Clinical trial NCT03811197: Efficacy of Diet and Hypnotic Suggestions or Telemedicine in Obesity Management
Official title: Efficacy of Medical Nutrition Therapy of Obese Patients Supported by Hypnotic Suggestions or Telemedicine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Weight Loss
Keywords: Obesity
Weight Loss
Telemedicine
Hypnotic Suggestions
Lead sponsor: Warsaw University of Life Sciences
Sponsor class: OTHER
First posted: 2019-01-22
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Body Weight
timeFrame: 6 months (Part A); up to 12 months (Part B)
measure: Body Mass Index
timeFrame: 6 months (Part A); up to 12 months (Part B)
Secondary outcomes:
measure: Waist circumference
timeFrame: 6 months (Part A); up to 12 months (Part B)
measure: Hip circumference
timeFrame: up to 6 months (Part A); up to 12 months (Part B)
measure: Arm circumference
timeFrame: 6 months (Part A); up to 12 months (Part B)
measure: Body composition
timeFrame: 6 months (Part A); up to 12 months (Part B)
measure: Health related quality of life
timeFrame: baseline, month 6, 9, 12
measure: Dietary intake
timeFrame: 6 months (Part A); up to 12 months (Part B)
measure: Sleep behaviour
timeFrame: baseline and month 6 for Parts A and month 12 for Part B
measure: Subjective assessment of health status
timeFrame: baseline and month 6 for Parts A and month 12 for Part B
Other outcomes:
measure: Arterial stiffness
timeFrame: baseline, month 12
measure: Resting Metabolic Rate
timeFrame: baseline, month 12
measure: Nutritional knowledge score baseline
timeFrame: baseline, month 6
measure: The patient's readiness for making changes
timeFrame: baseline
Locations:
city: Warsaw
country: Poland
facility: Faculty of Human Nutrition and Consumer Sciences of the Warsaw University of Life Sciences
Study officials:
affiliation: Department of Dietetics, Warsaw University of Life Sciences
name: Danuta Gajewska, PhD
role: PRINCIPAL_INVESTIGATOR
References: