Clinical trial NCT06155552: Evaluating the Occurrence of Participation Trends Among Weight Loss Clinical Trials Patients
Official title: Exploring Enrollment and Participation Patterns in Weight Loss Clinical Trials Patients: An Observational Clinical Trial Perspective
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Weight Loss
Keywords: weight loss
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-12-04
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Weight loss clinical trials patients who are actively considering enrolling in a clinical trial for the said condition, but have not yet completed enrollment and randomization phases.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Rate of patients who decide to enroll in a weight loss clinical study.
timeFrame: 3 months
measure: Number of weight loss study participants who remain in clinical study until completion.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Power Life Sciences
state: California
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: Sarma S, Palcu P. Weight loss between glucagon-like peptide-1 receptor agonists and bariatric surgery in adults with obesity: A systematic review and meta-analysis. Obesity (Silver Spring). 2022 Nov;30(11):2111-2121. doi: 10.1002/oby.23563.
citation: Palacios OM, Kramer M, Maki KC. Diet and prevention of type 2 diabetes mellitus: beyond weight loss and exercise. Expert Rev Endocrinol Metab. 2019 Jan;14(1):1-12. doi: 10.1080/17446651.2019.1554430. Epub 2018 Dec 6.
citation: Jin S, Lu Q, Sun Y, Xiao S, Zheng B, Pang D, Yang P. Nutrition impact symptoms and weight loss in head and neck cancer during radiotherapy: a longitudinal study. BMJ Support Palliat Care. 2021 Mar;11(1):17-24. doi: 10.1136/bmjspcare-2019-002077. Epub 2020 Feb 4.