NCT03811197

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 13, 2017

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 17, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 22, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2019

Completed
Last Updated

May 27, 2020

Status Verified

May 1, 2020

Enrollment Period

1.7 years

First QC Date

January 17, 2019

Last Update Submit

May 25, 2020

Conditions

ObesityWeight Loss

Keywords

ObesityWeight LossTelemedicineHypnotic Suggestions

Outcome Measures

Primary Outcomes (2)

  • 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)

    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)

    6 months (Part A); up to 12 months (Part B)

Secondary Outcomes (8)

  • Waist circumference

    6 months (Part A); up to 12 months (Part B)

  • Hip circumference

    up to 6 months (Part A); up to 12 months (Part B)

  • Arm circumference

    6 months (Part A); up to 12 months (Part B)

  • Body composition

    6 months (Part A); up to 12 months (Part B)

  • Health related quality of life

    baseline, month 6, 9, 12

  • +3 more secondary outcomes

Other Outcomes (4)

  • Arterial stiffness

    baseline, month 12

  • Resting Metabolic Rate

    baseline, month 12

  • Nutritional knowledge score baseline

    baseline, month 6

  • +1 more other outcomes

Study Arms (3)

individual MNT

EXPERIMENTAL

Dietary counseling via face to face meeting

Behavioral: Dietary counseling via face to face meeting

Individual MNT and T

EXPERIMENTAL

Dietary counseling via face to face meeting and Telemedicine

Behavioral: Dietary counseling via face to face meetingBehavioral: Telemedicine

Individual MNT and HS

EXPERIMENTAL

Dietary counseling via face to face meeting and Hypnotic Suggestions

Behavioral: Dietary counseling via face to face meetingBehavioral: Hypnotic Suggestions

Interventions

Dietary counseling via face to face meetingBEHAVIORAL

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).

Individual MNT and HSIndividual MNT and Tindividual MNT
TelemedicineBEHAVIORAL

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).

Individual MNT and T
Hypnotic SuggestionsBEHAVIORAL

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).

Individual MNT and HS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Human Nutrition and Consumer Sciences of the Warsaw University of Life Sciences

Warsaw, 02-776, Poland

Location

MeSH Terms

Conditions

ObesityWeight Loss

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Danuta Gajewska, PhD

    Department of Dietetics, Warsaw University of Life Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Adjunct Professor at the Department of Dietetics,PhD

Study Record Dates

First Submitted

January 17, 2019

First Posted

January 22, 2019

Study Start

October 13, 2017

Primary Completion

June 30, 2019

Study Completion

December 10, 2019

Last Updated

May 27, 2020

Record last verified: 2020-05

Locations

PL(1)