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NCT Number: NCT07769736

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

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

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Key information

Conditions

Obesity & Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ümraniye No.19 Family Health Center

Istanbul, Ümraniye, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Motivational Interviewing

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. Change in Physical Activity Level

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

    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.

  2. Qualitative Assessment of Motivational Factors

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

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

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Istinye University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 18, 2026
Registry last updated
Aug 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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