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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Body Mass Index (BMI)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged:18-64 years,
- •Body Mass Index (BMI): 25.0-35.0 kg/m² (Overweight or Class I Obesity)
- •Literate,
- •Voluntary agreement to participate.
排除标准
- •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.
结局指标
主要结局
Change in Body Mass Index (BMI)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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.)
研究者
Simay Hiçyılmaz
MD, PhD Candidate
Istinye University