NCT04192357进行中（未招募）不适用
A Randomised Controlled Trial of a Weight Loss Maintenance Program for Adults With Obesity: The WLM3P Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Change in weight
研究概览
简要总结
The aim of this study is to evaluate the effectiveness of a Weight Loss Maintenance 3 Phases Program (WLM3P) in maintaining long-term weight loss (at least 5% of initial body weight loss at 18 months), compared to a standard low carbohydrate diet (LCD) in adults with obesity.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women aged 18 to 65 years
- •BMI ≥ 30 kg/m2 and ≤ 39.9 kg/m2
- •Interested in being enrolled in a weight loss program
- •Available to comply with study protocol and sign informed consent
排除标准
- •Pregnant, breastfeeding or planning to become pregnant within the study period.
- •Subjects with chronic inflammatory bowel disease (clinical history of Crohn's disease, ulcerative colitis, irritable colon and diverticulitis)
- •Subjects with hormonal or thyroid pathology (hyper and hypothyroidism where TSH is not within normal range)
- •Subjects with renal impairment
- •Subjects with chronic liver disease other than non-alcoholic hepatic steatosis
- •Subjects with autoimmune diseases and/or chronic use of corticosteroids.
- •Use of weight loss medications/other nutritional supplements
- •Subjects with psychiatric or neurological illness
- •Subjects sensitive to any component of supplements
- •Subjects with surgery or hospitalization in the last 30 days
- •Subjects prescribed with 5 or more drugs
- •Previous attempt to lose weight in the last month and/or weight loss of more than 10kg in the 3 months prior to the start of the study
- •Subjects with excessive alcohol consumption (self-reported: drinking more than 3 glasses of wine/day - or equivalent)
- •Subjects with history of drug, alcohol or other substances abuse.
- •Eating behavior disorders
- •Pacemaker carrier
- •Urinary incontinence
- •Vegetarians or vegans
- •Subjects underwent bariatric surgery
- •Type 1 or type 2 diabetes mellitus
- •Altered blood clotting
- •Severe heart failure
研究组 & 干预措施
WLM3P
Experimental
Participants will receive the M3F program. The M3F program is divided into three phases, being the first two of weight loss and the third phase of weight maintenance.
干预措施: WLM3P (Behavioral)
Low-carb diet
Active Comparator
Participants will receive the low-carb diet program. The low-carb diet program is divided into two phases, being the first of weight loss which follows a low carb diet, and a second phase of weight maintenance.
干预措施: Low-carb diet (Behavioral)
结局指标
主要结局
Change in weight
时间窗: 18 months
Difference between the intervention and control group in the change of weight from baseline to the end of follow-up.
次要结局
- Change in total fat mass(18 months)
- Change in fasting plasma high density lipoprotein (HDL) concentrations(18 months)
- Change in fasting plasma glycated hemoglobin A1c (HbA1c) concentrations(18 months)
- Change in alanine aminotransferase (ALT) concentrations(18 months)
- Change in aspartate aminotransferase (AST) concentrations(18 months)
- Change in gamma-glutamyl transpeptidase (GGT) concentrations(18 months)
- Change in HOMA-IR(18 months)
- Change in creatinine concentrations(18 months)
- Change in vitamin D concentrations(18 months)
- Change in high-sensitivity C-reactive protein (hs-CRP) concentrations(18 months)
- Change in sodium concentrations(18 months)
- Change in potassium concentrations(18 months)
- Change in magnesium concentrations(18 months)
- Change in waist circumference(18 months)
- Change in body mass index(18 months)
- Change in systolic and diastolic blood pressure(18 months)
- Change in intestinal microbiota(18 months)
- Change in fasting plasma glucose concentrations(18 months)
- Change in fasting plasma insulin concentrations(18 months)
- Change in fasting plasma triglycerides concentrations(18 months)
- Change in fasting plasma low density lipoprotein (LDL) concentrations(18 months)
研究者
研究点 (1)
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