Virtual Environments For Supporting Obesity Treatment (AVATOB)
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Purpose
Participants 60 Patients seeking 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.
Procedures 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 6 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 three conditions.
- Nutritional groups In this condition (NT) the participants (N=20) subjects enter only 5 weekly nutritional groups held by dieticians based on the LEARN manual (Brownell, 1985), whose goal will be to provide practical guidelines for the self-monitoring of eating and lessons on nutrition (e.g stressing gradual weight loss with the caloric restriction achieved largely by reductions in fat intake), plus a low-calorie diet (1,200 kcal/day) and physical training (30 min of walking two times a week as a minimum).
Cognitive-Behavioral therapy CBT group (N=20) will be based on the same treatment proposed in the first condition plus 15 additional sessions over 6 weeks.
Therapists will follow a detailed manual that outlined the content of each session. This manual was based on the cognitive—behavioral treatment approach described by Cooper and colleagues (Cooper & Fairburn, 2002; Cooper et al., 2003). It was developed during a year of intensive pilot work and adapted to the in-patient setting. Patients will be taught to self-monitor their food intake and eating patterns and thoughts, as well as the circumstances and environment surrounding eating (e.g. whether eating alone or with others, speed of eating, and place of eating). Patients will also be taught to identify problems in eating, mood, and thinking patterns and to gradually develop alternative patterns.
In particular, after the first week the patients will enter 5 weekly group sessions aimed at addressing weight and primary goals, and 10 biweekly individual sessions aimed at establishing and maintaining weight loss, addressing barriers to weight loss, increasing activity, addressing body image concerns and supporting weight maintenance.
- Experiential Cognitive therapy Experiential CT group (N=4) involved the same treatment proposed in the first condition plus 15 additional sessions over 4/6 weeks.
In the sessions we will use the "20/20/20 rule". During the first 20 minutes, the therapist focus on getting a clear understanding of the patient's current concerns, level of general functioning, and the experiences related to food. This part of the session tends to be characterized by patients doing most of the talking, although therapist guides with questions and reflection to get a sense of the patient's current status. The second 20 minutes is devoted to the virtual reality experience. During this part of the session the patient enters the virtual environment and faces a specific critical situation (Kitchen, Supermarket, Pub, Restaurant, Gymnasium, etc.). Here the patient is helped in developing specific strategies for avoiding and/or coping with it. In the final 20 minutes the therapist explores the patient's understanding of what happened in VR and the specific reactions - emotional and behavioral - to the different situations experienced. If needed, some new strategies for coping with the VR situations are presented and discussed. To support the empowerment process, the therapists follow the Socratic style: they use a series of questions, related to the contents of the virtual environment, to help clients synthesize information and reach conclusions on their own.
In accordance with informed consent, assessments will be obtained before treatment, at posttreatment, 3 and 6 months after the treatment conclusion.
| Condition | Intervention | Phase |
|---|---|---|
|
Obesity Morbid Obesity |
Behavioral: Experiential-Cognitive Therapy for Obesity Behavioral: Behavioral cognitive Treatment Dietary Supplement: Nutritional groups (NT) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Health Services Research |
| Official Title: | Ambientes Virtuales Como Auxiliares en el Tratamiento de la Obesidad |
- Anxiety Inventory: State-Trait IDARE [ Time Frame: Change from Baseline in Anxiety Inventory: State-Trait IDARE at 6 weeks, Change from Baseline in Anxiety Inventory: State-Trait IDARE at 6 months ] [ Designated as safety issue: Yes ]The scale A-Trait Anxiety Inventory consists of twenty statements in which subjects are asked to describe how they feel generally. A-State scale also consists of 20 statements, but the instructions required that subjects indicate how they feel at any given time. Measures two dimensions of anxiety: state (referring to how the subject feels at that moment) and trait (how you feel usually). Instrument validated in Mexico (Spielberger & Diaz Guerrero, 1975)
- Body Image Questionnaire (BSQ) [ Time Frame: Change frome Baseline in Body Image Questionnaire (BSQ) at 6 weeks, Change frome Baseline in Body Image Questionnaire (BSQ) at 6 months ] [ Designated as safety issue: Yes ]Designed by Cooper, Taylor, Cooper and Fairburn (1987), adapted to Spanish population by Raich et al. (1996) and to Mexican women by Galán (2004). Consists of 34 questions scored on a Likert scale of 1 to 6. Lets get an overall score (sum of raw scores of the items) and can be derived 4 subscales: body dissatisfaction, fear of gaining weight, low esteem by the appearance and want to lose weight.
- Weight [ Time Frame: Changes in weight from de first week will be assessed up to 6 weeks, changes in weight at 6 months ] [ Designated as safety issue: No ]Weight loss after the treatment and after the follow-up phase
- BULIT Bulimia Test [ Time Frame: Change from Baseline in BULIT Bulimia Test at 6 weeks, Change from Baseline in BULIT Bulimia Test at 6 months ] [ Designated as safety issue: Yes ]Self-administered questionnaire of 36 items designed to assess bulimic symptomatology (Smith & Thelen, 1984). The questions are related to body weight, binge mood and purgative behavior. Adapted to Mexican population (Alvarez & Vazquez-Manzilla, 2000).
- Three Food Factors Questionnaire (TFEQ) [ Time Frame: Change from Baseline in Three Food Factors Questionnaire (TFEQ) at 6 weeks, Change from Baseline in Three Food Factors Questionnaire (TFEQ) at 6 months ] [ Designated as safety issue: Yes ]Questionnaire comprising 51 items that measure three factors: cognitive dietary restraint, ie the perception that food intake is limited constants in an effort to control the body weight, disinhibition and hunger. (Stunkard & Messick, 1985).
- Opinion on exposure therapy [ Time Frame: Opinion on exposure therapy at 6 weeks ] [ Designated as safety issue: Yes ]Questionnaire developed for this study, which will reflect the level of satisfaction with treatment, which will assess how useful it has been each of the components of the treatment program (educational component, relaxation training, exposure component of each virtual scenarios (for conditions with virtual reality exposure).
| Estimated Enrollment: | 40 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: ECT
Experiential-Cognitive Therapy for Obesity
|
Behavioral: Experiential-Cognitive Therapy for Obesity
Is a relatively short-term, integrated, patient oriented approach that focuses on individual discovery (Riva, Bacchetta, Baruffi, Rinaldi, & Molinari, 1998, 1999; Riva et al., 2000). It shares with the cognitive-behavioral approach proposed by Cooper and colleagues the use of a combination of cognitive and behavioral procedures to help the patient identify and change the maintaining mechanisms (Cooper et al., 2003). However, it considers morbid obesity as a peculiar form of addiction. So, as in the cognitive-behavioral treatment of addictions (Carroll et al., 1994) the two main goals are the functional analysis of the maintaining mechanisms and the required skill training (relapse prevention).
Other Name: Virtual Reality Enhanced Therapy for Obesity
|
|
Active Comparator: BCT
Cognitive behavioral treatment program
|
Behavioral: Behavioral cognitive Treatment
Therapists will follow a detailed manual that outlined the content of each session. This manual was based on the cognitive—behavioral treatment approach described by Cooper and colleagues (Cooper & Fairburn, 2002; Cooper et al., 2003). It was developed during a year of intensive pilot work and adapted to the in-patient setting. Patients will be taught to self-monitor their food intake and eating patterns and thoughts, as well as the circumstances and environment surrounding eating (e.g. whether eating alone or with others, speed of eating, and place of eating). Patients will also be taught to identify problems in eating, mood, and thinking patterns and to gradually develop alternative patterns.
Other Names:
|
|
Sham Comparator: NT
Nutritional groups In this condition (NT) the participants enter only 5 weekly nutritional groups held by dietitians.
|
Dietary Supplement: Nutritional groups (NT)
5 weekly nutritional treatment based on the LEARN manual (Brownell, 1985), whose goal will be to provide practical guidelines for the self-monitoring of eating and lessons on nutrition (e.g stressing gradual weight loss with the caloric restriction achieved largely by reductions in fat intake), plus a low-calorie diet (1,200 kcal/day) and physical training (30 min of walking two times a week as a minimum).
Other Name: Nutritional treatment
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients seeking treatment at the Obesity Unit of the Hospital Medica Sur, Mexico City, Mexico
- a Body Mass Index higher than 40;
- written and informed consent to participate.
Exclusion Criteria:
- other concurrent severe psychiatric disturbances (psychosis, depression with suicidal risk, alcohol or drug abuse);
- concurrent medical condition not related to the disorder;
- one or more failures in following an obesity treatment.
Contacts and Locations| Contact: Georgina Cardenas-Lopez, PhD | (55)56222292 | cardenas.georgina@gmail.com |
| Contact: Gonzalo Torres-Villalobos, MD | (55)43466430 | torresvgm@yahoo.com.mx |
| Mexico | |
| Hospital Medica Sur | Recruiting |
| Mexico, Distrito Federal, Mexico, 14050 | |
| Contact: Gonzalo Torres-Villalobos, MD (55)43466430 torresvgm@yahoo.com.mx | |
| Sub-Investigator: Gonzalo Torres-Villalobos, MD | |
| Study Chair: | Giuseppe Riva, PhD | Catholic University of Milan |
| Study Director: | Gonzalo Torres-Villalobos, MD | Medica Sur Foundation |
| Study Director: | Andrea Gaggioli, PhD | Istituto Auxologico Italiano |
More Information
Additional Information:
Publications:
| Responsible Party: | DRA. GEORGINA CARDENAS LOPEZ, Full time professor, Universidad Nacional Autonoma de Mexico |
| ClinicalTrials.gov Identifier: | NCT01394393 History of Changes |
| Other Study ID Numbers: | SALUD-2010-1-140220, SALUD-2010-1-140220.PHASE1 |
| Study First Received: | June 27, 2011 |
| Last Updated: | May 30, 2012 |
| Health Authority: | Mexico: National Council of Science and Technology Mexico: Coordinación de Investigación en Salud |
Keywords provided by Universidad Nacional Autonoma de Mexico:
|
obesity treatment evidence based intervention cognitive behavioral treatment virtual reality environments |
Additional relevant MeSH terms:
|
Obesity Obesity, Morbid Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013