Weight Loss Clinical Trial
— HelplineOfficial title:
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)
NCT number | NCT06463249 |
Other study ID # | IRB00403808 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2024 |
Est. completion date | December 2027 |
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 | Recruiting |
Enrollment | 200 |
Est. completion date | December 2027 |
Est. primary completion date | December 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 (Mounjaroâ„¢), 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 |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins ProHealth | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Maryland Cigarette Restitution Fund |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Weight (pounds) change from baseline to 2 months in all participants | Weight change for CORE Helpline over the first 2 months in all participants | 2 months | |
Other | Within-program weight (pounds) changes from baseline to 5, 8, and 12 months in all programs | Weight change for each program over 12 months | 12 months | |
Primary | Weight (pounds) changes at 8 months from 2-month between Enhanced Helpline and Intensive Helpline arms | Weight change for Enhanced Helpline and Intensive Helpline in early non-responders | 8 months | |
Secondary | Weight (pounds) change at 5 and 12 months from 2-month between Enhanced Helpline and Intensive Helpline arms | Weight change for Enhanced Helpline and Intensive Helpline in early non-responders | 12 months |
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