Behavioral Weight Loss for Cancer Survivors in Maryland: A Trial With Adaptive Interventions
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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)
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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
Where it's recruiting
Baltimore
Source: ClinicalTrials.gov · NCT06463249 · last updated 2025-07-20