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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Weight Loss
• Intervention / Treatment: Behavioral: Dietary counseling via face to face meeting; Behavioral: Telemedicine; Behavioral: Hypnotic Suggestions

Detailed 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).

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Warsaw, Poland, 02-776
    • Faculty of Human Nutrition and Consumer Sciences of the Warsaw University of Life Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: individual MNT; Dietary counseling via face to face meeting	Behavioral: Dietary counseling via face to face meeting; 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).
EXPERIMENTAL: Individual MNT and T; Dietary counseling via face to face meeting and Telemedicine	Behavioral: Dietary counseling via face to face meeting; 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).; Behavioral: Telemedicine; 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).
EXPERIMENTAL: Individual MNT and HS; Dietary counseling via face to face meeting and Hypnotic Suggestions	Behavioral: Dietary counseling via face to face meeting; 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).; Behavioral: Hypnotic Suggestions; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Weight	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)	6 months (Part A); up to 12 months (Part B)
Body Mass Index	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)	6 months (Part A); up to 12 months (Part B)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Waist circumference	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)	6 months (Part A); up to 12 months (Part B)
Hip circumference	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)	up to 6 months (Part A); up to 12 months (Part B)
Arm circumference	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)	6 months (Part A); up to 12 months (Part B)
Body composition	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)	6 months (Part A); up to 12 months (Part B)
Health related quality of life	Changes in Health related quality of life using the EQ-5D-5L questionnaire	baseline, month 6, 9, 12
Dietary intake	Changes in dietary intakes using 4-day recorded diet diaries from baseline (month 0) to each post-randomization visit	6 months (Part A); up to 12 months (Part B)
Sleep behaviour	Sleep behaviour using Athens Insomnia Scale (AIS)	baseline and month 6 for Parts A and month 12 for Part B
Subjective assessment of health status	Changes in subjective assessment of health status using 5-points Likert-type rating scale	baseline and month 6 for Parts A and month 12 for Part B

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arterial stiffness	Arterial stiffness measurement using an applanation tonometer (Sphygmocor, AtCor Medical, Sydney, Australia	baseline, month 12
Resting Metabolic Rate	Resting Metabolic Rate measurement using FitMate metabolic system (Cosmed, Rome, Italy)	baseline, month 12
Nutritional knowledge score baseline	Nutritional knowledge measurement using Nutritional Knowledge 13-items Test	baseline, month 6
The patient's readiness for making changes	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	baseline

Collaborators and Investigators

• Sponsor: Warsaw University of Life Sciences
• Investigators: Principal Investigator: Danuta Gajewska, PhD, Department of Dietetics, Warsaw University of Life Sciences

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 13, 2017
• Primary Completion (ACTUAL): June 30, 2019
• Study Completion (ACTUAL): December 10, 2019

Study Registration Dates

• First Submitted: January 17, 2019
• First Submitted That Met QC Criteria: January 17, 2019
• First Posted (ACTUAL): January 22, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 27, 2020
• Last Update Submitted That Met QC Criteria: May 25, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Telemedicine; Obesity; Weight Loss; Hypnotic Suggestions
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Body Weight Changes; Obesity; Weight Loss; Physiological Effects of Drugs; Central Nervous System Depressants; Hypnotics and Sedatives
• Other Study ID Numbers: Hipnoza2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No