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)
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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)
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 parti…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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…
Interventions
- BehavioralCORE Helpline
All participants will receive the Core Helpline program (CORE) for 2 months, which includes written weight loss material, use of a smartphone app, weekly text messages and email reminders and 1 optional participant-initiated coaching call per month.
- BehavioralExtended Helpline
Those who achieved 2% weight loss at 2-month, will continue to Extended Helpline, where the participants can continue receiving all CORE resources including1-on-1 coaching through 1 optional participant-initiated call per month for 6 months.
- BehavioralEnhanced Helpline
Those who do not reach 2% weight loss at the end of 2 months will be randomized. Participants will continue to receive all CORE resources plus 1 optional participant-initiated call/month for 6 months. Additionally, the participants will receive 2 individualized coach-scripted feedback emails per month, and the option to receive daily text message reminders.
- BehavioralIntensive Helpline
Those who do not reach 2% weight loss at the end of 2 months will be randomized. Participants will continue to receive all CORE resources plus 2 scheduled coaching calls/month for 6 months. Additionally, the participants will receive 2 individual coach-scripted feedback emails per month, and the option to receive daily text message reminders.
Location
- Johns Hopkins ProHealthBaltimore, Maryland