Scaling up Behavioral Weight Loss Opportunities for Cancer Survivors With Overweight or Obesity in Maryland: A Randomized Trial With Adaptive Interventions (Helpline for Weight Loss)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Weight (pounds) changes at 8 months from 2-month between Enhanced Helpline and Intensive Helpline arms
研究概览
简要总结
The objective of the HELPLINE Weight Loss Program is to determine the comparative effectiveness of two active multi-component, augmented interventions for cancer survivors with overweight or obesity who do not achieve early weight loss goal in the initial intervention period (termed, early non-responders). The core study design is randomized controlled trial with adaptive intervention.
- CORE Helpline in all participants (first 2 months)
- Extended Helpline in early responders (additional 6 months)
- Enhanced Helpline in early non-responders (additional 6 months)
- Intensive Helpline in early non-responders (additional 6 months)
详细描述
All participants will receive
- written Johns Hopkins weight loss material
- instructions for using a smartphone weight loss app to keep track of food and exercise every day (either android or iPhone)
- a weekly weight loss tip by text message and email, and a text message on weight loss progress each week
- a research scale and specific instructions for verifying weights at 5 specific times over the next year.
The participants may also request two 20-minute phone calls during the first 2 months with a weight loss coach.
After the first 2 months, depending on weight loss progress, the participants will be assigned to another program which may include additional assistance for 6 more months.
Additional assistance may include scheduled phone calls with a Johns Hopkins weight loss coach each month, individualized emails from a Johns Hopkins weight loss coach, and the option for daily text message reminders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women and men ages 18 or older
- •Able to complete all study requirements in English
- •Have been previously diagnosed with a malignant solid tumor, completed the required surgical, and/or chemotherapy and/or radiation curative intent therapy at least three months prior to enrollment, and have an anticipated treatment-free life span of 12 months or longer. Chemoprophylaxis with tamoxifen or aromatase inhibitors for breast cancer in women and anti- luteinizing hormone-releasing hormone (LHRH) therapy for prostate cancer in men will be permitted.
- •Have a BMI ≥ 27 kg/m2 (BMI ≥ 25 kg/m2 for Asians) and weight ≤ 400 lbs.
- •Have an email address for regular personal use
- •Have a smartphone for personal use, and are willing to use the phone to read emails and text messages, and use an app
- •Have adequate data plan and cell service to support daily use of weight loss app, receive text messages and to support coaching calls
- •Are willing to record weekly weights
- •Are willing to use a tracking app to log food and exercise daily
- •Are willing to complete coaching calls as planned
- •Are willing to prioritize weight loss efforts by making dietary changes and increasing physical activity
排除标准
- •Received any chemotherapy (unless anti-hormonal therapy) and/or radiation three months or less prior to the proposed program date
- •Women who are breastfeeding, pregnant, or planning pregnancy within the next year
- •self-identification of uncontrolled concurrent medical condition likely to limit compliance with the program as determined by investigators.
- •current involvement in another organized weight loss program
- •current use of medications known to substantially affect body weight, including chronic oral steroids, Tirzepatide (Mounjaro™), and weight loss doses of other glucagon-like peptide 1 (GLP-1) agonists (e.g. Wegovy.)
- •bariatric surgery scheduled within the next 12 months
- •plan to move outside the continental United States in the next 12 months
- •Weight loss or gain of >5.0% of body weight during 2 months prior to screening
研究组 & 干预措施
CORE Helpline
All participants will receive the CORE Helpline program for 2 months
干预措施: CORE Helpline (Behavioral)
Intensive Helpline
Participants receive 2 scheduled coaching calls/month and individualized coach-scripted feedback via emails twice/month for 6 months.
干预措施: CORE Helpline (Behavioral)
Intensive Helpline
Participants receive 2 scheduled coaching calls/month and individualized coach-scripted feedback via emails twice/month for 6 months.
干预措施: Intensive Helpline (Behavioral)
Enhanced Helpline
Participants receive 1 participant-initiated call/month. Additionally, the participants receive individualized coach-scripted feedback via emails twice/month for 6 months
干预措施: CORE Helpline (Behavioral)
Enhanced Helpline
Participants receive 1 participant-initiated call/month. Additionally, the participants receive individualized coach-scripted feedback via emails twice/month for 6 months
干预措施: Enhanced Helpline (Behavioral)
Extended Helpline
Participants who achieved 2% weight loss at 2-month, will continue to Extended Helpline, where the participants can continue receiving 1-on-1 coaching through 1 participant-initiated calls per month for 6 months.
干预措施: CORE Helpline (Behavioral)
Extended Helpline
Participants who achieved 2% weight loss at 2-month, will continue to Extended Helpline, where the participants can continue receiving 1-on-1 coaching through 1 participant-initiated calls per month for 6 months.
干预措施: Extended Helpline (Behavioral)
结局指标
主要结局
Weight (pounds) changes at 8 months from 2-month between Enhanced Helpline and Intensive Helpline arms
时间窗: 8 months
Weight change for Enhanced Helpline and Intensive Helpline in early non-responders
次要结局
- Weight (pounds) change at 5 and 12 months from 2-month between Enhanced Helpline and Intensive Helpline arms(12 months)