NCT02736669已完成不适用
Fixed Versus Variable Energy Reduction During Behavioral Obesity Treatment
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 223
- 试验地点
- 2
- 主要终点
- Measure change in body weight (kg) from baseline to follow-up assessments
研究概览
简要总结
This research study will compare two weight loss programs that provide different recommendations for how to reduce your energy (or calorie) intake to achieve weight loss in an effort to determine if fixed calorie reduction or varied calorie reduction is more effective for weight loss.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 21-75
- •Body mass index (BMI) 30-50 kg/m2
排除标准
- •Uncontrolled hypertension (blood pressure >160/100 mm Hg)
- •Any of the following other medical conditions: myocardial infarction or cerebrovascular accident within the last six months; unstable angina within the past six months; congestive heart failure; cancer requiring treatment in past five years (exception: non-melanoma skin cancer); serious infectious diseases (e.g., self-reported HIV); chronic hepatitis; cirrhosis; chronic malabsorption syndrome; chronic pancreatitis; chronic lung diseases or orthopedic problems that limit physical activity
- •Current use of any of the following medications: antipsychotic agents, monoamine oxidase inhibitors, systemic corticosteroids, antibiotics for HIV or TB, or chemotherapeutic drugs; prescription weight loss medications (past six months)
- •Unwilling or unable to do any of the following: give informed consent; read English at the 5th grade level; accept random assignment; travel to the intervention site
- •Likely to relocate out of the area in the next 2 years
- •Participation in another randomized research project
- •Weight loss > 10 pounds in past six months
- •History of bariatric surgery
- •Major depressive or psychiatric disorder, or excessive alcohol intake
- •Potential participants living farther than 30 miles driving distance from UAB will be excluded from the study.
- •Potential participants (female) that are pregnant or plan to become pregnant in the next 18 months will be excluded from participation in the study. This is a weight loss study and weight gain/loss due to pregnancy and/or delivery would confound study results. Additionally, weight loss is not recommended for pregnant women.
结局指标
主要结局
Measure change in body weight (kg) from baseline to follow-up assessments
时间窗: Baseline, 6 months, 18 months
Participants will be weighed by body scale in kilograms
次要结局
- Resting energy expenditure(6, 12, and 18 months)
- Body composition(6, 12, and 18 months)
- Laboratory analyses(6, 12, and 18 months)
- Blood pressure(6, 12, and 18 months)
- Hormones - ghrelin(6, 12, and 18 months)
- Hormones - leptin(6, 12, and 18 months)
- Satiety/hunger(6, 12, and 18 months)
- Physical activity - objective(6, 12, and 18 months)
- Physical activity - self-report(6, 12, and 18 months)
- Treatment adherence(6, 12, and 18 months)
- Treatment novelty(6, 12, and 18 months)
- Treatment burden(6, 12, and 18 months)
- Treatment satisfaction(6, 12, and 18 months)
研究者
Gareth R. Dutton PhD
Associate Professor
University of Alabama at Birmingham
研究点 (2)
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