LifestyleNCT01913496
Development of Web Application and Evaluation Its Impact on Healthy Lifestyle
A study testing ebalance in people with Lifestyle, run by Hebrew University of Jerusalem at 1 site in Israel.
Trial 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 ). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lifestyle
- What is being tested?
- ebalance
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2013to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- People aged more than 18 years
- Web and e-mail experience
- Interested in either reducing weight or maintaining a healthy lifestyle
Who cannot join
- without any mail experience
- pregnancy
- involvement in other diet programs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Lifestyle
- Being tested
- ebalance
- Keywords
- web application, nutrition knowledge, physical activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ebalanceOther
using the ebalance application for 14 weeks
| Study group | Role | What they receive |
|---|---|---|
| Standard care | Placebo comparator | standard care ,without the web application ebalance Receives: Other: ebalance |
| ebalance | Active comparator | using the ebalance application for 14 weeks Receives: Other: ebalance |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight
measuring weight at baseline and end of 14 weeks
Measured: 14 weeks
Secondary outcomes (4)
duration of physical activity
at baseline and end of study
Measured: 14 weeks
Nutrition knowledge
questionnaire at baseline and end of study
Measured: 14 weeks
waist circumference
waist circumference will be measured at baseline and end of 14 weeks
Measured: 14 weeks
height
height will be measured at baseline
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2013 (estimated)
- Study startApr 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LifestyleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hebrew University of Jerusalem
- Sponsor type
- University, hospital or other
- Collaborators
- Ben-Gurion University of the Negev
- Responsible party
- Principal investigator, Jenny Naimark, Hebrew University of Jerusalem
- Investigators
- Jenny Naimark, PhD student, Principal investigator, Hebrew University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01913496
- Sponsor's protocol ID
- eBalance
- Status last verified
- Mar 2016
- First submitted
- 25 Jul 2013
- Last updated
- 15 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25732936
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Internet Web Application and Evaluation of Its Impact as a Tool in Promoting Healthy Lifestyle Indicators in Adults
- ClinicalTrials.gov ID
- NCT01913496
- Acronym / sponsor ID
- eBalance
- Conditions
- Lifestyle
- Keywords
- web application, nutrition knowledge, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Hebrew University of JerusalemUniversity, hospital or other
- Collaborators
- Ben-Gurion University of the Negev
- Study start
- Apr 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 1 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care | Placebo comparator | Other: ebalancestandard care ,without the web application ebalance |
| ebalance | Active comparator | Other: ebalanceusing the ebalance application for 14 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- People aged more than 18 years
- Web and e-mail experience
- Interested in either reducing weight or maintaining a healthy lifestyle
Key exclusion criteria (3 listed)
- without any mail experience
- pregnancy
- involvement in other diet programs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ebalanceusing the ebalance application for 14 weeks | Other | Standard care, ebalance |
Primary outcome
weight
Time frame: 14 weeks
measuring weight at baseline and end of 14 weeks
4 secondary outcomes
duration of physical activity
Time frame: 14 weeks
Nutrition knowledge
Time frame: 14 weeks
waist circumference
Time frame: 14 weeks
height
Time frame: 14 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2016.
- Derived from this study: PubMed 25732936Safran 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jenny Naimark, PhD student principal investigator
Hebrew University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ebalance in people with Lifestyle, run by Hebrew University of Jerusalem at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight (time frame: 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01913496, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2016.