Obesity Clinical Trial
Official title:
REWARD (Revving-Up Exercise for Sustained Weight Loss by Altering Neurological Reward and Drive): A Randomized Trial of Assisted Exercise in Obese Endometrial Cancer Patients
Verified date | January 2020 |
Source | Case Comprehensive Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is an assisted exercise trial involving exercise on a stationary bike, brain imaging and DNA(genetics)sampling. The purpose of this study is to find out if performing a progressive, supervised assisted exercise program on a stationary bike improves quality of life, increases motivation to continue to exercise, improves dietary behavior and leads to sustained weight loss in women who have had early-stage endometrial cancer. Questionnaires will be used to assess exercise motivation and dietary behavior. Brain's responses to different visual images will also be assessed.
Status | Completed |
Enrollment | 95 |
Est. completion date | September 4, 2019 |
Est. primary completion date | September 4, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Histologically confirmed Stage I endometrial adenocarcinoma (EC), grade 1 or 2, with no adjuvant chemotherapy. Patients will be eligible to enroll as soon as 3 months after completion of treatment but no later than 4 years after completion of treatment. - BMI = 30.0 (obese) - Approved to be contacted by the patient's treating gynecologic oncologist - Meets screening criteria including successful completion of a cardiopulmonary stress test - Receives medical clearance from the patient's primary care physician (PCP) or gynecologic oncologist to exercise in this study Exclusion Criteria: - Individuals unable to read and provide informed consent. - Women currently participating in a structured weight loss or exercise program in the past 6 months or any woman who has previously had bariatric surgery or is planning to undergo bariatric surgery in the next 12 months - Participants who do not consent to be in the study or who will be unavailable for follow-up assessments, - Pre-existing medical conditions that would be a barrier for participation in supervised exercise |
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland | Ohio |
United States | The Cleveland Clinic Foundation | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
Case Comprehensive Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Weight change from pre- to post-intervention | 24 weeks after exercise intervention (EOT) | ||
Secondary | Change in Body Composition from baseline | Body fat, lean mass and bone mass will be measured with a Lunar iDXA™ (GE Healthcare, Madison, WI. BMI will be computed (weight in kg divided by square of height in meters) and categorized as: < 18.5 (underweight), 18.5 to 24.9 (normal weight), 25.0 to 29.9 (overweight) | at 4 weeks after exercise intervention(EOT) | |
Secondary | Change in Motivation to Exercise from baseline | Evaluate motivation to exercise using the Exercise Motivations Inventory (EMI-2) 122 and the Intrinsic Motivational Inventory (IMI) modified for exercise. Past physical activity habits will be assessed with the Godin Leisure-Time Exercise (LSI) questionnaire. | 24 weeks after exercise intervention (EOT) | |
Secondary | Change in Eating Behavior from baseline | Eating behavior will be assessed using the Three-Factor Eating Questionnaire (TFEQ). The TFEQ includes 51 items and addresses three dimensions of human eating behavior; restraint, disinhibition, and perceived hunger. | 24 weeks after exercise intervention (EOT) | |
Secondary | Change in Quality of Life (QoL)from baseline | The Functional Assessment of Cancer Therapy - General (FACT-G) is a 27-item core questionnaire evaluating various domains of QoL including, physical, functional, family-social, and emotional well-being. The FACT-En is a 16-item subscale specific for endometrial cancer (EC) and assesses hormone withdrawal, pelvic symptoms, and possible adjuvant therapy side effects. Short-form Medical Outcomes (SF-36) consists of 36 questions scored on a Likert scale, producing overall physical and mental component summary measures. | 24 weeks after exercise intervention (EOT) | |
Secondary | Change in Depression from baseline | The Beck Depression Inventory (BDI) is a 21-item, Likert-scaled instrument of depressive symptoms that is well-validated and frequently used in lifestyle research studies. Each item is rated on a 4- point scale ranging from 0 to 3 (higher scores are associated with greater symptoms). | 24 weeks after exercise intervention (EOT) | |
Secondary | Exercise Session Adherence | Barriers to adhering to the exercise protocol will be assessed prospectively using an elicitation procedure similar to that suggested in the theory of planned behavior, whereby an open-ended question is asked to solicit the barrier without any preconceived notion of what the barrier might be. Specifically, participants in the exercise groups will be asked to book their weekly supervised exercise sessions with the Exercise Specialist/Physiologist. Participants cancelling an exercise session or requesting to be removed from the study will be asked why they are no longer interested in completed the program. | 24 weeks after exercise intervention (EOT) |
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