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)

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Maryland
Johns Hopkins ProHealth
RECRUITING
Baltimore
Contact Information
Primary
Jessica Yeh, PhD
hyeh1@jhmi.edu
410-614-4316
Backup
Linda Bunyard, MS, RD
lbunyar1@jh.edu
410-281-6168
Time Frame
Start Date: 2024-06-17
Estimated Completion Date: 2027-12
Participants
Target number of participants: 200
Treatments
Experimental: Intensive Helpline
Participants receive 2 scheduled coaching calls/month and individualized coach-scripted feedback via emails twice/month for 6 months.
Active_comparator: Enhanced Helpline
Participants receive 1 participant-initiated call/month. Additionally, the participants receive individualized coach-scripted feedback via emails twice/month for 6 months
Other: Extended Helpline
Participants who achieved 2% weight loss at 2-month, will continue to Extended Helpline, where the participants can continue receiving 1-on-1 coaching through 1 participant-initiated calls per month for 6 months.
Other: CORE Helpline
All participants will receive the CORE Helpline program for 2 months
Related Therapeutic Areas
Sponsors
Collaborators: Maryland Cigarette Restitution Fund
Leads: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

This content was sourced from clinicaltrials.gov