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

Study of the Effects of Mindfulness on Impulsive Eating, Motivation Toward Exercise, and Weight Loss in Obese Patients: Randomized Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02571387
Acronym
MindOb
Enrollment
50
Registered
2015-10-08
Start date
2016-05-31
Completion date
2019-10-31
Last updated
2018-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Binge-Eating Disorder, Obesity

Keywords

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

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.

Interventions

BEHAVIORALMindfulness-based intervention
BEHAVIORALSham meditation

Sponsors

Hospital Ambroise Paré Paris
CollaboratorOTHER
Nestlé Foundation
CollaboratorOTHER
University of Paris 5 - Rene Descartes
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* 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 * Informed consent provided during inclusion interview

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frameDescription
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.Behavioral Regulation in Exercise Questionnaire-II (5 subscales): amotivation, external regulation, introjected regulation, identified regulation, intrinsic regulation
Change in self-reported physical activity (IPAQ)From baseline to study completion (12 months). Assessments at baseline, 1 month, 6 months and 12 months.International Physical Activity Questionnaire short form
Change in pedometers-measured physical activityFrom baseline to study completion (12 months). Assessments at baseline, 6 months and 12 months.Pedometers on a daily basis for 7 days (ref: ONWalk100)
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.Hospital Anxiety and Depression Scale (2 subscales): anxiety and depression
Change in daily mindful responding (DMRS)From baseline to study completion (12 months). Assessments at baseline, 6 months and 12 months.Daily Mindful Responding Scale on a daily basis for 7 days (at baseline, 6 months and 12 months)
Change in plasma concentration of leptin, adiponection and BDNFFrom baseline to study completion (12 months). Assessments at baseline, 6 months and 12 months.
Change in body mass index (kg/m2)From baseline to study completion (12 months). Assessments at baseline, 6 months and 12 months.BMI as measured by a physician
Change in food intakeFrom baseline to study completion (12 months). Assessments at baseline, 6 months and 12 months.Dietary survey on a daily basis for 7 days (at baseline, 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.Combination of scores in Mindful Attention Awareness Scale; Acceptance and Action Questionnaire-II

Other

MeasureTime frame
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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026