- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05622045
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
Conditions
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.
Sponsor
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
- Alberga AS, Russell-Mayhew S, von Ranson KM, McLaren L. Weight bias: a call to action. J Eat Disord. 2016 Nov 7;4:34. doi: 10.1186/s40337-016-0112-4. eCollection 2016.
- Dalle Grave R, Calugi S, Compare A, El Ghoch M, Petroni ML, Tomasi F, Mazzali G, Marchesini G. Weight Loss Expectations and Attrition in Treatment-Seeking Obese Women. Obes Facts. 2015;8(5):311-8. doi: 10.1159/000441366. Epub 2015 Oct 8.
- Flint SW, Leaver M, Griffiths A, Kaykanloo M. Disparate healthcare experiences of people living with overweight or obesity in England. EClinicalMedicine. 2021 Sep 15;41:101140. doi: 10.1016/j.eclinm.2021.101140. eCollection 2021 Nov.
- Flint SW, Piotrkowicz A, Watts K. Use of Artificial Intelligence to understand adults' thoughts and behaviours relating to COVID-19. Perspect Public Health. 2022 May;142(3):167-174. doi: 10.1177/1757913920979332. Epub 2021 Jan 21.
- Hardcastle SJ, Taylor AH, Bailey MP, Harley RA, Hagger MS. Effectiveness of a motivational interviewing intervention on weight loss, physical activity and cardiovascular disease risk factors: a randomised controlled trial with a 12-month post-intervention follow-up. Int J Behav Nutr Phys Act. 2013 Mar 28;10:40. doi: 10.1186/1479-5868-10-40.
- Puhl RM, Phelan SM, Nadglowski J, Kyle TK. Overcoming Weight Bias in the Management of Patients With Diabetes and Obesity. Clin Diabetes. 2016 Jan;34(1):44-50. doi: 10.2337/diaclin.34.1.44. No abstract available.
- Wilding JPH, Batterham RL, Calanna S, Davies M, Van Gaal LF, Lingvay I, McGowan BM, Rosenstock J, Tran MTD, Wadden TA, Wharton S, Yokote K, Zeuthen N, Kushner RF; STEP 1 Study Group. Once-Weekly Semaglutide in Adults with Overweight or Obesity. N Engl J Med. 2021 Mar 18;384(11):989-1002. doi: 10.1056/NEJMoa2032183. Epub 2021 Feb 10.
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
Keywords
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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