Lifestyle Change for Better Health

Study Overview
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Brief Summary
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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.

Official Title
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Leukocyte Telomere Length: Diet and Exercise Trial

Conditions
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Bladder Cancer, Telomere Shortening, Colorectal Adenoma

Intervention / Treatment
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* Behavioral: Dietary Intervention
* Behavioral: Physical Activity Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 84 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DIET<br>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. | Behavioral: Dietary Intervention<br>* The behavioral weight loss intervention strategies will not be limited to, self-monitoring, goal setting, problem solving, mastery skills, social support, and relapse prevention. Participants will receive a standard behavioral weight control program, delivered on a one-on-one basis. They will attend in-person sessions ( 30-45 minutes) with time to: distribute intervention materials, interact with the participant, identify participants that need additional support, and conduct the intervention. Each in-person visit focuses on a specific behavioral topic related to weight loss to address eating behaviors. Subjects will also participate in phone calls with the interventionist ( 10 minutes). Depending on the week, subjects will have between 10 and 45 minutes of total intervention contact.<br>|
| Active Comparator: DIET-PA<br>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. | Behavioral: Dietary Intervention<br>* The behavioral weight loss intervention strategies will not be limited to, self-monitoring, goal setting, problem solving, mastery skills, social support, and relapse prevention. Participants will receive a standard behavioral weight control program, delivered on a one-on-one basis. They will attend in-person sessions ( 30-45 minutes) with time to: distribute intervention materials, interact with the participant, identify participants that need additional support, and conduct the intervention. Each in-person visit focuses on a specific behavioral topic related to weight loss to address eating behaviors. Subjects will also participate in phone calls with the interventionist ( 10 minutes). Depending on the week, subjects will have between 10 and 45 minutes of total intervention contact.<br>Behavioral: Physical Activity Intervention<br>* The behavioral weight loss intervention strategies will not be limited to, self-monitoring, goal setting, problem solving, mastery skills, social support, and relapse prevention. Participants will receive a standard behavioral weight control program, delivered on a one-on-one basis. They will attend in-person sessions ( 30-45 minutes) with time to: distribute intervention materials, interact with the participant, identify participants that need additional support, and conduct the intervention. Each in-person visit focuses on a specific behavioral topic related to weight loss to address physical activity behaviors. Subjects will also participate in phone calls with the interventionist ( 10 minutes). Depending on the week, subjects will have 10 to 45 minutes of total intervention contact.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leukocyte telomere length (LTL) at the 6 month assessment (controlling for appropriate covariates) | LTL will be measured in blood samples from participants | Blood samples will be collected as part of the 6 month assessment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leukocyte telomere length (LTL) at the 3 month assessment (controlling for appropriate covariates) | LTL will be measured in blood samples from participants | Blood samples will be collected as part of the 3 month assessment | 
| Leukocyte telomere length (LTL) at the 12 month assessment (controlling for appropriate covariates) | LTL will be measured in blood samples from participants | Blood samples will be collected as part of the 12 month assessment (as feasible) | 
| Telomerase level at 3 months (controlling for appropriate covariates) | Telomerase will be measured in blood samples from participants | Blood samples will be collected as part of the 3 month assessment | 
| Telomerase level at 6 months (controlling for appropriate covariates) | Telomerase will be measured in blood samples from participants | Blood samples will be collected as part of the 6 month assessment | 
| Telomerase level at 12 months (controlling for appropriate covariates) | Telomerase will be measured in blood samples from participants | Blood samples will be collected as part of the 12 month assessment (as feasible) | 
| 8-OHdG level at 3 months (controlling for appropriate covariates) | 8-OHdG will be measured in samples from participants | Samples will be collected as part of the 3 month assessment | 
| 8-OHdG level at 6 months (controlling for appropriate covariates) | 8-OHdG will be measured in samples from participants | Samples will be collected as part of the 6 month assessment | 
| Superoxide dismutase 1 (SOD1) at 3 months (controlling for appropriate covariates) | SOD1 will be measured in samples from participants | Samples will be collected as part of the 3 month assessment | 
| Superoxide dismutase 1 (SOD1) at 6 months (controlling for appropriate covariates) | SOD1 will be measured in samples from participants | Samples will be collected as part of the 6 month assessment | 
| Superoxide dismutase 2 (SOD2) at 3 months (controlling for appropriate covariates) | SOD2 will be measured in samples from participants | Samples will be collected as part of the 3 month assessment | 
| Superoxide dismutase 2 (SOD2) at 6 months (controlling for appropriate covariates) | SOD2 will be measured in samples from participants | Samples will be collected as part of the 6 month assessment | 
| Glutathione peroxidase (Gpx) at 3 months (controlling for appropriate covariates) | Gpx will be measured in samples from participants | Samples will be collected as part of the 3 month assessment | 
| Glutathione peroxidase (Gpx) at 6 months (controlling for appropriate covariates) | Gpx will be measured in samples from participants | Samples will be collected as part of the 6 month assessment | 
| Systemic Inflammatory Response (SIR) at 3 months (controlling for appropriate covariates) | SIR will be measured in samples from participants | Samples will be collected as part of the 3 month assessment | 
| Systemic Inflammatory Response (SIR) at 6 months (controlling for appropriate covariates) | SIR will be measured in samples from participants | Samples will be collected as part of the 6 month assessment |