Nutrition, HealthyNCT05930743
Climate Change Resilience of Indigenous SocioEcological Systems
An observational study of Nutrition, Healthy, run by Mahidol University at 1 site in Thailand.
Trial summary
The RISE project aims to understand how future climate change may compromise traditional food systems (TFS) by altering related human-nature interactions. A comparative case study approach coupling on-site socioeconomic, nutritional, and ecological surveys of the target indigenous socioecological systems (ISES) of… Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nutrition, Healthy
- How many people
- 345 participants
- Where
- 1 siteThailand
- Study dates
- 1 Nov 2021to 28 Feb 2023
- Phase
- Observational
- 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 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The indigenous group of Karen people stays in Thungyai - Huai Kha Khaeng Wildlife Sanctuary, the area in the west of Kanchanaburi Province. The population data of the two villages, Saneaphong and Koh Sadueng, were surveyed in 2021. Three aspects of nutritional assessment will compose of three groups of local people according to age range, including (i) school-aged children (6 - 12 y), (ii) adults (19 - 59 y), and (iii) elderly (60 y and over). The population of Saneaphong and Koh Sadueng were 696 and 262 people, respectively. Then the sample size in each village was calculated using the Taro Yamane formula, 1973.
Who may be able to join
- School-aged children 6-12 years old who are the Karen living in Laiwo Subdistrict, Sangkhlaburi District, Kanchanaburi Province, Thailand
- Working adults 19-59 years old
- who are the Karen living in Laiwo Subdistrict, Sangkhlaburi District, Kanchanaburi Province, Thailand
- with no history of mental illness that has been diagnosed by a doctor, such as schizophrenia, delusional psychosis, bipolar disorder, acute mental illness, psychosis caused by physical disease, and psychosis caused by various substances or drugs.
- who do not have serious underlying diseases such as heart disease, or cancer, which are specified by a doctor and are advised to eat a therapeutic diet.
- Elderly aged 60 and over
Show all 9Show fewer
- who are the Karen living in Laiwo Subdistrict, Sangkhlaburi District, Kanchanaburi Province, Thailand
- with no history of mental illness that has been diagnosed by a doctor, such as schizophrenia, delusional psychosis, bipolar disorder, acute mental illness, psychosis caused by physical disease, and psychosis caused by various substances or drugs.
- who do not have serious underlying diseases such as heart disease, or cancer, which are specified by a doctor and are advised to eat a therapeutic diet.
Who cannot join
- Participants who are seriously ill, such as accidents, symptoms from underlying diseases, or other diseases during the data collection are unable to conduct an interview.
- Participants who were out of the village during the data collection period are unable to provide information to the research team.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Climate Change Resilience of Indigenous SocioEcological Systems: RISE
The RISE project aims to understand how future climate change may compromise traditional food systems (TFS) by altering related human-nature interactions. A comparative case study approach coupling on-site socioeconomic, nutritional, and ecological surveys of the target indigenous socioecological systems (ISES) of Karen (Kanchanaburi, Thailand) and Sakha (Republic of Sakha, Russian Federation) people with statistical models projecting future changes in the distribution and composition of traditional food species under contrasting climate change scenarios.
Read the detailed description
The UN Declaration on the Rights of Indigenous Peoples (IPs) recognizes "the right to the lands, territories, and resources which IPs have traditionally owned, occupied or otherwise used or acquired." Within this context, food sovereignty and the sustainability of TFS are emergent issues within the sustainable development agenda as recognized by the United Nations Permanent Forum of Indigenous Peoples' Issues (UNPFII). However, IPs are especially vulnerable to climate change and other environmental impacts. Disrupted ISES are characterized by increased food insecurity and inequalities, loss of traditional identity, westernization of livelihoods, and nutritional problems. The degree of vulnerability to these factors depends upon their adaptation capacity and resilience. Understanding the complex relationships among climate change, socioeconomic development, and TFS is crucial for informing adaptive strategies and promoting the sustainability of ISS in line with international agendas such as the Paris Agreement and the 2030 Sustainable Development Goals (SDGs).
The movement for development emphasizes collaboration among various partners to deal with climate change effectively and to strengthen people's capacity to cope with present and future threats. Thailand has addressed relevant agenda to transform missions in response to climate change as the movement to establish food security based on the sufficient economic principle, the promotion of sustainable agricultural development, the encouragement of good food manufacturing, empowerment of health impact management, and the protection of biodiversity to reenergize natural ecosystem sustainability, for instances.
RISE aims at bridging this gap by using a novel, transdisciplinary risk assessment framework in a comparative case study context using two contrasting ISES: the Karen people, the most indigenous ethnic minority of Thailand, and indigenous communities of the Sakha Republic (Yakutia) in Siberia. The Arctic and Tropics are sentinels and harbingers of climate and environmental change. They are home to a significant proportion of the world's IPs and face some of the most unprecedented, pressing anthropogenic and environmental impacts.
Multiple components of the research study include the following studies. 1) Socioeconomic analysis of indigenous socioecological systems 2) Nutritional/dietary analysis of Indigenous Socioecological Systems 3) Project future changes in traditional food systems from contrasting scenarios of climate change and socioeconomic development 4) Estimate the risk to ISES sustainability and explore limits and enablers of adaptation to inform regional development and the climate and sustainably policy agendas.
- Conditions
- Nutrition, Healthy
What is being measured
The primary outcome is the main question the study is designed to answer.
Dietary intake assessment (24-hour dietary recall)
The 24-hour dietary recall interview will be conducted on a single day in both rainy and dry seasons. The resulting data will be analyzed for energy and nutrient intakes using the INMUCAL Nutrients v4 program (INMU, Thailand). Differences in nutritional composition between traditional and market food will be investigated.
Measured: 1 month
Dietary intake assessment (food frequency questionnaire (FFQ))
A food frequency questionnaire or checklist of specific food items will be developed to determine seasonal food consumption patterns. Data collection will be conducted in both rainy and dry seasons.
Measured: 1 month
Secondary outcomes (1)
Biochemical assessment
Biochemical assessment from venous blood samples taken after a 12-h overnight fast. Blood samples will be transferred to the hospital laboratory for biochemical analysis. Whole blood samples in EDTA vacutainer will be analyzed for complete blood count using automated analyzer. Other blood samples will be centrifuged and analyzed for lipid profile including total cholesterol, high density lipoprotein cholesterol, low density lipoprotein cholesterol and triglycerides using enzymatic colorimetric technique.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start1 Nov 2021
- Primary completion30 Aug 2022
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Nutrition, HealthyStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 345 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05930743
- Sponsor's protocol ID
- MU-CIRB2021/227.3004
- Status last verified
- Aug 2023
- First submitted
- 26 Jun 2023
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sirisai S, Chotiboriboon S, Sapsuwan C, Tantivatanasathien P, Setapun N, Duangnosan P, Thongkam N, Chuangyanyong S. Matriarchy, Buddhism, and food security in Sanephong, Thailand. Matern Child Nutr. 2017 Nov;13 Suppl 3(Suppl 3):e12554. doi: 10.1111/mcn.12554.
PubMed 29359429Azais-Braesco V, Goffi C, Labouze E. Nutrient profiling: comparison and critical analysis of existing systems. Public Health Nutr. 2006 Aug;9(5):613-22. doi: 10.1079/phn2006966.
PubMed 16923293Joompa P, Gowachirapant S, Chotiboriboon S, Sarasak R, Thongkam N, Kongpunya P, Kriengsinyos W. Seasonal variation in dietary diversity and food variety scores among an indigenous Karen population in western Thailand: a cross-sectional study. Public Health Nutr. 2025 Sep 25;28(1):e168. doi: 10.1017/S1368980025101225.
PubMed 40995620
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Climate Change Resilience of Indigenous SocioEcological Systems: RISE
- ClinicalTrials.gov ID
- NCT05930743
- Acronym / sponsor ID
- MU-CIRB2021/227.3004
- Conditions
- Nutrition, Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 345 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 5 Jul 2023 (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.
The RISE project aims to understand how future climate change may compromise traditional food systems (TFS) by altering related human-nature interactions. A comparative case study approach coupling on-site socioeconomic, nutritional, and ecological surveys of the target indigenous socioecological systems (ISES) of Karen (Kanchanaburi, Thailand) and Sakha (Republic of Sakha, Russian Federation) people with statistical models projecting future changes in the distribution and composition of traditional food species under contrasting climate change scenarios.
Detailed description
The UN Declaration on the Rights of Indigenous Peoples (IPs) recognizes "the right to the lands, territories, and resources which IPs have traditionally owned, occupied or otherwise used or acquired." Within this context, food sovereignty and the sustainability of TFS are emergent issues within the sustainable development agenda as recognized by the United Nations Permanent Forum of Indigenous Peoples' Issues (UNPFII). However, IPs are especially vulnerable to climate change and other environmental impacts. Disrupted ISES are characterized by increased food insecurity and inequalities, loss of traditional identity, westernization of livelihoods, and nutritional problems. The degree of vulnerability to these factors depends upon their adaptation capacity and resilience. Understanding the complex relationships among climate change, socioeconomic development, and TFS is crucial for informing adaptive strategies and promoting the sustainability of ISS in line with international agendas such as the Paris Agreement and the 2030 Sustainable Development Goals (SDGs).
The movement for development emphasizes collaboration among various partners to deal with climate change effectively and to strengthen people's capacity to cope with present and future threats. Thailand has addressed relevant agenda to transform missions in response to climate change as the movement to establish food security based on the sufficient economic principle, the promotion of sustainable agricultural development, the encouragement of good food manufacturing, empowerment of health impact management, and the protection of biodiversity to reenergize natural ecosystem sustainability, for instances.
RISE aims at bridging this gap by using a novel, transdisciplinary risk assessment framework in a comparative case study context using two contrasting ISES: the Karen people, the most indigenous ethnic minority of Thailand, and indigenous communities of the Sakha Republic (Yakutia) in Siberia. The Arctic and Tropics are sentinels and harbingers of climate and environmental change. They are home to a significant proportion of the world's IPs and face some of the most unprecedented, pressing anthropogenic and environmental impacts.
Multiple components of the research study include the following studies. 1) Socioeconomic analysis of indigenous socioecological systems 2) Nutritional/dietary analysis of Indigenous Socioecological Systems 3) Project future changes in traditional food systems from contrasting scenarios of climate change and socioeconomic development 4) Estimate the risk to ISES sustainability and explore limits and enablers of adaptation to inform regional development and the climate and sustainably policy agendas.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The indigenous group of Karen people stays in Thungyai - Huai Kha Khaeng Wildlife Sanctuary, the area in the west of Kanchanaburi Province. The population data of the two villages, Saneaphong and Koh Sadueng, were surveyed in 2021. Three aspects of nutritional assessment will compose of three groups of local people according to age range, including (i) school-aged children (6 - 12 y), (ii) adults (19 - 59 y), and (iii) elderly (60 y and over). The population of Saneaphong and Koh Sadueng were 696 and 262 people, respectively. Then the sample size in each village was calculated using the Taro Yamane formula, 1973.
Key inclusion criteria (9 listed)
- School-aged children 6-12 years old who are the Karen living in Laiwo Subdistrict, Sangkhlaburi District, Kanchanaburi Province, Thailand
- Working adults 19-59 years old
- who are the Karen living in Laiwo Subdistrict, Sangkhlaburi District, Kanchanaburi Province, Thailand
- with no history of mental illness that has been diagnosed by a doctor, such as schizophrenia, delusional psychosis, bipolar disorder, acute mental illness, psychosis caused by physical disease, and psychosis caused by various substances or drugs.
- who do not have serious underlying diseases such as heart disease, or cancer, which are specified by a doctor and are advised to eat a therapeutic diet.
Key exclusion criteria (2 listed)
- Participants who are seriously ill, such as accidents, symptoms from underlying diseases, or other diseases during the data collection are unable to conduct an interview.
- Participants who were out of the village during the data collection period are unable to provide information to the research team.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dietary intake assessment (24-hour dietary recall)
Time frame: 1 month
The 24-hour dietary recall interview will be conducted on a single day in both rainy and dry seasons. The resulting data will be analyzed for energy and nutrient intakes using the INMUCAL Nutrients v4 program (INMU, Thailand). Differences in nutritional composition between traditional and market food will be investigated.
Dietary intake assessment (food frequency questionnaire (FFQ))
Time frame: 1 month
A food frequency questionnaire or checklist of specific food items will be developed to determine seasonal food consumption patterns. Data collection will be conducted in both rainy and dry seasons.
1 secondary outcome
Biochemical assessment
Time frame: 5 days
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 Aug 2023.
- Background: PubMed 29359429Sirisai S, Chotiboriboon S, Sapsuwan C, Tantivatanasathien P, Setapun N, Duangnosan P, Thongkam N, Chuangyanyong S. Matriarchy, Buddhism, and food security in Sanephong, Thailand. Matern Child Nutr. 2017 Nov;13 Suppl 3(Suppl 3):e12554. doi: 10.1111/mcn.12554.
- Background: PubMed 16923293Azais-Braesco V, Goffi C, Labouze E. Nutrient profiling: comparison and critical analysis of existing systems. Public Health Nutr. 2006 Aug;9(5):613-22. doi: 10.1079/phn2006966.
- Derived from this study: PubMed 40995620Joompa P, Gowachirapant S, Chotiboriboon S, Sarasak R, Thongkam N, Kongpunya P, Kriengsinyos W. Seasonal variation in dietary diversity and food variety scores among an indigenous Karen population in western Thailand: a cross-sectional study. Public Health Nutr. 2025 Sep 25;28(1):e168. doi: 10.1017/S1368980025101225.
- Indigenous People's Food Systems: the many dimensions of culture, diversity and environment for nutrition and healthLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nutrition, Healthy, run by Mahidol University at 1 site in Thailand.
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 9 inclusion and 2 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 Aug 2023. 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 Thailand. 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?
Dietary intake assessment (24-hour dietary recall) (time frame: 1 month). The study lists 2 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 NCT05930743, which also lists 3 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 Aug 2023.