Clinical trial NCT03286699: Lifestyle Change for Better Health
Official title: Leukocyte Telomere Length: Diet and Exercise Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bladder Cancer
Telomere Shortening
Colorectal Adenoma
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-09-18
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Leukocyte telomere length (LTL) at the 6 month assessment (controlling for appropriate covariates)
timeFrame: Blood samples will be collected as part of the 6 month assessment
Secondary outcomes:
measure: Leukocyte telomere length (LTL) at the 3 month assessment (controlling for appropriate covariates)
timeFrame: Blood samples will be collected as part of the 3 month assessment
measure: Leukocyte telomere length (LTL) at the 12 month assessment (controlling for appropriate covariates)
timeFrame: Blood samples will be collected as part of the 12 month assessment (as feasible)
measure: Telomerase level at 3 months (controlling for appropriate covariates)
timeFrame: Blood samples will be collected as part of the 3 month assessment
measure: Telomerase level at 6 months (controlling for appropriate covariates)
timeFrame: Blood samples will be collected as part of the 6 month assessment
measure: Telomerase level at 12 months (controlling for appropriate covariates)
timeFrame: Blood samples will be collected as part of the 12 month assessment (as feasible)
measure: 8-OHdG level at 3 months (controlling for appropriate covariates)
timeFrame: Samples will be collected as part of the 3 month assessment
measure: 8-OHdG level at 6 months (controlling for appropriate covariates)
timeFrame: Samples will be collected as part of the 6 month assessment
measure: Superoxide dismutase 1 (SOD1) at 3 months (controlling for appropriate covariates)
timeFrame: Samples will be collected as part of the 3 month assessment
measure: Superoxide dismutase 1 (SOD1) at 6 months (controlling for appropriate covariates)
timeFrame: Samples will be collected as part of the 6 month assessment
measure: Superoxide dismutase 2 (SOD2) at 3 months (controlling for appropriate covariates)
timeFrame: Samples will be collected as part of the 3 month assessment
measure: Superoxide dismutase 2 (SOD2) at 6 months (controlling for appropriate covariates)
timeFrame: Samples will be collected as part of the 6 month assessment
measure: Glutathione peroxidase (Gpx) at 3 months (controlling for appropriate covariates)
timeFrame: Samples will be collected as part of the 3 month assessment
measure: Glutathione peroxidase (Gpx) at 6 months (controlling for appropriate covariates)
timeFrame: Samples will be collected as part of the 6 month assessment
measure: Systemic Inflammatory Response (SIR) at 3 months (controlling for appropriate covariates)
timeFrame: Samples will be collected as part of the 3 month assessment
measure: Systemic Inflammatory Response (SIR) at 6 months (controlling for appropriate covariates)
timeFrame: Samples will be collected as part of the 6 month assessment
Other outcomes:
measure: Body Mass Index (BMI) at 3 months (controlling for appropriate covariates)
timeFrame: Measurements will be collected as part of the 3 month assessment
measure: Body Mass Index (BMI) at 6 months (controlling for appropriate covariates)
timeFrame: Measurements will be collected as part of the 6 month assessment
measure: Body composition at 3 months (controlling for appropriate covariates)
timeFrame: Measurements will be collected as part of the 3 month assessment
measure: Body composition at 6 months (controlling for appropriate covariates)
timeFrame: Measurements will be collected as part of the 6 month assessment
measure: Regional adiposity (DXA) at 3 months (controlling for appropriate covariates)
timeFrame: Measurements will be collected as part of the 3 month assessment
measure: Regional adiposity (DXA) at 6 months (controlling for appropriate covariates)
timeFrame: Measurements will be collected as part of the 6 month assessment
measure: Waist-to-hip ratio at 3 months (controlling for appropriate covariates)
timeFrame: Measurements will be collected as part of the 3 month assessment
measure: Waist-to-hip ratio at 6 months (controlling for appropriate covariates)
timeFrame: Measurements will be collected as part of the 6 month assessment
measure: Objective physical activity level at 3 months (controlling for appropriate covariates)
timeFrame: Total physical activity will be calculated from measurements collected for 7 consecutive days following the 3 month assessment
measure: Objective physical activity level at 6 months (controlling for appropriate covariates)
timeFrame: Total physical activity will be calculated from measurements collected for 7 consecutive days following the 6 month assessment
measure: Self-reported physical activity level at 3 months (controlling for appropriate covariates)
timeFrame: Self-reports will be obtained as part of the 3 month assessment
measure: Self-reported physical activity level at 6 months (controlling for appropriate covariates)
timeFrame: Self-reports will be obtained as part of the 6 month assessment
measure: Cardiorespiratory fitness at 3 months (controlling for appropriate covariates)
timeFrame: Measurements will be collected as part of the 3 month assessment
measure: Cardiorespiratory fitness at 6 months (controlling for appropriate covariates)
timeFrame: Measurements will be collected as part of the 6 month assessment
measure: Depressive symptoms at 3 months (controlling for appropriate covariates)
timeFrame: Questionnaires will be completed as part of the 3 month assessment
measure: Depressive symptoms at 6 months (controlling for appropriate covariates)
timeFrame: Questionnaires will be completed as part of the 6 month assessment
measure: Symptoms of anxiety at 3 months (controlling for appropriate covariates)
timeFrame: Questionnaires will be completed as part of the 3 month assessment
measure: Symptoms of anxiety at 6 months (controlling for appropriate covariates)
timeFrame: Questionnaires will be completed as part of the 6 month assessment
measure: Perceived stress at 3 months (controlling for appropriate covariates)
timeFrame: Questionnaires will be completed as part of the 3 month assessment
measure: Perceived stress at 6 months (controlling for appropriate covariates)
timeFrame: Questionnaires will be completed as part of the 6 month assessment
measure: Sleep quality at 3 months (controlling for appropriate covariates)
timeFrame: Questionnaires will be completed as part of the 3 month assessment
measure: Sleep quality at 6 months (controlling for appropriate covariates)
timeFrame: Questionnaires will be completed as part of the 6 month assessment
measure: Quality of life at 3 months (controlling for appropriate covariates)
timeFrame: Questionnaires will be completed as part of the 3 month assessment
measure: Quality of life at 6 months (controlling for appropriate covariates)
timeFrame: Questionnaires will be completed as part of the 6 month assessment
Locations:
city: Pittsburgh
country: United States
facility: UPMC Shadyside
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Dana Bovbjerg, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: John Jakicic, PhD
role: PRINCIPAL_INVESTIGATOR
References: