behavioral weight loss for cancer survivors in maryland: a trial with adaptive interventions

Conditions: Weight Loss

Summary: 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)

all participants will receive * written johns hopkins weight loss material * instructions for using a smartphone weight loss app to keep track of food and exercise every day (either android or iphone) * a weekly weight loss tip by text message and email, and a text message on weight loss progress each week * a research scale and specific instructions for verifying weights at 5 specific times over the next year. the participants may also request two 20-minute phone calls during the first 2 months with a weight loss coach. after the first 2 months, depending on weight loss progress, the participants will be assigned to another program which may include additional assistance for 6 more months. additional assistance may include scheduled phone calls with a johns hopkins weight loss coach each month, individualized emails from a johns hopkins weight loss coach, and the option for daily text message reminders. after the first 8 months of assistance, the participants will continue the program on the participant's own for 4 more months and provide the study team with final weights 12 months after the start of the program.

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