NCT02857647

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 3, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 5, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 12, 2021

Status Verified

January 1, 2021

Enrollment Period

1.3 years

First QC Date

August 3, 2016

Last Update Submit

January 11, 2021

Conditions

Bariatric Surgery Candidates

Keywords

Bariatric surgeryAnxietyNutrition knowledgeWeight loss expectations

Outcome Measures

Primary Outcomes (1)

  • Anxiety

    Pre-surgery anxiety level will be measured by the state-trait anxiety inventory (STAI) questionnaire.

    pre-surgery

Secondary Outcomes (2)

  • Bariatric surgery and nutrition knowledge

    pre-surgery

  • Weight loss expectation

    pre-surgery

Study Arms (2)

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.

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.

Interventions

An information videoBEHAVIORAL

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).

The experimental group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 29455404DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Shiri Sherf Dagan

Study Record Dates

First Submitted

August 3, 2016

First Posted

August 5, 2016

Study Start

August 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

January 12, 2021

Record last verified: 2021-01