Behavioral Weight Loss Program for Cancer Survivors in Maryland

Study Overview
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Brief Summary
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Behavioral Weight Loss for Overweight and Obese Cancer Survivors in Maryland: A Demonstration Project

Detailed Description
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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.

Official Title
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Behavioral Weight Loss for Overweight and Obese Cancer Survivors in Maryland: A Demonstration Project

Conditions
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Breast Cancer, Prostate Cancer, Melanoma (Skin), Endometrial Cancer, Gallbladder Cancer, Rectal Cancer, Kidney Cancer, Bladder Cancer

Intervention / Treatment
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* Behavioral: Written Weight Loss Material
* Behavioral: Weight Loss App
* Behavioral: Behavioral Lifestyle Weight Loss Intervention (Coaching)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Self-Directed Weight Loss with year-long weight tracking<br>Written Weight Loss Material. | Behavioral: Written Weight Loss Material<br>* Participants will receive written weight loss material by email.<br>|
| Other: App-Directed Weight Loss with year-long weight tracking<br>Smart phone Weight Loss App. | Behavioral: Weight Loss App<br>* Participants will receive written weight loss material as well as instructions for using a free weight loss app on their phone or computer.<br>|
| Other: Coach-Directed Weight Loss with year-long weight tracking<br>Behavioral Lifestyle Weight Loss Intervention with Smart phone Weight Loss App. | Behavioral: Weight Loss App<br>* Participants will receive written weight loss material as well as instructions for using a free weight loss app on their phone or computer.<br>Behavioral: Behavioral Lifestyle Weight Loss Intervention (Coaching)<br>* Participants will receive weekly coaching phone calls to encourage regular dietary, exercise, and self-monitoring practices which encourage gradual, healthy weight loss.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |