NCT05046938

Brief Summary

The aim of this study is to determine the effect of online group motivational interviewing (MI) on eating behavior, healthy lifestyle behaviors and quality of life in nursing participants with food addiction at three state universities in Ankara. The population of the research will be those who meet the diagnostic criteria for food addiction according to the Yale Food Addiction Scale. The research sample size was calculated with the G\* Power package program. As a result of the power analysis, a total of 52 participants, 26 for the intervention group and 26 for the control group, were found sufficient for the sample with 90% power, 5% margin of error and 0.2065 effect size. Considering that the number of participants would decrease during the research process, the number of samples was increased by 10% to a total of 58 university participants, 29 of which were interventions and 29 were controls. Among the participants who meet the food addiction criteria, the participants who meet the inclusion criteria and agree to participate in the research will be randomly assigned to the intervention and control groups (n1=29; n2=29). After these participants are stratified according to the change (pre-contemplation and contemplation stage) phase, a simple random assignment process within the strata will be done by an independent researcher to avoid selection bias. Random assignment will be done through a simple random numbers table. The independent researcher who does not know which group is the intervention group and which group is the control group will collect the data. Data collection tools will be applied to the participants in the intervention and control groups in the pre-MI session, the post-MI session, and 2 months later in the follow-up session. It was planned to apply 5 sessions of MI to the intervention group, and to follow-up 2 months after the interviews were completed. No application will be made to the participants in the control group, and at the end of the study, a seminar on food addiction and quality of life will be given to the participants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

September 1, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

September 7, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 16, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2022

Completed
Last Updated

August 18, 2022

Status Verified

August 1, 2022

Enrollment Period

7 months

First QC Date

September 1, 2021

Last Update Submit

August 16, 2022

Conditions

Keywords

food addictionmotivational interviewinghealthy life style behaviorsquality of life

Outcome Measures

Primary Outcomes (1)

  • Evolution of eating behaviour

    Yale Food Addiction Scale (Measured by the Yale Food Addiction Scale Minimum score = 0 symptoms, Maximum score = 11 symptoms. Greater symptoms mean worse outcome.

    5 weeks after randomization

Secondary Outcomes (2)

  • Evolution of health lifestyle behaviour

    From baseline, up to 3 months

  • Evolution of SF-36 quality of life

    From baseline, up to 3 months

Study Arms (2)

intervention group

EXPERIMENTAL

It was planned to apply 5 sessions of MI to the intervention group, and to follow-up 2 months after the interviews were completed.

Behavioral: Motivational İnterviewing

control group

NO INTERVENTION

No application will be made to the students in the control group, and at the end of the study, a seminar on food addiction and quality of life will be given to the students.

Interventions

Students with food addiction will be provided with motivational interviews about food addiction in 5 sessions, each of which varies between 6-8 groups.

intervention group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Meeting at least 3 diagnostic criteria according to the Yale Food Addiction Scale (YFAS) and having clinical significance
  • Not having a written or verbal communication problem
  • Volunteer to participate in research
  • Among the motivational interview change stages, those who do not intend to change their eating behavior and those who intend to do so

You may not qualify if:

  • Having a neurological or psychiatric illness that interferes with reading and understanding data collection tools
  • Have previously received treatment/psychotherapy for food addiction/eating disorder
  • Receiving ongoing treatment/psychotherapy/psychological counseling regarding food addiction/eating disorder
  • Having trouble speaking/understanding Turkish
  • Being at the stage of preparation, action and maintenance in making changes in nutritional behavior, which is one of the motivational interview change stages

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turkey

Ankara, 06300, Turkey (Türkiye)

Location

Related Publications (5)

  • Gearhardt AN, Corbin WR, Brownell KD. Preliminary validation of the Yale Food Addiction Scale. Appetite. 2009 Apr;52(2):430-6. doi: 10.1016/j.appet.2008.12.003. Epub 2008 Dec 11.

    PMID: 19121351BACKGROUND
  • Ware JE Jr. SF-36 health survey update. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3130-9. doi: 10.1097/00007632-200012150-00008. No abstract available.

    PMID: 11124729BACKGROUND
  • Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.

    PMID: 1593914BACKGROUND
  • Walker SN, Sechrist KR, Pender NJ. The Health-Promoting Lifestyle Profile: development and psychometric characteristics. Nurs Res. 1987 Mar-Apr;36(2):76-81.

    PMID: 3644262BACKGROUND
  • Mokhtari MR, Alavi M, Pahlavanzadeh S, Weimand BM, Visentin D, Cleary M. Comparison of the effectiveness of a 12 step substance use recovery program on quality of life. Nurs Health Sci. 2020 Jun;22(2):390-397. doi: 10.1111/nhs.12668. Epub 2019 Dec 11.

    PMID: 31828941BACKGROUND

MeSH Terms

Conditions

Food Addiction

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Behavior, AddictiveCompulsive BehaviorImpulsive BehaviorBehaviorFeeding and Eating DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Merve Işık

    Gazi University Faculty of Health Sciences Department of Nursing

    PRINCIPAL INVESTIGATOR
  • Satı Demir

    Gazi University Faculty of Health Sciences Department of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Among the students who meet the food addiction criteria, the students who meet the inclusion criteria and agree to participate in the research will be randomly assigned to the intervention and control groups (n1=29; n2=29). After these students are stratified according to the change (pre-contemplation and contemplation stage) phase, a simple random assignment process within the strata will be done by an independent researcher to avoid selection bias. Random assignment will be done through a simple random numbers table. The independent researcher who does not know which group is the intervention group and which group is the control group will collect the data.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: randomized controlled experimental design
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
research assistant

Study Record Dates

First Submitted

September 1, 2021

First Posted

September 16, 2021

Study Start

September 7, 2021

Primary Completion

March 30, 2022

Study Completion

March 30, 2022

Last Updated

August 18, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations