- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06004531
Planetary Health and Loneliness (PAL)
Planetary Health and Loneliness: Survey and Mini-intervention to Study the Interrelations of Multiple Behavior Change and Perception of Social Isolation
Study Overview
Status
Conditions
Intervention / Treatment
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*
I. 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?
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Bremen, Germany, 28759
- Germany
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Ability to participate in surveys (e.g., sufficient German or English language skills)
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Eco-anxiety priming
Participants viewed a 2-minute climate change video presenting environmental threats to human survival.
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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 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.
|
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Experimental: Control Arm
Participants viewed a 2-minute neutral nature documentary without climate change content.
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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 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Young Consumers' Sustainable Consumption Behaviors (YCSCB) validated scale
Time Frame: This scale will take approximately 2 minutes to fill out completely.
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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
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This scale will take approximately 2 minutes to fill out completely.
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Ethically Minded Consumer Behavior (EMCB) validated scale
Time Frame: This scale will take approximately 2 minutes to fill out completely.
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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. 2. 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. |
This scale will take approximately 2 minutes to fill out completely.
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Loneliness item from the Center for Epidemiological Studies-Depression-(CES D)-Scale
Time Frame: This item will take less than 1 minute to complete.
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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. |
This item will take less than 1 minute to complete.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sonia Lippke, Dr., Constructor University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
- 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.
- 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.
- Osbaldiston, R., & Schott, J. P. (2012). Environmental Sustainability and Behavioral Science: Meta-Analysis of Proenvironmental Behavior Experiments. Environment and Behavior, 44(2), 257-299.
- Prochaska JJ, Spring B, Nigg CR. Multiple health behavior change research: an introduction and overview. Prev Med. 2008 Mar;46(3):181-8. doi: 10.1016/j.ypmed.2008.02.001. Epub 2008 Feb 6.
- Riediger M, Freund AM. Interference and facilitation among personal goals: differential associations with subjective well-being and persistent goal pursuit. Pers Soc Psychol Bull. 2004 Dec;30(12):1511-23. doi: 10.1177/0146167204271184.
- Santos, O., Virgolino, A., Vaz Carneiro, A., & De Matos, M. G. (2021). Health Behavior and Planetary Health: A Multi-Level Environmental Health Approach. European Psychologist, 26(3), 212-218.
- Steg, L., & Vlek, C. (2009). Encouraging pro-environmental behaviour: An integrative review and research agenda. Journal of Environmental Psychology, 29(3), 309-317.
- Truelove, H. B., Carrico, A. R., Weber, E. U., Raimi, K. T., & Vandenbergh, M. P. (2014). Positive and negative spillover of pro-environmental behavior: An integrative review and theoretical framework. Global Environmental Change, 29, 127-138.
- United Nations Development Programme. (2022). United Nations (UN).
- World Health Organization. COP26 special report on climate change and health: The health argument for climate action. Report No.: 9240036725. (2021). World Health Organization.
- Wu S, Zhu W, Thompson P, Hannun YA. Evaluating intrinsic and non-intrinsic cancer risk factors. Nat Commun. 2018 Aug 28;9(1):3490. doi: 10.1038/s41467-018-05467-z.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Respiratory Tract Infections
- Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Pneumonia, Viral
- Pneumonia
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- Behavior
- COVID-19
- Anxiety Disorders
- Health Behavior
- Investigative Techniques
- Epidemiologic Research Design
- Epidemiologic Methods
- Research Design
- Methods
- Control Groups
Other Study ID Numbers
- CUB_PHAL2023
- Lippke202308 (Other Identifier: Constructor University (formerly Jacobs University))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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