MindOb: A 12-month Computerized Mindfulness-based Intervention for Obese Individuals

NCT02571387 | Unknown

• 1 other identifier: EA4057-mindob
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy of a daily 12-month computerized mindfulness-based intervention in obese patients diagnosed with Binge Eating Disorder (BED) on: impulsive eating, motivation toward exercise, and weight loss.

Conditions

Obesity; Binge-Eating Disorder

Keywords

Motivation; Impulsive eating; Mindfulness; Self-help; Physical activity; Weight-loss

Outcome Measures

Primary Outcomes (1)

• Change in impulsive eating (TFEQ-R18 "uncontrolled eating" subscale)

  From baseline to study completion (12 months). Assessments at baseline, 1 month, 6 months and 12 months.

Secondary Outcomes (9)

• Change in motivational regulation toward exercise (BREQ-II)

  From baseline to study completion (12 months). Assessments at baseline, 1 month, 6 months and 12 months.

• Change in self-reported physical activity (IPAQ)

  From baseline to study completion (12 months). Assessments at baseline, 1 month, 6 months and 12 months.

• Change in pedometers-measured physical activity

  From baseline to study completion (12 months). Assessments at baseline, 6 months and 12 months.

• Change in self-reported anxiety and depression (HADS)

  From baseline to study completion (12 months). Assessments at baseline, 1 month, 6 months and 12 months.

• Change in mindfulness skills (MAAS, AAQ-II)

  From baseline to study completion (12 months). Assessments at baseline, 1 month, 6 months and 12 months.

Other Outcomes (1)

• Compliance to the intervention (number of sessions done divided by number of session due)

  From baseline to study completion (12 months). Assessments at baseline, 1 month, 6 months and 12 months.

Study Arms (3)

Mindfulness

EXPERIMENTAL

Computerized mindfulness-based intervention. 10 minutes per day, every day for 12 months of MP3 listening. Guidelines are in line with main mindfulness-based interventions (MBSR, MBCT, ACT). Participants can choose between 4 audio recordings (sessions): awareness of the breathing, awareness of postures and bodily sensations, acceptance of thoughts and emotions, and awareness of bodily sensations and related thoughts and emotions while executing 5 squats.

Behavioral: Mindfulness-based intervention

Sham meditation

SHAM COMPARATOR

Computerized sham meditation intervention. 10 minutes per day, every day for 12 months of MP3 listening. The unique guideline is to "meditate" at the beginning of each session. Participants can choose between 4 audio backgrounds: forest, night, beach, and river.

Behavioral: Sham meditation

Treatment as usual

NO INTERVENTION

Usual care in a nutrition pole in France: nutrition, diet, exercise.

Interventions

Mindfulness-based intervention BEHAVIORAL

Mindfulness

Sham meditation BEHAVIORAL

Sham meditation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult aged between 18 and 65 years
• Obese (BMI \>= 30)
• Recruited from the nutrition pole of Ambroise Paré Hospital
• Diagnosed with Binge-Eating Disorder (BED) according to DSM5 criteria

You may not qualify if:

• Already participating in a clinical trial
• Bariatric surgery patients (except for gastric band removed at least 3 years before)
• Planned bariatric surgery
• Central obese (genetic)
• Pregnant women
• No internet access at home
• Difficulties to understand French language
• Patients under social protection
• Cognitive dysfunctions in understanding simple guidelines provided by the paramedical staff (e.g., diet or exercise guidelines)
• Auditory disorders not allowing to hear audio files
• Blurred vision not allowing to use Internet

Sponsors & Collaborators

• University of Paris 5 - Rene Descartes: lead
• Hospital Ambroise Paré Paris: collaborator
• Nestlé Foundation: collaborator

Study Sites (1)

Hôpital Ambroise Paré, Assistance Publique-Hôpitaux de Paris

Boulogne-Billancourt, 92100, France

Location

Related Publications (1)

• Ruffault A, Carette C, Lurbe I Puerto K, Juge N, Beauchet A, Benoliel JJ, Lacorte JM, Fournier JF, Czernichow S, Flahault C. Randomized controlled trial of a 12-month computerized mindfulness-based intervention for obese patients with binge eating disorder: The MindOb study protocol. Contemp Clin Trials. 2016 Jul;49:126-33. doi: 10.1016/j.cct.2016.06.012. Epub 2016 Jun 29.

  PMID: 27370231 DERIVED

Related Links

• Academic webpage of the PhD candidate running the study

MeSH Terms

Conditions

Obesity; Binge-Eating Disorder; Motor Activity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Feeding and Eating Disorders; Mental Disorders; Behavior; Body Weight Changes

Study Officials

• Sébastien Czernichow, Pr

  Hospital Ambroise Paré Paris

  PRINCIPAL INVESTIGATOR

• Cécile Flahault, PhD

  University Paris 5 - Rene Descartes

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral candidate

Study Record Dates

• First Submitted: October 2, 2015
• First Posted: October 8, 2015
• Study Start: May 1, 2016
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: December 26, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)