NCT06463249Active, not recruiting
Behavioral Weight Loss for Cancer Survivors in Maryland: A Trial With Adaptive Interventions
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)
Source: ClinicalTrials.gov · Last updated 20 Jul 2026
Brief summary (registry, in English)
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)
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 12 Jun 2024
- Start date
- 17 Jun 2024
- Primary completion date
- Jul 2027
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Diseases
- Obesity
- NCT number
- NCT06463249
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 17 Jun 2024 to the primary completion date, Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Received any chemotherapy (unless anti-hormonal therapy) and/or radiation three months or less prior to the proposed program date
- self-identification of uncontrolled concurrent medical condition likely to limit compliance with the program as determined by investigators.
- 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
- Weight loss or gain of \>5.0% of body weight during 2 months prior to screening
Other
- Women who are breastfeeding, pregnant, or planning pregnancy within the next year
- current involvement in another organized weight loss program
- plan to move outside the continental United States in the next 12 months
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johns Hopkins ProHealth Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.