NCT05930743

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
345

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 5, 2023

Completed
Last Updated

August 8, 2023

Status Verified

August 1, 2023

Enrollment Period

10 months

First QC Date

June 26, 2023

Last Update Submit

August 4, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    1 month

Secondary Outcomes (1)

  • Biochemical assessment

    5 days

Other Outcomes (4)

  • measurement of height

    5 days

  • measurement of body weight

    5 days

  • measurement of percentage of body fat

    5 days

  • +1 more other outcomes

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanaephong and Koh Sadueng

Kanchanaburi, 71240, Thailand

Location

Related Publications (2)

  • 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.

    PMID: 29359429BACKGROUND
  • Azais-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.

    PMID: 16923293BACKGROUND

Related Links

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2023

First Posted

July 5, 2023

Study Start

November 1, 2021

Primary Completion

August 30, 2022

Study Completion

February 28, 2023

Last Updated

August 8, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations