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Effectiveness of a Mindfulness Based Diet Program on Weight Loss

Primary Purpose

Obesity, Weight Loss

Status

Recruiting

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Dietary and mindfulness intervention

About this trial

This is an interventional supportive care trial for Obesity focused on measuring Obesity, Weight loss, Mindfulness

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Being between the ages of 20-65
Being obese (BMI≥30 kg/m2)
Volunteering to participate in research

Exclusion Criteria:

Being pregnant/lactating
Having a psychological problem
Being on a followed diet program

Sites / Locations

Ümüş Özbey YücelRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Mindfulness+Diet intervention

Diet intervention

Arm Description

Diet and mindfulness intervention

Diet intervention

Outcomes

Primary Outcome Measures

Weight chance

BMI (kilogram/ metre2 (kg/m2))

Secondary Outcome Measures

Depression, Anxiety and Stress scale score change

The score ranges from 0 to 100 points, with an increased score reflecting decreased depression, anxiety and stress level

Full Information

NCT ID

NCT05328791

First Posted

April 7, 2022

Last Updated

July 5, 2023

Sponsor

Ankara University

Collaborators

Amasya University

1. Study Identification

Unique Protocol Identification Number

NCT05328791

Brief Title

Effectiveness of a Mindfulness Based Diet Program on Weight Loss

Official Title

Effectiveness of a Mindfulness Based Diet Program Given to Obese Individuals on Weight Loss and Psychological Parameters

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 15, 2022 (Actual)

Primary Completion Date

April 30, 2024 (Anticipated)

Study Completion Date

May 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ankara University

Collaborators

Amasya University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Meditation interventions, including mindfulness-based approaches, can be effective in reducing psychological stress . Mindfulness meditation, which cultivates awareness of present-moment experience with a nonjudging attitude, is theorized to promote adaptive self-regulation,which is thought to be key to maintaining long-term eating habits and appetite regulation.In the light of this information, in this study, it is aimed to observe the effect of mindfulness approach on body weight and appetite control.

Detailed Description

The use of minfulness based programs for body weight control and stress management is increasing. One of the main reasons for this situation is that individuals care more about the diet and body weidght as a result of the increase in health concerns and stress. In addition, such cognitive support programs in the diet process provide a more comfortable and stress-free continuation of the diet. Based on the above-mentioned information; in this study, it is aimed to determine the effect of mindfulness based diet intervention on weight loss and phsycological parameters Individuals who meet the research criteria will randomize according to their file numbers (with the ramdomizer program) and divide into 2 groups: mindfulness group (15) and control group . Food consumption records, anthropometric measurements and quality of life scale scores of all individuals will record at the beginning and end of the study. In order to prevent interaction between individuals, all diet programs will prepare at different times and individually.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Weight Loss

Keywords

Obesity, Weight loss, Mindfulness

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Mindfulness+Diet intervention

Arm Type

Experimental

Arm Description

Diet and mindfulness intervention

Arm Title

Diet intervention

Arm Type

Experimental

Arm Description

Diet intervention

Intervention Type

Behavioral

Intervention Name(s)

Dietary and mindfulness intervention

Intervention Description

Dietary intervention: Preparation and follow-up of diet program Mindfulness intervention: Implementation of cognitive stress reduction program

Primary Outcome Measure Information:

Title

Weight chance

Description

BMI (kilogram/ metre2 (kg/m2))

Time Frame

At the end of the 2 months

Secondary Outcome Measure Information:

Title

Depression, Anxiety and Stress scale score change

Description

The score ranges from 0 to 100 points, with an increased score reflecting decreased depression, anxiety and stress level

Time Frame

At the end of the 2 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Being between the ages of 20-65 Being obese (BMI≥30 kg/m2) Volunteering to participate in research Exclusion Criteria: Being pregnant/lactating Having a psychological problem Being on a followed diet program

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

ümüş Ö yücel

Phone

05061552797

umus_ozbey@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

ümüş Ö yücel

Organizational Affiliation

Ankara University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ümüş Özbey Yücel

City

Ankara

State/Province

Select An Option…

ZIP/Postal Code

06000

Country

Turkey

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

ümüş Ö yücel

Phone

05061552797

umus_ozbey@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD

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Effectiveness of a Mindfulness Based Diet Program on Weight Loss

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