NCT05328791

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 eating behaviours.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started May 2022

Typical duration for not_applicable obesity

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 14, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

May 15, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2024

Completed
Last Updated

July 23, 2024

Status Verified

July 1, 2024

Enrollment Period

2.1 years

First QC Date

April 7, 2022

Last Update Submit

July 22, 2024

Conditions

Keywords

ObesityWeight lossMindfulness

Outcome Measures

Primary Outcomes (1)

  • Weight chance

    BMI (kilogram/ metre2 (kg/m2))

    At the end of the 2 months

Secondary Outcomes (1)

  • Three factor eating questionnaire (TFEQ) scale score change

    At the end of the 2 months

Study Arms (2)

Mindfulness+Diet intervention

EXPERIMENTAL

Diet and mindfulness intervention

Behavioral: Dietary and mindfulness intervention

Diet intervention

EXPERIMENTAL

Diet intervention

Behavioral: Dietary and mindfulness intervention

Interventions

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

Diet interventionMindfulness+Diet intervention

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ümüş Özbey Yücel

Ankara, Select An Option…, 06000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

ObesityWeight Loss

Interventions

Diet

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • ümüş Ö yücel

    Ankara University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Researcher of the Amasya University Nutrition and Diet Department

Study Record Dates

First Submitted

April 7, 2022

First Posted

April 14, 2022

Study Start

May 15, 2022

Primary Completion

June 5, 2024

Study Completion

July 20, 2024

Last Updated

July 23, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations