Behavioral Weight Loss for Cancer Survivors in Maryland: A Trial With Adaptive Interventions (Helpline)

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)

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)

Study Overview

• Status: Recruiting
• Conditions: Weight Loss
• Intervention / Treatment: Behavioral: CORE Helpline; Behavioral: Intensive Helpline; Behavioral: Enhanced Helpline; Behavioral: Extended Helpline

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jessica Yeh, PhD; Phone Number: 410-614-4316; Email: hyeh1@jhmi.edu
• Study Contact Backup: Name: Linda Bunyard, MS, RD; Phone Number: 410-281-6168; Email: lbunyar1@jh.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21207
      • Recruiting
      • Johns Hopkins ProHealth
      • Contact: Linda Bunyard, MS, RD; Phone Number: 410-281-6168; Email: lbunyar1@jh.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 (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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intensive Helpline; Participants receive 2 scheduled coaching calls/month and individualized coach-scripted feedback via emails twice/month for 6 months.	Behavioral: CORE Helpline; All participants will receive the Core Helpline program (CORE) for 2 months, which includes written weight loss material, use of a smartphone app, weekly text messages and email reminders and 1 optional participant-initiated coaching call per month.; Behavioral: Intensive Helpline; Those who do not reach 2% weight loss at the end of 2 months will be randomized. Participants will continue to receive all CORE resources plus 2 scheduled coaching calls/month for 6 months. Additionally, the participants will receive 2 individual coach-scripted feedback emails per month, and the option to receive daily text message reminders.
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	Behavioral: CORE Helpline; All participants will receive the Core Helpline program (CORE) for 2 months, which includes written weight loss material, use of a smartphone app, weekly text messages and email reminders and 1 optional participant-initiated coaching call per month.; Behavioral: Enhanced Helpline; Those who do not reach 2% weight loss at the end of 2 months will be randomized. Participants will continue to receive all CORE resources plus 1 optional participant-initiated call/month for 6 months. Additionally, the participants will receive 2 individualized coach-scripted feedback emails per month, and the option to receive daily text message reminders.
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.	Behavioral: CORE Helpline; All participants will receive the Core Helpline program (CORE) for 2 months, which includes written weight loss material, use of a smartphone app, weekly text messages and email reminders and 1 optional participant-initiated coaching call per month.; Behavioral: Extended Helpline; Those who achieved 2% weight loss at 2-month, will continue to Extended Helpline, where the participants can continue receiving all CORE resources including1-on-1 coaching through 1 optional participant-initiated call per month for 6 months.
Other: CORE Helpline; All participants will receive the CORE Helpline program for 2 months	Behavioral: CORE Helpline; All participants will receive the Core Helpline program (CORE) for 2 months, which includes written weight loss material, use of a smartphone app, weekly text messages and email reminders and 1 optional participant-initiated coaching call per month.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborators: Maryland Cigarette Restitution Fund
• Investigators: Principal Investigator: Jessica Yeh, PhD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: June 12, 2024
• First Submitted That Met QC Criteria: June 12, 2024
• First Posted (Actual): June 17, 2024

Study Record Updates

• Last Update Posted (Actual): July 20, 2025
• Last Update Submitted That Met QC Criteria: July 16, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight Changes; Weight Loss; Body Weight
• Other Study ID Numbers: IRB00403808

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No