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| ID | Type | Description | Link |
|---|---|---|---|
| R21CA212628 | U.S. NIH Grant/Contract | View source |
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Due to challenges with recruitment, we were unable to complete recruitment as planned during the period we had funding to do so.
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DIET | Active Comparator | 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. |
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| DIET-PA | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary Intervention | Behavioral | 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. |
| 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 |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Body Mass Index (BMI) at 3 months (controlling for appropriate covariates) | BMI will be calculated from height and weight measurements | Measurements will be collected as part of the 3 month assessment |
| Body Mass Index (BMI) at 6 months (controlling for appropriate covariates) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dana Bovbjerg, PhD | University of Pittsburgh | Principal Investigator |
| John Jakicic, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Shadyside | Pittsburgh | Pennsylvania | 15232 | United States |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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| Physical Activity Intervention | Behavioral | 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. |
|
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 |
BMI will be calculated from height and weight measurements |
| 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) | 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) | 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) | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Questionnaires will be completed as part of the 6 month assessment |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |