<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03811197</url>
  </required_header>
  <id_info>
    <org_study_id>Hipnoza2019</org_study_id>
    <nct_id>NCT03811197</nct_id>
  </id_info>
  <brief_title>Efficacy of Diet and Hypnotic Suggestions or Telemedicine in Obesity Management</brief_title>
  <acronym>TASTY</acronym>
  <official_title>Efficacy of Medical Nutrition Therapy of Obese Patients Supported by Hypnotic Suggestions or Telemedicine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Warsaw University of Life Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Warsaw University of Life Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is the assessment of the effectiveness of medical nutrition therapy&#xD;
      (MNT) among obese patients, including a well-balanced low-calories diet, an individual&#xD;
      dietary counseling conducted by dietitians and supported by telemedicine (T) or hypnotic&#xD;
      suggestions (HS).&#xD;
&#xD;
      The study will cover a group of 90 adult patients, both sexes, with obesity (BMI ≥30 kg/m^2)&#xD;
      undergoing MNT a dietetic treatment. Three arms are planned in the study scheme, according to&#xD;
      the scheme: Group 1 - individual MNT (30 people); Group 2 -individual MNT and T (30 people);&#xD;
      Group 3 - individual MNT and HS (30 people).&#xD;
&#xD;
      The authors hope that the results of the study will allow to develop a new model of the most&#xD;
      effective management of obesity, resulting in weight reduction and maintaining this effect&#xD;
      over time. The results obtained during the study will also allow to assess the impact of the&#xD;
      therapy applied on lifestyle changes, dietary habits and the knowledge about the disease&#xD;
      among obese patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective randomized control trial among obese subjects. The scope of the study&#xD;
      includes: identification of nutritional habits leading to obesity; assessment of patient's&#xD;
      motivation to introduce life style changes; assessment of anthropometric parameters, body&#xD;
      composition, arterial stiffness and resting metabolic rate at baseline and at specific&#xD;
      control points; development of individual medical nutrition therapy (MNT) and weight&#xD;
      reduction plan depending on the initial body weight of the subjects; quantitative and&#xD;
      qualitative assessment of the diet at baseline and in each month for a period of 6 months&#xD;
      (Part A) and 9, 12 months (Part B); assessment of nutritional knowledge at baseline and at&#xD;
      specific control points; education of patients using the behavioral-cognitive method,&#xD;
      conducted for 6 months; introduction of hypnotic suggestion (HS) or telemedicine (T) to&#xD;
      support the achievement and the maintenance of the lifestyle changes.&#xD;
&#xD;
      The study covers a group of 90 adults, both sexes, with obesity (BMI ≥30 kg/m^2), undergoing&#xD;
      individual MNT, randomly assigned to one of three groups for 6 months (Part A): Group 1 -&#xD;
      individual MNT (30 people); Group 2 - individual MNT and T (30 people); Group 3 - individual&#xD;
      MNT and HS (30 people). All subjects will continue the program for additional 6 months (Part&#xD;
      B follow up).&#xD;
&#xD;
      The selection of subjects for the study is purposeful and the participation in the study is&#xD;
      voluntary. All subjects are educated to follow a reduced calorie Dietary Approaches to Stop&#xD;
      Hypertension diet (&quot;DASH&quot;) for 6 months (Part A). Education materials (handouts and sample&#xD;
      meal plans) are provided to the subjects.&#xD;
&#xD;
      The primary and secondary outcomes will be evaluated at baseline, months 1,2,3,4,5, 6 (Part&#xD;
      A) and months 9, 12 (Part B follow up).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 13, 2017</start_date>
  <completion_date type="Actual">December 10, 2019</completion_date>
  <primary_completion_date type="Actual">June 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Body Weight</measure>
    <time_frame>6 months (Part A); up to 12 months (Part B)</time_frame>
    <description>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)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body Mass Index</measure>
    <time_frame>6 months (Part A); up to 12 months (Part B)</time_frame>
    <description>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)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Waist circumference</measure>
    <time_frame>6 months (Part A); up to 12 months (Part B)</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hip circumference</measure>
    <time_frame>up to 6 months (Part A); up to 12 months (Part B)</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arm circumference</measure>
    <time_frame>6 months (Part A); up to 12 months (Part B)</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body composition</measure>
    <time_frame>6 months (Part A); up to 12 months (Part B)</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health related quality of life</measure>
    <time_frame>baseline, month 6, 9, 12</time_frame>
    <description>Changes in Health related quality of life using the EQ-5D-5L questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dietary intake</measure>
    <time_frame>6 months (Part A); up to 12 months (Part B)</time_frame>
    <description>Changes in dietary intakes using 4-day recorded diet diaries from baseline (month 0) to each post-randomization visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep behaviour</measure>
    <time_frame>baseline and month 6 for Parts A and month 12 for Part B</time_frame>
    <description>Sleep behaviour using Athens Insomnia Scale (AIS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective assessment of health status</measure>
    <time_frame>baseline and month 6 for Parts A and month 12 for Part B</time_frame>
    <description>Changes in subjective assessment of health status using 5-points Likert-type rating scale</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Arterial stiffness</measure>
    <time_frame>baseline, month 12</time_frame>
    <description>Arterial stiffness measurement using an applanation tonometer (Sphygmocor, AtCor Medical, Sydney, Australia</description>
  </other_outcome>
  <other_outcome>
    <measure>Resting Metabolic Rate</measure>
    <time_frame>baseline, month 12</time_frame>
    <description>Resting Metabolic Rate measurement using FitMate metabolic system (Cosmed, Rome, Italy)</description>
  </other_outcome>
  <other_outcome>
    <measure>Nutritional knowledge score baseline</measure>
    <time_frame>baseline, month 6</time_frame>
    <description>Nutritional knowledge measurement using Nutritional Knowledge 13-items Test</description>
  </other_outcome>
  <other_outcome>
    <measure>The patient's readiness for making changes</measure>
    <time_frame>baseline</time_frame>
    <description>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</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Obesity</condition>
  <condition>Weight Loss</condition>
  <arm_group>
    <arm_group_label>individual MNT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dietary counseling via face to face meeting</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Individual MNT and T</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dietary counseling via face to face meeting and Telemedicine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Individual MNT and HS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dietary counseling via face to face meeting and Hypnotic Suggestions</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Dietary counseling via face to face meeting</intervention_name>
    <description>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).</description>
    <arm_group_label>Individual MNT and HS</arm_group_label>
    <arm_group_label>Individual MNT and T</arm_group_label>
    <arm_group_label>individual MNT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Telemedicine</intervention_name>
    <description>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).</description>
    <arm_group_label>Individual MNT and T</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Hypnotic Suggestions</intervention_name>
    <description>All subjects received individual hypnotic suggestion (HS) for 6 months as a supplementary method for dietary counseling. HS will be adapted to the &quot;small steps&quot; 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).</description>
    <arm_group_label>Individual MNT and HS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is over 18 years.&#xD;
&#xD;
          -  Subject is diagnosed with obesity (BMI ≥ 30 kg / m^2 at the screening visit).&#xD;
&#xD;
          -  Subject understands the study procedures and is able to give written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject is under 18 years.&#xD;
&#xD;
          -  Subject is a pregnant women or a breast-feeding mother; or subject is planning to be&#xD;
             pregnant during the study period&#xD;
&#xD;
          -  Subject is suffering from chronic liver diseases or renal failure&#xD;
&#xD;
          -  Subject has untreated or uncompensated thyroid diseases&#xD;
&#xD;
          -  Subject has a history of presence of mental disorders&#xD;
&#xD;
          -  Subject has a history of presence of epilepsy&#xD;
&#xD;
          -  Subject has a history of presence of cancer&#xD;
&#xD;
          -  Any other uncontrolled physical or psychological condition that increases&#xD;
             significantly the health risks for the subject&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Danuta Gajewska, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Dietetics, Warsaw University of Life Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of Human Nutrition and Consumer Sciences of the Warsaw University of Life Sciences</name>
      <address>
        <city>Warsaw</city>
        <zip>02-776</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>January 17, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>May 25, 2020</last_update_submitted>
  <last_update_submitted_qc>May 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Warsaw University of Life Sciences</investigator_affiliation>
    <investigator_full_name>Danuta Gajewska</investigator_full_name>
    <investigator_title>Principal Investigator, Adjunct Professor at the Department of Dietetics,PhD</investigator_title>
  </responsible_party>
  <keyword>Obesity</keyword>
  <keyword>Weight Loss</keyword>
  <keyword>Telemedicine</keyword>
  <keyword>Hypnotic Suggestions</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Weight Loss</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypnotics and Sedatives</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03811197
org study id: Hipnoza2019
nct id: NCT03811197
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Body Weight
time frame: 6 months (Part A); up to 12 months (Part B)
description: 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)
measure: Body Mass Index
time frame: 6 months (Part A); up to 12 months (Part B)
description: 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)
measure: Waist circumference
time frame: 6 months (Part A); up to 12 months (Part B)
description: 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)
measure: Hip circumference
time frame: up to 6 months (Part A); up to 12 months (Part B)
description: 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)
measure: Arm circumference
time frame: 6 months (Part A); up to 12 months (Part B)
description: 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)
measure: Body composition
time frame: 6 months (Part A); up to 12 months (Part B)
description: 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)
measure: Health related quality of life
time frame: baseline, month 6, 9, 12
description: Changes in Health related quality of life using the EQ-5D-5L questionnaire
measure: Dietary intake
time frame: 6 months (Part A); up to 12 months (Part B)
description: Changes in dietary intakes using 4-day recorded diet diaries from baseline (month 0) to each post-randomization visit
measure: Sleep behaviour
time frame: baseline and month 6 for Parts A and month 12 for Part B
description: Sleep behaviour using Athens Insomnia Scale (AIS)
measure: Subjective assessment of health status
time frame: baseline and month 6 for Parts A and month 12 for Part B
description: Changes in subjective assessment of health status using 5-points Likert-type rating scale
measure: Arterial stiffness
time frame: baseline, month 12
description: Arterial stiffness measurement using an applanation tonometer (Sphygmocor, AtCor Medical, Sydney, Australia
measure: Resting Metabolic Rate
time frame: baseline, month 12
description: Resting Metabolic Rate measurement using FitMate metabolic system (Cosmed, Rome, Italy)
measure: Nutritional knowledge score baseline
time frame: baseline, month 6
description: Nutritional knowledge measurement using Nutritional Knowledge 13-items Test
measure: The patient's readiness for making changes
time frame: baseline
description: 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
arm group label: individual MNT
arm group type: Experimental
description: Dietary counseling via face to face meeting
arm group label: Individual MNT and T
arm group type: Experimental
description: Dietary counseling via face to face meeting and Telemedicine
arm group label: Individual MNT and HS
arm group type: Experimental
description: Dietary counseling via face to face meeting and Hypnotic Suggestions
intervention type: Behavioral
intervention name: Dietary counseling via face to face meeting
description: 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).
arm group label: Individual MNT and HS
arm group label: Individual MNT and T
arm group label: individual MNT
intervention type: Behavioral
intervention name: Telemedicine
description: 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).
arm group label: Individual MNT and T
intervention type: Behavioral
intervention name: Hypnotic Suggestions
description: 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).
arm group label: Individual MNT and HS
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Danuta Gajewska, PhD
role: Principal Investigator
affiliation: Department of Dietetics, Warsaw University of Life Sciences
facility: 
country: Poland
responsible party type: Principal Investigator
investigator affiliation: Warsaw University of Life Sciences
investigator full name: Danuta Gajewska
investigator title: Principal Investigator, Adjunct Professor at the Department of Dietetics,PhD
mesh term: Obesity
mesh term: Weight Loss
mesh term: Hypnotics and Sedatives
sharing ipd: Undecided