RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Official Title

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)

Quick Facts

Study Start:2024-06-17

Study Completion:2027-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06463249

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Jessica Yeh, PhD

CONTACT

410-614-4316

hyeh1@jhmi.edu

Linda Bunyard, MS, RD

CONTACT

410-281-6168

lbunyar1@jh.edu

Principal Investigator

Jessica Yeh, PhD

PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Study Locations (Sites)

Johns Hopkins ProHealth

Baltimore, Maryland, 21207

United States

Collaborators and Investigators

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Jessica Yeh, PhD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-17

Study Completion Date2027-12

Study Record Updates

Study Start Date2024-06-17

Study Completion Date2027-12

Terms related to this study

Additional Relevant MeSH Terms

Weight Loss