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Evaluating the Occurrence of Participation Trends Among Weight Loss Clinical Trials Patients

Sponsor
Power Life Sciences Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06155552
Collaborator
(none)
500
Enrollment
1
Location
24
Anticipated Duration (Months)
20.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Clinical studies, with a distinct focus on weight loss, play a crucial role in evaluating the safety and effectiveness of novel treatments. These trials serve as instrumental means to determine whether new medications surpass conventional therapies, providing substantial evidence for their broader adoption.

The primary objective is to meticulously scrutinize trial completion rates and voluntary withdrawals within this specific patient group.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Case-Crossover
    Time Perspective:
    Prospective
    Official Title:
    Exploring Enrollment and Participation Patterns in Weight Loss Clinical Trials Patients: An Observational Clinical Trial Perspective
    Anticipated Study Start Date :
    Dec 1, 2024
    Anticipated Primary Completion Date :
    Dec 1, 2025
    Anticipated Study Completion Date :
    Dec 1, 2026

    Outcome Measures

    Primary Outcome Measures

    1. Rate of patients who decide to enroll in a weight loss clinical study. [3 months]

    2. Number of weight loss study participants who remain in clinical study until completion. [12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Interested in losing weight and not enrolled in a formal weight loss program or taking medications or supplements that may cause weight change

    • Participant must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, and other requirements of the study.

    • Aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed

    Exclusion Criteria:

    • Enrolled in another research study

    • Inability to provide written informed consent

    • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Power Life Sciences San Francisco California United States 94107

    Sponsors and Collaborators

    • Power Life Sciences Inc.

    Investigators

    • Study Director: Michael B Gill, Power Life Sciences Inc.

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Power Life Sciences Inc.
    ClinicalTrials.gov Identifier:
    NCT06155552
    Other Study ID Numbers:
    • 66708946
    First Posted:
    Dec 4, 2023
    Last Update Posted:
    Dec 4, 2023
    Last Verified:
    Nov 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Power Life Sciences Inc.
    weight loss
    Additional relevant MeSH terms:
    Body Weight
    Weight Loss

    Study Results

    No Results Posted as of Dec 4, 2023