Lifestyle Change for Better Health

NCT ID: NCT03286699

Last Updated: 2025-01-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2024-10-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Dietary Intervention

Intervention Type: 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-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.

Group Type: ACTIVE_COMPARATOR

Dietary Intervention

Intervention Type: 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.

Physical Activity Intervention

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 84 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Dana Bovbjerg

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dana Bovbjerg, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

John Jakicic, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

UPMC Shadyside

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

R21CA212628

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY19070303

Identifier Type: -

Identifier Source: org_study_id