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Completed

NCT Number: NCT02292108

Hypnosis, Self-hypnosis and Weight Loss in Obese Patients

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).

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Key information

Conditions

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

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pitié Salpetriere Hospital

Paris, 75013, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • sensory impairments (hearing, visual skills) and cognitive impairing its award of rating scales
  • planned or ongoing pregnancy
  • refusal of hypnosis.

Treatment and study plan

dietetic counselling

Behavioral

Hypnosis and self-hypnosis

Behavioral

Erickson's hypnosis and self-hypnosis

Primary outcomes

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

    Time frame: 8 months

Secondary outcomes

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

    Time frame: 8 months

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

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

    Time frame: 8 months

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

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

    Time frame: 8 months

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

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

    Time frame: 8 months

    Weight will be measured in Kg

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

    Time frame: 8 months

    Waist circumference will be measured in Cm

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

    Time frame: 8 months

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

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

    Time frame: 8 months

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

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

    Time frame: 8 months

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

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

    Time frame: 8 months

    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

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

    Time frame: 8 months

    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.

  11. Evolution of carbohydrate intakes

    Time frame: 8 months

    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

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

    Time frame: 8 months

    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

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

    Time frame: 8 months

    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

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

    Time frame: 8 months

    Total cholesterol will be measured in g/L

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

    Time frame: 8 months

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

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

    Time frame: 8 months

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

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

    Time frame: 8 months

    Triglyceride will be measured in g/L

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

    Time frame: 8 months

    Fasting glucose will be measured in mmol/L

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

    Time frame: 8 months

    HbA1c will be measured in %

  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

    Time frame: 8 months

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

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

    Time frame: 8 months

    stress will be measured by General Health Questionnaire (GHQ28)

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

    Time frame: 8 months

    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.

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

    Time frame: 8 months

    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..

  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

    Time frame: 8 months

    Analysis of speech content using Sphinx software

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

    Time frame: 8 months

    Analysis of speech content using Sphinx software

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

    Time frame: 8 months

    Analysis of speech content using Sphinx software

  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

    Time frame: 8 months

    Analysis of speech content using Sphinx software

  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

    Time frame: 8 months

    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

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

    Time frame: 8 months

    Walking will be measure in number of steps/day

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study 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

Acronym: HYPNODIET

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Nov 17, 2014
Registry last updated
Jan 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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