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LonelinessPALNCT06004531

Planetary Health and Loneliness

A study testing Regulation Of Craving Training (ROC-T) in people with Loneliness and Anxiety, run by Jacobs University Bremen gGmbH at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this 3-phase study is the evaluation of planetary health behaviors and its cognitive processes in relation to levels of eco-anxiety, general well-being, and levels of loneliness. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Loneliness, Anxiety, Health-Related Behavior
What is being tested?
Regulation Of Craving Training (ROC-T)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,684 participants
Where
1 siteGermany
Study dates
28 Dec 2024to 31 Dec 2025
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Ability to participate in surveys (e.g., sufficient German or English language skills)

Who cannot join

  • Not being of age
  • Illiteracy
  • Massively limited cognitive abilities (linguistic components of the digital offerings must be able to be used and questionnaires completed or interviews participated in)

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Germany

    Bremen, 28759

Other trials in Germany

About this study

Official title: Planetary Health and Loneliness: Survey and Mini-intervention to Study the Interrelations of Multiple Behavior Change and Perception of Social Isolation

The aim of this 3-phase study is the evaluation of planetary health behaviors and its cognitive processes in relation to levels of eco-anxiety, general well-being, and levels of loneliness. As climate change progresses at a dangerous rate, it is important to establish and maintain lifestyles that are productive, fulfilling, environmentally conscious, and low in anxiety. Through a better understanding of the interconnected nature of planetary health behaviors with other aspects of healthy living and perception of social isolation, and the effect of an intervention, this research will add to current state of science to help inform the creation of interventions promoting sustainable, healthy, happy living among the general public and specific subgroups.

Read the detailed description

The aim of this study with three phases is the evaluation of healthy behaviors and its cognitive processes, and anxiety levels in relation to selected physical, mental, and environmental health aspects by means of online survey in (1) general population and (2) rehabiliation setting as well as with (3) an experimental design with students/ see section "Arms and Interventions".

The umbrella terminology of "planetary health" is used in the context of this study. As climate change progresses at a dangerous rate, it is important to establish and maintain lifestyles that are productive, fulfilling, environmentally conscious, and low in anxiety and stress. By evaluating prevalence of healthy behaviors and levels of eco-anxiety as well as loneliness as one early indicator of health risk, this study hopes to build on existing public health knowledge to develop interventions targeting and encouraging multiple aspects of healthy, eco-friendly lifestyles. This study will also help later intervention design by determining effective methods of persuasion and promotion of sustainable planetary health behaviors.

Main research questions are

*Phase 1/general population*

  1. Is climate-awareness (in terms of EMCB, YCSCB and Mindful Health) more likely to also increase motivation to promote own health (in terms of physical activity and healthy nutrition)?

*Phase 1/general population*

II. What is the (non-)linear relationship between eco-anxiety and climate-sensitiveness/health behavior?

*Phase 1/general population and Phase 2/rehabiliation setting*

III. Is climate-sensitiveness and eco-anxiety invariant to socio-demographic variables such as clinic, gender, occupation, and age? (No differences)

*Phase 2/rehabiliation setting*

IV. To what extent are pattern in medical rehabilitation different from the general population?

*Phase 3/students and experiment-based*

VI. Does priming eco-anxiety lead individuals to process eco-health-related decisions more deliberately and to make more decisions beneficial to eco-health?

*Phase 3/students and experiment-based*

VII. Is an intervention leading individuals to make more behavioral decisions beneficial to personal and ecological health?

*Phase 3/students and experiment-based*

VIII. Does environmental anxiety induction interact with ROC-T intervention? How does ecological anxiety initiation or intervention effect manifest through changes in the parameters of the drift-diffusion model to reflect changes in the decision-making process?

*Phase 3/students and experiment-based*

IX. Do the observed effects on personal health decisions extend (transfer) to the ecological choice domain?

Being tested
Regulation Of Craving Training (ROC-T), Control group
Keywords
Planetary Health, Eco-Friendly Behavior, Eco-Anxiety, Covid-19
Medical subject headings
Anxiety Disorders, Health Behavior, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Regulation Of Craving Training (ROC-T)Behavioural

    Participants read a 5-minute article on food and ecological health describing the environmental impacts of food choices and actions to support planetary health. During a subsequent choice task, participants received prompts to recall article content and self-monitor their selections.

  • Control groupBehavioural

    Control participants read a time-matched article unrelated to sustainability (no multi-domain pro-environmental behaviors including transportation, consumption, and daily activities; just on the beauty of the German nature) and completed the choice task without recall prompts.

Study groups in NCT06004531
Study groupRoleWhat they receive
Eco-anxiety primingExperimentalParticipants viewed a 2-minute climate change video presenting environmental threats to human survival.
Receives: Behavioral: Regulation Of Craving Training (ROC-T); Behavioral: Control group
Control ArmExperimentalParticipants viewed a 2-minute neutral nature documentary without climate change content.
Receives: Behavioral: Regulation Of Craving Training (ROC-T); Behavioral: Control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Young Consumers' Sustainable Consumption Behaviors (YCSCB) validated scale

    The primary outcome measure will be the YCSCB validated scale questionnaire. This will be given to participants right after they have completed the intervention section of the survey.

    The answering options range from "Never" (0, minimum score) to "Sometimes" (1) and "Often" (2) up to "Always" (3, maximum score). The items are worded

    1. I eat meat (steak, ham, etc.).
    2. I eat dairy products (butter, cheese, yoghurt, etc.).
    3. I keep a healthy diet.
    4. There are times when I discard food products.
    5. I buy locally grown food products.
    6. I reuse my leftovers for the next meal. and items # 1, 2 and 4 need to be reversed, then all items can be used as single items or as aggregated scales, with higher scores indicating a better outcome in terms of planetary health.

    Measured: This scale will take approximately 2 minutes to fill out completely.

  2. Ethically Minded Consumer Behavior (EMCB) validated scale

    The second primary outcome measure will be the EMCB validated scale questionnaire. This will be given to participants right after they have completed the intervention section of the survey.

    The answering options range from "Never true" (0, minimum score) to "Rarely true" (1), "Sometimes true" (2), "Mostly true" (3) and "Always true" (4, maximum score). The items are worded (for instance) 1. When there is a choice, I always choose the product that contributes to the least amount of environmental damage.

    1. I have switched products for environmental reasons. 3. If I understand the potential damage to the environment that some products can cause, I do not purchase those products.

    ... 10. I have paid more for socially responsible products when there is a cheaper alternative.

    All items can be used as single items or as aggregated scales, with higher scores indicating a better outcome in terms of planetary health.

    Measured: This scale will take approximately 2 minutes to fill out completely.

  3. Loneliness item from the Center for Epidemiological Studies-Depression-(CES D)-Scale

    To study some of the research questions unrelated to the intervention, the perceived social isolation is measured with a standardized scale building on the item in the Center for Epidemiological Studies-Depression-(CES-D)-Scale. The item is worded "How often did you feel lonely?" with the answering options "Daily" (3), "Several times a week" (2), "Once a week" (1) and "Rarely/never" (0).

    The item can be used as single items, with higher scores indicating a worse outcome in terms of more loneliness.

    Measured: This item will take less than 1 minute to complete.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2023
  2. Study start28 Dec 2024
  3. Primary completion31 Dec 2024
  4. Study completion31 Dec 2025

Resources

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
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
1,684 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06004531
Sponsor's protocol ID
CUB_PHAL2023
Other IDs
Lippke202308
Acronym
PAL
Status last verified
Sep 2026
First submitted
16 Aug 2023
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be published. Other researchers are welcome to get in contact with the PI to get access to anonymous data.

Publications

  • Arias, P., Bellouin, N., Coppola, E., Jones, C., Krinner, G., Marotzke, J., Naik, V., Plattner, G.-K., Rojas, M., Sillmann, J., Storelvmo, T., Thorne, P., Trewin, B., Achutarao, K., Adhikary, B., Armour, K., Bala, G., Barimalala, R., Berger, S., & Zickfeld, K. (2021, January). Climate Change 2021: The Physical Science Basis. Contribution of Working Group I to the Sixth Assessment Report of the Intergovernmental Panel on Climate Change; Technical Summary.

  • Bull ER, McCleary N, Li X, Dombrowski SU, Dusseldorp E, Johnston M. Interventions to Promote Healthy Eating, Physical Activity and Smoking in Low-Income Groups: a Systematic Review with Meta-Analysis of Behavior Change Techniques and Delivery/Context. Int J Behav Med. 2018 Dec;25(6):605-616. doi: 10.1007/s12529-018-9734-z.

    PubMed 30003476

  • Cheng J, Xu Z, Bambrick H, Prescott V, Wang N, Zhang Y, Su H, Tong S, Hu W. Cardiorespiratory effects of heatwaves: A systematic review and meta-analysis of global epidemiological evidence. Environ Res. 2019 Oct;177:108610. doi: 10.1016/j.envres.2019.108610. Epub 2019 Jul 26.

    PubMed 31376629

  • Dohle S, Hofmann W. Consistency and Balancing in Everyday Health Behaviour: An Ecological Momentary Assessment Approach. Appl Psychol Health Well Being. 2019 Mar;11(1):148-169. doi: 10.1111/aphw.12148. Epub 2018 Nov 13.

    PubMed 30426704

  • Druckman, A., & Jackson, T. (2016). Understanding Households as Drivers of Carbon Emissions. In R. Clift & A. Druckman (Eds.), Taking Stock of Industrial Ecology (pp. 181-203). Springer International Publishing. https://doi.org/10.1007/978-3-319-20571-7_9

  • Ford ES, Bergmann MM, Boeing H, Li C, Capewell S. Healthy lifestyle behaviors and all-cause mortality among adults in the United States. Prev Med. 2012 Jul;55(1):23-7. doi: 10.1016/j.ypmed.2012.04.016. Epub 2012 Apr 29.

    PubMed 22564893

  • Geller K, Lippke S, Nigg CR. Future directions of multiple behavior change research. J Behav Med. 2017 Feb;40(1):194-202. doi: 10.1007/s10865-016-9809-8. Epub 2016 Oct 26.

    PubMed 27785652

  • Lacroix, K. (2018). Comparing the relative mitigation potential of individual pro-environmental behaviors. Journal of Cleaner Production, 195, 1398-1407. https://doi.org/10.1016/j.jclepro.2018.05.068

  • Lange, F., & Dewitte, S. (2019). Measuring pro-environmental behavior: Review and recommendations. Journal of Environmental Psychology, 63, 92-100. https://doi.org/10.1016/j.jenvp.2019.04.009

  • Loef M, Walach H. The combined effects of healthy lifestyle behaviors on all cause mortality: a systematic review and meta-analysis. Prev Med. 2012 Sep;55(3):163-70. doi: 10.1016/j.ypmed.2012.06.017. Epub 2012 Jun 24.

    PubMed 22735042

  • Mauch CE, Edney SM, Viana JNM, Gondalia S, Sellak H, Boud SJ, Nixon DD, Ryan JC. Precision health in behaviour change interventions: A scoping review. Prev Med. 2022 Oct;163:107192. doi: 10.1016/j.ypmed.2022.107192. Epub 2022 Aug 11.

    PubMed 35963310

  • Meader N, King K, Wright K, Graham HM, Petticrew M, Power C, White M, Sowden AJ. Multiple Risk Behavior Interventions: Meta-analyses of RCTs. Am J Prev Med. 2017 Jul;53(1):e19-e30. doi: 10.1016/j.amepre.2017.01.032. Epub 2017 Feb 28.

    PubMed 28258777

  • Moran, D., Wood, R., Hertwich, E., Mattson, K., Rodriguez, J. F. D., Schanes, K., & Barrett, J. (2020). Quantifying the potential for consumer-oriented policy to reduce European and foreign carbon emissions. Climate Policy, 20(sup1), S28-S38.

  • Nisa CF, Belanger JJ, Schumpe BM, Faller DG. Meta-analysis of randomised controlled trials testing behavioural interventions to promote household action on climate change. Nat Commun. 2019 Oct 4;10(1):4545. doi: 10.1038/s41467-019-12457-2.

    PubMed 31586060

  • Nisbet, E. K. L., & Gick, M. L. (2008). Can health psychology help the planet? Applying theory and models of health behaviour to environmental actions. Canadian Psychology / Psychologie Canadienne, 49(4), 296-303.

Questions about this trial

What is this clinical trial studying?

A study testing Regulation Of Craving Training (ROC-T) in people with Loneliness and Anxiety, run by Jacobs University Bremen gGmbH at 1 site in Germany.

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 1 inclusion and 3 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 11 Sep 2026. 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 Germany. 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?

Young Consumers' Sustainable Consumption Behaviors (YCSCB) validated scale (time frame: This scale will take approximately 2 minutes to fill out completely.). 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 NCT06004531, which also lists 24 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 11 Sep 2026.

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