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Lifestyle Change for Better Health (LCBH)

Primary Purpose

Bladder Cancer, Telomere Shortening, Colorectal Adenoma

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dietary Intervention
Physical Activity Intervention
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Bladder Cancer

Eligibility Criteria

18 Years - 84 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UPMC Shadyside

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

DIET

DIET-PA

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Leukocyte telomere length (LTL) at the 6 month assessment (controlling for appropriate covariates)
LTL will be measured in blood samples from participants

Secondary Outcome Measures

Leukocyte telomere length (LTL) at the 3 month assessment (controlling for appropriate covariates)
LTL will be measured in blood samples from participants
Leukocyte telomere length (LTL) at the 12 month assessment (controlling for appropriate covariates)
LTL will be measured in blood samples from participants
Telomerase level at 3 months (controlling for appropriate covariates)
Telomerase will be measured in blood samples from participants
Telomerase level at 6 months (controlling for appropriate covariates)
Telomerase will be measured in blood samples from participants
Telomerase level at 12 months (controlling for appropriate covariates)
Telomerase will be measured in blood samples from participants
8-OHdG level at 3 months (controlling for appropriate covariates)
8-OHdG will be measured in samples from participants
8-OHdG level at 6 months (controlling for appropriate covariates)
8-OHdG will be measured in samples from participants
Superoxide dismutase 1 (SOD1) at 3 months (controlling for appropriate covariates)
SOD1 will be measured in samples from participants
Superoxide dismutase 1 (SOD1) at 6 months (controlling for appropriate covariates)
SOD1 will be measured in samples from participants
Superoxide dismutase 2 (SOD2) at 3 months (controlling for appropriate covariates)
SOD2 will be measured in samples from participants
Superoxide dismutase 2 (SOD2) at 6 months (controlling for appropriate covariates)
SOD2 will be measured in samples from participants
Glutathione peroxidase (Gpx) at 3 months (controlling for appropriate covariates)
Gpx will be measured in samples from participants
Glutathione peroxidase (Gpx) at 6 months (controlling for appropriate covariates)
Gpx will be measured in samples from participants
Systemic Inflammatory Response (SIR) at 3 months (controlling for appropriate covariates)
SIR will be measured in samples from participants
Systemic Inflammatory Response (SIR) at 6 months (controlling for appropriate covariates)
SIR will be measured in samples from participants

Full Information

First Posted
January 31, 2017
Last Updated
January 4, 2023
Sponsor
University of Pittsburgh
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03286699
Brief Title
Lifestyle Change for Better Health
Acronym
LCBH
Official Title
Leukocyte Telomere Length: Diet and Exercise Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer, Telomere Shortening, Colorectal Adenoma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DIET
Arm Type
Active Comparator
Arm Description
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.
Arm Title
DIET-PA
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Dietary Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Physical Activity Intervention
Intervention Description
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 Measure Information:
Title
Leukocyte telomere length (LTL) at the 6 month assessment (controlling for appropriate covariates)
Description
LTL will be measured in blood samples from participants
Time Frame
Blood samples will be collected as part of the 6 month assessment
Secondary Outcome Measure Information:
Title
Leukocyte telomere length (LTL) at the 3 month assessment (controlling for appropriate covariates)
Description
LTL will be measured in blood samples from participants
Time Frame
Blood samples will be collected as part of the 3 month assessment
Title
Leukocyte telomere length (LTL) at the 12 month assessment (controlling for appropriate covariates)
Description
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)
Title
Telomerase level at 3 months (controlling for appropriate covariates)
Description
Telomerase will be measured in blood samples from participants
Time Frame
Blood samples will be collected as part of the 3 month assessment
Title
Telomerase level at 6 months (controlling for appropriate covariates)
Description
Telomerase will be measured in blood samples from participants
Time Frame
Blood samples will be collected as part of the 6 month assessment
Title
Telomerase level at 12 months (controlling for appropriate covariates)
Description
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)
Title
8-OHdG level at 3 months (controlling for appropriate covariates)
Description
8-OHdG will be measured in samples from participants
Time Frame
Samples will be collected as part of the 3 month assessment
Title
8-OHdG level at 6 months (controlling for appropriate covariates)
Description
8-OHdG will be measured in samples from participants
Time Frame
Samples will be collected as part of the 6 month assessment
Title
Superoxide dismutase 1 (SOD1) at 3 months (controlling for appropriate covariates)
Description
SOD1 will be measured in samples from participants
Time Frame
Samples will be collected as part of the 3 month assessment
Title
Superoxide dismutase 1 (SOD1) at 6 months (controlling for appropriate covariates)
Description
SOD1 will be measured in samples from participants
Time Frame
Samples will be collected as part of the 6 month assessment
Title
Superoxide dismutase 2 (SOD2) at 3 months (controlling for appropriate covariates)
Description
SOD2 will be measured in samples from participants
Time Frame
Samples will be collected as part of the 3 month assessment
Title
Superoxide dismutase 2 (SOD2) at 6 months (controlling for appropriate covariates)
Description
SOD2 will be measured in samples from participants
Time Frame
Samples will be collected as part of the 6 month assessment
Title
Glutathione peroxidase (Gpx) at 3 months (controlling for appropriate covariates)
Description
Gpx will be measured in samples from participants
Time Frame
Samples will be collected as part of the 3 month assessment
Title
Glutathione peroxidase (Gpx) at 6 months (controlling for appropriate covariates)
Description
Gpx will be measured in samples from participants
Time Frame
Samples will be collected as part of the 6 month assessment
Title
Systemic Inflammatory Response (SIR) at 3 months (controlling for appropriate covariates)
Description
SIR will be measured in samples from participants
Time Frame
Samples will be collected as part of the 3 month assessment
Title
Systemic Inflammatory Response (SIR) at 6 months (controlling for appropriate covariates)
Description
SIR will be measured in samples from participants
Time Frame
Samples will be collected as part of the 6 month assessment
Other Pre-specified Outcome Measures:
Title
Body Mass Index (BMI) at 3 months (controlling for appropriate covariates)
Description
BMI will be calculated from height and weight measurements
Time Frame
Measurements will be collected as part of the 3 month assessment
Title
Body Mass Index (BMI) at 6 months (controlling for appropriate covariates)
Description
BMI will be calculated from height and weight measurements
Time Frame
Measurements will be collected as part of the 6 month assessment
Title
Body composition at 3 months (controlling for appropriate covariates)
Description
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
Title
Body composition at 6 months (controlling for appropriate covariates)
Description
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
Title
Regional adiposity (DXA) at 3 months (controlling for appropriate covariates)
Description
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
Title
Regional adiposity (DXA) at 6 months (controlling for appropriate covariates)
Description
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
Title
Waist-to-hip ratio at 3 months (controlling for appropriate covariates)
Description
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
Title
Waist-to-hip ratio at 6 months (controlling for appropriate covariates)
Description
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
Title
Objective physical activity level at 3 months (controlling for appropriate covariates)
Description
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
Title
Objective physical activity level at 6 months (controlling for appropriate covariates)
Description
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
Title
Self-reported physical activity level at 3 months (controlling for appropriate covariates)
Description
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
Title
Self-reported physical activity level at 6 months (controlling for appropriate covariates)
Description
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
Title
Cardiorespiratory fitness at 3 months (controlling for appropriate covariates)
Description
Cardiorespiratory Fitness (oxygen consumption) will be measured by submaximal treadmill test
Time Frame
Measurements will be collected as part of the 3 month assessment
Title
Cardiorespiratory fitness at 6 months (controlling for appropriate covariates)
Description
Cardiorespiratory Fitness (oxygen consumption) will be measured by submaximal treadmill test
Time Frame
Measurements will be collected as part of the 6 month assessment
Title
Depressive symptoms at 3 months (controlling for appropriate covariates)
Description
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
Title
Depressive symptoms at 6 months (controlling for appropriate covariates)
Description
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
Title
Symptoms of anxiety at 3 months (controlling for appropriate covariates)
Description
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
Title
Symptoms of anxiety at 6 months (controlling for appropriate covariates)
Description
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
Title
Perceived stress at 3 months (controlling for appropriate covariates)
Description
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
Title
Perceived stress at 6 months (controlling for appropriate covariates)
Description
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
Title
Sleep quality at 3 months (controlling for appropriate covariates)
Description
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
Title
Sleep quality at 6 months (controlling for appropriate covariates)
Description
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
Title
Quality of life at 3 months (controlling for appropriate covariates)
Description
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
Title
Quality of life at 6 months (controlling for appropriate covariates)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
84 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dana Bovbjerg, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John Jakicic, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
UPMC Shadyside
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Lifestyle Change for Better Health

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