A Sustainable Diet for Hadassah Employees Workers | NCT01686399

Studies
A Sustainable Diet for Hadassah Employees Workers

NCT01686399

Sponsor

Hadassah Medical Organization

Status

Unknown status

Last Update Posted

Mar 24, 2015Estimated

Enrollment

450Estimated

Phase

Not Applicable

Conditions

Obesity
Physical Activity

Interventions

Nutritional and Activity Promotion

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2015

Primary Completion Date

Mar 2016Estimated

Completion Date

Mar 2016Estimated

First Submitted Date

Sep 9, 2012

First Submission Date that Met QC Criteria

Sep 12, 2012

First Posted Date

Sep 18, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 22, 2015

Last Update Posted Date

Mar 24, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ram Weiss, Associate Professor, Hadassah Medical OrganizationPrincipal Investigator

Lead Sponsor

Hadassah Medical OrganizationOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this protocol is to use a multidisciplinary approach to convey nutrition and activity messages to randomly selected Hadassah Medical Center employees. The intervention will be for one academic year and include frontal talks, email and internet focus group interactions, public demonstrations and a focused intervention within the hospital kitchen.

The outcomes are specific parameters of dietary modifications, degree of physical activity and health related perspectives. Outcomes will be recorded at baseline and by the end of the intervention ( one year).

Detailed Description

The participants will be selected randomly from the campus employees. They will be exposed to multiple levels of health promotion at the work place as well as via multiple media tools. Analysis will be performed at baseline by using multiple nutrition and health perception questionnaires. A second group from the employees will be selected for assessment of the same outcomes at the end of the year.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

450Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
The study has a single arm	Experimental	The study has one arm The whole population of the campus will be exposed to the intervention. the effectiveness will be assessed using a random selection twice - before and after the intervention	Behavioral: Nutritional and Activity Promotion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nutritional and Activity Promotion	Behavioral	Multi disciplinary nutritional and behavioral messages to improve diet and activity levels	The study has a single arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in amount of fruit/vegetable consumption per day	Amount of fruit/vegetable consumption will be evaluated via questionnaires	one year

Secondary Outcomes

Measure	Description	Time Frame
Amount of physical activity per week	Amount of physical activity will be assessed via questionnaires	one year

Other Outcomes

Measure	Description	Time Frame
Amount of soft drinks consumed per day	The amount of soft drinks consumed per day will be assessed via questionnaires	one year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Hadassah medical center employees Age 21-67

Exclusion Criteria:

- Refusal to participate

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

67 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dorit Adler, MPH	Contact	02677551

Overall Officials

Name	Affiliation	Role
Ram Weiss, MD PhD	Hadassah Medical Organization	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah Medical Center		Jerusalem Region		91120	Israel

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity
D009043	Motor Activity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided