NCT06229847

Brief Summary

The goal of this observational study is to learn about the association of the level of mindful eating with the current glycemic control in patients with type 2 diabetes. The researchers will compare different glycemic control levels with the participants mindfulness while eating. And secondly, the researchers will compare the levels of eating awareness of those with and without obesity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
448

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2019

Shorter than P25 for all trials

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

Study Start

First participant enrolled

July 1, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

January 14, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 29, 2024

Completed
Last Updated

January 29, 2024

Status Verified

January 1, 2024

Enrollment Period

5 months

First QC Date

January 14, 2024

Last Update Submit

January 26, 2024

Conditions

Keywords

type 2 diabetesmindful eatingglycemic controlBMI

Outcome Measures

Primary Outcomes (1)

  • mindful eating, its subgroups and diabetes control in patients with type 2 diabetes

    To investigate the relationship between mindful eating and its subgroups with glycemic control, as evaluated by HbA1c, in individuals diagnosed with type 2 diabetes for at least 6 months.

    baseline

Secondary Outcomes (1)

  • mindful eating, its subgroups and the presence of obesity in patients with type 2 diabetes

    baseline

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals attending to the diabetes outpatient clinic with type 2 diabetes diagnosis for at least 6 months, and received treatment for diabetes

You may qualify if:

  • given consent to the study
  • having applied to Diabetes Outpatient Clinic for diabetes management
  • having diagnosed with type 2 diabetes for at least 6 months
  • having the mental competence to answer the questions in the questionnaire

You may not qualify if:

  • Inconclusive diagnosis of type 2 diabetes
  • having not received or not using any treatment for diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medeniyet University Goztepe Research and TRaining Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (4)

  • Fanning J, Osborn CY, Lagotte AE, Mayberry LS. Relationships between dispositional mindfulness, health behaviors, and hemoglobin A1c among adults with type 2 diabetes. J Behav Med. 2018 Dec;41(6):798-805. doi: 10.1007/s10865-018-9938-3. Epub 2018 May 25.

    PMID: 29802533BACKGROUND
  • Dunn C, Haubenreiser M, Johnson M, Nordby K, Aggarwal S, Myer S, Thomas C. Mindfulness Approaches and Weight Loss, Weight Maintenance, and Weight Regain. Curr Obes Rep. 2018 Mar;7(1):37-49. doi: 10.1007/s13679-018-0299-6.

    PMID: 29446036BACKGROUND
  • St-Onge MP, Ard J, Baskin ML, Chiuve SE, Johnson HM, Kris-Etherton P, Varady K; American Heart Association Obesity Committee of the Council on Lifestyle and Cardiometabolic Health; Council on Cardiovascular Disease in the Young; Council on Clinical Cardiology; and Stroke Council. Meal Timing and Frequency: Implications for Cardiovascular Disease Prevention: A Scientific Statement From the American Heart Association. Circulation. 2017 Feb 28;135(9):e96-e121. doi: 10.1161/CIR.0000000000000476. Epub 2017 Jan 30.

    PMID: 28137935BACKGROUND
  • Mason AE, Saslow L, Moran PJ, Kim S, Wali PK, Abousleiman H, Hartman A, Richler R, Schleicher S, Hartogensis W, Epel ES, Hecht F. Examining the Effects of Mindful Eating Training on Adherence to a Carbohydrate-Restricted Diet in Patients With Type 2 Diabetes (the DELISH Study): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Feb 20;8(2):e11002. doi: 10.2196/11002.

    PMID: 30545813BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Ayşe N Erbakan, MD

    Istanbul Medeniyet University Goztepe Prof Dr Suleyman Yalcın City Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 14, 2024

First Posted

January 29, 2024

Study Start

July 1, 2019

Primary Completion

November 30, 2019

Study Completion

December 30, 2019

Last Updated

January 29, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations