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Not yet recruitingNCT07769736Updated Aug 18, 2026

Motivational Interviews Based on the Five-Step (5A) Model on Obesity Risk

An interventional study of Motivational Interviewing in Obesity & Overweight, sponsored by Istinye University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-08-18.

Sponsored by Istinye University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
All
01

Study summary

The goal of this clinical trial is to learn if a structured motivational interviewing program based on the Five-Step (5A) model works to promote healthy lifestyle behaviors in individuals at high risk of obesity. It will also learn about the effects on anthropometric measurements and physical activity levels. The main questions it aims to answer are:

  • Does this structured program promote healthy lifestyle behaviors in individuals at high risk of obesity?
  • To what extent does it increase participants' intrinsic motivation and readiness for behavioral change?

Participants will:

  • Attend structured interview sessions throughout the designated process
  • Visit the clinic at regular intervals for follow-up and evaluations
  • Record their lifestyle changes, physical activity levels, and experiences throughout the process
02

Conditions studied

  • Obesity & Overweight

Keywords

  • Obesity
  • Motivational Interviewing
  • Behavior Change
03

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Aged:18-64 years,
  • Body Mass Index (BMI): 25.0-35.0 kg/m² (Overweight or Class I Obesity)
  • Literate,
  • Voluntary agreement to participate.

Exclusion criteria

Exclusion Criteria:

  • Body Mass Index (BMI): >35.0 kg/m²,
  • Active involvement in a concurrent weight loss program,
  • Current use of anti-obesity medication,
  • Severe psychiatric or cognitive disorders,
  • Pregnancy,
  • Missing more than one motivational interview session,
  • Orthopedic conditions precluding physical activity.
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Intervention Group

    Experimental Group: Participants receive five structured motivational interviewing sessions over a three-month intervention period, with anthropometric measurements repeated at each session.

    Behavioral: Motivational Interviewing

  • No intervention
    Control Group

    Control Group: Participants are monitored with standard routine care over a three-month intervention period without motivational interviewing sessions.

Interventions

  • BehavioralMotivational Interviewing

    Motivational Interviewing Techniques and the Five-Step (5A) Model Framework

05

What researchers measure

Primary outcomes

  1. Change in Body Mass Index (BMI)

    Changes in body mass index measured in kg/m² from baseline to the end of the intervention period.

    Time frame: Until the end of five motivational interviews that will take place over a three-month period

  2. Change in Body Weight

    Changes in body weight measured in kilograms (kg) from baseline to the end of the intervention period.

    Time frame: Until the end of five motivational interviews that will take place over a three-month period

  3. Change in Waist Circumference

    Changes in waist circumference measured in centimeters (cm) from baseline to the end of the intervention period.

    Time frame: Until the end of five motivational interviews that will take place over a three-month period

  4. University of Rhode Island Change Assessment (URICA) Scale Score

    Changes in readiness score measured by the 32-item University of Rhode Island Change Assessment (URICA) scale. Each item is rated on a 5-point Likert scale ranging from 1 to 5, where higher scores indicate greater readiness for change.

    Time frame: Until the end of five motivational interviews that will take place over a three-month period

Secondary outcomes

  1. Change in Physical Activity Level

    Changes in physical activity levels measured by the General Practice Physical Activity Questionnaire (GPPAQ) instrument from baseline to the end of the intervention period, categorizing participants into four activity levels (active, moderately active, moderately inactive, and inactive) based on occupational physical activity and exercise/cycling hours.

    Time frame: Until the end of five motivational interviews that will take place over a three-month period.

  2. Qualitative Assessment of Motivational Factors

    Qualitative themes encompassing awareness, motivational barriers, health responsibility, and self-efficacy assessed via in-depth interviews.

    Time frame: Until the end of five motivational interviews that will take place over a three-month period.

06

Study locations

1 site
  • Ümraniye No.19 Family Health Center
    Istanbul, Ümraniye, Turkey (Türkiye)
    • Simay Hiçyılmaz, MD, PhD Candidate · Principal investigator
07

References and documents

Individual participant data

Plan to share: Yes — The datasets generated and/or analyzed during the current study will not be publicly available due to participant privacy but will be available from the corresponding author on reasonable request after the publication of the main trial results. De-identified participant data will be shared subject to approval.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07769736
Lead sponsor
Istinye University
Responsible party
Simay Hiçyılmaz (MD, PhD Candidate, Istinye University) — Principal investigator
First posted
Aug 18, 2026
Start date
Sep 2026 (estimated)
Primary completion
Nov 2026 (estimated)
Completion
Nov 2026 (estimated)
Last update
Aug 18, 2026

Study contacts

Simay Hiçyılmaz, MD, PhD Candidate
Contact
223006008@stu.istinye.edu.tr
+905398591714
Gülhan Kalmuk, Assist. Prof. Dr.
study director · Istinye University
Simay Hiçyılmaz, MD, PhD Candidate
principal investigator · Istinye University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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