Evaluating a Remotely Delivered Behavioral Weight Loss Intervention Using an Ad Libitum Plant-Based Diet Versus a Balanced Calorie Deficit Diet
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Weight Change
研究概览
简要总结
This pilot randomized controlled trial will compare a remotely delivered behavioral weight loss program with a balanced calorie deficit diet (the current gold-standard) to a behavioral weight loss program with an ad libitum whole food plant-based diet (WFPBD) amongst adults with overweight/obesity (N = 52). The 6-month intervention will consist of 3 months of moderate-intensity intervention (weekly online modules and brief coaching calls), then a low-intensity period (3 calls over 3-months). Assessments will occur at baseline, 6-weeks, 12-weeks, and post-treatment (6-months). Acceptability, dietary adherence, weight, quality of life, depressive symptoms, and subjective appetite will be assessed.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI 27-50 kg/m2
- •Ages 18-75 years
- •Resides in the U.S.
- •Consistent access to internet at home
- •Proficient skill level in speaking, writing, and understanding English
- •Reporting a desire to lose weight
- •Consistently available for 15-minute once-weekly video appointment between the hours of 8 AM and 7 PM EST
- •Willing to follow a whole food plant-based diet or a traditional calorie-reduced diet for the study duration
- •Individuals must provide consent for the research team to contact their personal physician if necessary, to provide clearance or to consult about rapid weight loss
排除标准
- •Currently pregnant or breastfeeding or planned pregnancy within the study period
- •Recent weight loss (≥ 5% weight loss in 3-months prior to the study)
- •History of bariatric surgery
- •Currently following a low-fat plant-based diet
- •Medical condition (e.g., cancer, type I diabetes, renal failure), current substance use problem, or psychiatric condition (e.g., active substance abuse, eating disorder) that may pose a risk to the participant during intervention or cause a change in weight
- •Recently began or changed the dose of a medication that can cause significant change in weight
- •Planning on quitting cigarette smoking over the program period
- •Participation in a concurrent weight loss program during the study period
- •Medical diagnosis currently influencing weight or appetite
- •Medical condition that would limit ability to participate in this program (for example, mild stroke, diabetes if taking insulin, head trauma, cognitive disorder)
- •Acute suicidality
- •Currently meets criteria for regular loss-of-control eating (i.e., ≥ 9 binge episodes in past 3 months
- •Currently reports engaging in a compensatory behavior
研究组 & 干预措施
Lifestyle Modification with a Balanced Calorie Deficit Diet
Lifestyle modification intervention with a balanced calorie deficit diet (i.e., participants will be prescribed a calorie goal and will track their dietary intake in order to meet this goal).
干预措施: Lifestyle Modification Intervention (Behavioral)
Lifestyle Modification with a Balanced Calorie Deficit Diet
Lifestyle modification intervention with a balanced calorie deficit diet (i.e., participants will be prescribed a calorie goal and will track their dietary intake in order to meet this goal).
干预措施: Balanced Calorie Deficit Eating Plan (Behavioral)
Lifestyle Modification with an Ad Libitum Whole Food Plant-Based Eating Plan
Lifestyle modification intervention with an ad libitum whole food plant-based diet (i.e., participants will eat, ad libitum, fruits, vegetables, starches, legumes, and whole grains, and will avoid eating processed foods, refined oils, and animal products)
干预措施: Ad Libitum Whole Food Plant-Based Eating Plan (Behavioral)
Lifestyle Modification with an Ad Libitum Whole Food Plant-Based Eating Plan
Lifestyle modification intervention with an ad libitum whole food plant-based diet (i.e., participants will eat, ad libitum, fruits, vegetables, starches, legumes, and whole grains, and will avoid eating processed foods, refined oils, and animal products)
干预措施: Lifestyle Modification Intervention (Behavioral)
结局指标
主要结局
Weight Change
时间窗: Measured at each assessment baseline, mid-treatment (6- and 12-weeks) and post-treatment (6-months).
Weight loss will be self-reported by participants using a standardized weighing procedure. Participants will weigh themselves in lightweight clothes without shoes with a digital scale accurate to 0.1 kg. Percent weight loss at 6-months will be calculated as the percentage loss in initial body weight at baseline by the time of the post-treatment assessment.
次要结局
- Subjective Appetite as assessed by visual analogue scale (VAS)(Measured at baseline, mid-treatment (6- and 12-weeks) and post-treatment (6-months).)