NCT07750782

Brief Summary

This study will determine whether extreme ambient temperatures increase the incidence and severity of occupational injuries in Israel, and we request Helsinki Committee approval to conduct the analysis using de-identified National Insurance and historical meteorological data, with a waiver of informed consent. The project will link the date, time, and geographic location of recognized occupational accidents with corresponding historical temperature and humidity measurements. The study is retrospective, observational, and involves no direct contact with participants, no intervention, and no alteration of medical care or benefit eligibility.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
350,000

participants targeted

Target at P75+ for all trials

Timeline
5mo left

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress94%
Jan 2020Dec 2026

Study Start

First participant enrolled

January 1, 2020

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 6, 2026

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

August 6, 2026

Status Verified

August 1, 2026

Enrollment Period

5 years

First QC Date

August 2, 2026

Last Update Submit

August 2, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Occurrence of Recognized Occupational Injury During Case Versus Matched Control Periods

    The number of accepted occupational-injury events occurring during predefined case periods will be evaluated in relation to ambient temperature, relative humidity, and wind speed obtained from the nearest representative meteorological station. Each injury period will be compared with control periods matched by geographic-climatic region, calendar year and month, day of the week, and three-hour time interval. The association between environmental exposure and occupational-injury occurrence will be estimated using time-stratified case-crossover analysis with conditional logistic regression.

    At the index injury date and matched control dates, January 1, 2020-December 31, 2024.

Study Arms (7)

Northern valleys and inland north

Occupational injuries occurring in the northern valleys and inland northern region will be assigned to this geographic-climatic division according to the location of the workplace or accident. Meteorological exposure will be determined using data from the nearest representative monitoring station, including Dafna, Tavor Kadoorie, or Nazareth. This region is characterized by inland climatic conditions with substantial seasonal variation in temperature and humidity. Accident occurrence and severity will be evaluated in relation to temperature, relative humidity, wind speed, extreme heat, extreme cold, and other predefined environmental indicators.

Other: Ambient Weather Exposure

Northern Mediterranean coast

Occupational injuries occurring along the northern Mediterranean coastal region will be assigned to this geographic-climatic division according to the location of the workplace or accident. Meteorological exposure will be determined using data from the Haifa Technion monitoring station or the nearest available representative station. This region is characterized by a Mediterranean coastal climate, with relatively high humidity, moderate winter temperatures, warm summers, and frequent sea-breeze effects. Accident occurrence and severity will be evaluated in relation to ambient temperature, relative humidity, wind speed, extreme heat, extreme cold, and other predefined environmental indicators.

Other: Ambient Weather Exposure

Central Mediterranean coast

Occupational injuries occurring within the central Mediterranean coastal region will be assigned to this geographic-climatic division according to the workplace or accident location. Meteorological exposure will be determined using data from the Tel Aviv Coast monitoring station or the nearest available representative station. This region is characterized by a warm Mediterranean climate, relatively high humidity, mild winters, hot summers, and frequent sea-breeze effects. The occurrence and severity of occupational injuries will be evaluated in relation to ambient temperature, relative humidity, wind speed, extreme heat, extreme cold, and other predefined environmental indicators.

Other: Ambient Weather Exposure

Southern Mediterranean coast

Occupational injuries occurring within the southern Mediterranean coastal region will be assigned to this geographic-climatic division according to the workplace or accident location. Meteorological exposure will be determined using data from the Ashqelon Port monitoring station or the nearest available representative station. This region is characterized by a warm coastal Mediterranean climate, relatively high humidity, mild winters, hot summers, and frequent sea-breeze effects. The occurrence and severity of occupational injuries will be evaluated in relation to ambient temperature, relative humidity, wind speed, extreme heat, extreme cold, and other predefined environmental indicators.

Other: Ambient Weather Exposure

Central highlands

Occupational injuries occurring within the central highlands region will be assigned to this geographic-climatic division according to the workplace or accident location. Meteorological exposure will be determined using data from the Jerusalem Centre monitoring station or the nearest available representative station. This region is characterized by higher elevation, lower average humidity than the coastal areas, greater day-night temperature variation, cooler winters, and warm, dry summers. The occurrence and severity of occupational injuries will be evaluated in relation to ambient temperature, relative humidity, wind speed, extreme heat, extreme cold, and other predefined environmental indicators.

Other: Ambient Weather Exposure

Negev desert

Occupational injuries occurring within the Negev desert region will be assigned to this geographic-climatic division according to the workplace or accident location. Meteorological exposure will be determined using data from the Avdat monitoring station or the nearest available representative station. This region is characterized by an arid desert climate, very low relative humidity, intense solar exposure, high daytime temperatures, substantial day-night temperature variation, and limited rainfall. The occurrence and severity of occupational injuries will be evaluated in relation to ambient temperature, relative humidity, wind speed, extreme heat, extreme cold, and other predefined environmental indicators.

Other: Ambient Weather Exposure

Dead Sea and extreme arid region

Occupational injuries occurring within the Dead Sea and extreme arid region will be assigned to this geographic-climatic division according to the workplace or accident location. Meteorological exposure will be determined using data from the Massada monitoring station or the nearest available representative station. This region is characterized by very low elevation, an extremely hot and arid climate, low annual rainfall, intense solar radiation, prolonged periods of extreme heat, and substantial seasonal temperature variation. The occurrence and severity of occupational injuries will be evaluated in relation to ambient temperature, relative humidity, extreme heat, extreme cold, and other predefined environmental indicators. Wind speed will be analyzed when reliable measurements are available.

Other: Ambient Weather Exposure

Interventions

Ambient temperature, relative humidity, and wind speed at the occupational-injury location and time will be retrospectively obtained from the nearest representative meteorological monitoring station. Environmental exposures will be analyzed in relation to occupational-injury occurrence and severity.

Central Mediterranean coastCentral highlandsDead Sea and extreme arid regionNegev desertNorthern Mediterranean coastNorthern valleys and inland northSouthern Mediterranean coast

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population will include adults aged 18 years or older with occupational injuries recognized by the National Insurance Institute between January 1, 2020, and December 31, 2024. Eligible records will be selected from the national occupational-injury administrative database and assigned to one of seven predefined geographic-climatic regions according to the workplace or accident location. Environmental exposure will be determined by linking each injury date, time, and location to the nearest representative meteorological monitoring station. The study will include workplace, occupational-traffic, and commuting injuries meeting the prespecified eligibility criteria.

You may qualify if:

  • Individuals aged 18 years or older with an occupational injury recognized by the National Insurance Institute.
  • Occupational injury occurring between January 1, 2020, and December 31, 2024.
  • Injury occurring at the workplace, during occupational travel, or while commuting to or from work.
  • Valid injury date and geographic information sufficient to assign the accident to one of the seven predefined geographic-climatic regions and the nearest representative meteorological station.
  • Meteorological measurements available for the injury period and eligible matched control periods.
  • For time-specific analyses, a valid recorded accident time permitting linkage to the closest preceding three-hour meteorological observation.

You may not qualify if:

  • Occupational diseases, repetitive-exposure conditions, or gradual-onset disorders without a clearly defined accident date.
  • Rejected, withdrawn, or unconfirmed occupational-injury claims.
  • Missing or invalid accident date or geographic information preventing linkage with meteorological data.
  • Accidents occurring outside the predefined geographic-climatic regions or beyond the prespecified maximum distance from an eligible meteorological station.
  • Duplicate or administratively repeated records referring to the same occupational-injury event.
  • Injury events for which no eligible matched control periods or corresponding meteorological measurements are available.
  • Individuals younger than 18 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Israel National Insurance Institute

Rishon LeZiyyon, 7526557, Israel

Location

Related Publications (3)

  • Calkins MM, Bonauto D, Hajat A, Lieblich M, Seixas N, Sheppard L, Spector JT. A case-crossover study of heat exposure and injury risk among outdoor construction workers in Washington State. Scand J Work Environ Health. 2019 Nov 1;45(6):588-599. doi: 10.5271/sjweh.3814. Epub 2019 Mar 14.

    PMID: 30869152BACKGROUND
  • Sheng R, Li C, Wang Q, Yang L, Bao J, Wang K, Ma R, Gao C, Lin S, Zhang Y, Bi P, Fu C, Huang C. Does hot weather affect work-related injury? A case-crossover study in Guangzhou, China. Int J Hyg Environ Health. 2018 Apr;221(3):423-428. doi: 10.1016/j.ijheh.2018.01.005. Epub 2018 Jan 11.

    PMID: 29361390BACKGROUND
  • Marinaccio A, Scortichini M, Gariazzo C, Leva A, Bonafede M, De' Donato FK, Stafoggia M, Viegi G, Michelozzi P; BEEP Collaborative Group. Nationwide epidemiological study for estimating the effect of extreme outdoor temperature on occupational injuries in Italy. Environ Int. 2019 Dec;133(Pt A):105176. doi: 10.1016/j.envint.2019.105176. Epub 2019 Oct 22.

    PMID: 31654985BACKGROUND

Study Officials

  • Eytan Ellenberg, M.D.

    Israel National Insurance Institute

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Medicine doctor

Study Record Dates

First Submitted

August 2, 2026

First Posted

August 6, 2026

Study Start

January 1, 2020

Primary Completion

December 31, 2024

Study Completion (Estimated)

December 31, 2026

Last Updated

August 6, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be publicly shared because the study uses confidential administrative records owned and controlled by the National Insurance Institute. Access is restricted to authorized researchers within a secure research environment and is governed by institutional confidentiality agreements, data-protection requirements, and applicable privacy legislation. The combination of accident dates, geographic information, occupational characteristics, and disability outcomes may create a residual risk of participant re-identification even after removal of direct identifiers. Only aggregated, disclosure-controlled results approved by the data custodian may be reported or published.

Locations