    Visual aesthetics, defined as an orderly and clear design, are closely related to many design rules advocated by usability experts.

    “Visual aesthetics, defined as an orderly and clear design, are closely related to many of the design rules advocated by usability experts [21].”
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    Premisecitation

    Perceiving something as enjoyable is linked to a positive effect on use when the system is perceived to be useful.

    “Perceiving something as enjoyable is linked to a positive effect on use when the system is perceived to be useful [23].”
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    • cites [23] source

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  • Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

    Study design and conductnone given

    A conservative approach will be adopted whereby the theoretical model will be adjusted only if this results in a large improvement in the model.

    “A conservative approach will be adopted whereby the theoretical model will be adjusted only if this results in a large improvement in the model.”
    Quote in the paperNot a substantial claim

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    Study design and conductcitation

    All usability issues were resolved, leading to the final app.

    “All usability issues were resolved, leading to the final app.”
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    • cites [46] Groot, S, 2020, Wageningen University & Research

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    Premisecitation

    Self-determination Theory postulates that human beings have three essential psychological needs: autonomy, competence, and relatedness.

    “Briefly, SDT postulates that human beings have 3 essential psychological needs: autonomy (the feeling of being the origin of one’s own behaviors), competence (feeling effective), and relatedness (the need to feel belongingness and connectedness with others).”
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    • cites [29] source

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    Premisecitation

    In previous studies by the authors, women were more interested in lifestyle-related studies, resulting in focus group sessions with an overrepresentation of women.

    “In previous studies [44], we found women to be more interested in lifestyle-related studies, resulting in focus group sessions with an overrepresentation of women.”
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    • cites [44] Kramer, LL, 2021, Design for Health

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  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductcitation

    The PACO development process was based on the first three steps of the CeHRes Roadmap: contextual inquiry, value specification, and design phase.

    “The PACO development process was based on the first 3 steps of the Center for eHealth Research and Disease Management (CeHRes) Roadmap [43]: the contextual inquiry, the value specification, and the design phase.”
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    • cites [43] source

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  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductcitation

    The design phase of the PACO app was based on the previous two phases and used Self-determination Theory as a foundation.

    “The design phase of the PACO app was based on the previous 2 phases. In addition, the SDT [29] was used as a foundation.”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [29] source

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    Premisecitation

    ECAs' ability to make interventions more engaging is often ascribed to their capacity to establish and maintain an emphatic relationship.

    “This ability is often ascribed to ECAs’ capacity to establish and maintain an emphatic relationship [12,13].”
    Quote in the paperNot a substantial claim0 of 2 sources checked
    • cites [12] source

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  • May combine two claims.

    Premisecitation

    ECAs are perceived as enjoyable, usable, and acceptable for addressing health behavior change.

    “ECAs are perceived as enjoyable, usable, and acceptable for addressing health behavior change [16-18].”
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  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductnone given

    Qualitative coding will be performed independently by two researchers, with differences resolved through discussion to produce a final codebook and coded transcripts.

    “An initial list of inductive codes will be generated by LK and supplemented independently by another researcher. Differences will be discussed, leading to a final and agreed upon codebook. Each transcript will be coded by LK and another project member. Differences will be discussed again, leading to a final coded transcript.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Premisecitation

    Older adults from populations in which eHealth literacy is generally lower also form relationships with ECAs and consider them companions.

    “including those from populations in which eHealth literacy is generally lower [15]”
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    Study design and conductnone given

    Encouraging participants to invite relatives might induce a risk of contamination in the study.

    “participants are encouraged to invite relatives, and this might induce a risk of contamination”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Premisecitation

    Evidence of ECA effectiveness and underlying working mechanisms is scarce and remains inconclusive.

    “Furthermore, and even more importantly, evidence of ECA effectiveness and underlying working mechanisms is scarce and remains inconclusive [12].”
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    • cites [12] source

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    Study design and conductnone given

    All collected data will be kept in secure online databases that are password-protected, with access limited to the study team.

    “All collected data will be kept in secure online databases that are password-protected, with access limited to the study team.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    In the case of patient portals, aesthetics have been found to influence usability in the context of explaining technology acceptance.

    “In the case of patient portals, aesthetics have thus been found to influence usability in the context of explaining technology acceptance [22].”
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    Study design and conductcitation

    All secondary study parameters will be measured via validated, self-assessed, online questionnaires.

    “All these parameters will be measured via validated, self-assessed, online questionnaires.”
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    Study design and conductcitation

    The study expects to include more women than men.

    “We expect to include more women than men.”
    Quote in the paperNot a substantial claim0 of 2 sources checked
    • cites [44] Kramer, LL, 2021, Design for Health

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    • cites [61] CBSBevolking; geslacht, leeftijd en burgerlijke staat,Statline202009072020-12-23Den HaagCBShttps://opendata.cbs.nl/statline/#/CBS/nl/dataset/7461bev/table?ts=1565696300750

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    Premisecitation

    94.5% of older Dutch adults aged 65-75 years have internet access at home, with 77% using the internet daily.

    “The latter 2 criteria seem feasible, as 94.5% of all older Dutch adults aged 65-75 years have internet access at home, with 77% using the internet daily [34].”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [34] CBSInternet; toegang, gebruik en faciliteiten; 2012-2019Statline201910082020-12-23https://opendata.cbs.nl/statline/#/CBS/nl/dataset/83429NED/table?fromstatweb

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    Premisecitation

    Willingness to share personal information and preferences (absence of privacy concerns) is argued to be a prerequisite for convenience and a useful system.

    “Willingness to share personal information and preferences (ie, the absence of privacy concerns) is argued to be a prerequisite for convenience and a useful system [24].”
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    Study design and conductreasoning

    A data safety monitoring board will not be used during the study.

    “As participants are not exposed to any risks, a data safety monitoring board will not be used during the study.”
    Quote in the paperNot a substantial claim
    • Rests on an assumption: Participants are not exposed to any risks.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    In human-computer interaction literature, control has been identified as a crucial factor in the occurrence of perceived usefulness and use.

    “Especially in human-computer interaction literature, control has been identified as a crucial factor in the occurrence of perceived usefulness and use [26,27].”
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    Premisecitation

    The inclusion criteria fit a potential target audience of almost 1 million people.

    “These inclusion criteria fit a potential target audience of almost 1 million people [33].”
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    • cites [33] CBSHuishoudens; personen naar geslachtStatline20201019Den HaagCBShttps://opendata.cbs.nl/#/CBS/nl/dataset/71488ned/table?dl=25C1C

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    Study design and conductnone given

    Audio recordings of the interviews will be transcribed until data saturation is reached.

    “Audio recordings of the interviews will be transcribed until data saturation is reached.”
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    Study design and conductnone given

    Participants will be allocated to cohorts by random assignment of a digit (1 or 2) in a list generated by Excel.

    “To allocate participants to a cohort, they will be randomly assigned a digit, either 1 or 2, in a list generated by Excel (version 16.0.13426.20274; Microsoft).”
    Quote in the paperSubstantial claim

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    Interpretationcitation

    The scarcity and inconclusiveness of evidence on ECA effectiveness limits the possibility to learn from others' efforts and prevents knowledge accumulation.

    “This limits the possibility to learn from others’ efforts and prevents knowledge accumulation.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Premisecitation

    Early studies show that older adults who interact with an ECA form a relationship with the ECA and consider it a companion.

    “Early studies show that older adults who interact with an ECA form a relationship with the ECA and consider it a companion [14]”
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36 of 36

  • The authors state this as an assumption.

    An eHealth intervention will not be used if it does not create any benefit (perceived usefulness) or if it has a substantial number of usability problems.

    “It is assumed that an eHealth intervention will not be used if it does not create any benefit (perceived usefulness) or if it has a substantial number of usability problems [20].”

  • The paper relies on this without support.

    It is challenging to realize an actual change in eating behavior and deal with loneliness.

    “However, it is challenging to realize an actual change in eating behavior and deal with loneliness.”

  • The paper relies on this without support.

    Both unhealthy eating and loneliness are important risk factors for chronic diseases and are clearly associated with unhealthy eating behaviors.

    “Both are important risk factors for chronic diseases and are clearly associated with unhealthy eating behaviors.”

  • The paper relies on this without support.

    Participants are not exposed to any risks.

    “As participants are not exposed to any risks, a data safety monitoring board will not be used during the study.”

  • The paper relies on this without support.

    ECAs are a promising means of addressing health behavior change in general, including among community-dwelling older adults.

    “ECAs seem to be a promising means of addressing health behavior change in general, including among community-dwelling older adults.”
5 of 5

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

Cites

Flagged first, then by citations

Research works printed but not linked: 5

  1. Ramic, E, 2011, Med. Arh, 65, 92
  2. van Duin, C, 2016, Huishoudensprognose 2015–2060: jongeren en ouderen langer thuis, 1
  3. Ruttkay, Z, 2004, From Brows to Trust, 1
  4. Kramer, LL, 2021, Design for Health
  5. Groot, S, 2020, Wageningen University & Research, 1

Cited by

Sorted by citations

Related

Authors
Kramer, L. L., Mulder, B. C., van Velsen, L., & de Vet, E.
Affiliations
Wageningen University & Research (NL)
Corresponding author
Kramer, Lean L
ORCID
Venue
JMIR Research Protocols
Publisher
JMIR Publications Inc.
Published
2021-01-06
Volume
10
Issue
1
Pages
e22186
ISSN
1929-0748 (ISSN-L)
DOI
10.2196/22186
PMC
PMC7817356
OpenAlex
W3101961110
Semantic Scholar
cb8b63573714204d79ccc26b3a7a39ab0567cfd3
Cited by
23
References
58
Citations by year
2026: 2 · 2025: 5 · 2024: 5 · 2023: 4 · 2022: 3 · 2021: 4
FWCI
3.01
Type
journal article
Language
en
Open access
Licence
cc-by
Locations
  • JMIR Research Protocols (publishedVersion, cc-by)
  • Europe PMC (PubMed Central) (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • University of Twente Research Information (publishedVersion, cc-by)
  • Socio-Environmental Systems Modeling (submittedVersion, cc-by)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
  • University of Twente Research Information (submittedVersion, cc-by)
  • Data Archiving and Networked Services (DANS) (submittedVersion, cc-by)
Funders
  • ZonMw (40-44300-98-110)
  • Wageningen University and Research
Topics
  • Social Sciences › Psychology › Social Psychology › Social Robot Interaction and HRI
  • Social Sciences › Demography › Technology Use by Older Adults
  • Social Sciences › Psychology › Applied Psychology › Digital Mental Health Interventions
Keywords
embodied conversational agents, dietary habits, loneliness, older adults, community-dwelling older adults, dietary behavior change, digital health interventions, self-determination theory, behaviour change techniques, persuasive technology, online intervention

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