Demark‐Wahnefried 2019.

Trial name or title
Methods	Design: single‐blinded randomised clinical trial Country: USA Accrual dates: NR Trial Reg: NCT04000880
Participants	Age 50 years or older; resident of Alabama, Mississippi, North Carolina, or Tennessee in the United States; diagnosed with multiple myeloma or localised kidney or ovarian cancer; or (localised (includes in situ) through regional) breast, colorectum, endometrium, or prostate cancer
Interventions	Participants will participate in 1 of 3 arms Diet followed by exercise intervention Exercise followed by diet intervention Wait‐list control followed by combined diet and exercise intervention
Outcomes	Primary outcomes: Change in dietary quality and intake (patient‐reported outcome) Change in body weight Change in physical activity and sleep Physical activity and sleep will be measured objectively via blank screen accelerometers, which are small devices (1 × 2 inches) that will be worn at the waist during waking hours and switched to a wrist band during sleep for a 7‐day period at each assessment point Secondary outcomes: Change in waist circumference Waist circumference Change in muscle mass To assess muscle mass, 3 days before home assessment, participants will take a capsule containing deuterium‐labelled creatine (creatine is a substance commonly found in protein‐containing foods, and deuterium is a naturally occurring element), administration of which is proven as safe with several studies conducted in humans across the lifespan from pre‐term infants to elders Change in physical performance Participants will complete the Senior Fitness Battery during in‐person assessments, which includes chair stands, 3‐metre walk, sit‐to‐stand, reaching (stretching exercises of the arms and legs), and the 2‐minute step test Change in physical activity (patient‐reported outcome) Physical activity will be measured via validated questionnaires (e.g. the Godin Leisure Time Exercise Questionnaire) Change in quality of life (patient‐reported outcome) Participants will complete questionnaires (PROMIS Cancer‐Related Item Bank and Short Form‐12) to self‐report quality of life Change in healthcare utilisation (patient‐reported outcome) Participants will complete a healthcare utilisation survey to capture physician and emergency room visits and hospitalisations
Starting date	June 2019
Contact information	Wendy Demark‐Wahnefried, PhD, University of Alabama at Birmingham; tel. 833‐535‐7934; AMPLIFY@UABMC.EDU
Notes	Protocol