Development of Web Application and Evaluation Its Impact... | NCT01913496

Studies
Development of Web Application and Evaluation Its Impact on Healthy Lifestyle

NCT01913496

Sponsor

Hebrew University of Jerusalem

Status

Completed

Last Update Posted

Mar 15, 2016Estimated

Enrollment

99Actual

Phase

Not Applicable

Conditions

Lifestyle

Interventions

ebalance

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 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2013

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Jul 25, 2013

First Submission Date that Met QC Criteria

Jul 30, 2013

First Posted Date

Aug 1, 2013Estimated

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 12, 2016

Last Update Posted Date

Mar 15, 2016Estimated

Name	Class
Ben-Gurion University of the Negev	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 study is planned for people who would like to reduce or maintain their weight and keep a healthy life style .After signing an informed consent, participants will be divided randomly into two groups :control group and an intervention group that will get the application (eBalance ). Participants will be followed for 12 weeks.

Detailed Description

Primary objective: to develop a web application based on energy balance and evaluates its effectiveness in promoting healthy lifestyle habits versus a control group.

Secondary objectives:

To evaluate the frequency and convenient of usage of the internet intervention
To test the impact of the intervention on nutrition knowledge, diet quality and physical activity
To evaluate the effect of the intervention on weight management status

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

99Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Standard care	Placebo Comparator	standard care ,without the web application ebalance	Other: ebalance
ebalance	Active Comparator	using the ebalance application for 14 weeks	Other: ebalance

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ebalance	Other	using the ebalance application for 14 weeks	Standard care ebalance

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
weight	measuring weight at baseline and end of 14 weeks	14 weeks

Secondary Outcomes

Measure	Description	Time Frame
duration of physical activity	at baseline and end of study	14 weeks
Nutrition knowledge	questionnaire at baseline and end of study

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

People aged more than 18 years
Web and e-mail experience
Interested in either reducing weight or maintaining a healthy lifestyle

Exclusion Criteria:

without any mail experience
pregnancy
involvement in other diet programs

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jenny Naimark, PhD student	Hebrew University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hebrew University		Jerusalem			Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25732936	Derived	Safran Naimark J, Madar Z, Shahar DR. The impact of a Web-based app (eBalance) in promoting healthy lifestyles: randomized controlled trial. J Med Internet Res. 2015 Mar 2;17(3):e56. doi: 10.2196/jmir.3682.