Lifestyle Change for Better Health

NCT03286699 | Terminated

• 2 other identifiers: STUDY19070303R21CA212628
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer; Telomere Shortening; Colorectal Adenoma

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (15)

• Leukocyte telomere length (LTL) at the 3 month assessment (controlling for appropriate covariates)

  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)

  Blood samples will be collected as part of the 12 month assessment (as feasible)

• Telomerase level at 3 months (controlling for appropriate covariates)

  Blood samples will be collected as part of the 3 month assessment

• Telomerase level at 6 months (controlling for appropriate covariates)

  Blood samples will be collected as part of the 6 month assessment

• Telomerase level at 12 months (controlling for appropriate covariates)

  Blood samples will be collected as part of the 12 month assessment (as feasible)

Other Outcomes (24)

• Body Mass Index (BMI) at 3 months (controlling for appropriate covariates)

  Measurements will be collected as part of the 3 month assessment

• Body Mass Index (BMI) at 6 months (controlling for appropriate covariates)

  Measurements will be collected as part of the 6 month assessment

• Body composition at 3 months (controlling for appropriate covariates)

  Measurements will be collected as part of the 3 month assessment

Study Arms (2)

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.

Behavioral: Dietary Intervention

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.

Behavioral: Dietary Intervention; Behavioral: Physical Activity Intervention

Interventions

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.

DIET; DIET-PA

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.

DIET-PA

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

UPMC Shadyside

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Dana Bovbjerg, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• John Jakicic, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 31, 2017
• First Posted: September 18, 2017
• Study Start: June 1, 2017
• Primary Completion: December 31, 2020
• Study Completion: October 1, 2024
• Last Updated: January 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)