Whole-Food Plant-Based Diet to Control Weight and MetaboInflammation in Overweight/Obese Men With Prostate Cancer

NARecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

September 22, 2022

Primary Completion Date

March 31, 2026

Study Completion Date

December 31, 2026

Conditions
Prostate Cancer
Interventions
BEHAVIORAL

Whole-food, Plant-Based Diet

Pre-packaged, freshly made plant-based meals (provided by either Plantable or CookUnity) will be delivered weekly to participants' homes for 8 weeks. Meals are made with whole ingredients including whole grains, vegetables, legumes, nuts and seeds. Added sugar, animal-based products, refined grains, and processed foods are not used in any meal. Participants will be coached via phone calls, SMS, emails, and the app throughout the intervention to prepare meals in accordance with the diet. Participants will have access to a Registered Dietitian. During the first 4 weeks, 12 meals/week will be provided to participants; followed by 6 meals/week for the next 4 weeks; followed by 18 weeks where participants will continue to receive coaching, but will be expected to make all their own whole-food, plant-based meals with staff assistance available.

BEHAVIORAL

General Nutritional Counseling

"All study participants will receive consult with a Registered Dietitian at the Baseline visit and visit 1 study assessments. After visit 1, study participants assigned to the general nutritional counseling arm will receive an additional in-person or telehealth consultation with a Registered Dietitian that will consist of identification and counseling to improve diet quality and achieve a healthy body weight consistent with American Cancer Society guidelines.~Study participants in the control group will continue to receive general nutritional counseling and education with weekly scheduled telephone consultations with a Registered Dietitian for the first 4 weeks of the study period. For the remainder of the study period, they will receive counseling and education from Registered Dietitians via monthly scheduled phone calls."

Trial Locations (3)

10021

RECRUITING

Weill Cornell Medicine, New York

10032

RECRUITING

Columbia University Medical Center, New York

21231

RECRUITING

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore

All Listed Sponsors
collaborator

Plantable Inc.

UNKNOWN

collaborator

Prostate Cancer Foundation

OTHER

collaborator

CookUnity

UNKNOWN

lead

Weill Medical College of Cornell University

OTHER