NCT01628419

Brief Summary

The purpose of the current investigation is to examine the effects of health intervention program at the workplace on health risks for cardiovascular disease, well-being and absenteeism at the workplace. Participants: 1500 male and female employees from 10 different companies across Israel will take part in the study. Age: older than 18 yrs. Hypothesis 1: The intervention program will have positive effects on the health risks for cardiovascular disease. For example: Will be reflected in a decrease in LDL and increase in HDL. Hypothesis 2: The intervention program will have positive effects on the absenteeism at the workplace (e.g. decrease in days of sick leave per employee).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2012

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 26, 2012

Completed
5 days until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

December 9, 2015

Status Verified

December 1, 2015

Enrollment Period

2.4 years

First QC Date

June 21, 2012

Last Update Submit

December 8, 2015

Conditions

Keywords

Health promotionInterventionWorkplaceExercise program

Outcome Measures

Primary Outcomes (1)

  • Anthropometric measures

    The following measures will be evaluated: Height and body mass (Kg) and Body mass index will be calculated (BMI), hip and waist circumference and the ratio between the two measures will be calculated.

    6 months

Secondary Outcomes (2)

  • Absenteeism from work

    6 months

  • Blood tests results

    6 months

Study Arms (1)

Health intervention program

EXPERIMENTAL

Health promotion intervention program will be implemented at each workplace and will include: exercise program, nutritional counseling for the kitchen service, lectures on different topics (physical activity, nutrition, sleeping behaviour etc.).

Behavioral: Health intervention

Interventions

physical activity program at the workplace - once a week with a certified trainer. (The program will include: aerobic exercises as well as resistance exercises). The employees will encourage to perform two additional workouts during the week. Nutritional counseling for the kitchen staff Lectures - lectures will be given at each worksite on different topics: physical activity, nutrition, sleeping behaviour, mental aspects.

Health intervention program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • agreement to participate in the study,
  • older than 18 yrs

You may not qualify if:

  • Missing blood tests results and anthropometric measures prior to the beginning of the study,
  • unstable cardiac disease,
  • unstable hypertension during rest (above 200 mmHg systolic blood pressure and above 110 mmHg of diastolic blood pressure),
  • pregnancy,
  • using pacemaker,
  • past cardiac incidence during the 6 months preceding the test,
  • other disease that might cause contraindication for exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wingate Institute

Netanya, Israel

Location

MeSH Terms

Interventions

Play Therapy

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Eyal Shargal, PhD

    Wingate Institute, Israel

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2012

First Posted

June 26, 2012

Study Start

July 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

December 9, 2015

Record last verified: 2015-12

Locations