Research Bites—November 2011

| November 21, 2011

Virtual Environments For Supporting Obesity Treatment (AVATOB)

Purpose. Seeking 60 participants to undergo treatment at the Obesity Unit of the Medica Sur Hospital in México City, Mexico. Informed consent to participate will be aleatory assigned to a three different conditions. In the initial interview, prospective participants will be provided with detailed information about the study and the treatments. All patients included in the study will be randomly assigned to the one (N=20) of the three treatment conditions described below, all conducted on an inpatient basis. The duration for all treatments will be six weeks and will be administered by two chartered clinical psychologists and one chartered psychotherapist under the supervision of a senior chartered psychotherapist. The three therapists will be balanced among the the following three conditions: nutritional, cognitive-behavioral therapy (CBT), and experiential cognitive therapy.

Eligibility. Participants must be woman who are 18 to 50 years old. This study does not accept healthy volunteers.

Primary outcome measures.
•    Anxiety inventory: State-Trait IDARE. [Time frame: Change from Baseline in Anxiety Inventory: State-Trait IDARE at six weeks, change from Baseline in Anxiety Inventory: State-Trait IDARE at six months ] [Designated as safety issue: Yes ]
• The scale A-Trait Anxiety Inventory consists of 20 statements in which subjects are asked to describe how they feel generally. A-State scale also consists of 20 statements, but the instructions require that subjects indicate how they feel at any given time. It measures two dimensions of anxiety: state (referring to how the subject feels at that moment) and trait (how you feel usually).
•    Body Image Questionnaire: [Time Frame: Change frome Baseline in Body Image Questionnaire (BSQ) at six weeks, Change frome Baseline in BSQ at six months] [Designated as safety issue: Yes ]
• The BSQ consists of 34 questions scored on a Likert scale of 1 to 6. Includes four subscales: body dissatisfaction, fear of gaining weight, low esteem by the appearace, and want to lose weight.
•    Weight: [Time Frame: Changes in weight from the first week will be assessed up to six weeks, changes in weight at six months] [Designated as safety issue: No]
• Weight loss after the treatment and after the follow-up phase.

Sponsor. Universidad Nacional Autonoma de Mexico

Collaborators. Istituto Auxologico Italiano Medica Sur Clinic and Foundation

Information provided by. Universidad Nacional Autonoma de Mexico

Protein Need and Interest of “Quick Proteins” to the Obese Subject Operated by Bariatric Surgery (BIBOP)

Purpose. The main objective of the study is to evaluate the protein requirement associated with postoperative weight loss caused by bypass (shunt which leads to a certain degree of malabsorption) or sleeve gastrectomy (more technically conservative with less malabsorption), through the study of nitrogen balance. The benefit of protein supply easily absorbed and with high essential amino acids content (proteins “fast” soluble milk) on protein metabolism and muscle function will also be studied. Endotoxemia and intestinal flora variations were measured before and after bariatric surgery.

Eligibility. Seeking men and women participants ages 18 to 60. This study does not accept healthy volunteers.

Primary outcome measures. To measure the nitrogen balance and its variation during weight loss [Time frame: before, after three months and one year following the operation] [Designated as safety issue: Yes]

Sponsor. University Hospital, Clermont-Ferrand

Collaborators. Centre de Recherche en Nutrition Humaine d’Auvergne, Centre de Recherche en Nutrition Humaine Rhone-Alpe, Hospices Civils de Lyon, Service de médecine du Sport et des Explorations Fonctionnelles—CHRU de Clermont-Ferrand

Information provided by. University Hospital, Clermont-Ferrand

ClinicalTrials.gov identifier. NCT01249326

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Category: Past Articles, Research Bites

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