Behavioral Weight Loss for Cancer Survivors in Maryland: A Trial With Adaptive Interventions
- Conditions
- Weight Loss
- Interventions
- Behavioral: CORE HelplineBehavioral: Extended HelplineBehavioral: Enhanced HelplineBehavioral: Intensive Helpline
- Registration Number
- NCT06463249
- Brief Summary
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.
1. CORE Helpline in all participants (first 2 months)
2. Extended Helpline in early responders (additional 6 months)
3. Enhanced Helpline in early non-responders (additional 6 months)
4. Intensive Helpline in early non-responders (additional 6 months)
- Detailed Description
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.
After the first 8 months of assistance, the participants will continue the program on the participant's own for 4 more months and provide the study team with final weights 12 months after the start of the program.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Extended Helpline 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. Intensive Helpline CORE Helpline Participants receive 2 scheduled coaching calls/month and individualized coach-scripted feedback via emails twice/month for 6 months. Enhanced Helpline CORE Helpline Participants receive 1 participant-initiated call/month. Additionally, the participants receive individualized coach-scripted feedback via emails twice/month for 6 months Enhanced Helpline Enhanced Helpline Participants receive 1 participant-initiated call/month. Additionally, the participants receive individualized coach-scripted feedback via emails twice/month for 6 months Extended Helpline CORE 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. Intensive Helpline Intensive Helpline Participants receive 2 scheduled coaching calls/month and individualized coach-scripted feedback via emails twice/month for 6 months. CORE Helpline CORE Helpline All participants will receive the CORE Helpline program for 2 months
- Primary Outcome Measures
Name Time Method Weight (pounds) changes at 8 months from 2-month between Enhanced Helpline and Intensive Helpline arms 8 months Weight change for Enhanced Helpline and Intensive Helpline in early non-responders
- Secondary Outcome Measures
Name Time Method Weight (pounds) change at 5 and 12 months from 2-month between Enhanced Helpline and Intensive Helpline arms 12 months Weight change for Enhanced Helpline and Intensive Helpline in early non-responders
Trial Locations
- Locations (1)
Johns Hopkins ProHealth
🇺🇸Baltimore, Maryland, United States