NCT06668272尚未招募不适用
Small Changes Clinical Weight Loss Trial
The University of Texas Health Science Center, Houston4 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2024年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 52
- 试验地点
- 4
- 主要终点
- Change in weight
研究概览
简要总结
The purpose of this study is to assess the effectiveness of the Small Changes program in facilitating weight loss and to assess treatment effects on body composition, blood markers of metabolic health, and blood pressure, and to assess attrition and compliance
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body Mass Index greater than or equal to 25
- •Stable weight with less than a 5% body weight change in the past 3 months.
- •Willingness and ability to follow a written dietary plan.
- •Ambulatory and capable of attending bi-weekly in-person and phone appointments.
- •Must reside in the geographic area for the duration of the 12-week study.
- •Clearance for weight loss by their health care provider.
排除标准
- •Pregnant or lactating.
- •Acute medical conditions such as kidney disease, liver disease, pancreatitis, or cancer.
- •A history of bariatric surgery or gastrointestinal resection.
- •Current use of anti-obesity medications or diabetes medications, such as Glucagon-like peptide-1 receptor agonists (GLP-1RAs), that induce weight loss.
- •A history of commercial weight loss program participation within the last six months.
- •A history of anorexia nervosa or other eating disorders.
- •A history of anxiety or depression.
- •Extreme dietary restrictions or allergies that limit the ability to follow the weight loss plan.
结局指标
主要结局
Change in weight
时间窗: Baseline,12 weeks
次要结局
- Change in Hemoglobin A1C levels(Baseline, 12 weeks)
- Change in triglycerides levels(Baseline, 12 weeks)
- Change in total cholesterol levels(Baseline, 12 weeks)
- Change in HDL cholesterol levels(Baseline, 12 weeks)
- Change in fasting blood glucose levels(Baseline, 12 weeks)
- Change in lean body mass(baseline, week 4, week 8, week 12)
- Change in fat mass(baseline, week 4, week 8, week 12)
- Compliance as measured by the percentage of meals that follow the diet plan as reported in a daily food log(From baseline to week 12)
- Attrition as assessed by number of participants that complete the study(week 12)
研究者
Leah Whigham
Associate Professor
The University of Texas Health Science Center, Houston
研究点 (4)
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