ObesityTASTYNCT03811197
Efficacy of Diet and Hypnotic Suggestions or Telemedicine in Obesity Management
A study testing Dietary counseling via face to face meeting, Telemedicine and Hypnotic Suggestions in people with Obesity and Weight Loss, run by Warsaw University of Life Sciences at 1 site in Poland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Weight Loss
- What is being tested?
- Dietary counseling via face to face meeting, Telemedicine and Hypnotic Suggestions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePoland
- Study dates
- 13 Oct 2017to 10 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site
Faculty of Human Nutrition and Consumer Sciences of the Warsaw University of Life Sciences
Warsaw, 02-776
About this study
Official title: 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.
Read the 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).
- Conditions
- Obesity, Weight Loss
- Being tested
- Dietary counseling via face to face meeting, Telemedicine, Hypnotic Suggestions
- Keywords
- Obesity, Weight Loss, Telemedicine, Hypnotic Suggestions
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary counseling via face to face meetingBehavioural
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).
TelemedicineBehavioural
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).
Hypnotic SuggestionsBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| individual MNT | Experimental | Dietary counseling via face to face meeting Receives: Behavioral: Dietary counseling via face to face meeting |
| Individual MNT and T | Experimental | Dietary counseling via face to face meeting and Telemedicine Receives: Behavioral: Dietary counseling via face to face meeting; Behavioral: Telemedicine |
| Individual MNT and HS | Experimental | Dietary counseling via face to face meeting and Hypnotic Suggestions Receives: Behavioral: Dietary counseling via face to face meeting; Behavioral: Hypnotic Suggestions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 6 months (Part A); up to 12 months (Part B)
Secondary outcomes (8)
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 6 months (Part A); up to 12 months (Part B)
Sleep behaviour
Sleep behaviour using Athens Insomnia Scale (AIS)
Measured: 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
Measured: baseline and month 6 for Parts A and month 12 for Part B
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2019
- Study start13 Oct 2017
- Primary completion30 Jun 2019
- Study completion10 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Warsaw University of Life Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Danuta Gajewska, Warsaw University of Life Sciences
- Investigators
- Danuta Gajewska, PhD, Principal investigator, Department of Dietetics, Warsaw University of Life Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03811197
- Sponsor's protocol ID
- Hipnoza2019
- Acronym
- TASTY
- Status last verified
- May 2020
- First submitted
- 17 Jan 2019
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Medical Nutrition Therapy of Obese Patients Supported by Hypnotic Suggestions or Telemedicine
- ClinicalTrials.gov ID
- NCT03811197
- Acronym / sponsor ID
- TASTY / Hipnoza2019
- Conditions
- Obesity, Weight Loss
- Keywords
- Obesity, Weight Loss, Telemedicine, Hypnotic Suggestions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Warsaw University of Life SciencesUniversity, hospital or other
- Study start
- 13 Oct 2017 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 10 Dec 2019 (actual)
- First posted
- 22 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| individual MNT | Experimental | Behavioral: Dietary counseling via face to face meetingDietary counseling via face to face meeting |
| Individual MNT and T | Experimental | Behavioral: Dietary counseling via face to face meeting, Behavioral: TelemedicineDietary counseling via face to face meeting and Telemedicine |
| Individual MNT and HS | Experimental | Behavioral: Dietary counseling via face to face meeting, Behavioral: Hypnotic SuggestionsDietary counseling via face to face meeting and Hypnotic Suggestions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary counseling via face to face meetingAll 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). | Behavioural | Individual MNT and HS, Individual MNT and T, individual MNT |
| TelemedicineAll 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). | Behavioural | Individual MNT and T |
| Hypnotic SuggestionsAll 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). | Behavioural | Individual MNT and HS |
Primary outcome
Body Weight
Time frame: 6 months (Part A); up to 12 months (Part B)
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)
Body Mass Index
Time frame: 6 months (Part A); up to 12 months (Part B)
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)
8 secondary outcomes
Waist circumference
Time frame: 6 months (Part A); up to 12 months (Part B)
Hip circumference
Time frame: up to 6 months (Part A); up to 12 months (Part B)
Arm circumference
Time frame: 6 months (Part A); up to 12 months (Part B)
Body composition
Time frame: 6 months (Part A); up to 12 months (Part B)
Health related quality of life
Time frame: baseline, month 6, 9, 12
Dietary intake
Time frame: 6 months (Part A); up to 12 months (Part B)
Sleep behaviour
Time frame: baseline and month 6 for Parts A and month 12 for Part B
Subjective assessment of health status
Time frame: baseline and month 6 for Parts A and month 12 for Part B
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danuta Gajewska, PhD principal investigator
Department of Dietetics, Warsaw University of Life Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary counseling via face to face meeting, Telemedicine and Hypnotic Suggestions in people with Obesity and Weight Loss, run by Warsaw University of Life Sciences at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Weight (time frame: 6 months (Part A); up to 12 months (Part B)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2020.