Obesity Surgery, Counseling, and Psychological Well-Being

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by American University of Sharfah
Sponsor:
Collaborators:
Sheikh Khalifa Medical City
Jordan Hospital
Information provided by (Responsible Party):
Dr Sabrina Tahboub-Schulte, American University of Sharfah
ClinicalTrials.gov Identifier:
NCT01865227
First received: May 27, 2013
Last updated: June 13, 2013
Last verified: June 2013
  Purpose

Obesity has become a global epidemic causing enormous human and economic costs. Incidence rates have doubled over the last few decades and obesity-related illnesses such as diabetes and cardiovascular diseases now constitute one of the major contributors to the global burden of disability. Overall, obesity has been recognized as one of the most pressing public health concerns worldwide and effective treatment and prevention strategies are urgently required. While behavioral and pharmacological treatments (e.g.low calorie diets, medication) are successful means for overcoming overweight and mild obesity, more severe cases of obesity usually fail to respond to such interventions. As a result, the demand for weight loss surgery is growing among this population. However, uncertainties about the effectiveness of obesity surgery persist and high relapse rates (i.e. weight regain) are common. Further research in this field is needed to identify risk factors that may trigger relapse and to understand patients' treatment needs in greater depth. Previous studies have pointed toward high levels of mental health problems among patients. However, the impact of preoperative psychopathology on actual surgery outcomes remains unclear. Similarly, few studies have investigated the effect of postoperative therapy on patients' psychological functioning and weight loss patterns. Research addressing these gaps is imperative to establish best-practice approaches. This challenge applies in particular to Middle East and North Africa(MENA) countries where research in the field of bariatric surgery and related mental health is largely missing. This is a major concern given the fact that the MENA region experienced the highest increase in overweight and obesity in recent decades compared to other countries.

The proposed study aims to address this deficiency by examining obesity surgery patients in two Arab countries (UAE and Jordan). The goals of the project are to investigate the nature and extent of psychological health concerns among these patients before and after surgery and potential associations with treatment outcomes. Moreover, it will test the efficacy of post-operative counseling to improve weight loss and psychological health. For this purpose, a randomized clinical trial design will be employed so that cause and effect relationships between postoperative counseling and treatment outcomes(i.e. weight loss and psychological functioning) can be examined experimentally. The study will start by assessing participants' psychological health prior to surgery by using standardized self-report measures.

After surgery, participants will be randomly assigned to either the intervention condition consisting of 3-monthly post-operative medical checkups plus group counseling or the treatment as usual condition (i.e. 3-monthly standard medical checkups only). Additionally, participants' psychological health will be reassessed in both groups at 3, 6, 9 and 12 months after surgery. The benefit of the experimental study design is that it allows comparing patient outcomes between groups while at the same time controlling for a wide range of potential confounding variables.

The data collected are expected to make a significant contribution to the treatment challenge of one of the most pressing public health concerns worldwide. Study results will add to clinical practice by broadening and deepening our knowledge of the treatment needs of obese patients. By identifying psychological health concerns that may threaten successful treatment outcomes high-risk patient groups can be recognized early, which in turn may help to reduce postoperative weight regain and other complications.

To the best of the PI's knowledge, the proposed work would be the first study of this kind in the Arab world. Findings will be helpful for developing culturally sensitive and evidence-based best-practice guidelines, which are vital to achieve satisfying long-term outcomes. Moreover, study results will be relevant for research communities and practitioners outside the MENA region since empirical support for the effectiveness of obesity surgery remains weak internationally.


Condition Intervention
Obesity
Bariatric Surgery
Behavioral: Group Counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Impact of Counseling on Obesity Surgery Outcomes and Psychological Functioning: A Randomized Clinical Trial in 2 Arab Countries

Resource links provided by NLM:


Further study details as provided by American University of Sharfah:

Primary Outcome Measures:
  • weight loss [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Body weight will be measured in regular intervals to record weight loss.

  • psychological health [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    A set of standardized measures is being used to assess participants' psychological health including the following:

    Three Factor Eating Questionnaire, Binge Eating Scale, Parts of Bulimic Investigatory Test, Beck Depression Inventory (revised), Zung Anxiety Scale, Rosenberg Self-Esteem Scale, Experience of Shame Scale, Obsessive-Compulsive Inventory, Parts of Eating Disorders Quality of Life Scale and the Mini Mental State Examination.



Estimated Enrollment: 100
Study Start Date: November 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group Counseling
The major aim of the post-operative counseling groups is to engage patients in discussing and exchanging their thoughts on issues of concern related to their surgery and overall well-being. The selected patients will be informed about the purpose of these support groups and will be made aware that their attendance is entirely voluntary.
Behavioral: Group Counseling
No Intervention: Standard treatment

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients registered for bariatric surgery

Exclusion Criteria:

  • Not applicable
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01865227

Contacts
Contact: Sabrina Tahboub-Schulte, PhD 00971508829098 stahboubschulte@aus.edu

Locations
Jordan
Jordan Hospital Recruiting
Amman, Jordan
Contact: Bashir       ahmad.bashir.md@gmail.com   
Principal Investigator: Ahmad Bashir         
United Arab Emirates
SKMC Recruiting
Abu Dhabi, United Arab Emirates
Contact: Abdelrahman Nimeiri         
Principal Investigator: Abdelrahman Nimeiri         
Sponsors and Collaborators
American University of Sharfah
Sheikh Khalifa Medical City
Jordan Hospital
  More Information

No publications provided

Responsible Party: Dr Sabrina Tahboub-Schulte, Assistant Professor of Psychology, American University of Sharfah
ClinicalTrials.gov Identifier: NCT01865227     History of Changes
Other Study ID Numbers: FRG12-2-16
Study First Received: May 27, 2013
Last Updated: June 13, 2013
Health Authority: United Arab Emirates: General Authority for Health Services for Abu Dhabi

Keywords provided by American University of Sharfah:
Obesity
Bariatric surgery
Binge Eating Disorder
Psychological Health
Counselling

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 18, 2014