Breast Cancer Clinical Trial
— ASPIREOfficial title:
Behavioral Weight Loss for Overweight and Obese Cancer Survivors in Maryland: A Demonstration Project
Verified date | October 2023 |
Source | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Behavioral Weight Loss for Overweight and Obese Cancer Survivors in Maryland: A Demonstration Project
Status | Completed |
Enrollment | 340 |
Est. completion date | June 30, 2023 |
Est. primary completion date | December 15, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 - 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: - 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 Additional exclusion criteria for participants in weight tracking and/or Coach-Directed Program - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins ProHealth | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Maryland Cigarette Restitution Fund |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Program participation as assessed by participant enrollment | Examine the enrollment in each program as a measure of program participation. | End of enrollment, up to 2 years | |
Other | Adoption of weight loss program activities as assessed by app use frequency | Evaluate the "adoption" of the App-Directed Weight Loss Program and Coach-Directed Weight Loss Program by examining app-use frequency at six months. | 6 months | |
Other | Implementation of weight loss program as assessed by a participant survey | Evaluate the implementation of the Coach-Directed Weight Loss Program through a participant survey. | 6 months | |
Other | Weight change at 12 months by program | Evaluate the "maintenance" of the Self-Directed, App-Directed and Coach-Directed weight loss programs in a real world setting by examining weight change [in kilograms (kg)] at 12-months by program. | Baseline and 12 months | |
Primary | 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 | Weight change at 6 months in Self-Directed and App-Directed Weight Loss Programs | Evaluate the "effectiveness" of the Self-Directed and App-Directed weight loss programs in a real world setting by examining weight change [in kilograms (kg)] at 6-months. | Baseline and 6 months |
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