An interventional study of Dietary counseling via face to face meeting and Telemedicine in Obesity and Weight Loss, sponsored by Warsaw University of Life Sciences. Completed at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-27.
Sponsored by Warsaw University of Life Sciences · Not applicable, Interventional, and Treatment
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).
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's enrollment of 90 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Warsaw University of Life Sciences is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dietary counseling via face to face meeting
Behavioral: Dietary counseling via face to face meeting
Dietary counseling via face to face meeting and Telemedicine
Behavioral: Dietary counseling via face to face meeting · Behavioral: Telemedicine
Dietary counseling via face to face meeting and Hypnotic Suggestions
Behavioral: Dietary counseling via face to face meeting · Behavioral: Hypnotic Suggestions
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).
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).
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).
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)
Time frame: 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)
Time frame: 6 months (Part A); up to 12 months (Part B)
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 6 months (Part A); up to 12 months (Part B)
Sleep behaviour
Sleep behaviour using Athens Insomnia Scale (AIS)
Time frame: 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
Time frame: baseline and month 6 for Parts A and month 12 for Part B
Arterial stiffness
Arterial stiffness measurement using an applanation tonometer (Sphygmocor, AtCor Medical, Sydney, Australia
Time frame: baseline, month 12
Resting Metabolic Rate
Resting Metabolic Rate measurement using FitMate metabolic system (Cosmed, Rome, Italy)
Time frame: baseline, month 12
Nutritional knowledge score baseline
Nutritional knowledge measurement using Nutritional Knowledge 13-items Test
Time frame: 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
Time frame: baseline
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Oct 2017 to primary completion in Jun 2019, 20 months.
Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 20 months is below that.
Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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Warsaw University of Life Sciences