NCT02978105

Brief Summary

The investigators hypothesized that hypnosis is an alternative technique that could be applied to help patients with obesity to lose weight. The possibility that a self-conditioning technique (self-hypnosis) added to traditional approach (diet, exercise and behavioral recommendations) will be effective in determining weight loss with respect to the traditional approach in subjects with a body mass index (BMI) between 35 and 50 kg/m2 will be studied.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P25-P50 for phase_3 obesity

Timeline
Completed

Started Feb 2015

Typical duration for phase_3 obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

November 26, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 30, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

January 24, 2018

Status Verified

January 1, 2018

Enrollment Period

2.4 years

First QC Date

November 26, 2016

Last Update Submit

January 22, 2018

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • weight loss

    12 months after randomization

Secondary Outcomes (4)

  • Change in body fat percentage

    12 months after randomization

  • Change in fasting glucose

    12 months after randomization

  • Change in insulin circulating values

    12 months after randomization

  • Change in quality of life

    12 months after randomization

Study Arms (2)

Experimental

EXPERIMENTAL

self-conditioning techniques plus standard care

Other: self-conditioning techniquesOther: standard care (diet, exercise and behavioral therapy)

Control

ACTIVE COMPARATOR

Standard care: dietary recommendations, exercise recommendations, and behavioral recommendations

Other: standard care (diet, exercise and behavioral therapy)

Interventions

self-conditioning techniquesOTHER

Self-hypnosis to increase self-control before meals and every food compulsion episode

Experimental
standard care (diet, exercise and behavioral therapy)OTHER

dietary recommendations, exercise recommendations, and behavioral recommendations

ControlExperimental

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to give written informed consent
  • BMI between 35 and 50 kg/m2
  • Age 20-70 years

You may not qualify if:

  • Current or previous mental disorders and/or on any psychotropic drug
  • Insulin treatment
  • Candidates for bariatric surgery
  • Current (or discontinued for less than 6 months) treatment with anti-obesity drugs
  • Patients at risk of heart failure, edema, ascites (heart diseases, chronic liver diseases, nephrotic syndrome, renal failure)
  • Patients with untreated or uncompensated thyroid diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Città della Salute e della Scienza di Torino

Turin, 10126, Italy

Location

Related Publications (1)

  • Bo S, Rahimi F, Goitre I, Properzi B, Ponzo V, Regaldo G, Boschetti S, Fadda M, Ciccone G, Abbate Daga G, Mengozzi G, Evangelista A, De Francesco A, Belcastro S, Broglio F. Effects of Self-Conditioning Techniques (Self-Hypnosis) in Promoting Weight Loss in Patients with Severe Obesity: A Randomized Controlled Trial. Obesity (Silver Spring). 2018 Sep;26(9):1422-1429. doi: 10.1002/oby.22262.

    PMID: 30226009DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Standard of CareDietExerciseBehavior Therapy

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and EvaluationNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Simona Bo, MD

    University of Turin, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 26, 2016

First Posted

November 30, 2016

Study Start

February 1, 2015

Primary Completion

July 1, 2017

Study Completion

September 1, 2017

Last Updated

January 24, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)