Behavioral Weight Loss

Sponsor:

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Code:

NCT06463249

Conditions

Weight Loss

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CORE Helpline

Extended Helpline

Enhanced Helpline

Intensive Helpline

Study Details

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. 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)

Conditions

Weight Loss

Study ID

NCT06463249

Start date

Jun 17, 2024

Status verified date

Jul, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

Interventions

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.

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.

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.

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.

Primary outcome measure

  • Weight (pounds) changes at 8 months from 2-month between Enhanced Helpline and Intensive Helpline arms [ Time Frame: 8 months ]

Central Contacts and Locations

More Information

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Last update posted

Jul 20, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-04. This information was provided to ClinicalTrials.gov by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins on 2026-07-20.