Ignite Creation Date:
2024-05-06 @ 12:39 PM
Last Modification Date:
2024-10-26 @ 1:02 PM
Study NCT ID:
NCT03811197
Status:
COMPLETED
Last Update Posted:
2020-05-27
First Post:
2019-01-17
Brief Title:
Efficacy of Diet and Hypnotic Suggestions or Telemedicine in Obesity Management
Sponsor:
Warsaw University of Life Sciences
Organization:
Warsaw University of Life Sciences
Study Overview
Official Title:
Efficacy of Medical Nutrition Therapy of Obese Patients Supported by Hypnotic Suggestions or Telemedicine
Status:
COMPLETED
Status Verified Date:
2020-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TASTY
Brief Summary:
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 kgm2 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
The study will cover a group of 90 adult patients both sexes with obesity BMI 30 kgm2 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
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 patients 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 kgm2 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 12345 6 Part A and months 9 12 Part B follow up
The study covers a group of 90 adults both sexes with obesity BMI 30 kgm2 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 12345 6 Part A and months 9 12 Part B follow up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None