Efficacy of Diet and Hypnotic Suggestions or Telemedicine in Obesity Management (TASTY)

Warsaw University of Life Sciences

Status: Completed

Conditions: Weight Loss; Obesity

Treatments: Behavioral: Telemedicine; Behavioral: Dietary counseling via face to face meeting; Behavioral: Hypnotic Suggestions

Study type: Interventional

Funder types: Other

Identifiers

NCT03811197

Hipnoza2019

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

individual MNT

Experimental group

Description:

Dietary counseling via face to face meeting

Treatment:

Behavioral: Dietary counseling via face to face meeting

Individual MNT and T

Experimental group

Description:

Dietary counseling via face to face meeting and Telemedicine

Treatment:

Behavioral: Telemedicine

Behavioral: Dietary counseling via face to face meeting

Individual MNT and HS

Experimental group

Description:

Dietary counseling via face to face meeting and Hypnotic Suggestions

Treatment:

Behavioral: Dietary counseling via face to face meeting

Behavioral: Hypnotic Suggestions