Physiological Changes Underlying the Weight Loss Plateau in Human
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Change in fMRI BOLD signal
研究概览
简要总结
Behavioral weight loss programs for obesity can result in weight loss and health benefits. However, behavioral weight loss often stops despite efforts to continue losing weight, this can be called an involuntarily weight loss plateau. This study investigates changes in metabolism and/or the brain that contribute to the occurrence of an involuntary weight loss plateau.
详细描述
Participants will be asked to enroll for 18-months. Each participant will complete 3 in-person study visits, then participate an a 6-month weight loss program delivered remotely. Some participants may be invited to complete 3 additional in-person visits. Study Visit activities include questionnaires, blood draws, brain MRIs, body measurement and dual energy x-ray absorptiometry (DXA) scan for body composition measurement, a breathing test, and biopsies of muscle and fat tissue. Each participant will be provided a fitness tracker and body weight scale to use throughout the study.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI 30.0 - 50.0 kg/m2
- •Able to attend study intervention classes and study visits/assessments
- •Independently living with access to food preparation facilities
排除标准
- •Current smoker or regular use of nicotine containing products and/or cannabis
- •Heavy alcohol use (≥2 drinks/d for females, ≥3 drinks/d for males) or drug use
- •Known cognitive impairments or h/o stroke
- •Type 2 diabetes (known diagnosis or by screening A1c (≥6.5%))
- •Medical conditions (chronic diseases, cancer, MS) or labs limiting ability to participate
- •Females: currently pregnant (or 6-months postpartum of full-term pregnancy) and/or current breastfeeding
- •Use of medications with significant effects on appetite (e.g., weight loss medications, atypical antipsychotics, stimulants) and/or chronic use of anticoagulants
- •History of bariatric surgery
- •History of eating disorder
- •Current participation in a formal weight loss program
- •Prior or current participation in a research study involving weight loss
- •Weight-reduced by >10% within past year
- •Weight > 330 pounds (MRI limit)
- •Allergy or intolerance to or unwillingness to consume study foods provided at visit
- •MRI contraindication (e.g., implanted metal, claustrophobia)
- •Do not have a phone compatible with activity tracker or access to videoconferencing platform that will be used for the dietary intervention or other appropriate technology needed to complete study procedures
- •Any condition(s) found by the study team and confirmed with the PI(s) that make it unsafe to participate
研究组 & 干预措施
Behavioral Weight Loss
Participants will undergo a behavioral weight loss program.
干预措施: Behavioral Weight Loss Program (Behavioral)
结局指标
主要结局
Change in fMRI BOLD signal
时间窗: From baseline to a weight loss plateau (after active weight loss, at least 21 days of halted weight loss, or +/- 0.25 pounds/week).
fMRI BOLD signal to visual food cues within a priori brain regions of interest pre and post consuming a standardized meal. Meal-induced change will be calculated by post-pre meal BOLD signal.
Change in maximal respiratory capacity (oxygen consumption rate) in peripheral blood mononuclear cells
时间窗: From baseline to active weight loss (at least 21 days of weight loss equivalent or greater than 0.5 pounds per week) and from baseline to weight loss plateau (after active weight loss, at least 21 days of halted weight loss, or +/- 0.25 pounds/week).
Mitochondrial maximal respiratory capacity will be measured in fasting samples from peripheral blood mononuclear cells.
Entry into involuntary weight loss plateau
时间窗: throughout 18-month enrollment
binary outcome (Y/N) and time from baseline
次要结局
未报告次要终点
研究者
Ellen Schur, MD, MS
Professor: School of Medicine
University of Washington