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

NCT07769736 | Not Yet Recruiting DMC

• 1 other identifier: 26-249
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Obesity & Overweight

Keywords

Obesity; Motivational Interviewing; Behavior Change

Outcome Measures

Primary Outcomes (4)

• Change in Body Mass Index (BMI)

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

  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.

  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.

  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.

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

Secondary Outcomes (2)

• Change in Physical Activity Level

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

• Qualitative Assessment of Motivational Factors

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

Study Arms (2)

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.

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.

Interventions

Motivational Interviewing BEHAVIORAL

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

Intervention Group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istinye University: lead

Study Sites (1)

Ümraniye No.19 Family Health Center

Istanbul, Ümraniye, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obesity; Overweight

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Gülhan Kalmuk, Assist. Prof. Dr.

  Istinye University

  STUDY DIRECTOR

• Simay Hiçyılmaz, MD, PhD Candidate

  Istinye University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simay Hiçyılmaz, MD, PhD Candidate

CONTACT

+905398591714; 223006008@stu.istinye.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD Candidate

Study Record Dates

• First Submitted: August 9, 2026
• First Posted: August 18, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: August 18, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)