A Prolonged Nightly Fasting for Men on ADT for PCa

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Thomas Jefferson University
Study ID
NCT07462403
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Prolonged Nightly Fasting (PNF+) — BEHAVIORAL
    participants will be invited to participate in weekly counseling calls with a trained health coach and will be encouraged to fast at least 12 hours nightly, gradually increasing to 16 hours. This will be complemented by an interactive TXT system. Participants will interact with the study platform, to report when they begin and end their overnight fasting as well as their sleep pattern data. The platform will provide positive reinforcement messages when their fasting goal is successfully met as well as guidance and tips for fasting.
  • Healthy Diet Text Messaging — BEHAVIORAL
    Healthy Diet Group will receive general messages about healthy diet derived from AICR.

Study Details

This small study tested a 3-month text-based health coaching program for men with prostate cancer on hormone therapy. The program was feasible and well accepted, with participants showing good engagement and some improvements in weight and quality of life. However, differences between groups were not statistically significant, so larger studies are needed to confirm the benefits.

Key Dates

Start date
May 2, 2024
Status verified
May 2026
Primary completion
May 2, 2025
Completion
May 2, 2025

Study Design

Enrollment
40 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Prolonged Nightly Fasting (PNF+)
    Participants will be invited to participate in weekly calls with a trained health coach during the and will be encouraged to fast at least 12 hours nightly, gradually increasing to 16 hours. This will be complemented by an interactive TXT system. Participants will interact with the study platform, to report when they begin and end their overnight fasting as well as their sleeping behaviors. The platform will provide positive reinforcement messages when their fasting goal is successfully met as well as guidance and tips for fasting. The health eating attention control group: participants will
  • Active Comparator: Healthy Diet Group
    The health eating attention control group: participants will receive text messages twice a day to focus on information and tips on general healthy eating, based on AICR evidence-based materials.

Primary Outcome Measure

Accrual Rate [ Time Frame: 12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Thomas Jefferson University HospitalPhiladelphiaPennsylvania19107-

Find similar trials in Philadelphia, PA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Thomas Jefferson University Hospital· Philadelphia, PA

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