Obesity (BMI>30)NCT07557979
Comparison Between the Health Effects of an AI-driven Model With Those of Human Professional Guidelines for the Treatment of Obesity
A study testing AI-assisted dietitian group (combination), A dietitian-led group (human) and AI-only group using ChatGPT Premium in people with Obesity (BMI>30), run by Texas Tech University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity (BMI>30)
- What is being tested?
- AI-assisted dietitian group (combination), A dietitian-led group (human) and AI-only group using ChatGPT Premium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants with age 18 to 60 years,
- BMI>30
- Living in Lubbock-TX
- Willing to participate in the study
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Obesity (BMI>30)
- Being tested
- AI-assisted dietitian group (combination), A dietitian-led group (human), AI-only group using ChatGPT Premium
- Keywords
- An AI-driven model, Human professional guidelines, Treatment of obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-assisted dietitian group (combination)Other
- An AI-assisted dietitian group (combination), in which the same dietitian is permitted to use ChatGPT Premium as a supportive tool during the consultation.
A dietitian-led group (human)Other
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.
AI-only group using ChatGPT PremiumOther
Arm Description: A human assisted AI (ChatGPT Premium), in which dietary plans are developed and clinical judgment will be made.
| Study group | Role | What they receive |
|---|---|---|
| AI-only group using ChatGPT Premium | Experimental | A human assisted AI (ChatGPT Premium), in which dietary plans are developed and clinical judgment will be made. Receives: Other: A dietitian-led group (human) |
| A dietitian-led group (human) | Experimental | 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. Receives: Other: AI-assisted dietitian group (combination) |
| AI-assisted dietitian group (combination) | Active comparator | An AI-assisted dietitian group (combination), in which the same dietitian is permitted to use ChatGPT Premium as a supportive tool during the consultation Receives: Other: AI-only group using ChatGPT Premium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of weight change, Fat %, Muscle Mass, and BMI
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start1 Jan 2027 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity (BMI>30)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas Tech University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07557979
- Sponsor's protocol ID
- R11912013
- Status last verified
- Sep 2026
- First submitted
- 23 Apr 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Health Effects of an AI-driven Model With Those of Human Professional Guidelines for the Treatment of Obesity
- ClinicalTrials.gov ID
- NCT07557979
- Acronym / sponsor ID
- R11912013
- Conditions
- Obesity (BMI>30)
- Keywords
- An AI-driven model, Human professional guidelines, Treatment of obesity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Texas Tech UniversityUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 30 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AI-only group using ChatGPT Premium | Experimental | Other: A dietitian-led group (human)A human assisted AI (ChatGPT Premium), in which dietary plans are developed and clinical judgment will be made. |
| A dietitian-led group (human) | Experimental | Other: AI-assisted dietitian group (combination)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. |
| AI-assisted dietitian group (combination) | Active comparator | Other: AI-only group using ChatGPT PremiumAn AI-assisted dietitian group (combination), in which the same dietitian is permitted to use ChatGPT Premium as a supportive tool during the consultation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participants with age 18 to 60 years,
- BMI>30
- Living in Lubbock-TX
- Willing to participate in the study
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | A dietitian-led group (human) |
| 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-only group using ChatGPT Premium |
| AI-only group using ChatGPT PremiumArm Description: A human assisted AI (ChatGPT Premium), in which dietary plans are developed and clinical judgment will be made. | Other | AI-assisted dietitian group (combination) |
Primary outcome
Rate of weight change, Fat %, Muscle Mass, and BMI
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing AI-assisted dietitian group (combination), A dietitian-led group (human) and AI-only group using ChatGPT Premium in people with Obesity (BMI>30), run by Texas Tech University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Surya Raj Niraula, PhD, Postdoc ((817) 371-5448, surya.niraula@ttu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of weight change, Fat %, Muscle Mass, and BMI (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.