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Completed

NCT Number: NCT03811197

Efficacy of Diet and Hypnotic Suggestions or Telemedicine in Obesity Management

The aim of the study is the assessment of the effectiveness of medical nutrition therapy (MNT) among obese patients, including a well-balanced low-calories diet, an individual dietary counseling conducted by dietitians and supported by telemedicine (T) or hypnotic suggestions (HS).

The study will cover a group of 90 adult patients, both sexes, with obesity (BMI ≥30 kg/m^2) undergoing MNT a dietetic treatment. Three arms are planned in the study scheme, according to the scheme: Group 1 - individual MNT (30 people); Group 2 -individual MNT and T (30 people); Group 3 - individual MNT and HS (30 people).

The authors hope that the results of the study will allow to develop a new model of the most effective management of obesity, resulting in weight reduction and maintaining this effect over time. The results obtained during the study will also allow to assess the impact of the therapy applied on lifestyle changes, dietary habits and the knowledge about the disease among obese patients.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Human Nutrition and Consumer Sciences of the Warsaw University of Life Sciences

Warsaw, 02-776, Poland

About this study

This is a prospective randomized control trial among obese subjects. The scope of the study includes: identification of nutritional habits leading to obesity; assessment of patient's motivation to introduce life style changes; assessment of anthropometric parameters, body composition, arterial stiffness and resting metabolic rate at baseline and at specific control points; development of individual medical nutrition therapy (MNT) and weight reduction plan depending on the initial body weight of the subjects; quantitative and qualitative assessment of the diet at baseline and in each month for a period of 6 months (Part A) and 9, 12 months (Part B); assessment of nutritional knowledge at baseline and at specific control points; education of patients using the behavioral-cognitive method, conducted for 6 months; introduction of hypnotic suggestion (HS) or telemedicine (T) to support the achievement and the maintenance of the lifestyle changes.

The study covers a group of 90 adults, both sexes, with obesity (BMI ≥30 kg/m^2), undergoing individual MNT, randomly assigned to one of three groups for 6 months (Part A): Group 1 - individual MNT (30 people); Group 2 - individual MNT and T (30 people); Group 3 - individual MNT and HS (30 people). All subjects will continue the program for additional 6 months (Part B follow up).

The selection of subjects for the study is purposeful and the participation in the study is voluntary. All subjects are educated to follow a reduced calorie Dietary Approaches to Stop Hypertension diet ("DASH") for 6 months (Part A). Education materials (handouts and sample meal plans) are provided to the subjects.

The primary and secondary outcomes will be evaluated at baseline, months 1,2,3,4,5, 6 (Part A) and months 9, 12 (Part B follow up).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject is over 18 years.
  • Subject is diagnosed with obesity (BMI ≥ 30 kg / m^2 at the screening visit).
  • Subject understands the study procedures and is able to give written informed consent.

Exclusion criteria

  • Subject is under 18 years.
  • Subject is a pregnant women or a breast-feeding mother; or subject is planning to be pregnant during the study period
  • Subject is suffering from chronic liver diseases or renal failure
  • Subject has untreated or uncompensated thyroid diseases
  • Subject has a history of presence of mental disorders
  • Subject has a history of presence of epilepsy
  • Subject has a history of presence of cancer
  • Any other uncontrolled physical or psychological condition that increases significantly the health risks for the subject

Treatment and study plan

Dietary counseling via face to face meeting

Behavioral

All subjects received individual MNT and individual dietary recommendations based on DASH (Dietary Approaches to Stop Hypertension) diet plan for 6 months (Part A). Dietary counseling is provided by a trained dietitian. Months 9 and 12 - follow up (Part B).

Telemedicine

Behavioral

All subjects received an additional dietary counseling for 6 months (via internet, messenger or telephone) two weeks after each standard visit will be added to the counseling (Part A). Standard and additional dietary counseling (T) are provided by a trained dietitian. Months 9 and 12 - follow up (Part B).

Hypnotic Suggestions

Behavioral

All subjects received individual hypnotic suggestion (HS) for 6 months as a supplementary method for dietary counseling. HS will be adapted to the "small steps" method used in the management of obesity. During the visit, HS will be recorded and the individual will listen to it every day (Part A). HS will be provided by a physician, qualified in the field of hypnotherapy. Months 9 and 12 - follow up (Part B).

Primary outcomes

  1. Body Weight

    Time frame: 6 months (Part A); up to 12 months (Part B)

    Changes in body weight from baseline (month 0) to each post-randomization visit (month 1, 3, 6 for Parts A and 9, 12 months for Part B)

  2. Body Mass Index

    Time frame: 6 months (Part A); up to 12 months (Part B)

    Changes in BMI from baseline (month 0) to each post-randomization visit (month 1, 3, 6 for Parts A and 9, 12 months for Part B)

Secondary outcomes

  1. Waist circumference

    Time frame: 6 months (Part A); up to 12 months (Part B)

    Changes in waist circumference from baseline (month 0) to each post-randomization visit (month 1, 3, 6 for Parts A and 9, 12 months for Part B)

  2. Hip circumference

    Time frame: up to 6 months (Part A); up to 12 months (Part B)

    Changes in hip circumference from baseline (month 0) to each post-randomization visit (month 1, 3, 6 for Parts A and 9, 12 months for Part B)

  3. Arm circumference

    Time frame: 6 months (Part A); up to 12 months (Part B)

    Changes in arm circumference from baseline (month 0) to each post-randomization visit (month 1, 3, 6 for Parts A and 9, 12 months for Part B)

  4. Body composition

    Time frame: 6 months (Part A); up to 12 months (Part B)

    Changes in body fat mass, fat free mass, muscle mass using bioelectrical impedance analysis from baseline (month 0) to each post-randomization visit (month 1, 3, 6 for Parts A and 9, 18 months for Part B)

  5. Health related quality of life

    Time frame: baseline, month 6, 9, 12

    Changes in Health related quality of life using the EQ-5D-5L questionnaire

  6. Dietary intake

    Time frame: 6 months (Part A); up to 12 months (Part B)

    Changes in dietary intakes using 4-day recorded diet diaries from baseline (month 0) to each post-randomization visit

  7. Sleep behaviour

    Time frame: baseline and month 6 for Parts A and month 12 for Part B

    Sleep behaviour using Athens Insomnia Scale (AIS)

  8. Subjective assessment of health status

    Time frame: baseline and month 6 for Parts A and month 12 for Part B

    Changes in subjective assessment of health status using 5-points Likert-type rating scale

Other outcomes

  1. Arterial stiffness

    Time frame: baseline, month 12

    Arterial stiffness measurement using an applanation tonometer (Sphygmocor, AtCor Medical, Sydney, Australia

  2. Resting Metabolic Rate

    Time frame: baseline, month 12

    Resting Metabolic Rate measurement using FitMate metabolic system (Cosmed, Rome, Italy)

  3. Nutritional knowledge score baseline

    Time frame: baseline, month 6

    Nutritional knowledge measurement using Nutritional Knowledge 13-items Test

  4. The patient's readiness for making changes

    Time frame: baseline

    The patient's readiness for making changes assessed by a questionnaire (Intrinsic Motivation Inventory, IMI-SR Motivation Questionnaire) and the scale of perception of own competences

Sponsors and collaborators

Lead sponsor

Warsaw University of Life Sciences

Other

Registry information

Official study title

Efficacy of Medical Nutrition Therapy of Obese Patients Supported by Hypnotic Suggestions or Telemedicine

Acronym: TASTY

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 22, 2019
Registry last updated
May 27, 2020

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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