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Behavioral Weight Loss for Cancer Survivors in Maryland: A Trial With Adaptive Interventions

Active Not RecruitingNA

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Conditions: Weight Loss

Interventions: CORE Helpline, Extended Helpline, Enhanced Helpline, Intensive Helpline

Countries: United States

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)

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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

Locations (1)

Baltimore, Maryland, United States