Leukocyte Telomere Length: Diet and Exercise Trial
| Registry | NCT03286699, acronym LCBH |
|---|---|
| Status | Terminated - Due to challenges with recruitment, we were unable to complete recruitment as planned during the period we had funding to do so. |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, supportive care |
| Enrollment | 8 (Actual) |
| Sponsor | University of Pittsburgh (Other); collaborators: National Cancer Institute (NCI) |
| Conditions | Bladder Cancer, Telomere Shortening, Colorectal Adenoma |
| Interventions | Dietary Intervention, Physical Activity Intervention (Behavioral) |
| Dates | start 2017-06-01, primary completion 2020-12-31, completion 2024-10-01, first posted 2017-09-18, last updated 2025-01-10 |
| Locations | 1 site in United States |
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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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| DIET | Active comparator | Behavioral: Dietary Intervention | 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. |
| DIET-PA | Active comparator | Behavioral: Dietary Intervention; Behavioral: Physical Activity Intervention | 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. |
Sex: All, ages: 18 Years to 84 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| UPMC Shadyside | Pittsburgh, Pennsylvania | United States |
NIH grants: R21CA212628