💬In plain words
What the trial is, and whether it could suit you
The Impact 360 study will evaluate the effects of a combined intervention of exercise, mindfulness, and nutrition on 8 key indicators of health and the mechanisms that drive these changes. 60 subjects aged 50 to 75 without a current diagnosis of a brain disorder will be recruited. This study will follow a partial crossover design. All participants will receive the intervention. Participants randomized into the intervention group after their baseline screening will receive the 6-month intervention. Those randomized into the waitlist group will complete another assessment at the end of the 6-month care as usual phase before receiving the intervention.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* Participants who are able to complete questionnaires and follow directions for interventions
* Have access to a smartphone that can support the Fitbit app
Exclusion Criteria:
* Any neurological disease/disorder diagnosis (Ex: Parkinson's Disease, Multiple Sclerosis, Traumatic Brain Injury, Brain lesion, Stroke, etc)
* Any chronic medical condition which would affect ability to participate in exercise
* Any contraindication for exercise based on the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+) and medical clearance form
* Participants who were told by a medical doctor that they need to be medically supervised for exercise
* Montreal Cognitive Assessment (MoCA) scores \<21/30
* Significant cognitive impairment, depression, or eating disorder
* Any contraindication to MRI scanning; such as implanted metal clips or wires (see list below)
* Participants currently doing 180 minutes or more of moderate-vigorous intensity exercise per week AND either of the following:
* Completion of an Mindfulness-Based Stress Reduction course OR; Score \>8/15 in the Mediterranean-Dietary Approaches to Stop Hypertension (DASH) Intervention for Neurodegenerative Delay (MIND) Diet Questionnaire
* Significant or unstable cardiovascular or respiratory disease
* Severe/multiple head trauma(s)
* Subjects who are pregnant or breastfeeding
* Subjects with a history or major episodes of drug or alcohol abuse
* Chronic/acute bacterial/viral infection
* GI cancer
* Inflammatory bowel disease
Exclusion for MRI scanning:
* Individuals weighing \> 400 lbs (limit of MRI machine)
* Artificial heart valve
* Brain aneurysm clip
* Electrical stimulator for nerves or bones
* Ear or eye implant
* Implanted drug infusion pump
* Coil, catheter, or filter in any blood vessel
* Orthopedic hardware (artificial joint, plate, screws)
* Other metallic prostheses
* Shrapnel, bullets, or other metal fragments
* Surgery or tattoos (including tattooed eyeliner) in the last six weeks
* Brain surgery
* Have a cardiac pacemaker, wires or defibrillator
* Have had an injury where a piece of metal lodged in the eye or orbit
* Have a ferromagnetic aneurysm clip
HealthTeky