Feasibility and Preliminary Efficacy of a Reverse Diet as a Novel Weight Loss Maintenance Strategy for Weight-Reduced Adults With Overweight/Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Enrollment Success
研究概览
简要总结
The purpose of this project is to test, for the first time, a reverse diet in adults with current or prior overweight/obesity (Ow/Ob). Weight-reduced adults with current or prior Ow/Ob will be randomized to a reverse diet or "standard care" control (CON) intervention for 12 weeks. Eligible participants will have lost >10% body mass. The reverse diet group will receive personalized caloric intake goals, increasing 2-3%/week. The CON group will receive standard weight maintenance recommendations with matched contact. At baseline and week 12, resting energy expenditure (REE), body mass and composition, subjective appetite, and food intake behaviors will be evaluated. In addition to the pre- and post-intervention measures, body mass and adherence to reverse diet will be monitored weekly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All ethnic groups and both genders
- •Age: 21-70 years
- •BMI: 18.5-40 kg/m2
- •Weight loss of >10% body mass achieved within 4 weeks of enrollment in study.
排除标准
- •Uncontrolled cardio metabolic disease such as: cardiovascular disease (CVD), diabetes mellitus, hypertension (defined as: systolic blood pressure >160 mmHg or diastolic blood pressure >100mmHg, as measured during the screening visit with participants seated quietly, following established guidelines), renal disease (e.g. chronic kidney disease, polycystic kidney disease, nephritis, etc.), hepatic disease (e.g. cirrhosis, liver failure, fatty liver, jaundice, etc.), untreated thyroid disease (e.g. Grave's disease, Hashimoto's disorder, goiters, thyroid cancers, etc.), or any other medical condition affecting weight or energy metabolism. Participants who are deemed ineligible based upon uncontrolled hypertension criteria will be referred to their primary care physicians for treatment. If these conditions become controlled they will be allowed to be re-evaluated for inclusion in the current trial.
- •Symptoms suggestive of CVD: chest pain, shortness of breath at rest or with mild exertion, syncope.
- •Significant gastrointestinal disorders including: inflammatory bowel disease requiring treatment within the past year, chronic malabsorptive conditions, chronic diarrhea, or active gallbladder disease.
- •Use of pharmacotherapy agents to achieve weight loss prior to study enrollment.
- •Current treatment with medications known to significantly affect appetite, weight, energy metabolism, energy intake or energy expenditure. (e.g. systemic corticosteroids, appetite suppressants, lithium, stimulants, anti-psychotics, tricyclic antidepressants).
- •History of surgical or endoscopic procedure for weight loss at any time (e.g. gastroplasty, gastric bypass, gastrectomy or partial gastrectomy, adjustable banding, gastric sleeve, intragastric balloons, aspiration therapy, etc); history of extensive bowel resection for other reasons.
- •Currently pregnant, lactating or less than 6 months post-partum.
- •Planning to become pregnant during study enrollment period
- •Self-report of alcohol or substance abuse within the past 12 months.
- •History of clinically diagnosed eating disorders including anorexia nervosa, bulimia, binge eating disorder, or score >20 on the EATS-
- •Participants with a score >20 on the EATS-26 will be referred to their primary care physician for further evaluation.
- •Major psychiatric disorder (e.g. diagnosis of schizophrenia, bipolar disorder, or other psychotic disorders).
- •Current severe depression or history of severe depression within the previous year (based on reported history, study physician examination findings, and/or a score >21 on the CES-D). Participants meeting any of these criteria will be referred to their primary care physician and/or the emergency department (based upon study physician determined level of severity).
- •Currently participating in or planning to participate in any formal weight loss programs or clinical trials.
- •Other medical, psychiatric, or behavioral limitations that may interfere with participation (as determined by study physician).
- •Unable or unwilling to undergo study procedures
结局指标
主要结局
Enrollment Success
时间窗: 9 months
The investigators will assess whether they are able to enroll 24 participants meeting study inclusion/exclusion criteria over a 9-month recruitment window. If enrollment is \<24, the investigators will determine barriers to enrollment and re-evaluate the study design and/or recruitment strategies. The investigators will also assess participation rate (number approached versus enrolled), reasons potential participants decline enrollment, and ability to meet demographic goals for the larger trial (approximately equal men and women, ≥33% racial and ethnic minorities).
Attrition Rate
时间窗: 12 Months
The investigators will assess the participant drop-out rate and reasons for attrition over the 12-week study, determine reasons for drop-outs and examine whether drop-out rates differ between intervention arms.
Adherence to the prescribed diet
时间窗: 12 weeks
Self-reported caloric intake compared to prescribed caloric intake
次要结局
- Effort(Weekly, throughout the 12-Week Trial)
- Self-Efficacy(Weekly, throughout the 12-Week Trial)
- Changes in Body Composition(At baseline and post intervention (Week 12).)
- Changes in Resting Energy Expenditure(At baseline and post intervention (Week 12).)
- Changes in Body Mass(Measured weekly throughout the 12-week trial.)
- Dietary Adherence(Measured weekly throughout the 12-week trial.)
- Changes in Food-Related Behaviors(At baseline and post intervention (Week 12).)