Behavioral Weight Loss Program for Cancer Survivors in Maryland
NCT ID: NCT04534309
Last Updated: 2023-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
340 participants
INTERVENTIONAL
2020-09-22
2023-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Behavioral Weight Loss for Cancer Survivors in Maryland: A Trial With Adaptive Interventions
NCT06463249
POWER-remote Weight Loss Program in Early Stage Breast Cancer
NCT01871116
Promoting Weight-Loss in African American Cancer Survivors in the Deep South
NCT03150381
A Study of Lifestyle Intervention in Overweight or Obese Women With Early Stage Breast Cancer
NCT02037542
Evaluating the Effectiveness of an Individualized Nutrition and Physical Activity Counseling Program
NCT04365569
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
1. Self-Directed Weight Loss: educational materials only;
2. App-Directed Weight Loss: educational materials, weight loss app with weekly e-mail support; and
3. Coach-Directed Weight Loss: educational materials, weight loss app, weekly e-mail support and one-to-one weekly telephonic coach support.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Self-Directed Weight Loss with year-long weight tracking
Written Weight Loss Material.
Written Weight Loss Material
Participants will receive written weight loss material by email.
App-Directed Weight Loss with year-long weight tracking
Smart phone Weight Loss App.
Weight Loss App
Participants will receive written weight loss material as well as instructions for using a free weight loss app on their phone or computer.
Coach-Directed Weight Loss with year-long weight tracking
Behavioral Lifestyle Weight Loss Intervention with Smart phone Weight Loss App.
Weight Loss App
Participants will receive written weight loss material as well as instructions for using a free weight loss app on their phone or computer.
Behavioral Lifestyle Weight Loss Intervention (Coaching)
Participants will receive weekly coaching phone calls to encourage regular dietary, exercise, and self-monitoring practices which encourage gradual, healthy weight loss.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Written Weight Loss Material
Participants will receive written weight loss material by email.
Weight Loss App
Participants will receive written weight loss material as well as instructions for using a free weight loss app on their phone or computer.
Behavioral Lifestyle Weight Loss Intervention (Coaching)
Participants will receive weekly coaching phone calls to encourage regular dietary, exercise, and self-monitoring practices which encourage gradual, healthy weight loss.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* completed all required surgical, and/or chemotherapy and/or radiation curative intent therapy at least three months prior to enrollment,
* anticipated treatment-free life span of 12 months or longer.
* chemoprophylaxis with tamoxifen or aromatase inhibitors for breast cancer in women will be permitted
* anti- Luteinizing-hormone releasing therapy for prostate cancer in men will be permitted.
* BMI ≥ 25 kg/m2 (BMI ≥ 23 kg/m2 for Asians) and weight ≤ 400 lbs.
* have an email address for regular personal use
Additional criteria for participants in weight tracking (self-directed or app directed)
* willingness to record/transmit quarterly weights for 12 months
Additional criteria for App-Directed Program:
* willingness to change diet and increase physical activity and track weight, diet and physical activity
* have a smart phone for personal use
* sufficient data plan/Internet to support daily use of weight loss app\*
Additional Criteria for Coach-Directed Weight Loss Program
* willingness to lose weight by changing diet and physical activity habits
* willingness to track weight, diet and physical activity
* willingness to record/transmit quarterly weights for 12 months
* smart phone for personal use
* data plan/Internet to support daily use of weight loss app\*
* willingness to complete coaching calls (12 weekly calls and 3 monthly calls)
* sufficient call plan to support coaching calls
* a corresponding website could be used, then daily Internet access is required for person use.
Exclusion Criteria
* 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 steroids or other medication known to affect body weight
* bariatric surgery scheduled within the next 6 months, or
* plan to move outside the continental US in the next 12 months
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Maryland Cigarette Restitution Fund
OTHER_GOV
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jessica Yeh, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Johns Hopkins ProHealth
Baltimore, Maryland, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Jerome GJ, Appel LJ, Bunyard L, Dalcin AT, Durkin N, Charleston JB, Kanarek NF, Carducci MA, Wang NY, Yeh HC. Behavioral Weight Loss Programs for Cancer Survivors Throughout Maryland: Protocol for a Pragmatic Trial and Participant Characteristics. JMIR Res Protoc. 2024 Jun 12;13:e54126. doi: 10.2196/54126.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRB00229163
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.