Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-31 @ 12:16 AM
Study NCT ID:
NCT07462403
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-03-23
First Post:
2026-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A mLifestyle Intervention for Men on Androgen Deprivation Therapy for PCa
Sponsor:
Thomas Jefferson University
Organization:
Study Overview
Official Title:
A mLifestyle Intervention for Men on Androgen Deprivation Therapy for PCa
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Participants in the study will have weekly phone calls with a trained health coach. During these calls, they will receive guidance on extending their overnight fasting time-starting with at least 12 hours and slowly working toward 16 hours each night. Participants will also use a text-message system to report when they start and stop fasting and to share information about their sleep. The system will send encouraging messages when they meet their fasting goals, along with tips and helpful reminders.
Healthy Eating Attention Control Group:
Participants in this group will receive two text messages each day with simple, evidence-based information and tips on healthy eating. These messages are based on materials from the American Institute for Cancer Research (AICR).
Healthy Eating Attention Control Group:
Participants in this group will receive two text messages each day with simple, evidence-based information and tips on healthy eating. These messages are based on materials from the American Institute for Cancer Research (AICR).
Detailed Description:
Androgen deprivation therapy (ADT) is a common and effective treatment for prostate cancer (PCa), but it is associated with metabolic disturbances such as impaired glucose tolerance, insulin resistance, and weight gain. Men with PCa who are being evaluated for ADT already have a high prevalence of metabolic risk factors and face an increased risk of developing diabetes and potentially cardiovascular (CVD) mortality. Given the established benefits of meal-timing interventions on cardiovascular health and the demonstrated feasibility of using mobile text messaging (TXT) to support lifestyle behaviors in other populations, the investigators aim to evaluate, for one of the first times in this setting, the feasibility and acceptability of a telehealth coaching and interactive TXT-integrated intervention (mLifestyle-PCa). This intervention promotes a 16-hour nightly fasting duration among men receiving ADT for PCa.
mLifestyle Intervention: Participants will engage 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. The counseling will be supplemented by an interactive TXT system through which participants will report the start and end times of their overnight fasts, as well as sleep pattern data. The platform will provide positive reinforcement when fasting goals are met and will offer guidance and practical tips. Participants randomized to the Healthy Diet Group will receive general healthy-eating messages derived from the American Institute for Cancer Research (AICR).
The investigators plan to approach up to 68 patients for participation and enroll 45 participants. Enrolled participants will be randomized 2:1 to the mLifestyle intervention versus the attention control (AC) condition, resulting in 30 participants in the mLifestyle arm and 15 in the AC arm.
For the primary aim, feasibility will be assessed through study accrual, attrition, time-restricted eating (TRE) compliance, and adverse event monitoring. The investigators aim for a 70% accrual rate, consistent with prior studies in similar populations, though rates above 60% will be considered acceptable. The intervention will be considered feasible if attrition does not exceed 30% and if at least 70% of participants adhere to the fasting protocol on at least 70% of study days (63 out of 90). The investigators anticipate few, if any, treatment-related adverse events (e.g., digestive issues), with rates above 10% deemed unacceptable. Acceptability will be assessed using a validated treatment satisfaction measure and patient interview data, with a group median score ≥28 on the CSQ-8 indicating high acceptability.
The investigators will also explore the potential impact of the mLifestyle intervention on secondary and exploratory outcomes. Pre-post change scores and standard deviations will be calculated for each participant, and intervention effects will be evaluated using Wilcoxon tests or Fisher's exact tests, as appropriate. These pilot findings will provide preliminary estimates of treatment effects and inform power calculations for larger future trials.
mLifestyle Intervention: Participants will engage 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. The counseling will be supplemented by an interactive TXT system through which participants will report the start and end times of their overnight fasts, as well as sleep pattern data. The platform will provide positive reinforcement when fasting goals are met and will offer guidance and practical tips. Participants randomized to the Healthy Diet Group will receive general healthy-eating messages derived from the American Institute for Cancer Research (AICR).
The investigators plan to approach up to 68 patients for participation and enroll 45 participants. Enrolled participants will be randomized 2:1 to the mLifestyle intervention versus the attention control (AC) condition, resulting in 30 participants in the mLifestyle arm and 15 in the AC arm.
For the primary aim, feasibility will be assessed through study accrual, attrition, time-restricted eating (TRE) compliance, and adverse event monitoring. The investigators aim for a 70% accrual rate, consistent with prior studies in similar populations, though rates above 60% will be considered acceptable. The intervention will be considered feasible if attrition does not exceed 30% and if at least 70% of participants adhere to the fasting protocol on at least 70% of study days (63 out of 90). The investigators anticipate few, if any, treatment-related adverse events (e.g., digestive issues), with rates above 10% deemed unacceptable. Acceptability will be assessed using a validated treatment satisfaction measure and patient interview data, with a group median score ≥28 on the CSQ-8 indicating high acceptability.
The investigators will also explore the potential impact of the mLifestyle intervention on secondary and exploratory outcomes. Pre-post change scores and standard deviations will be calculated for each participant, and intervention effects will be evaluated using Wilcoxon tests or Fisher's exact tests, as appropriate. These pilot findings will provide preliminary estimates of treatment effects and inform power calculations for larger future trials.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| JT 42246 | OTHER | JeffTrial Number | View |