Bariatric Surgery CandidatesNCT02857647
The Effects of an Information Video on Anxiety and Bariatric Surgery Knowledge Among Bariatric Surgery Candidates
A study testing An information video in people with Bariatric Surgery Candidates, run by Assuta Medical Center.
Trial summary
An interventional prospective study on 200 bariatric surgery candidates from the Assuta Medical Center (AMC). The first 100 patients will be assigned to the control group and the later 100 patients will be assigned to the experimental group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bariatric Surgery Candidates
- What is being tested?
- An information video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Dec 2017
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pre-surgery: 18 years old or older, BMI > 40 kg/m² or BMI > 35 kg/m² with comorbidities and approval of the AMC committee to undergo bariatric surgery.
- Surgery types: laparoscopic sleeve gastrectomy (LSG), Roux-en-Y gastric bypass (RYGB) and Single-anastomosis gastric bypass (SAGB)
- Surgery will take place at Assuta medical center.
- Reading and speaking Hebrew.
Who cannot join
- Previous bariatric surgery.
- Surgery types: laparoscopic adjustable gastric band (LAGB) or biliopancreatic diversion with duodenal switch (BPD-DS)
- Less than 2 weeks between bariatric committee and surgery date
About this study
An interventional prospective study on 200 bariatric surgery candidates from the Assuta Medical Center (AMC). The first 100 patients will be assigned to the control group and the later 100 patients will be assigned to the experimental group. All the participants will receive standard care, and only those participants who will assigned to the experimental group will be asked to watch a videotaped lecture of 30 minutes 1-2 weeks prior to the surgery date. The videotaped lecture will include information and guidelines of bariatric surgery preparation. All participants will complete Bariatric surgery knowledge questionnaire and The state-trait anxiety inventory (STAI) questionnaire at the bariatric committee and once again at the pre-surgery clinic which take place 1-10 days pre-surgery.In addition, 20 participants will be recruited to a pilot study for the validation of the Bariatric surgery knowledge questionnaire.
Read the detailed description
Only few studies have investigated anxiety level, bariatric surgery and nutrition knowledge and weight loss expectations prior to bariatric surgery. No studies have been published on how preparation lectures prior to bariatric surgery impact on anxiety level and on patients' knowledge. A better preparation process prior to the bariatric surgery may have an impact on higher success rates of bariatric surgeries.
Our study is an interventional prospective study on 200 bariatric surgery candidates from the Assuta Medical Center (AMC). The first 100 patients will be assigned to the control group and the later 100 patients will be assigned to the experimental group. All the participants will receive standard care, and only those participants who will assigned to the experimental group will be asked to watch a videotaped lecture of 30 minutes 1-2 weeks prior to the surgery date. The videotaped lecture will include information and guidelines of bariatric surgery preparation. Topics includes: types of surgeries, preparation to the hospitalization process and to the surgery (e.g. what to expect, personal equipment needs, description of the surgery admission process, etc.), dietary guidelines pre- and post-surgery (e.g. low carb diet 2-3 week prior to the surgery, post-surgery diet progression, techniques of eating and drinking, recommended dietary supplements), recommendation and tips for long term surgery success (e.g. definition of weight loss expectations, physiological, nutritional and life-style strategies for long-term weight loss). All participants will complete Bariatric surgery knowledge questionnaire and The state-trait anxiety inventory (STAI) questionnaire at the bariatric committee and once again at the pre-surgery clinic which take place 1-10 days pre-surgery. In addition, 20 participants be recruited to a pilot study for the validation of the Bariatric surgery knowledge questionnaire.
- Conditions
- Bariatric Surgery Candidates
- Being tested
- An information video
- Keywords
- Bariatric surgery, Anxiety, Nutrition knowledge, Weight loss expectations
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
An information videoBehavioural
Participants who will assigned to the experimental group will be asked to watch a 30 minutes videotaped lecture 1-2 weeks prior to the surgery date. Topics includes: types of surgeries, preparation to the hospitalization process and to the surgery (e.g. what to expect, personal equipment needs, description of the surgery admission process, etc.), dietary guidelines pre- and post-surgery (e.g. low carb diet 2-3 week prior to the surgery, post-surgery diet progression, techniques of eating and drinking, recommended dietary supplements), recommendation and tips for long term surgery success (e.g. definition of weight loss expectations, physiological, nutritional and life-style strategies for long-term weight loss).
| Study group | Role | What they receive |
|---|---|---|
| The experimental group | Experimental | Participants who will assigned to the experimental group will be asked to watch an information video of 30 minutes 1-2 weeks prior to the surgery date.
n=100. Receives: Behavioral: An information video |
| The control group | No intervention | Participants who will assigned to the control group will receive standard care and will not asked to watch a videotaped lecture prior to the surgery. n=100. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
Pre-surgery anxiety level will be measured by the state-trait anxiety inventory (STAI) questionnaire.
Measured: pre-surgery
Secondary outcomes (2)
Bariatric surgery and nutrition knowledge
Bariatric surgery and nutrition knowledge will be measured by a questionnaire written by investigators.
Measured: pre-surgery
Weight loss expectation
Measured: pre-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2017
- Study completionDec 2017
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 Bariatric Surgery CandidatesStudies 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
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assuta Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shiri Sherf Dagan, Assuta Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02857647
- Sponsor's protocol ID
- 0041-16
- Status last verified
- Jan 2021
- First submitted
- 3 Aug 2016
- Last updated
- 12 Jan 2021
- Results posted
- No
Publications
Sherf-Dagan S, Hod K, Mardy-Tilbor L, Gliksman S, Ben-Porat T, Sakran N, Zelber-Sagi S, Goitein D, Raziel A. The Effect of Pre-Surgery Information Online Lecture on Nutrition Knowledge and Anxiety Among Bariatric Surgery Candidates. Obes Surg. 2018 Jul;28(7):1876-1885. doi: 10.1007/s11695-018-3134-y.
PubMed 29455404
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of an Information Video on Anxiety and Bariatric Surgery Knowledge Among Bariatric Surgery Candidates
- ClinicalTrials.gov ID
- NCT02857647
- Acronym / sponsor ID
- 0041-16
- Conditions
- Bariatric Surgery Candidates
- Keywords
- Bariatric surgery, Anxiety, Nutrition knowledge, Weight loss expectations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Assuta Medical CenterUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 5 Aug 2016 (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.
An interventional prospective study on 200 bariatric surgery candidates from the Assuta Medical Center (AMC). The first 100 patients will be assigned to the control group and the later 100 patients will be assigned to the experimental group. All the participants will receive standard care, and only those participants who will assigned to the experimental group will be asked to watch a videotaped lecture of 30 minutes 1-2 weeks prior to the surgery date. The videotaped lecture will include information and guidelines of bariatric surgery preparation. All participants will complete Bariatric surgery knowledge questionnaire and The state-trait anxiety inventory (STAI) questionnaire at the bariatric committee and once again at the pre-surgery clinic which take place 1-10 days pre-surgery.In addition, 20 participants will be recruited to a pilot study for the validation of the Bariatric surgery knowledge questionnaire.
Detailed description
Only few studies have investigated anxiety level, bariatric surgery and nutrition knowledge and weight loss expectations prior to bariatric surgery. No studies have been published on how preparation lectures prior to bariatric surgery impact on anxiety level and on patients' knowledge. A better preparation process prior to the bariatric surgery may have an impact on higher success rates of bariatric surgeries.
Our study is an interventional prospective study on 200 bariatric surgery candidates from the Assuta Medical Center (AMC). The first 100 patients will be assigned to the control group and the later 100 patients will be assigned to the experimental group. All the participants will receive standard care, and only those participants who will assigned to the experimental group will be asked to watch a videotaped lecture of 30 minutes 1-2 weeks prior to the surgery date. The videotaped lecture will include information and guidelines of bariatric surgery preparation. Topics includes: types of surgeries, preparation to the hospitalization process and to the surgery (e.g. what to expect, personal equipment needs, description of the surgery admission process, etc.), dietary guidelines pre- and post-surgery (e.g. low carb diet 2-3 week prior to the surgery, post-surgery diet progression, techniques of eating and drinking, recommended dietary supplements), recommendation and tips for long term surgery success (e.g. definition of weight loss expectations, physiological, nutritional and life-style strategies for long-term weight loss). All participants will complete Bariatric surgery knowledge questionnaire and The state-trait anxiety inventory (STAI) questionnaire at the bariatric committee and once again at the pre-surgery clinic which take place 1-10 days pre-surgery. In addition, 20 participants be recruited to a pilot study for the validation of the Bariatric surgery knowledge questionnaire.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The experimental group | Experimental | Behavioral: An information videoParticipants who will assigned to the experimental group will be asked to watch an information video of 30 minutes 1-2 weeks prior to the surgery date. n=100. |
| The control group | No intervention | –Participants who will assigned to the control group will receive standard care and will not asked to watch a videotaped lecture prior to the surgery. n=100. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pre-surgery: 18 years old or older, BMI > 40 kg/m² or BMI > 35 kg/m² with comorbidities and approval of the AMC committee to undergo bariatric surgery.
- Surgery types: laparoscopic sleeve gastrectomy (LSG), Roux-en-Y gastric bypass (RYGB) and Single-anastomosis gastric bypass (SAGB)
- Surgery will take place at Assuta medical center.
- Reading and speaking Hebrew.
Key exclusion criteria (3 listed)
- Previous bariatric surgery.
- Surgery types: laparoscopic adjustable gastric band (LAGB) or biliopancreatic diversion with duodenal switch (BPD-DS)
- Less than 2 weeks between bariatric committee and surgery date
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 |
|---|---|---|
| An information videoParticipants who will assigned to the experimental group will be asked to watch a 30 minutes videotaped lecture 1-2 weeks prior to the surgery date. Topics includes: types of surgeries, preparation to the hospitalization process and to the surgery (e.g. what to expect, personal equipment needs, description of the surgery admission process, etc.), dietary guidelines pre- and post-surgery (e.g. low carb diet 2-3 week prior to the surgery, post-surgery diet progression, techniques of eating and drinking, recommended dietary supplements), recommendation and tips for long term surgery success (e.g. definition of weight loss expectations, physiological, nutritional and life-style strategies for long-term weight loss). | Behavioural | The experimental group |
Primary outcome
Anxiety
Time frame: pre-surgery
Pre-surgery anxiety level will be measured by the state-trait anxiety inventory (STAI) questionnaire.
2 secondary outcomes
Bariatric surgery and nutrition knowledge
Time frame: pre-surgery
Weight loss expectation
Time frame: pre-surgery
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 12 Jan 2021.
- Derived from this study: PubMed 29455404Sherf-Dagan S, Hod K, Mardy-Tilbor L, Gliksman S, Ben-Porat T, Sakran N, Zelber-Sagi S, Goitein D, Raziel A. The Effect of Pre-Surgery Information Online Lecture on Nutrition Knowledge and Anxiety Among Bariatric Surgery Candidates. Obes Surg. 2018 Jul;28(7):1876-1885. doi: 10.1007/s11695-018-3134-y.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing An information video in people with Bariatric Surgery Candidates, run by Assuta Medical Center.
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 4 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 12 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Anxiety (time frame: pre-surgery). 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 NCT02857647, 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 12 Jan 2021; AzTrials last refreshed its copy on 8 Nov 2026.