Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
NCT ID:
NCT07259434
Eligibility Criteria:
Inclusion Criteria:
* female
* aged 60-85 years
* BMI ≥25 kg/m2
* diagnosed with early-stage (I-III) BC in the past 15 years
* received chemotherapy treatment that was completed ≥1 year earlier
* Montreal Cognitive Assessment (MoCA) score of 10-30 which aligns with no impairment to moderate impairment thresholds.
Exclusion Criteria:
* does not have a mobile device that connects to Bluetooth and can send/receive text messages
* history of physician-diagnosed heart disease, dementia or Alzheimer's disease, diabetes that requires insulin or sulfonylurea usage, or eating disorder
* MoCA total score \<10 (indicating dementia)
* ≥5kg weight change within past 3 months
* taking lipid- or weight-lowering medication (e.g. statins or GLP-1 agonists)
* high-risk for malnutrition (≥3 on the Malnutrition Screening Tool)
* research MRI contraindications (e.g., pacemaker, breast tissue expander, magnetic implants)
* eating all daily calories in \<10h/d in the past 3 months
* following a structured dietary practice (e.g., ketogenic diet, Weight Watchers) or actively trying to lose weight in the past 3 months
* being unable to make adjustments to eating time or nutrient intake
* regularly doing \>90 min/week of moderate physical activity in the past 3 months
* severe claustrophobia
* BMI\>40 kg/m2 (due to body habitus fit within MRI scanner bore)
* major psychiatric disorders (e.g. bipolar, post-traumatic stress disorder, schizophrenia)
* neurological disorders that significantly impact physical or cognitive function (epilepsy, stroke, Parkinson's disease, multiple sclerosis, amyotrophic lateral sclerosis, muscular dystrophy) or traumatic brain injury resulting in ongoing neurological deficits. If the screening process identifies patients with undiagnosed severe cognitive function (MoCA score \<10) or at high risk for malnutrition (≥3 on the Malnutrition Screening Tool), the investigators will recommend that the individual see their family physician. In this process, the investigators will ask the participant if there is a family member that can also receive this information.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
60 Years
Maximum Age:
85 Years
Study:
NCT07259434
Study Brief:
Protocol Section:
NCT07259434