Behavioral Weight Loss Program for Cancer Survivors in Maryland (ASPIRE)
Status
Conditions
Treatments
Details and patient eligibility
About
Behavioral Weight Loss for Overweight and Obese Cancer Survivors in Maryland: A Demonstration Project
Full description
The objective of the ASPIRE Project is to design, implement, and evaluate a real-world, lifestyle-based, support for overweight or obese cancer survivors in both urban and rural areas of Maryland. The project will provide three options of support to encourage lifestyle change to achieve and maintain a healthy weight for cancer survivors:
- Self-Directed Weight Loss: educational materials only;
- App-Directed Weight Loss: educational materials, weight loss app with weekly e-mail support; and
- Coach-Directed Weight Loss: educational materials, weight loss app, weekly e-mail support and one-to-one weekly telephonic coach support.
Enrollment
Sex
Ages
Volunteers
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
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willingness to lose weight by changing diet and physical activity habits
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willingness to track weight, diet and physical activity
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willingness to record/transmit quarterly weights for 12 months
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smart phone for personal use
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data plan/Internet to support daily use of weight loss app*
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willingness to complete coaching calls (12 weekly calls and 3 monthly calls)
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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
Trial design
Primary purpose
Allocation
Interventional model
Masking
340 participants in 3 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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