Virtual Environments For Supporting Obesity Treatment

NCT01394393 | Unknown Phase 1 DMC

• 2 other identifiers: SALUD-2010-1-140220SALUD-2010-1-140220.PHASE1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

1. 1.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).
2. 2.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.
3. 3.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.

Conditions

Obesity; Morbid Obesity

Keywords

obesity treatment; evidence based intervention; cognitive behavioral treatment; virtual reality environments

Outcome Measures

Primary Outcomes (3)

• Anxiety Inventory: State-Trait IDARE

  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)

  Change from Baseline in Anxiety Inventory: State-Trait IDARE at 6 weeks, Change from Baseline in Anxiety Inventory: State-Trait IDARE at 6 months

• Body Image Questionnaire (BSQ)

  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.

  Change frome Baseline in Body Image Questionnaire (BSQ) at 6 weeks, Change frome Baseline in Body Image Questionnaire (BSQ) at 6 months

• Weight

  Weight loss after the treatment and after the follow-up phase

  Changes in weight from de first week will be assessed up to 6 weeks, changes in weight at 6 months

Secondary Outcomes (3)

• BULIT Bulimia Test

  Change from Baseline in BULIT Bulimia Test at 6 weeks, Change from Baseline in BULIT Bulimia Test at 6 months

• Three Food Factors Questionnaire (TFEQ)

  Change from Baseline in Three Food Factors Questionnaire (TFEQ) at 6 weeks, Change from Baseline in Three Food Factors Questionnaire (TFEQ) at 6 months

• Opinion on exposure therapy

  Opinion on exposure therapy at 6 weeks

Study Arms (3)

ECT

EXPERIMENTAL

Experiential-Cognitive Therapy for Obesity

Behavioral: Experiential-Cognitive Therapy for Obesity

BCT

ACTIVE COMPARATOR

Cognitive behavioral treatment program

Behavioral: Behavioral cognitive Treatment

NT

SHAM COMPARATOR

Nutritional groups In this condition (NT) the participants enter only 5 weekly nutritional groups held by dietitians.

Dietary Supplement: Nutritional groups (NT)

Interventions

Experiential-Cognitive Therapy for Obesity BEHAVIORAL

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).

Also known as: Virtual Reality Enhanced Therapy for Obesity

ECT

Behavioral cognitive Treatment BEHAVIORAL

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.

Also known as: Behavioral cognitive therapy, Obesity cognitive behavioral approach

BCT

Nutritional groups (NT) DIETARY_SUPPLEMENT

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).

Also known as: Nutritional treatment

NT

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Nacional Autonoma de Mexico: lead
• Istituto Auxologico Italiano: collaborator
• Medica Sur Clinic & Foundation: collaborator

Study Sites (1)

Hospital Medica Sur

Mexico City, Mexico City, 14050, Mexico

RECRUITING

Related Publications (3)

• Riva G, Bacchetta M, Cesa G, Conti S, Castelnuovo G, Mantovani F, Molinari E. Is severe obesity a form of addiction? Rationale, clinical approach, and controlled clinical trial. Cyberpsychol Behav. 2006 Aug;9(4):457-79. doi: 10.1089/cpb.2006.9.457.

  PMID: 16901250 BACKGROUND

• Riva G, Bacchetta M, Baruffi M, Molinari E. Virtual reality-based multidimensional therapy for the treatment of body image disturbances in obesity: a controlled study. Cyberpsychol Behav. 2001 Aug;4(4):511-26. doi: 10.1089/109493101750527079.

  PMID: 11708731 BACKGROUND

• Riva G. The key to unlocking the virtual body: virtual reality in the treatment of obesity and eating disorders. J Diabetes Sci Technol. 2011 Mar 1;5(2):283-92. doi: 10.1177/193229681100500213.

  PMID: 21527095 BACKGROUND

Related Links

• A previous Italian controlled trial based on the same protocol (it also included eating disorders, not covered by the actual trial)

MeSH Terms

Conditions

Obesity; Obesity, Morbid

Interventions

Adiposity; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Body Fat Distribution; Body Weights and Measures; Body Constitution; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Body Composition; Biochemical Phenomena; Chemical Phenomena; Metabolism; Physiological Phenomena; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Giuseppe Riva, PhD

  Catholic University of Milan

  STUDY CHAIR

• Gonzalo Torres-Villalobos, MD

  Medica Sur Foundation

  STUDY DIRECTOR

• Andrea Gaggioli, PhD

  Istituto Auxologico Italiano

  STUDY DIRECTOR

Central Study Contacts

Georgina Cardenas-Lopez, PhD

CONTACT

(55)56222292; cardenas.georgina@gmail.com

Gonzalo Torres-Villalobos, MD

CONTACT

(55)43466430; torresvgm@yahoo.com.mx

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full time professor

Study Record Dates

• First Submitted: June 27, 2011
• First Posted: July 14, 2011
• Study Start: January 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2013
• Last Updated: May 31, 2012

Record last verified: 2012-05

Locations

ME (1)