Physiology of the Weight Reduced State
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 205
- 试验地点
- 6
- 主要终点
- Weight change from end of weight stabilization following at least 7 percent weight loss to 52 weeks after weight stabilization following at least 7 percent weight loss
研究概览
简要总结
The goal of this clinical trial is to determine the physiological basis for the differences in weight regain among adults (25-59 years old) with obesity following participation in a behavioral weight loss program. Eligible participants will undergo a baseline evaluation after which they will enter an up to 20 week behavioral weight loss program with the goal of losing at least 7 percent of their baseline weight within 35 weeks. Participants who meet the weight loss goal will be asked to remain weight stable for 2 weeks after which they will undergo a clinical examination. They will then be observed for 1 year during which they will undergo 2 additional clinical examinations, one 4 months after completing the weight loss program, and the other 12 months after completing the weight loss program.
详细描述
Primary Hypothesis:
Changes, integrated values and patterns in energy intake (EI), energy expenditure (EE), resting energy expenditure (REE) and non-resting energy expenditure (NREE), contribute to the variability in weight change during the 12 months following weight loss.
Assessment time points:
- Baseline (BL): prior to starting the weight loss intervention
- T0: at the end of a period of weight stabilization following at least 7 percent weight loss
- T4: four months (17 weeks) following T0
- T12: twelve months (52 weeks) following T0
Secondary Hypotheses:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 25 - <60 years
- •BMI: 30 - <40 kg/m2 at the first screening visit
- •Within 5% of current weight, for the past 6 months at the first screening visit
- •Able to participate in ergometry testing
- •Has a smart phone, tablet or computer with access to the internet
排除标准
- •If 25-29 years old, > 5% deviation from maximum weight (excluding weights while pregnant) since age 25 years
- •If at least 30 years old, > 5% deviation from maximum weight (excluding weights while pregnant) in last 5 years or ≥ 10% deviation from maximum weight (excluding weights while pregnant) since age 30 years
- •History of pulmonary embolus in the past 6 months
- •Cardiovascular disease (e.g. myocardial infarction, stroke, hospitalization for unstable angina, or transient ischemic attack) within the past 6 months
- •Current major depressive disorder or history of major depressive disorder within 2 years
- •Any regular tobacco or nicotine use in the past year
- •Currently engaging in intense physical training or training for a sports event including, but not limited to, a marathon or body building
- •Currently pregnant, or less than one-year post-partum or actively planning to become pregnant within the next two years
- •Presently classified as being in New York Heart Association Class II or greater or dysrhythmia
- •Diabetes (type 1 or 2 - HbA1c ≥ 6.5%, fasting glucose ≥ 126 mg/dL) or currently taking a glucose lowering medication
- •Thyroid disease requiring hormones or medication or TSH < 0.5 or > 5 mIU/L
- •Renal disease requiring dialysis
- •Known HIV infection
- •ALT or AST greater than 5 times the upper limit of normal or active gall bladder disease
- •Significant anemia (Hgb < 10 g/dL) or thrombocytopenia (platelet count < 60,000 /mm3)
- •Leukopenia defined as:
- •Males: WBC < 3,100 /mm3 or (WBC 3,100 - < 4,000 /mm3 and at least 1 Duffy antigen (A, B) positive or no result) Females: WBC < 3,400 /mm3 or (WBC 3,400 - < 4,000 /mm3 and at least 1 Duffy antigen (A, B) positive or no result)
- •Active cancer or current chemotherapy treatment, or history of cancer requiring treatment in the past 5 years except for non-melanoma skin cancers or cancers that have clearly been cured
- •Current or past history of anorexia nervosa or bulimia nervosa
- •Current or past diagnosis of binge eating disorder
- •Diagnosis of other severe psychiatric disorder (e.g. schizophrenia, bipolar disorder)
- •Unwillingness to abstain from marijuana/cannabis use for 3 weeks at each of the four assessment time points
- •Known or suspected abuse or misuse of alcohol, prescription drugs, or recreational drugs
- •Antiretroviral therapy (ART), including treatment for HIV, pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP) within the past 3 months
- •Regularly taking medication or supplement known to affect appetite, energy expenditure, or weight (e.g. appetite suppressants, steroids-including inhaled steroids but not topical, alpha-blockers, beta-blockers, certain psychotropic medications)
- •Currently taking anticoagulant medication
- •Currently enrolled in a supervised weight reduction program
- •Prior or planned bariatric surgery, endoscopic therapy, device-based therapy for obesity, liposuction, cryolipolysis, or abdominoplasty
- •Severely restricted diets: Vegan (no meat, fish, dairy, eggs, or honey), very low carbohydrate (<15% calorie as carbohydrate), very low fat (<15% calories as fat), or strictly gluten free
- •Current celiac or diagnosed gluten intolerance or inflammatory bowel disease requiring specialized diet
- •Night or rotating shift worker
- •Known severe allergy (e.g. anaphylaxis) to nuts or other foods
- •Systolic blood pressure (BP) <90 mmHg and/or diastolic BP <60 mmHg on 2 measurements during the clinical screening visit.
- •Systolic blood pressure (BP) >160 mmHg and/or diastolic BP >100 mmHg on at least 2 measurements during the clinical screening visit or resting heart rate < 45 beats per minute or >100 on 2 measurements during the clinical screening visit.
- •Metal implants, piercings that cannot be removed, or metal-based tattoos or hair treatments
- •Exceeds limitations to fit dual-energy X-ray absorptiometry (DXA) field of view
- •Known allergy to lidocaine or acetaminophen
- •Non-compliance with appointments or tasks (food diaries, etc.) during the screening phase
- •Blood clotting disorder or INR > ULN or PT > ULN or (a)PTT > ULN
- •Tendency to form thick or raised scars
- •Inability to achieve weight stability (defined in section 4.2.1) during the 2 weeks prior to initiation of the baseline Doubly Labeled Water (DLW) assessment
- •At high risk for suicide, as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
研究组 & 干预措施
Weight loss
A 37 week behavioral intervention aimed at decreasing energy intake and increasing physical activity.
干预措施: Weight loss (Behavioral)
结局指标
主要结局
Weight change from end of weight stabilization following at least 7 percent weight loss to 52 weeks after weight stabilization following at least 7 percent weight loss
时间窗: End of weight stabilization following at least 7 percent weight loss vs. 52 weeks after weight stabilization following at least 7 percent weight loss
Percentage of lost weight that is regained
次要结局
未报告次要终点
研究者
Steven Belle
Professor
University of Pittsburgh