Does Personality Predict Patient Adherence, Health Behaviors, and Weight Loss Outcomes During the Latino Crossover Semaglutide Study (LCSS)? (Story-LCSS Project) (StoryLCSS)

September 26, 2023 updated by: Celine Heskey, Loma Linda University

The goal of this observational study is to learn about the personality attributes and values of people living with obesity that are part of the Latino community, and how these personality attributes and values can help to predict success during a weight loss program.

The main questions it aims to answer are:

  • What are the personality attributes and values of people living with obesity that sign up to the LCSS-Latino Crossover Semaglutide Study trial?
  • Can behavioral artificial intelligence (a computer formula) predict which patients will complete the LCSS-Latino Crossover Semaglutide Study trial?
  • How do behavioral artificial Intelligence predictions (a computer formula) compare to clinician predictions of patient success?
  • Can behavioral artificial intelligence (a computer formula) predict patient weight loss, calorie consumption and physical activity levels during the LCSS-Latino Crossover Semaglutide Study trial? Participants will be recorded in English and Spanish while responding to a question regarding participation in a weight loss study.

Study Overview

Status

Active, not recruiting

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

59

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Celine Heskey, DrPH
  • Phone Number: 47181 909-558-1000
  • Email: cheskey@llu.edu

Study Contact Backup

  • Name: Amandeep Kaur, MPH
  • Phone Number: 47169 909-558-4300
  • Email: akaur1@llu.edu

Study Locations

    • California
      • Loma Linda, California, United States, 92350
        • Nutrition Research Center, School of Public Health, Loma Linda University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Hispanic men and women, 18 to 74 years of age, with obesity, residing in Southern California, who are taking part in the LCSS-Latino Crossover Semaglutide Study.

Description

Inclusion Criteria:

  • Participation in the LCSS-Latino Crossover Semaglutide Study

Exclusion Criteria:

  • Not a participant of the LCSS-Latino Crossover Semaglutide Study at the point of data collection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Story-LCSS
Recorded response to a question about their participation in a weight loss study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinician predictions
Time Frame: The clinician judgement will be measured during the second month of the subject's weight loss study.
Clinician (physician) judgement of patient weight loss success during a weight loss study.
The clinician judgement will be measured during the second month of the subject's weight loss study.
Predicted patient weight change success
Time Frame: The voice data measurement will take place at baseline and take about 10-15 minutes for collection to take place.
Predicted patient weight change as determined by Scaled Insights Behavioural Artificial Intelligence based on subject voice data. Weight loss exceeding 5-10 pounds over 6 months will be considered to be successful. Predicted weight change will be compared to the weight change measured in a separate clinical trial [Latino Crossover Semaglutide Study (LCSS) NCT05087342]. Similar weight change values between the predicted and measured outcomes will indicate that the Scaled Insights Behavioural Artificial Intelligence is good predictor.
The voice data measurement will take place at baseline and take about 10-15 minutes for collection to take place.
Predicated patient calorie intake
Time Frame: The voice data measurement will take place during the subject's initial clinic visit and take about 10-15 minutes for collection to take place.
Predicted patient calorie intake as determined by Scaled Insights Behavioural Artificial Intelligence based on subject voice data. Predicted calorie intake will be compared to the calorie intake measured in a separate clinical trial [Latino Crossover Semaglutide Study (LCSS) NCT05087342]. Similar calorie values between the predicted and measured outcomes will indicate that the Scaled Insights Behavioural Artificial Intelligence is good predictor.
The voice data measurement will take place during the subject's initial clinic visit and take about 10-15 minutes for collection to take place.
Predicated patient physical activity level
Time Frame: The voice data measurement will take at baseline and take about 10-15 minutes for collection to take place.
Predicted patient physical activity level as determined by Scaled Insights Behavioural Artificial Intelligence based on subject voice data. Predicted physical activity will be compared to the physical activity measured in a separate clinical trial [Latino Crossover Semaglutide Study (LCSS) NCT05087342]. Similar physical activity level values between the predicted and measured outcomes will indicate that the Scaled Insights Behavioural Artificial Intelligence is good predictor.
The voice data measurement will take at baseline and take about 10-15 minutes for collection to take place.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Personality attributes and values
Time Frame: The voice data measurement will take place at baseline and take about 10-15 minutes for collection to take place.
Extrapolated personality attributes and values as determined by Scaled Insights Behavioural Artificial Intelligence based on subject voice data. These are qualitative non-numerical descriptors.
The voice data measurement will take place at baseline and take about 10-15 minutes for collection to take place.
Predicted patient attrition rate
Time Frame: The voice data measurement will take place at baseline and take about 10-15 minutes for collection to take place.
Predicted patient attrition rate from the weight loss study as determined by Scaled Insights Behavioural Artificial Intelligence based on subject voice data. Predicted patient attrition rate will be compared to the attrition rate occurring during the weight loss study. Similar attrition rates between the predicted and actual rates will indicate that the Scaled Insights Behavioural Artificial Intelligence is good predictor.
The voice data measurement will take place at baseline and take about 10-15 minutes for collection to take place.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Celine Heskey, DrPH, Loma Linda University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

November 7, 2022

First Submitted That Met QC Criteria

November 15, 2022

First Posted (Actual)

November 18, 2022

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 26, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5220330

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

There is not plan currently to share IPD outside of the collaborators that are part of the study. It is possible that requests may be made by students later on to use data for secondary data analysis as part of their academic research projects, and the research collaborators will decide if unidentified IPD would be shared at such a time.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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