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ObesityHYPNODIETNCT02292108

Hypnosis, Self-hypnosis and Weight Loss in Obese Patients

A study testing dietetic counselling and Hypnosis and self-hypnosis in people with Obesity, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

High food impulsiveness, impaired food reward and stress response are involved in the phenomena of weight gain and resistance at weight loss. Henceforth, hypnosis is a complementary medicine which is recognized as effective for defined indications. Read more about this study

Who is it for?
Ages 18 to 69 years
Conditions the study is for
Obesity
What is being tested?
dietetic counselling and Hypnosis and self-hypnosis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
1 siteFrance
Study dates
Sep 2014to Apr 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 69 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • subjects adult volunteers under 70 years old
  • high score of disinhibition (D> 8)
  • obesity grade 1 and 2 (BMI between 30 and 40 kg m ²)
  • no previous practice of hypnosis

Who cannot join

  • weight change of more than 3 kg peak to peak in the last 6 months
  • psychiatric illness known
  • craniopharyngioma
  • treatment with a significant influence on the weight and / or eating behavior: steroids, hyperthyroidism, uncontrolled hypothyroidism,
  • bariatric Surgery
  • major TCA according to DSM IV
Show all 9Show fewer
  • sensory impairments (hearing, visual skills) and cognitive impairing its award of rating scales
  • planned or ongoing pregnancy
  • refusal of hypnosis.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Pitié Salpetriere Hospital

    Paris, 75013

Other trials in France

About this study

Official title: Study of the Influence of Erickson's Hypnosis and Self-hypnosis Practice on Food Impulsivity and Weight Loss in Obese Patients: a Pilot Project

High food impulsiveness, impaired food reward and stress response are involved in the phenomena of weight gain and resistance at weight loss. Henceforth, hypnosis is a complementary medicine which is recognized as effective for defined indications. Complexity and diversity of methodological studies with hypnosis does not allow to conclude on its efficacy in treating this disease.

In obese subjects with high food impulsiveness, it is expected that Erickson's hypnosis and self-hypnosis practice would improve food disinhibition assessed by an adapted questionary (TFEQ 51).

Read the detailed description

Obese failing patients are recruited in an university hospital. Half of the subjects will be randomised to practice hypnosis and will learn to practice self-hypnosis to reduce food impulsivity and specially disinhibition. In the same time, all the included patients will follow therapeutic workshops based on current recommendations of the High Health Authority of France (HAS) for physical activity and the dietetic.

In the hypnosis group, eight workshops are planned during six months. Furthermore, patients have to practice daily self-hypnosis. In the same time, all the patients included will participate in eight dietetic workshops.

It is expected an improvement in patient involvement in personalized care plan, that eating behavior is more suited and consequently a significant decrease in weight.

Conditions
Obesity
Being tested
dietetic counselling, Hypnosis and self-hypnosis
Keywords
Hypnosis, self-hypnosis, obesity, high food impulsiveness
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dietetic counsellingBehavioural

  • Hypnosis and self-hypnosisBehavioural

    Erickson's hypnosis and self-hypnosis

Study groups in NCT02292108
Study groupRoleWhat they receive
Hypnosis and dietetic counsellingExperimentalPatient will benefit of usual dietetic counselling and experimental hypnosis
Receives: Behavioral: dietetic counselling; Behavioral: Hypnosis and self-hypnosis
dietetic counsellingOtherPatient will only benefit of usual dietetic counselling
Receives: Behavioral: dietetic counselling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evolution of disinhibition score estimated by the TFEQ 51 at the beginning and at the end of the study

    Measured: 8 months

Secondary outcomes (29)

  1. Evolution of cognitive restraint at the beginning and at the end of the study

    Cognitive restraint estimated by the Three Factor Eating Questionnaire (TFEQ 51)

    Measured: 8 months

  2. Evolution of flexible cognitive restraint at the beginning and at the end of the study

    Flexible cognitive restraint estimated by the Three Factor Eating Questionnaire (TFEQ 51)

    Measured: 8 months

  3. Evolution of rigid cognitive restraint at the beginning and at the end of the study

    Rigid cognitive restraint estimated by the Three Factor Eating Questionnaire (TFEQ 51)

    Measured: 8 months

  4. Evolution of weight at the beginning and at the end of study

    Weight will be measured in Kg

    Measured: 8 months

  5. Evolution of waist circumference at the beginning and at the end of study

    Waist circumference will be measured in Cm

    Measured: 8 months

  6. Evolution of body fat at the beginning and at the end of the study

    Body fat will be measured in Kg using dual-energy X-ray absorptiometry (DXA)

    Measured: 8 months

  7. Evolution of lean mass at the beginning and at the end of the study

    Lean mass will be measured in Kg using dual-energy X-ray absorptiometry (DXA)

    Measured: 8 months

  8. Evolution of water mass at the beginning and at the end of the study

    Water mass will be measured in Kg using dual-energy X-ray absorptiometry (DXA)

    Measured: 8 months

  9. Evolution of calories intakes. at the beginning and at the end of the study

    calories will be measured in Kcal/day, assessed for 3 representative days (two weekdays and one weekend day) and collected using an interactive self-administered food journal from the internet enabled during the week prior to the inclusion visit and the final visit

    Measured: 8 months

  10. Evolution of protein intakes.at the beginning and at the end of the study

    Protein will be measured in g/day assessed for 3 representative days (two weekdays and one weekend day) and collected using an interactive self-administered food journal frome the internet enabled during the week prior to the inclusion visit and the final visit.

    Measured: 8 months

  11. Evolution of carbohydrate intakes

    carbohydrates be measured in g/day, assessed for 3 representative days (two weekdays and one weekend day) and collected using an interactive self-administered food journal from the internet enabled during the week prior to the inclusion visit and the final visit

    Measured: 8 months

  12. Evolution of total fat intakes at the beginning and at the end of the study.

    Total fat will be measured in g/day assessed for 3 representative days (two weekdays and one weekend day) and collected using an interactive self-administered food journal from the internet enabled during the week prior to the inclusion visit and the final visit

    Measured: 8 months

  13. Evolution of saturated fatty acids intakes at the beginning and at the end of the study.

    Saturated fatty acids will be measured in g/day assessed for 3 representative days (two weekdays and one weekend day) and collected using an interactive self-administered food journal from the internet enabled during the week prior to the inclusion visit and the final visit

    Measured: 8 months

  14. Evolution of Total cholesterol at the beginning and the end of the study

    Total cholesterol will be measured in g/L

    Measured: 8 months

  15. Evolution of High-density lipoprotein-cholesterol (HDL-C) at the beginning and the end of the study

    High-density lipoprotein-cholesterol (HDL-C) will be measured in g/L

    Measured: 8 months

  16. Evolution of Low-density lipoprotein (LDL-C) at the beginning and the end of the study

    Low-density lipoprotein (LDL-C) will be measured in g/L

    Measured: 8 months

  17. Evolution of Triglyceride at the beginning and the end of the study

    Triglyceride will be measured in g/L

    Measured: 8 months

  18. Evolution of fasting glucose at the beginning and the end of the study

    Fasting glucose will be measured in mmol/L

    Measured: 8 months

  19. Evolution of HbA1c at the beginning and the end of the study

    HbA1c will be measured in %

    Measured: 8 months

  20. Evolution of quality of Live (QoL) estimated by The Short-Form Health Survey (SF-36) at beginning and the end of study at the beginning and the end of the study

    Scores range from 0 to 100 with a higher score indicating a greater QoL.

    Measured: 8 months

  21. Evolution of stress measured at beginning and the end of study.

    stress will be measured by General Health Questionnaire (GHQ28)

    Measured: 8 months

  22. Evolution of coping strategies measured by The Coping Inventory for Stressful Situations (CISS) at beginning and the end of study

    In the Coping Inventory for Stressful Situations (CISS) items are scored on a 5-point Likert scale (from 1 not at all to 5 very much). Scores for all items per scale are summed to form scale scores; higher scores indicate a greater use of that coping strategy.

    Measured: 8 months

  23. Evolution of the Self-esteem measured by The Self-esteem Inventory (SEI of Coopersmith) at beginning and the end of study

    The Self-esteem Inventory (SEI of Coopersmith) consists of 58 items and 4 subscales: general, social, family and professional self-esteem. A lie score is also computed to capture social desirability in participants answers. Higher scores indicate a greater self-esteem..

    Measured: 8 months

  24. : Evolution of the patient's involvement in the personalized care project evaluated by content analysis of a psychological interview at beginning and the end of study

    Analysis of speech content using Sphinx software

    Measured: 8 months

  25. : Evolution of the patient's emotional state evaluated by content analysis of a psychological interview at beginning and the end of study

    Analysis of speech content using Sphinx software

    Measured: 8 months

  26. Evolution of the food reward evaluated by content analysis of a psychological interview at beginning and the end of study

    Analysis of speech content using Sphinx software

    Measured: 8 months

  27. Evolution of the self-perception of self-care competence evaluated by content analysis of a psychological interview at beginning and the end of study

    Analysis of speech content using Sphinx software

    Measured: 8 months

  28. Evolution of the physical activity assessed with the abridged version of the International Physical Activity Questionnaire (IPAQ) completed online before the inclusion visit and before the final visit

    In the abridged version of the International Physical Activity Questionnaire (IPAQ) walking, moderate Physical activity and vigorous Physical activity will be measure in min/week, the Sedentary will be measure in min/day

    Measured: 8 months

  29. Evolution of the physical activity assessed with a pedometer for a week prior to the second and final visits.

    Walking will be measure in number of steps/day

    Measured: 8 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2014 (estimated)
  2. Study startSep 2014
  3. Primary completionApr 2016
  4. Study completionApr 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02292108
Sponsor's protocol ID
P131202
Acronym
HYPNODIET
Status last verified
Jan 2017
First submitted
12 Nov 2014
Last updated
11 Jan 2022
Results posted
No
Data monitoring committee
No

Publications

  • Delestre F, Lehericey G, Estellat C, Diallo MH, Hansel B, Giral P. Hypnosis reduces food impulsivity in patients with obesity and high levels of disinhibition: HYPNODIET randomized controlled clinical trial. Am J Clin Nutr. 2022 Jun 7;115(6):1637-1645. doi: 10.1093/ajcn/nqac046.

    PubMed 35170724

Questions about this trial

What is this clinical trial studying?

A study testing dietetic counselling and Hypnosis and self-hypnosis in people with Obesity, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evolution of disinhibition score estimated by the TFEQ 51 at the beginning and at the end of the study (time frame: 8 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02292108, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.

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