Actively Recruiting
Behavioral Weight Loss for Cancer Survivors in Maryland: A Trial With Adaptive Interventions
Led by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Updated on 2025-07-20
200
Participants Needed
1
Research Sites
180 weeks
Total Duration
On this page
Sponsors
S
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead Sponsor
M
Maryland Cigarette Restitution Fund
Collaborating Sponsor
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Behavioral Weight Loss for Cancer Survivors in Maryland: A Trial With Adaptive Interventions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women and men ages 18 or older
- Able to complete all study requirements in English
- Previously diagnosed with a malignant solid tumor
- Completed curative intent therapy (surgery, chemotherapy, radiation) at least 3 months before enrollment
- 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 therapy for prostate cancer in men allowed
- Body mass index (BMI) 27 kg/m2 or higher (BMI 25 kg/m2 or higher for Asians)
- Weight 400 pounds or less
- Have an email address for regular personal use
- Have a smartphone for personal use and willing to use it to read emails, texts, and use an app
- Have adequate data plan and cell service to support daily use of the weight loss app, receive texts, and coaching calls
- Willing to record weekly weights
- Willing to use a tracking app to log food and exercise daily
- Willing to complete coaching calls as planned
- Willing to prioritize weight loss by making dietary changes and increasing physical activity
You will not qualify if you...
- Received chemotherapy (except anti-hormonal therapy) and/or radiation within 3 months prior to program start
- Women who are breastfeeding, pregnant, or planning pregnancy within the next year
- Uncontrolled medical conditions likely to limit program compliance
- Currently involved in another organized weight loss program
- Current use of medications known to affect body weight substantially, including chronic oral steroids, Tirzepatide (Mounjaro), or weight loss doses of other GLP-1 agonists (e.g., Wegovy)
- Scheduled for bariatric surgery within the next 12 months
- Planning to move outside the continental United States within the next 12 months
- Weight loss or gain greater than 5% of body weight during the 2 months prior to screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Johns Hopkins ProHealth
Baltimore, Maryland, United States, 21207
Actively Recruiting
Research Team
J
Jessica Yeh, PhD
CONTACT
L
Linda Bunyard, MS, RD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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