Comparison Between the Health Effects of an AI-driven Model With Those of Human Professional Guidelines for the Treatment of Obesity

May 1, 2026 updated by: Texas Tech University

Many non-communicable diseases are diet-related and have a significant impact on public health. It is stated that global dietary shifts are needed to change disease patterns, highlighting the importance of nutrition in addressing public health issues, such as obesity. The field of nutrition has been dependent on clinical and observational studies; however, the emergence of Artificial Intelligence (AI) is transforming these approaches.

ChatGPT may be used to provide dietary recommendations due to its high speed, extensive access to a variety of meal data, and low complexity. However, initial evaluations have shown that ChatGPT may be inaccurate in terms of safety and reliability, and traditional nutrition approaches are highly reliant on experts' knowledge and the validity of nutritional guidelines. It has been suggested that AI in nutrition may be beneficial; however, further investigations are needed. Our proposal aims to fill the represented critical evidence gaps.

The study aims to compare the health effects of an AI-driven model with those of human professional guidelines for the treatment of obesity. Furthermore, investigators seek better strategies to utilize AI, if appropriate, for weight loss and other health benefits.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

An 8-week parallel-randomized clinical trial will be conducted. Participants will be recruited through printed flyers posted at approved locations, including Texas Tech University campus buildings and community centers in Lubbock, Texas. In addition to physical flyers, recruitment may include unpaid postings on social media platforms. No paid or targeted advertisements will be used. Flyers will include a QR code directing interested individuals an online survey. Based on their completed survey, they will be screened according to inclusion and exclusion criteria. If they meet the criteria, they will be invited for the baseline visit. Eligible participants will be asked to come fast for 8 hours to the Nutrition and Metabolic Health Initiative (NMHI). Upon arrival, the written consent form will be provided, and they will be enrolled in the study. They will be randomly allocated into one of the three groups in a 1:1:1 ratio. The REDCap will be used for electronic data capture for randomization and data management.

The experimental groups will include:

  • An AI-only group using ChatGPT Premium.
  • A dietitian-led group (human), in which dietary plans are developed by a licensed dietitian using standard professional resources and clinical judgment, without the use of generative AI tools.
  • An AI-assisted dietitian group (combination), in which the same dietitian is permitted to use ChatGPT Premium as a supportive tool during the consultation.

This design reflects real-world clinical practice, where dietitians commonly use professional judgment and non-AI resources.

After allocation, blood pressure will be measured. Resting metabolic rate, fasting blood glucose, lipid profile, and HbA1 will be recorded. Participants will be blinded to their group assignment; however, the study will be unable to blind the personnel due to the nature of the study. Additionally, the participants will be asked to complete the short form of the International Physical Activity Questionnaire (IPAQ).

The AI group participants will be in touch only with a trained study staff member (operator) who will facilitate communication with ChatGPT Premium so that the participants cannot see the operator's screen. The operator will not be a licensed dietitian or healthcare provider and will not provide any independent dietary advice. The operator will receive standardized training prior to study initiation to ensure consistency across participants.

The results of the BIA and finger prick tests will be given to the AI and asked to provide a dietary meal plan based on a standard prompt.

The human group participants will sit in the same room, but instead of the operator, they will have 60-minute consultations with the dietitian. The results of baseline assessments would be provided; however, the dietitian does not have any AI access.

Participants in the combination group will sit in the same room and be consulted for 60 minutes by the same dietitian as the human group. However, in this group, the dietitian has access to ChatGPT premium and can use it.

After 8 weeks, all participants will be asked to attend the clinic for their final visit and glycemic index, lipid profile, HbA1c, and body composition will be measured. In addition, the participants will be asked about their self-report compliance assessment.

Study Type

Interventional

Enrollment (Estimated)

21

Phase

  • Not Applicable

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

Study Contact Backup

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Participants with age 18 to 60 years,
  • BMI>30
  • Living in Lubbock-TX
  • Willing to participate in the study

Exclusion Criteria:

  • Pregnant women
  • Breastfeeding women
  • Recent diagnosis of a severe/acute medical condition within 6 months
  • Any other chronic diseases except obesity (e.g., diabetes, chronic kidney diseases, psychiatric conditions, cancer, acute pancreatitis)
  • Taking any anti-obesity medications

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AI-only group using ChatGPT Premium
A human assisted AI (ChatGPT Premium), in which dietary plans are developed and clinical judgment will be made.
Other: A dietitian-led group (human)
A dietitian-led group (human), in which dietary plans are developed by a licensed dietitian using standard professional resources and clinical judgment, without the use of generative AI tools.
Experimental: A dietitian-led group (human)
A dietitian-led group (human), in which dietary plans are developed by a licensed dietitian using standard professional resources and clinical judgment, without the use of generative AI tools.
Other: AI-assisted dietitian group (combination)
• An AI-assisted dietitian group (combination), in which the same dietitian is permitted to use ChatGPT Premium as a supportive tool during the consultation.
Active Comparator: AI-assisted dietitian group (combination)
An AI-assisted dietitian group (combination), in which the same dietitian is permitted to use ChatGPT Premium as a supportive tool during the consultation
Other: AI-only group using ChatGPT Premium
Arm Description: A human assisted AI (ChatGPT Premium), in which dietary plans are developed and clinical judgment will be made.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of weight change, Fat %, Muscle Mass, and BMI
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

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

Sponsor

Texas Tech University

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 (Estimated)

May 15, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

April 23, 2026

First Submitted That Met QC Criteria

April 23, 2026

First Posted (Actual)

April 30, 2026

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 1, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R11912013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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