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Lifestyle Change for Better Health (LCBH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03286699
Recruitment Status : Active, not recruiting
First Posted : September 18, 2017
Last Update Posted : February 4, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Dana Bovbjerg, 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.

Condition or disease Intervention/treatment Phase
Bladder Cancer Telomere Shortening Colorectal Adenoma Behavioral: Dietary Intervention Behavioral: Physical Activity Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Leukocyte Telomere Length: Diet and Exercise Trial
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: DIET
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
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.

Active Comparator: DIET-PA
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
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.

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 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.




Primary Outcome Measures :
  1. Leukocyte telomere length (LTL) at the 6 month assessment (controlling for appropriate covariates) [ Time Frame: Blood samples will be collected as part of the 6 month assessment ]
    LTL will be measured in blood samples from participants


Secondary Outcome Measures :
  1. Leukocyte telomere length (LTL) at the 3 month assessment (controlling for appropriate covariates) [ Time Frame: Blood samples will be collected as part of the 3 month assessment ]
    LTL will be measured in blood samples from participants

  2. Leukocyte telomere length (LTL) at the 12 month assessment (controlling for appropriate covariates) [ Time Frame: Blood samples will be collected as part of the 12 month assessment (as feasible) ]
    LTL will be measured in blood samples from participants

  3. Telomerase level at 3 months (controlling for appropriate covariates) [ Time Frame: Blood samples will be collected as part of the 3 month assessment ]
    Telomerase will be measured in blood samples from participants

  4. Telomerase level at 6 months (controlling for appropriate covariates) [ Time Frame: Blood samples will be collected as part of the 6 month assessment ]
    Telomerase will be measured in blood samples from participants

  5. Telomerase level at 12 months (controlling for appropriate covariates) [ Time Frame: Blood samples will be collected as part of the 12 month assessment (as feasible) ]
    Telomerase will be measured in blood samples from participants

  6. 8-OHdG level at 3 months (controlling for appropriate covariates) [ Time Frame: Samples will be collected as part of the 3 month assessment ]
    8-OHdG will be measured in samples from participants

  7. 8-OHdG level at 6 months (controlling for appropriate covariates) [ Time Frame: Samples will be collected as part of the 6 month assessment ]
    8-OHdG will be measured in samples from participants

  8. Superoxide dismutase 1 (SOD1) at 3 months (controlling for appropriate covariates) [ Time Frame: Samples will be collected as part of the 3 month assessment ]
    SOD1 will be measured in samples from participants

  9. Superoxide dismutase 1 (SOD1) at 6 months (controlling for appropriate covariates) [ Time Frame: Samples will be collected as part of the 6 month assessment ]
    SOD1 will be measured in samples from participants

  10. Superoxide dismutase 2 (SOD2) at 3 months (controlling for appropriate covariates) [ Time Frame: Samples will be collected as part of the 3 month assessment ]
    SOD2 will be measured in samples from participants

  11. Superoxide dismutase 2 (SOD2) at 6 months (controlling for appropriate covariates) [ Time Frame: Samples will be collected as part of the 6 month assessment ]
    SOD2 will be measured in samples from participants

  12. Glutathione peroxidase (Gpx) at 3 months (controlling for appropriate covariates) [ Time Frame: Samples will be collected as part of the 3 month assessment ]
    Gpx will be measured in samples from participants

  13. Glutathione peroxidase (Gpx) at 6 months (controlling for appropriate covariates) [ Time Frame: Samples will be collected as part of the 6 month assessment ]
    Gpx will be measured in samples from participants

  14. Systemic Inflammatory Response (SIR) at 3 months (controlling for appropriate covariates) [ Time Frame: Samples will be collected as part of the 3 month assessment ]
    SIR will be measured in samples from participants

  15. Systemic Inflammatory Response (SIR) at 6 months (controlling for appropriate covariates) [ Time Frame: Samples will be collected as part of the 6 month assessment ]
    SIR will be measured in samples from participants


Other Outcome Measures:
  1. Body Mass Index (BMI) at 3 months (controlling for appropriate covariates) [ Time Frame: Measurements will be collected as part of the 3 month assessment ]
    BMI will be calculated from height and weight measurements

  2. Body Mass Index (BMI) at 6 months (controlling for appropriate covariates) [ Time Frame: Measurements will be collected as part of the 6 month assessment ]
    BMI will be calculated from height and weight measurements

  3. Body composition at 3 months (controlling for appropriate covariates) [ Time Frame: Measurements will be collected as part of the 3 month assessment ]
    Body composition will be measured by dual-energy x-ray absorptiometry (DXA)

  4. Body composition at 6 months (controlling for appropriate covariates) [ Time Frame: Measurements will be collected as part of the 6 month assessment ]
    Body composition will be measured by dual-energy x-ray absorptiometry (DXA)

  5. Regional adiposity (DXA) at 3 months (controlling for appropriate covariates) [ Time Frame: Measurements will be collected as part of the 3 month assessment ]
    Regional adiposity will be measured by dual-energy x-ray absorptiometry (DXA)

  6. Regional adiposity (DXA) at 6 months (controlling for appropriate covariates) [ Time Frame: Measurements will be collected as part of the 6 month assessment ]
    Regional adiposity will be measured by dual-energy x-ray absorptiometry (DXA)

  7. Waist-to-hip ratio at 3 months (controlling for appropriate covariates) [ Time Frame: Measurements will be collected as part of the 3 month assessment ]
    Waist-to-hip ratio will be calculated from waist and hip measurements

  8. Waist-to-hip ratio at 6 months (controlling for appropriate covariates) [ Time Frame: Measurements will be collected as part of the 6 month assessment ]
    Waist-to-hip ratio will be calculated from waist and hip measurements

  9. Objective physical activity level at 3 months (controlling for appropriate covariates) [ Time Frame: Total physical activity will be calculated from measurements collected for 7 consecutive days following the 3 month assessment ]
    Physical Activity will be objectively measured with SenseWear BodyMedia

  10. Objective physical activity level at 6 months (controlling for appropriate covariates) [ Time Frame: Total physical activity will be calculated from measurements collected for 7 consecutive days following the 6 month assessment ]
    Physical Activity will be objectively measured with SenseWear BodyMedia

  11. Self-reported physical activity level at 3 months (controlling for appropriate covariates) [ Time Frame: Self-reports will be obtained as part of the 3 month assessment ]
    The Paffenbarger Physical Activity Questionnaire will be used to obtain a self-reported measure of physical activity

  12. Self-reported physical activity level at 6 months (controlling for appropriate covariates) [ Time Frame: Self-reports will be obtained as part of the 6 month assessment ]
    The Paffenbarger Physical Activity Questionnaire will be used to obtain a self-reported measure of physical activity

  13. Cardiorespiratory fitness at 3 months (controlling for appropriate covariates) [ Time Frame: Measurements will be collected as part of the 3 month assessment ]
    Cardiorespiratory Fitness (oxygen consumption) will be measured by submaximal treadmill test

  14. Cardiorespiratory fitness at 6 months (controlling for appropriate covariates) [ Time Frame: Measurements will be collected as part of the 6 month assessment ]
    Cardiorespiratory Fitness (oxygen consumption) will be measured by submaximal treadmill test

  15. Depressive symptoms at 3 months (controlling for appropriate covariates) [ Time Frame: Questionnaires will be completed as part of the 3 month assessment ]
    The Center for Epidemiologic Studies Depression Scale will be used to obtain a self-reported measure of depressive symptoms

  16. Depressive symptoms at 6 months (controlling for appropriate covariates) [ Time Frame: Questionnaires will be completed as part of the 6 month assessment ]
    The Center for Epidemiologic Studies Depression Scale will be used to obtain a self-reported measure of depressive symptoms

  17. Symptoms of anxiety at 3 months (controlling for appropriate covariates) [ Time Frame: Questionnaires will be completed as part of the 3 month assessment ]
    The State subscale of the State Trait Anxiety Inventory will be used to obtain a self-reported measure of acute anxiety

  18. Symptoms of anxiety at 6 months (controlling for appropriate covariates) [ Time Frame: Questionnaires will be completed as part of the 6 month assessment ]
    The State subscale of the State Trait Anxiety Inventory will be used to obtain a self-reported measure of acute anxiety

  19. Perceived stress at 3 months (controlling for appropriate covariates) [ Time Frame: Questionnaires will be completed as part of the 3 month assessment ]
    The Perceived Stress Scale will be used to obtain a self-reported measure of perceived stress

  20. Perceived stress at 6 months (controlling for appropriate covariates) [ Time Frame: Questionnaires will be completed as part of the 6 month assessment ]
    The Perceived Stress Scale will be used to obtain a self-reported measure of perceived stress

  21. Sleep quality at 3 months (controlling for appropriate covariates) [ Time Frame: Questionnaires will be completed as part of the 3 month assessment ]
    The Pittsburgh Sleep Quality Index will be used to obtain a self-reported measure of overall sleep quality

  22. Sleep quality at 6 months (controlling for appropriate covariates) [ Time Frame: Questionnaires will be completed as part of the 6 month assessment ]
    The Pittsburgh Sleep Quality Index will be used to obtain a self-reported measure of overall sleep quality

  23. Quality of life at 3 months (controlling for appropriate covariates) [ Time Frame: Questionnaires will be completed as part of the 3 month assessment ]
    The Functional Assessment of Cancer Therapy - Bladder Cancer will be used to obtain a self-reported measure of health-related quality of life

  24. Quality of life at 6 months (controlling for appropriate covariates) [ Time Frame: Questionnaires will be completed as part of the 6 month assessment ]
    The Functional Assessment of Cancer Therapy - Bladder Cancer will be used to obtain a self-reported measure of health-related quality of life



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 84 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03286699


Locations
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United States, Pennsylvania
UPMC Shadyside
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
University of Pittsburgh
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Dana Bovbjerg, PhD University of Pittsburgh
Principal Investigator: John Jakicic, PhD University of Pittsburgh
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Responsible Party: Dana Bovbjerg, Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03286699    
Other Study ID Numbers: CA212628
R21CA212628 ( U.S. NIH Grant/Contract )
First Posted: September 18, 2017    Key Record Dates
Last Update Posted: February 4, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenoma
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type