Obesity Surgery, Counseling, and Psychological Well-Being
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|ClinicalTrials.gov Identifier: NCT01865227|
Recruitment Status : Unknown
Verified June 2013 by Dr Sabrina Tahboub-Schulte, American University of Sharfah.
Recruitment status was: Recruiting
First Posted : May 30, 2013
Last Update Posted : June 14, 2013
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 or disease||Intervention/treatment||Phase|
|Obesity Bariatric Surgery||Behavioral: Group Counseling||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Impact of Counseling on Obesity Surgery Outcomes and Psychological Functioning: A Randomized Clinical Trial in 2 Arab Countries|
|Study Start Date :||November 2012|
|Estimated Primary Completion Date :||November 2014|
|Estimated Study Completion Date :||November 2014|
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|
- weight loss [ Time Frame: 12 months ]Body weight will be measured in regular intervals to record weight loss.
- psychological health [ Time Frame: 12 months ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01865227
|Contact: Sabrina Tahboub-Schulte, PhDfirstname.lastname@example.org|
|Contact: Bashir email@example.com|
|Principal Investigator: Ahmad Bashir|
|United Arab Emirates|
|Abu Dhabi, United Arab Emirates|
|Contact: Abdelrahman Nimeiri|
|Principal Investigator: Abdelrahman Nimeiri|