Actively Recruiting
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)
Led by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Updated on 2025-07-20
200
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
S
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead Sponsor
M
Maryland Cigarette Restitution Fund
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the comparative effectiveness of two multi-component, enhanced weight loss programs for cancer survivors with overweight or obesity who do not reach early weight loss goals during an initial intervention period. This randomized controlled trial with adaptive interventions aims to help survivors who have completed cancer treatment and have a body mass index (BMI) indicating overweight or obesity. The study is sponsored by the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins and focuses on improving weight management outcomes in this population. All participants begin with the CORE Helpline program for 2 months, which includes written weight loss materials, use of a smartphone app to track food and exercise daily, weekly text and email reminders, and an optional coaching call each month. After 2 months, participants who lose at least 2% of body weight continue with the Extended Helpline for an additional 6 months, involving ongoing coaching calls and support. Those who do not meet this goal are randomized to either the Enhanced Helpline, offering participant-initiated calls, twice-monthly individualized feedback emails, and optional daily text reminders, or the Intensive Helpline, which includes scheduled coaching calls twice a month along with similar email and text support. Participants will track their weight using a research scale at five specific times over one year and record their food and exercise daily via the app. The study team measures changes in weight at 8 months from the 2-month mark as the primary outcome, with additional weight measurements at 5 and 12 months. After 8 months of active support, participants continue the program on their own for 4 months and provide final weight data at 12 months. The study involves regular coaching calls, emails, and text messages to help participants stay engaged and monitor progress throughout the year.
CONDITIONS
Brief Title
Behavioral Weight Loss for Cancer Survivors in Maryland: A Trial With Adaptive Interventions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women and men ages 18 or older
- Able to complete all study requirements in English
- Previously diagnosed with a malignant solid tumor and completed curative treatments at least three months prior
- Anticipated treatment-free lifespan of 12 months or longer
- BMI 27 kg/m2 or higher (25 kg/m2 for Asians) and weight 400 lbs or less
- Have a personal email address and smartphone for daily app use, emails, and texts
- Willing to record weekly weights and log food and exercise daily
- Willing to complete coaching calls and prioritize weight loss efforts by diet and physical activity
You will not qualify if you...
- Received chemotherapy (except anti-hormonal therapy) or radiation within three months before starting the program
- Women who are breastfeeding, pregnant, or planning pregnancy within the next year
- Uncontrolled medical conditions that may limit program compliance
- Currently involved in another organized weight loss program
- Use of medications that significantly affect body weight, including chronic steroids, Tirzepatide, or high-dose GLP-1 agonists
- Scheduled bariatric surgery within the next 12 months
- Plans to move outside the continental United States within the next 12 months
- Weight loss or gain greater than 5% in the two months prior to screening
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) for eligibility assessment
Duration - 2 months
Participants receive the CORE Helpline program for 2 months, including written weight loss materials, daily use of a smartphone app to track food and exercise, weekly weight loss tips by text and email, and optional participant-initiated coaching calls.
Participants regularly track progress using the app and receive weekly messages; up to 2 optional coaching calls during the first 2 months
Duration - 6 months
After 2 months, participants are assigned based on weight loss progress: those with ≥2% weight loss continue with Extended Helpline featuring monthly participant-initiated coaching calls; those with less than 2% weight loss are randomized to Enhanced or Intensive Helpline, which include additional coaching calls, individualized emails, and optional daily text reminders for 6 months.
Monthly coaching calls (participant-initiated or scheduled depending on assignment), twice-monthly individualized emails for Enhanced and Intensive Helpline, optional daily text reminders
Duration - 4 months
Participants continue the program on their own for 4 months and provide final weight measurements 12 months after starting the program.
Participants provide weight data at specified times over the year using a research scale
Trial Site Locations
Total: 1 location
1
Johns Hopkins ProHealth
Baltimore, Maryland, United States, 21207
Actively Recruiting
Research Team
J
Jessica Yeh, PhD
L
Linda Bunyard, MS, RD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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