Effectiveness of Low-Calorie Diet versus Intermittent Fasting, with and without Behavioral Interventions, on Weight Loss and Metabolic Health: A Randomized Controlled Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in body weight from baseline to 12 months.
研究概览
简要总结
The WEIGHT-BEAM Study is an extensive randomized controlled trial designed to assess the effectiveness of two different dietary strategies—low-calorie diet and intermittent fasting—each implemented with and without additional behavioral interventions, in a larger population of 200 adults aged between 18 and 60 years, who have a body mass index (BMI) ranging from 24 to 40 kg/m². This study aims to provide insights into which diet method is more effective for sustainable weight loss and improving various metabolic health outcomes.
Over a 12-month period of active intervention followed by a 6-month follow-up phase without intervention, the study will monitor a variety of outcomes to understand the impact of these diets not only on weight loss but also on a broad spectrum of health parameters. These parameters include body composition changes such as fat mass and lean mass, metabolic health indicators like waist circumference, waist-to-hip ratio, and glycated hemoglobin levels. Moreover, the study will explore changes in lipid profiles, blood pressure, resting heart rate, and insulin resistance, measured through HOMA-IR and the Matsuda index.
Additionally, the trial will assess improvements in cardiorespiratory fitness, as well as psychological well-being, including general health perception, physical functioning, and emotional health. The inclusion of behavioral interventions aims to explore whether consistent coaching and psychological support can enhance the efficacy of these diets and promote better adherence to lifestyle changes.
By increasing the number of participants to 200, the study seeks to enhance the statistical power to detect meaningful differences between the interventions, thus providing more reliable conclusions. These insights are crucial for developing targeted dietary recommendations and public health policies aimed at combating obesity and its associated health risks. The comprehensive data collected will help delineate the nuanced effects of diet and behavior on long-term weight management and overall health improvement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults aged 18 to 60 years.
- •Body mass index (BMI) between 25 and 40 kg/m².
- •Generally healthy without significant acute or chronic illnesses that could interfere with diet adherence or affect study outcomes.
- •Willing and able to comply with the diet protocols and follow-up assessments for the duration of the study.
- •Able to provide written informed consent to participate in the study.
排除标准
- •Significant psychiatric disorders, pregnancy or breastfeeding.
- •Chronic diseases such as cardiovascular conditions.
- •Diabetes (Type 1 or Type 2) as their management could interfere with the dietary interventions planned in the study.
- •bariatric surgery.
结局指标
主要结局
Change in body weight from baseline to 12 months.
时间窗: Change in body weight from baseline to 12 months.
次要结局
- fat mass(baseline, 3 months, 6 months, 9 months, 12 months)
- lean mass.(baseline, 3 months, 6 months, 9 months, 12 months)
- body fat percentage(baseline, 3 months, 6 months, 9 months, 12 months)
- waist circumference(baseline, 3 months, 6 months, 9 months, 12 months)
- waist-to-hip ratio(baseline, 3 months, 6 months, 9 months, 12 months)
- glycated hemoglobin (HbA1c) levels(baseline, 3 months, 6 months, 9 months, 12 months)
- blood pressure (both systolic and diastolic)(baseline, 3 months, 6 months, 9 months, 12 months)
- lipid profiles, including cholesterol and triglycerides(baseline, 3 months, 6 months, 9 months, 12 months)
- resting heart rate(baseline, 3 months, 6 months, 9 months, 12 months)
- Homeostatic Model Assessment of Insulin Resistance (HOMA-IR).(baseline, 3 months, 6 months, 9 months, 12 months)
- Matsuda index(baseline, 3 months, 6 months, 9 months, 12 months)
- cardiorespiratory fitness.(baseline, 3 months, 6 months, 9 months, 12 months)
- general health perception.(baseline, 3 months, 6 months, 9 months, 12 months)
- physical functioning.(and emotional well-being.)
研究者
Amit Kumar Soni
Government MLB GIrls college indore