Weight loss program for cancer survivors in Maryland
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)
This study is testing a weight loss program for cancer survivors in Maryland who are struggling to lose weight, to see if extra support and coaching can help them reach their goals.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT06463249 on ClinicalTrials.gov |
What this trial studies
This program aims to evaluate the effectiveness of two different multi-component interventions designed for cancer survivors who are overweight or obese and do not meet initial weight loss goals. Participants will receive a core weight loss program for the first two months, followed by tailored interventions based on their progress, which may include additional coaching and support. The study employs a randomized controlled design with adaptive interventions to optimize weight loss strategies for individuals who need more assistance. Participants will utilize a smartphone app to track their food and exercise, receive weekly tips, and have the option for phone consultations with weight loss coaches.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older who have a history of malignant solid tumors and a BMI of 27 or higher.
Not a fit: Patients who are not cancer survivors or those with a BMI below the eligibility threshold may not benefit from this program.
Why it matters
Potential benefit: If successful, this program could significantly improve weight management and overall health outcomes for cancer survivors struggling with obesity.
How similar studies have performed: Other studies have shown promising results with similar adaptive intervention approaches for weight loss in cancer survivors.
Eligibility criteria
Show full inclusion / exclusion criteria
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 ≥ 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 Exclusion Criteria: * 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 this trial is running
Baltimore, Maryland
- Johns Hopkins ProHealth — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Jessica Yeh, PhD — Johns Hopkins University
- Study coordinator: Jessica Yeh, PhD
- Email: hyeh1@jhmi.edu
- Phone: 410-614-4316
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.