Lifestyle Change for Better Health
Not Applicable
Terminated
- Conditions
- Bladder CancerTelomere ShorteningColorectal Adenoma
- Interventions
- Behavioral: Dietary InterventionBehavioral: Physical Activity Intervention
- Registration Number
- NCT03286699
- Lead Sponsor
- University of Pittsburgh
- Brief Summary
The goal of the research is to provide a first critical test of the novel scientific idea that a combined diet and exercise intervention may ameliorate shortening of leukocyte telomere length (LTL) in individuals with histories of successfully treated non-metastatic bladder cancer (BC) or colorectal adenoma (CRA) compared to a diet only intervention.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 8
Inclusion Criteria
- BMI between 25.0 to <40 kg/m2 (allows for use of assessments such as DXA to be included)
- History of histologically confirmed bladder cancer (non-metastatic) or colorectal adenoma
- Under clinical surveillance with no evidence of disease
Exclusion Criteria
- WHO performance status 3-4 or deemed physically unable to participate by physician
- Currently pregnant or breastfeeding, were pregnant in the previous 6 months or breastfeeding in the previous 3 months, or planning pregnancy in the next year
- History of bariatric surgery
- Medical condition that could affect body weight (e.g., diabetes mellitus, hyperthyroidism, uncontrolled hypothyroidism, chronic renal insufficiency, chronic liver disease, gastrointestinal disorders including ulcerative colitis)
- Cancer diagnosis (other than bladder cancer or non-melanoma skin cancer) in the previous 5 years
- Current congestive heart failure, signs or symptoms indicative of an increased acute risk for a cardiovascular event
- History of myocardial infarction, coronary artery bypass or angioplasty, conditions requiring chronic anticoagulation (recent or recurrent DVT)
- Resting systolic blood pressure of >160 mmHg or diastolic blood pressure >100 mmHg
- Eating disorder that would contraindicate weight loss or physical activity
- Alcohol or substance abuse
- Current treatment for psychiatric issues (e.g., depression, bipolar disorder) or taking daily or extended release psychotropic medications in the previous 12 months
- Report exercising more than 100 minutes per week over the past 3 months (NOTE: includes physical activity performed for sport, fitness, or recreational activity; physical activity performed as part of occupation or household chores is not included)
- Weight loss of greater than 5% or participating in a weight reduction diet in the past 3 months
- Report plans to relocate to a location not accessible to the study site or having employment, personal, or travel commitments that prohibit attendance to at least 80 percent of the scheduled intervention sessions and all of the scheduled assessments
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DIET Dietary Intervention This group will be prescribed a Dietary Intervention that reduces energy intake by 500-1000 kcal/day and induces a weight loss of approximately 1-2 pounds per week during the intervention, with the weight loss goal individualized to each participant. DIET-PA Dietary Intervention This group will be prescribed a Dietary Intervention that reduces energy intake by 500-1000 kcal/day and induces a weight loss of approximately 1-2 pounds per week during the intervention, with the weight loss goal individualized to each participant. In addition, this group will be prescribed moderate-intensity Physical Activity Intervention that will progressively increase to the goal of 250 minutes/week. DIET-PA Physical Activity Intervention This group will be prescribed a Dietary Intervention that reduces energy intake by 500-1000 kcal/day and induces a weight loss of approximately 1-2 pounds per week during the intervention, with the weight loss goal individualized to each participant. In addition, this group will be prescribed moderate-intensity Physical Activity Intervention that will progressively increase to the goal of 250 minutes/week.
- Primary Outcome Measures
Name Time Method Leukocyte telomere length (LTL) at the 6 month assessment (controlling for appropriate covariates) Blood samples will be collected as part of the 6 month assessment LTL will be measured in blood samples from participants
- Secondary Outcome Measures
Name Time Method Telomerase level at 3 months (controlling for appropriate covariates) Blood samples will be collected as part of the 3 month assessment Telomerase will be measured in blood samples from participants
Telomerase level at 6 months (controlling for appropriate covariates) Blood samples will be collected as part of the 6 month assessment Telomerase will be measured in blood samples from participants
Telomerase level at 12 months (controlling for appropriate covariates) Blood samples will be collected as part of the 12 month assessment (as feasible) Telomerase will be measured in blood samples from participants
8-OHdG level at 3 months (controlling for appropriate covariates) Samples will be collected as part of the 3 month assessment 8-OHdG will be measured in samples from participants
8-OHdG level at 6 months (controlling for appropriate covariates) Samples will be collected as part of the 6 month assessment 8-OHdG will be measured in samples from participants
Leukocyte telomere length (LTL) at the 3 month assessment (controlling for appropriate covariates) Blood samples will be collected as part of the 3 month assessment LTL will be measured in blood samples from participants
Leukocyte telomere length (LTL) at the 12 month assessment (controlling for appropriate covariates) Blood samples will be collected as part of the 12 month assessment (as feasible) LTL will be measured in blood samples from participants
Superoxide dismutase 1 (SOD1) at 3 months (controlling for appropriate covariates) Samples will be collected as part of the 3 month assessment SOD1 will be measured in samples from participants
Superoxide dismutase 1 (SOD1) at 6 months (controlling for appropriate covariates) Samples will be collected as part of the 6 month assessment SOD1 will be measured in samples from participants
Superoxide dismutase 2 (SOD2) at 3 months (controlling for appropriate covariates) Samples will be collected as part of the 3 month assessment SOD2 will be measured in samples from participants
Glutathione peroxidase (Gpx) at 3 months (controlling for appropriate covariates) Samples will be collected as part of the 3 month assessment Gpx will be measured in samples from participants
Superoxide dismutase 2 (SOD2) at 6 months (controlling for appropriate covariates) Samples will be collected as part of the 6 month assessment SOD2 will be measured in samples from participants
Glutathione peroxidase (Gpx) at 6 months (controlling for appropriate covariates) Samples will be collected as part of the 6 month assessment Gpx will be measured in samples from participants
Systemic Inflammatory Response (SIR) at 3 months (controlling for appropriate covariates) Samples will be collected as part of the 3 month assessment SIR will be measured in samples from participants
Systemic Inflammatory Response (SIR) at 6 months (controlling for appropriate covariates) Samples will be collected as part of the 6 month assessment SIR will be measured in samples from participants
Trial Locations
- Locations (1)
UPMC Shadyside
🇺🇸Pittsburgh, Pennsylvania, United States