Behavioral Weight Loss Program for Cancer Survivors in Maryland
ASPIRE
Behavioral Weight Loss for Overweight and Obese Cancer Survivors in Maryland: A Demonstration Project
1 other identifier
interventional
340
1 country
1
Brief Summary
Behavioral Weight Loss for Overweight and Obese Cancer Survivors in Maryland: A Demonstration Project
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Sep 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2020
CompletedFirst Posted
Study publicly available on registry
September 1, 2020
CompletedStudy Start
First participant enrolled
September 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2023
CompletedOctober 10, 2023
October 1, 2023
2.2 years
August 26, 2020
October 9, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Weight change at 6 months in Coach-Directed Program
Evaluate the "effectiveness" of the Coach-Directed weight loss programs in a real world setting by examining weight change \[in kilograms (kg)\] at 6-months.
Baseline and 6 months
Secondary Outcomes (1)
Weight change at 6 months in Self-Directed and App-Directed Weight Loss Programs
Baseline and 6 months
Other Outcomes (4)
Program participation as assessed by participant enrollment
End of enrollment, up to 2 years
Adoption of weight loss program activities as assessed by app use frequency
6 months
Implementation of weight loss program as assessed by a participant survey
6 months
- +1 more other outcomes
Study Arms (3)
Self-Directed Weight Loss with year-long weight tracking
OTHERWritten Weight Loss Material.
App-Directed Weight Loss with year-long weight tracking
OTHERSmart phone Weight Loss App.
Coach-Directed Weight Loss with year-long weight tracking
OTHERBehavioral Lifestyle Weight Loss Intervention with Smart phone Weight Loss App.
Interventions
Participants will receive written weight loss material by email.
Participants will receive written weight loss material as well as instructions for using a free weight loss app on their phone or computer.
Participants will receive weekly coaching phone calls to encourage regular dietary, exercise, and self-monitoring practices which encourage gradual, healthy weight loss.
Eligibility Criteria
You may qualify if:
- previously diagnosed with a malignant solid tumor,
- 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
- +7 more criteria
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 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Johns Hopkins ProHealth
Baltimore, Maryland, 21207, United States
Related Publications (1)
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.
PMID: 38865181DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jessica Yeh, Ph.D.
Johns Hopkins University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2020
First Posted
September 1, 2020
Study Start
September 22, 2020
Primary Completion
December 15, 2022
Study Completion
June 30, 2023
Last Updated
October 10, 2023
Record last verified: 2023-10