An interventional study of Dietary Intervention and Physical Activity Intervention in Bladder Cancer, Telomere Shortening and Colorectal Adenoma, sponsored by University of Pittsburgh. Terminated at 1 site in United States. Open to participants aged 18 Years to 84 Years. Per ClinicalTrials.gov, last updated 2025-01-10.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Supportive care
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.
Exclusion Criteria:
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
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 · Behavioral: Physical Activity Intervention
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.
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.
Leukocyte telomere length (LTL) at the 6 month assessment (controlling for appropriate covariates)
LTL will be measured in blood samples from participants
Time frame: Blood samples will be collected as part of the 6 month assessment
Leukocyte telomere length (LTL) at the 3 month assessment (controlling for appropriate covariates)
LTL will be measured in blood samples from participants
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Samples will be collected as part of the 6 month assessment
Body Mass Index (BMI) at 3 months (controlling for appropriate covariates)
BMI will be calculated from height and weight measurements
Time frame: Measurements will be collected as part of the 3 month assessment
Body Mass Index (BMI) at 6 months (controlling for appropriate covariates)
BMI will be calculated from height and weight measurements
Time frame: Measurements will be collected as part of the 6 month assessment
Body composition at 3 months (controlling for appropriate covariates)
Body composition will be measured by dual-energy x-ray absorptiometry (DXA)
Time frame: Measurements will be collected as part of the 3 month assessment
Body composition at 6 months (controlling for appropriate covariates)
Body composition will be measured by dual-energy x-ray absorptiometry (DXA)
Time frame: Measurements will be collected as part of the 6 month assessment
Regional adiposity (DXA) at 3 months (controlling for appropriate covariates)
Regional adiposity will be measured by dual-energy x-ray absorptiometry (DXA)
Time frame: Measurements will be collected as part of the 3 month assessment
Regional adiposity (DXA) at 6 months (controlling for appropriate covariates)
Regional adiposity will be measured by dual-energy x-ray absorptiometry (DXA)
Time frame: Measurements will be collected as part of the 6 month assessment
Waist-to-hip ratio at 3 months (controlling for appropriate covariates)
Waist-to-hip ratio will be calculated from waist and hip measurements
Time frame: Measurements will be collected as part of the 3 month assessment
Waist-to-hip ratio at 6 months (controlling for appropriate covariates)
Waist-to-hip ratio will be calculated from waist and hip measurements
Time frame: Measurements will be collected as part of the 6 month assessment
Objective physical activity level at 3 months (controlling for appropriate covariates)
Physical Activity will be objectively measured with SenseWear BodyMedia
Time frame: Total physical activity will be calculated from measurements collected for 7 consecutive days following the 3 month assessment
Objective physical activity level at 6 months (controlling for appropriate covariates)
Physical Activity will be objectively measured with SenseWear BodyMedia
Time frame: Total physical activity will be calculated from measurements collected for 7 consecutive days following the 6 month assessment
Self-reported physical activity level at 3 months (controlling for appropriate covariates)
The Paffenbarger Physical Activity Questionnaire will be used to obtain a self-reported measure of physical activity
Time frame: Self-reports will be obtained as part of the 3 month assessment
Self-reported physical activity level at 6 months (controlling for appropriate covariates)
The Paffenbarger Physical Activity Questionnaire will be used to obtain a self-reported measure of physical activity
Time frame: Self-reports will be obtained as part of the 6 month assessment
Cardiorespiratory fitness at 3 months (controlling for appropriate covariates)
Cardiorespiratory Fitness (oxygen consumption) will be measured by submaximal treadmill test
Time frame: Measurements will be collected as part of the 3 month assessment
Cardiorespiratory fitness at 6 months (controlling for appropriate covariates)
Cardiorespiratory Fitness (oxygen consumption) will be measured by submaximal treadmill test
Time frame: Measurements will be collected as part of the 6 month assessment
Depressive symptoms at 3 months (controlling for appropriate covariates)
The Center for Epidemiologic Studies Depression Scale will be used to obtain a self-reported measure of depressive symptoms
Time frame: Questionnaires will be completed as part of the 3 month assessment
Depressive symptoms at 6 months (controlling for appropriate covariates)
The Center for Epidemiologic Studies Depression Scale will be used to obtain a self-reported measure of depressive symptoms
Time frame: Questionnaires will be completed as part of the 6 month assessment
Symptoms of anxiety at 3 months (controlling for appropriate covariates)
The State subscale of the State Trait Anxiety Inventory will be used to obtain a self-reported measure of acute anxiety
Time frame: Questionnaires will be completed as part of the 3 month assessment
Symptoms of anxiety at 6 months (controlling for appropriate covariates)
The State subscale of the State Trait Anxiety Inventory will be used to obtain a self-reported measure of acute anxiety
Time frame: Questionnaires will be completed as part of the 6 month assessment
Perceived stress at 3 months (controlling for appropriate covariates)
The Perceived Stress Scale will be used to obtain a self-reported measure of perceived stress
Time frame: Questionnaires will be completed as part of the 3 month assessment
Perceived stress at 6 months (controlling for appropriate covariates)
The Perceived Stress Scale will be used to obtain a self-reported measure of perceived stress
Time frame: Questionnaires will be completed as part of the 6 month assessment
Sleep quality at 3 months (controlling for appropriate covariates)
The Pittsburgh Sleep Quality Index will be used to obtain a self-reported measure of overall sleep quality
Time frame: Questionnaires will be completed as part of the 3 month assessment
Sleep quality at 6 months (controlling for appropriate covariates)
The Pittsburgh Sleep Quality Index will be used to obtain a self-reported measure of overall sleep quality
Time frame: Questionnaires will be completed as part of the 6 month assessment
Quality of life at 3 months (controlling for appropriate covariates)
The Functional Assessment of Cancer Therapy - Bladder Cancer will be used to obtain a self-reported measure of health-related quality of life
Time frame: Questionnaires will be completed as part of the 3 month assessment
Quality of life at 6 months (controlling for appropriate covariates)
The Functional Assessment of Cancer Therapy - Bladder Cancer will be used to obtain a self-reported measure of health-related quality of life
Time frame: Questionnaires will be completed as part of the 6 month assessment
Plan to share: No
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