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

NCT06463249 | Recruiting

• 1 other identifier: IRB00403808
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 1.CORE Helpline in all participants (first 2 months)
2. 2.Extended Helpline in early responders (additional 6 months)
3. 3.Enhanced Helpline in early non-responders (additional 6 months)
4. 4.Intensive Helpline in early non-responders (additional 6 months)

Conditions

Weight Loss

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Weight (pounds) change at 5 and 12 months from 2-month between Enhanced Helpline and Intensive Helpline arms

  12 months

Other Outcomes (2)

• Weight (pounds) change from baseline to 2 months in all participants

  2 months

• Within-program weight (pounds) changes from baseline to 5, 8, and 12 months in all programs

  12 months

Study Arms (4)

Intensive Helpline

EXPERIMENTAL

Participants receive 2 scheduled coaching calls/month and individualized coach-scripted feedback via emails twice/month for 6 months.

Behavioral: CORE Helpline; Behavioral: Intensive Helpline

Enhanced Helpline

ACTIVE COMPARATOR

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; Behavioral: Enhanced Helpline

Extended Helpline

OTHER

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; Behavioral: Extended Helpline

CORE Helpline

OTHER

All participants will receive the CORE Helpline program for 2 months

Behavioral: CORE Helpline

Interventions

CORE Helpline BEHAVIORAL

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.

CORE Helpline; Enhanced Helpline; Extended Helpline; Intensive Helpline

Extended Helpline BEHAVIORAL

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.

Extended Helpline

Enhanced Helpline BEHAVIORAL

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.

Enhanced Helpline

Intensive Helpline BEHAVIORAL

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.

Intensive Helpline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• Maryland Cigarette Restitution Fund: collaborator

Study Sites (1)

Johns Hopkins ProHealth

Baltimore, Maryland, 21207, United States

RECRUITING

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jessica Yeh, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Yeh, PhD

CONTACT

410-614-4316; hyeh1@jhmi.edu

Linda Bunyard, MS, RD

CONTACT

410-281-6168; lbunyar1@jh.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will receive Core Helpline intervention in the first two months. If participants achieve 2% or more weight loss in two months (i.e. early responders), they will continue to the Extended Helpline. If participants do not achieve at least 2% of weight loss in two months (i.e. early non-responders), they will be randomized to one of two stepped-up interventions: Enhanced Helpline or Intensive Helpline.

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 17, 2024
• Study Start: June 17, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)