Telephone Delivered Weight Loss, Nutrition, Exercise Study (WeLNES)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 418
- 试验地点
- 2
- 主要终点
- 10% or more weight loss
研究概览
简要总结
This phase III trial compares telephone delivered Acceptance and Commitment Therapy to standard behavioral therapy for improving weight loss in overweight or obese participants. Acceptance and Commitment Therapy focuses on increasing willingness to experience physical cravings, emotions, and thoughts while making values-guided committed behavior changes. Acceptance and Commitment Therapy may work better at improving weight loss compared to standard behavioral therapy.
详细描述
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants receive ACT telephone coaching over the course of 12 months, calls 1-16 weekly, calls 17-23 biweekly, and calls 24-25 monthly. Call 1 is 30 minutes in duration, while calls 2-25 are each 15-20 minutes in duration.
ARM II: Participants receive SBT telephone coaching over the course of 12 months, calls 1-16 weekly, calls 17-23 biweekly, and calls 24-25 monthly. Call 1 is 30 minutes in duration, while calls 2-25 are each 15-20 minutes in duration.
Participants are followed up at 6, 12, and 24 months after randomization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Overweight or obese (body mass index [BMI] >= 27) but not heavier than BMI of 45.5 (measured by weight & height)
- •Wants to lose weight in the next 30 days
- •Interested in learning skills to lose weight
- •Willing to be randomly assigned to either condition
- •Resides in United States (US)
- •Has daily access to their own phone and email
- •Does not have a medical or psychiatric condition that would limit their ability to comply with the behavioral recommendations of the program or pose a risk to the participant during weight loss, including meeting criteria for binge eating disorder, and meeting criteria for severe depression (CESD >= 25), or a diagnosis of serious heart disease, diabetes, uncontrolled hypertension, or cancer without written confirmation of approval from their physician office
- •Not pregnant, planning to become pregnant or breastfeeding in the next 12 months
- •In the past 3 months changed the dosage of prescription medications that can cause a significant change in weight or appetite
- •Have not lost more than 5% of their weight in the past 6 months
- •Willing and able to read in English
- •Not participating in or planning to participate in other weight loss programs
- •Has not participated in our other ACT intervention studies
- •Does not meet criteria for combined heavy plus binge drinking
- •Has access to a Bluetooth-enabled device and Wi-Fi and/or data plan
- •Is not planning to have or has not recently had (past 12 months) bariatric surgery
- •For outcome data retention, eligibility criteria included: Willing to complete follow-up surveys, and provide email, phone, and mailing address
排除标准
- •The reverse of the inclusion criteria
结局指标
主要结局
10% or more weight loss
时间窗: At 12 months after randomization
Will be measured remotely by cellular-enabled scales. Will compare the two telephone interventions, using logistic regression.
次要结局
- Percent weight change(At 6, 12, and 24-months post randomization)
- Dietary intake(At 6, 12, and 24-months post randomization)
- Physical activity(At 6, 12, and 24-months post randomization)
- Trajectories of weight change(At 6, 12, and 24-months post randomization)