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Clinical Trial 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)


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06463249
Study type Interventional
Source Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Contact Jessica Yeh, PhD
Phone 410-614-4316
Email hyeh1@jhmi.edu
Status Recruiting
Phase N/A
Start date June 2024
Completion date December 2027

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