Obesity & OverweightNCT07769736
Motivational Interviews Based on the Five-Step (5A) Model on Obesity Risk
A study testing Motivational Interviewing in people with Obesity & Overweight, run by Istinye University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Obesity & Overweight
- What is being tested?
- Motivational Interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Sep 2026to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged:18-64 years,
- Body Mass Index (BMI): 25.0-35.0 kg/m² (Overweight or Class I Obesity)
- Literate,
- Voluntary agreement to participate.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Ümraniye No.19 Family Health Center
Istanbul, Ümraniye
Simay Hiçyılmaz, MD, PhD Candidate
About this study
Official title: The Effect of Structured Motivational Interviews Based on the Five-Step (5A) Model on Behavioral Change in Individuals at High Risk of Obesity in Family Medicine: A Mixed-Methods Randomized Controlled Trial Study Protocol
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?
Read more
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
- Conditions
- Obesity & Overweight
- Being tested
- Motivational Interviewing
- Keywords
- Obesity, Motivational Interviewing, Behavior Change
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational InterviewingBehavioural
Motivational Interviewing Techniques and the Five-Step (5A) Model Framework
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Experimental Group: Participants receive five structured motivational interviewing sessions over a three-month intervention period, with anthropometric measurements repeated at each session. Receives: Behavioral: Motivational Interviewing |
| Control Group | No intervention | Control Group: Participants are monitored with standard routine care over a three-month intervention period without motivational interviewing sessions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Mass Index (BMI)
Changes in body mass index measured in kg/m² from baseline to the end of the intervention period.
Measured: Until the end of five motivational interviews that will take place over a three-month period
Change in Body Weight
Changes in body weight measured in kilograms (kg) from baseline to the end of the intervention period.
Measured: Until the end of five motivational interviews that will take place over a three-month period
Change in Waist Circumference
Changes in waist circumference measured in centimeters (cm) from baseline to the end of the intervention period.
Measured: Until the end of five motivational interviews that will take place over a three-month period
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.
Measured: Until the end of five motivational interviews that will take place over a three-month period
Secondary outcomes (2)
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.
Measured: Until the end of five motivational interviews that will take place over a three-month period.
Qualitative Assessment of Motivational Factors
Qualitative themes encompassing awareness, motivational barriers, health responsibility, and self-efficacy assessed via in-depth interviews.
Measured: Until the end of five motivational interviews that will take place over a three-month period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simay Hiçyılmaz, Istinye University
- Investigators
- Gülhan Kalmuk, Assist. Prof. Dr., Study director, Istinye UniversitySimay Hiçyılmaz, MD, PhD Candidate, Principal investigator, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07769736
- Sponsor's protocol ID
- 26-249
- Status last verified
- Aug 2026
- First submitted
- 9 Aug 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Structured Motivational Interviews Based on the Five-Step (5A) Model on Behavioral Change in Individuals at High Risk of Obesity in Family Medicine: A Mixed-Methods Randomized Controlled Trial Study Protocol
- ClinicalTrials.gov ID
- NCT07769736
- Acronym / sponsor ID
- 26-249
- Conditions
- Obesity & Overweight
- Keywords
- Obesity, Motivational Interviewing, Behavior Change
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 18 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Motivational InterviewingExperimental Group: Participants receive five structured motivational interviewing sessions over a three-month intervention period, with anthropometric measurements repeated at each session. |
| Control Group | No intervention | –Control Group: Participants are monitored with standard routine care over a three-month intervention period without motivational interviewing sessions. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Aged:18-64 years,
- Body Mass Index (BMI): 25.0-35.0 kg/m² (Overweight or Class I Obesity)
- Literate,
- Voluntary agreement to participate.
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational InterviewingMotivational Interviewing Techniques and the Five-Step (5A) Model Framework | Behavioural | Intervention Group |
Primary outcome
Change in Body Mass Index (BMI)
Time frame: Until the end of five motivational interviews that will take place over a three-month period
Changes in body mass index measured in kg/m² from baseline to the end of the intervention period.
Change in Body Weight
Time frame: Until the end of five motivational interviews that will take place over a three-month period
Changes in body weight measured in kilograms (kg) from baseline to the end of the intervention period.
Change in Waist Circumference
Time frame: Until the end of five motivational interviews that will take place over a three-month period
Changes in waist circumference measured in centimeters (cm) from baseline to the end of the intervention period.
University of Rhode Island Change Assessment (URICA) Scale Score
Time frame: Until the end of five motivational interviews that will take place over a three-month period
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.
2 secondary outcomes
Change in Physical Activity Level
Time frame: Until the end of five motivational interviews that will take place over a three-month period.
Qualitative Assessment of Motivational Factors
Time frame: Until the end of five motivational interviews that will take place over a three-month period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gülhan Kalmuk, Assist. Prof. Dr. study director
Istinye University
Simay Hiçyılmaz, MD, PhD Candidate principal investigator
Istinye University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing in people with Obesity & Overweight, run by Istinye University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Simay Hiçyılmaz, MD, PhD Candidate (+905398591714, 223006008@stu.istinye.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Mass Index (BMI) (time frame: Until the end of five motivational interviews that will take place over a three-month period). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.