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)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Weight Loss
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Weight (pounds) changes at 8 months from 2-month between Enhanced Helpline and Intensive Helpline arms
- Status
- Recruiting
- Last Updated
- 9 months ago
Overview
Brief 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.
- CORE Helpline in all participants (first 2 months)
- Extended Helpline in early responders (additional 6 months)
- Enhanced Helpline in early non-responders (additional 6 months)
- Intensive Helpline in early non-responders (additional 6 months)
Detailed Description
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.
Investigators
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
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
Outcomes
Primary Outcomes
Weight (pounds) changes at 8 months from 2-month between Enhanced Helpline and Intensive Helpline arms
Time Frame: 8 months
Weight change for Enhanced Helpline and Intensive Helpline in early non-responders
Secondary Outcomes
- Weight (pounds) change at 5 and 12 months from 2-month between Enhanced Helpline and Intensive Helpline arms(12 months)