- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01913496
Development of Web Application and Evaluation Its Impact on Healthy Lifestyle
March 12, 2016 updated by: Jenny Naimark, Hebrew University of Jerusalem
Development of Internet Web Application and Evaluation of Its Impact as a Tool in Promoting Healthy Lifestyle Indicators in Adults
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.
Study Overview
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
Study Type
Interventional
Enrollment (Actual)
99
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Jerusalem, Israel
- Hebrew University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Standard care
standard care ,without the web application ebalance
|
using the ebalance application for 14 weeks
|
|
Active Comparator: ebalance
using the ebalance application for 14 weeks
|
using the ebalance application for 14 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
weight
Time Frame: 14 weeks
|
measuring weight at baseline and end of 14 weeks
|
14 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
duration of physical activity
Time Frame: 14 weeks
|
at baseline and end of study
|
14 weeks
|
|
Nutrition knowledge
Time Frame: 14 weeks
|
questionnaire at baseline and end of study
|
14 weeks
|
|
waist circumference
Time Frame: 14 weeks
|
waist circumference will be measured at baseline and end of 14 weeks
|
14 weeks
|
|
height
Time Frame: 14 weeks
|
height will be measured at baseline
|
14 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jenny Naimark, PhD student, Hebrew University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2013
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
July 25, 2013
First Submitted That Met QC Criteria
July 30, 2013
First Posted (Estimate)
August 1, 2013
Study Record Updates
Last Update Posted (Estimate)
March 15, 2016
Last Update Submitted That Met QC Criteria
March 12, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- eBalance
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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