Obesity & OverweightTIANCT07740291
Tirzepatide Impact Assessment Study
A study testing GLP-1 Receptor Agonist Therapy and Structured Lifestyle Intervention in people with Obesity & Overweight and Cardiometabolic Health Indicators, run by Texas Tech University at 1 site in United States.
Trial summary
This study examines how two different weight-loss strategies affect heart and metabolic health, as well as changes at the molecular level in the body. One group includes adults who are starting a GLP-1 receptor agonist medication (i.e., semaglutide or tirzepatide) prescribed by their own doctor for weight loss. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity & Overweight, Cardiometabolic Health Indicators, Addiction
- What is being tested?
- GLP-1 Receptor Agonist Therapy and Structured Lifestyle Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2025to 7 Dec 2026
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- BMI of 27.5 kg/m2 or higher
- For GLP-1 RA arm: initiating semaglutide or tirzepatide for weight loss as prescribed by their own medical provider
- For LS comparator arm: not currently taking a GLP-1 receptor agonist or other weight-loss medication, and no use of weight-loss medication within the past 3 months
Who cannot join
- Pregnant
- Breastfeeding
- Wears a pacemaker or other internal medical device
- Chronic kidney disease in the past 2 years
- Active cancer or cancer treatment within the past 6 months
- Current diagnosis of any major endocrine, inflammatory, cardiovascular, or neurological disorder/condition, including Addison's disease, autism, congestive heart failure, Crohn's disease, Cushing's syndrome, hyperparathyroidism, multiple sclerosis, neuromuscular disorders (Guillain-Barre syndrome or myasthenia gravis), stroke, thyroid gland disorders (hyperthyroidism or hypothyroidism), type 1 diabetes, and ulcerative colitis
- Insulin therapy for type 2 diabetes
- For LS comparator arm only: initiating any weight-loss medication (including a GLP-1 receptor agonist) currently or within the past 3 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Nutrition Metabolic Health Initiative (NMHI)
Lubbock, Texas, 79410
Shannon Dr. Galyean, PhD, +18068342286, Shannon.Galyean@ttu.edu
About this study
Official title: Tirzepatide Impact Assessment: Exploring Health and Wellness Outcomes
This study examines how two different weight-loss strategies affect heart and metabolic health, as well as changes at the molecular level in the body. One group includes adults who are starting a GLP-1 receptor agonist medication (i.e., semaglutide or tirzepatide) prescribed by their own doctor for weight loss. The other group includes adults who will participate in a structured lifestyle program combining a reduced-calorie diet with increased physical activity. Both groups complete assessments at the start of the study and again after three months.
At each visit, participants have their weight, body composition, blood pressure, and resting metabolic rate measured. A blood draw is collected to evaluate cholesterol, blood sugar, insulin, appetite hormones, and liver and kidney function markers, and to analyze gene activity (RNA sequencing) and metabolites, which are small molecules that reflect how the body is using energy and nutrients. Participants also complete online questionnaires about diet, disordered eating, stress, mental health, and quality of life. Those in the lifestyle group attend three individual nutrition and physical activity counseling sessions over the course of the study.
Read more
The main goals of the study are (1) to determine whether GLP-1 receptor agonist medication or lifestyle changes produce greater improvements in heart and metabolic health markers over three months; (2) to examine if GLP-1 receptor agonist medication or lifestyle changes produce greater improvement in disordered eating, stress, mental health, and quality of life; (3) to investigate if GLP-1 receptor agonist medication or lifestyle changes produce greater improvement in appetite-related hormones (i.e., ghrelin, GLP-1, insulin, leptin, and peptide YY); and (4) to explore whether the two approaches cause different changes in gene expression and metabolic profiles. This is a pilot study conducted at Texas Tech University's Nutrition and Metabolic Health Initiative clinic in Lubbock, Texas.
Who can participate: Adults aged 18 years and older with a BMI of 27.5 or higher who are either starting semaglutide or tirzepatide therapy for weight management or who are seeking weight management without the use of weight-loss medications.
Who cannot participate: Individuals who are pregnant or lactating, have a pacemaker or internal medical device, have certain serious medical conditions (such as active cancer, uncontrolled hypertension, or severe kidney disease), have type 1 diabetes, or use insulin for type 2 diabetes.
Read the detailed description
This prospective non-randomized comparative pilot study is conducted at the Nutrition and Metabolic Health Initiative (NMHI) clinic at Texas Tech University in Lubbock, Texas. The study includes two arms: a GLP-1 receptor agonist (GLP-1 RA) arm and a lifestyle (LS) comparator arm. GLP-1 RA arm participants are recruited from obesity medicine and aesthetics clinics in Lubbock, Texas, and enrolled within 0 to 3 days of initiating semaglutide or tirzepatide as prescribed by their own medical provider. LS comparator arm participants are recruited from the community via flyers, community events, hospital intranet postings, and university listservs; they will receive a structured behavioral intervention at no cost.
Each arm follows a two-visit assessment schedule at baseline and at three months. In-person visits include anthropometric measurement, bioelectrical impedance analysis for body composition, resting metabolic rate assessment via MedGem indirect calorimetry, blood pressure measurement (average of two readings after a five-minute rest), and venipuncture for biological sample collection. Blood is drawn into serum-separating tubes and an EDTA tube. Serum is processed for lipid panels, basal metabolic panels, hepatic and renal function markers including alanine aminotransferase, aspartate aminotransferase, total bilirubin, and creatinine, as well as appetite-related hormones including ghrelin, GLP-1, insulin, leptin, and peptide YY. The EDTA tube is processed for whole-blood RNA sequencing and untargeted metabolomics. Participants also wear a Garmin device for two weeks following the baseline visit to monitor sleep, heart rate, and oxygen saturation. Online questionnaires are completed via Qualtrics prior to each in-person visit.
LS comparator participants receive three individual lifestyle education sessions across the study period: at baseline, at one month, and at two months. Sessions may be completed in person or via a HIPAA-secured video platform and last approximately 30 to 45 minutes each. Each participant's total energy expenditure (TEE) is estimated by multiplying measured resting metabolic rate by a physical activity factor. Participants are instructed to follow a 500 kilocalorie daily deficit from TEE and to accumulate 150 to 300 minutes of moderate-intensity physical activity per week. Meal plans are based on the Academy of Nutrition and Dietetics Nutrition Care Manual. Dietary and physical activity adherence is monitored using MyFitnessPal or a food journal, with records reviewed at each session.
Given the pilot nature of this study, the primary emphasis is on effect size estimation and variance characterization to inform future adequately powered trials rather than definitive hypothesis testing. For example, with 12 participants in the GLP-1 receptor agonist arm and 15 participants in the LS comparator arm, the study is powered to detect only large between-group differences in cardiometabolic outcomes. Transcriptomic and metabolomic findings should be interpreted as hypothesis-generating. IRB approval was obtained prior to study initiation (IRB Number: IRB2024-370).
- Conditions
- Obesity & Overweight, Cardiometabolic Health Indicators, Addiction, Eating Disorders, Mental Health
- Being tested
- GLP-1 Receptor Agonist Therapy, Structured Lifestyle Intervention
- Keywords
- GLP-1 receptor agonists, obesity, Multi-omics profiling, Semaglutide, Tirzepatide, Appetite Regulation, Addictive Behaviors, eating disorders, appetite-related hormones, mental health
- Medical subject headings
- Obesity, Overweight, Behavior, Addictive, Feeding and Eating Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLP-1 Receptor Agonist TherapyDrug
Participants receive semaglutide or tirzepatide as prescribed by their own medical provider prior to study enrollment. Dosing and titration followed the prescribing provider's clinical judgment and are not controlled by the study team. Both medications are GLP-1 receptor agonists approved for weight management and glycemic control; tirzepatide additionally acts on the glucose-dependent insulinotropic polypeptide (GIP) receptor.
Structured Lifestyle InterventionBehavioural
A reduced-calorie diet providing a 500 kcal daily deficit from individually calculated total energy expenditure, combined with a goal of 150 to 300 minutes of moderate-intensity physical activity per week. Total energy expenditure is estimated by multiplying each participant's measured resting metabolic rate (MedGem indirect calorimetry) by a standard physical activity factor. Meal plans are based on the Academy of Nutrition and Dietetics Nutrition Care Manual. Three individual counseling sessions are delivered over three months in person or via a HIPAA-secured video platform.
| Study group | Role | What they receive |
|---|---|---|
| GLP-1 Receptor Agonist (Semaglutide or Tirzepatide) | Experimental | Individuals in this study arm will be prescribed semaglutide or tirzepatide for weight management by their primary medical provider. Individuals will be invited to enroll in the study if they are starting semaglutide or tirzepatide within 0-3 days of coming into the NMHI clinic for their baseline assessment. Receives: Drug: GLP-1 Receptor Agonist Therapy |
| Lifestyle Comparator Arm | Active comparator | Participants receive a structured lifestyle intervention delivered by a nutritional sciences graduate student and developed by a Registered Dietitian. The intervention targets a 500 kcal daily deficit from measured total energy expenditure and 150 to 300 minutes of moderate-intensity physical activity per week. Three individual education sessions are provided at baseline, one month, and two months. Dietary adherence is monitored via MyFitnessPal or a food journal. The same physical assessments and biospecimen collection procedures as the GLP-1 RA arm are completed at baseline and three months. Receives: Behavioral: Structured Lifestyle Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fasting Blood Glucose
Fasting serum blood glucose measured from venipuncture sample and analyzed as part of the basal metabolic panel. Used as the reference outcome for power estimation; a between-group difference of 4.71 mg/dL was the minimum detectable effect based on a prior semaglutide meta-analysis (SD = 9.9 mg/dL).
Measured: Baseline and 3 months
Change in LDL Cholesterol
Serum LDL cholesterol measured from a fasting venipuncture sample. A decrease of 10% or more from baseline is considered clinically meaningful.
Measured: Baseline and 3 months
Change in Triglycerides
Serum triglycerides measured from fasting venipuncture sample. A decrease of 30% or more from baseline is considered clinically meaningful.
Measured: Baseline and 3 months
Change in Fasting Insulin
Serum fasting insulin measured from venipuncture sample. Used alongside fasting glucose to characterize insulin resistance.
Measured: Baseline and 3 months
Change in Blood Pressure
Systolic and diastolic blood pressure measured using a digital monitor after a five-minute rest period. The average of two readings taken five minutes apart is recorded.
Measured: Baseline and 3 months
Change in Disordered Eating
Disordered eating characteristics including dietary restraint, eating concern, shape concern, and weight concern assessed using the Eating Disorder Examination Questionnaire (EDE-Q) administered via Qualtrics.
Measured: Baseline and 3 months
Change in Food Addiction
Food addiction symptom count and severity assessed using the Modified Yale Food Addiction Scale Version 2.0 (mYFAS 2.0) administered via Qualtrics.
Measured: Baseline and 3 months
Change in Alcohol Use
Alcohol use frequency, quantity, and disorder risk assessed using the Alcohol Use Disorders Identification Test (AUDIT) and a 30-day frequency and quantity measure administered via Qualtrics.
Measured: Time Frame: Baseline and 3 months
Change in Substance Use
Tobacco and other substance use assessed using the Lifetime Smoking Questionnaire and a 30-day frequency and quantity of substance use measure administered via Qualtrics.
Measured: Time Frame: Baseline and 3 months
Change in Depressive Symptoms and Suicidal Ideation
Depressive symptom severity and suicidal ideation assessed using the Patient Health Questionnaire-9 (PHQ-9) administered via Qualtrics.
Measured: Time Frame: Baseline and 3 months
Change in Anxiety
Generalized anxiety symptom severity assessed using the Generalized Anxiety Disorder-7 (GAD-7) administered via Qualtrics.
Measured: Baseline and 3 months
Change in Perceived Stress
Perceived psychological stress assessed using the Perceived Stress Scale (PSS) administered via Qualtrics.
Measured: Baseline and 3 months
Change in Fatigue
Fatigue severity assessed using the Fatigue Assessment Scale (FAS) administered via Qualtrics.
Measured: Baseline and 3 months
Secondary outcomes (9)
Differential Gene Expression Profiles
Whole-blood RNA sequencing analyzed using DESeq2 to identify differentially expressed genes from baseline to 3 months within each arm and between arms. Gene Set Enrichment Analysis used to identify enriched biological pathways.
Measured: Baseline and 3 months
Change in Plasma Metabolomic Signatures
Untargeted metabolomics conducted on plasma samples. Univariate and multivariate analyses including principal component analysis and partial least squares discriminant analysis performed using the MetaboAnalyst R package.
Measured: Baseline and 3 months
Association Between Gene Expression Changes and Cardiometabolic Outcome Changes
Pearson or Spearman correlations and partial least squares regression used to examine associations between transcriptomic change scores and changes in lipid panel, blood glucose, insulin, and blood pressure within and between arms.
Measured: Baseline and 3 months
Change in Dietary Intake
Dietary intake patterns assessed using the Short Food Frequency Questionnaire administered via Qualtrics.
Measured: Baseline and 3 months
Change in Physical Activity
Self-reported physical activity level assessed using the Rapid Assessment of Physical Activity (RAPA) questionnaire administered via Qualtrics, with objective daily step count additionally tracked via Garmin Vivofit4 watch throughout the 3-month study period.
Measured: Baseline and 3 months
Change in Sleep Duration
Nightly sleep duration tracked continuously via Garmin Vivofit4 watch, with participants syncing device data to the Garmin app at least weekly throughout the 3-month study period.
Measured: Baseline and 3 months
Change in Health-Related Quality of Life
General health-related quality of life assessed using the WHO Health-Related Quality of Life (HRQOL) measure and gastrointestinal quality of life assessed using the Gastrointestinal Quality of Life questionnaire, both administered via Qualtrics.
Measured: Baseline and 3 months
Change in Liver Enzymes
Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) measured from a fasting venipuncture sample as indicators of hepatic function.
Measured: Baseline and 3 months
Change in Renal and Hepatic Markers
Serum total bilirubin and creatinine measured from a fasting venipuncture sample as indicators of hepatic and renal function.
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start2 Jan 2025
- Primary completion23 Nov 2026 (estimated)
- Study completion7 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas Tech University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melissa Chernoff, Texas Tech University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07740291
- Sponsor's protocol ID
- IRB2024-370
- Acronym
- TIA
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- 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 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tirzepatide Impact Assessment: Exploring Health and Wellness Outcomes
- ClinicalTrials.gov ID
- NCT07740291
- Acronym / sponsor ID
- TIA / IRB2024-370
- Conditions
- Obesity & Overweight, Cardiometabolic Health Indicators, Addiction, Eating Disorders, Mental Health
- Keywords
- GLP-1 receptor agonists, obesity, Multi-omics profiling, Semaglutide, Tirzepatide, Appetite Regulation, Addictive Behaviors, eating disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Texas Tech UniversityUniversity, hospital or other
- Study start
- 2 Jan 2025 (actual)
- Primary completion
- 23 Nov 2026 (estimated)
- Study completion
- 7 Dec 2026 (estimated)
- First posted
- 31 Jul 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.
This study examines how two different weight-loss strategies affect heart and metabolic health, as well as changes at the molecular level in the body. One group includes adults who are starting a GLP-1 receptor agonist medication (i.e., semaglutide or tirzepatide) prescribed by their own doctor for weight loss. The other group includes adults who will participate in a structured lifestyle program combining a reduced-calorie diet with increased physical activity. Both groups complete assessments at the start of the study and again after three months.
At each visit, participants have their weight, body composition, blood pressure, and resting metabolic rate measured. A blood draw is collected to evaluate cholesterol, blood sugar, insulin, appetite hormones, and liver and kidney function markers, and to analyze gene activity (RNA sequencing) and metabolites, which are small molecules that reflect how the body is using energy and nutrients. Participants also complete online questionnaires about diet, disordered eating, stress, mental health, and quality of life. Those in the lifestyle group attend three individual nutrition and physical activity counseling sessions over the course of the study.
The main goals of the study are (1) to determine whether GLP-1 receptor agonist medication or lifestyle changes produce greater improvements in heart and metabolic health markers over three months; (2) to examine if GLP-1 receptor agonist medication or lifestyle changes produce greater improvement in disordered eating, stress, mental health, and quality of life; (3) to investigate if GLP-1 receptor agonist medication or lifestyle changes produce greater improvement in appetite-related hormones (i.e., ghrelin, GLP-1, insulin, leptin, and peptide YY); and (4) to explore whether the two approaches cause different changes in gene expression and metabolic profiles. This is a pilot study conducted at Texas Tech University's Nutrition and Metabolic Health Initiative clinic in Lubbock, Texas.
Who can participate: Adults aged 18 years and older with a BMI of 27.5 or higher who are either starting semaglutide or tirzepatide therapy for weight management or who are seeking weight management without the use of weight-loss medications.
Who cannot participate: Individuals who are pregnant or lactating, have a pacemaker or internal medical device, have certain serious medical conditions (such as active cancer, uncontrolled hypertension, or severe kidney disease), have type 1 diabetes, or use insulin for type 2 diabetes.
Detailed description
This prospective non-randomized comparative pilot study is conducted at the Nutrition and Metabolic Health Initiative (NMHI) clinic at Texas Tech University in Lubbock, Texas. The study includes two arms: a GLP-1 receptor agonist (GLP-1 RA) arm and a lifestyle (LS) comparator arm. GLP-1 RA arm participants are recruited from obesity medicine and aesthetics clinics in Lubbock, Texas, and enrolled within 0 to 3 days of initiating semaglutide or tirzepatide as prescribed by their own medical provider. LS comparator arm participants are recruited from the community via flyers, community events, hospital intranet postings, and university listservs; they will receive a structured behavioral intervention at no cost.
Each arm follows a two-visit assessment schedule at baseline and at three months. In-person visits include anthropometric measurement, bioelectrical impedance analysis for body composition, resting metabolic rate assessment via MedGem indirect calorimetry, blood pressure measurement (average of two readings after a five-minute rest), and venipuncture for biological sample collection. Blood is drawn into serum-separating tubes and an EDTA tube. Serum is processed for lipid panels, basal metabolic panels, hepatic and renal function markers including alanine aminotransferase, aspartate aminotransferase, total bilirubin, and creatinine, as well as appetite-related hormones including ghrelin, GLP-1, insulin, leptin, and peptide YY. The EDTA tube is processed for whole-blood RNA sequencing and untargeted metabolomics. Participants also wear a Garmin device for two weeks following the baseline visit to monitor sleep, heart rate, and oxygen saturation. Online questionnaires are completed via Qualtrics prior to each in-person visit.
LS comparator participants receive three individual lifestyle education sessions across the study period: at baseline, at one month, and at two months. Sessions may be completed in person or via a HIPAA-secured video platform and last approximately 30 to 45 minutes each. Each participant's total energy expenditure (TEE) is estimated by multiplying measured resting metabolic rate by a physical activity factor. Participants are instructed to follow a 500 kilocalorie daily deficit from TEE and to accumulate 150 to 300 minutes of moderate-intensity physical activity per week. Meal plans are based on the Academy of Nutrition and Dietetics Nutrition Care Manual. Dietary and physical activity adherence is monitored using MyFitnessPal or a food journal, with records reviewed at each session.
Given the pilot nature of this study, the primary emphasis is on effect size estimation and variance characterization to inform future adequately powered trials rather than definitive hypothesis testing. For example, with 12 participants in the GLP-1 receptor agonist arm and 15 participants in the LS comparator arm, the study is powered to detect only large between-group differences in cardiometabolic outcomes. Transcriptomic and metabolomic findings should be interpreted as hypothesis-generating. IRB approval was obtained prior to study initiation (IRB Number: IRB2024-370).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GLP-1 Receptor Agonist (Semaglutide or Tirzepatide) | Experimental | Drug: GLP-1 Receptor Agonist TherapyIndividuals in this study arm will be prescribed semaglutide or tirzepatide for weight management by their primary medical provider. Individuals will be invited to enroll in the study if they are starting semaglutide or tirzepatide within 0-3 days of coming into the NMHI clinic for their baseline assessment. |
| Lifestyle Comparator Arm | Active comparator | Behavioral: Structured Lifestyle InterventionParticipants receive a structured lifestyle intervention delivered by a nutritional sciences graduate student and developed by a Registered Dietitian. The intervention targets a 500 kcal daily deficit from measured total energy expenditure and 150 to 300 minutes of moderate-intensity physical activity per week. Three individual education sessions are provided at baseline, one month, and two months. Dietary adherence is monitored via MyFitnessPal or a food journal. The same physical assessments and biospecimen collection procedures as the GLP-1 RA arm are completed at baseline and three months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older
- BMI of 27.5 kg/m2 or higher
- For GLP-1 RA arm: initiating semaglutide or tirzepatide for weight loss as prescribed by their own medical provider
- For LS comparator arm: not currently taking a GLP-1 receptor agonist or other weight-loss medication, and no use of weight-loss medication within the past 3 months
Key exclusion criteria (8 listed)
- Pregnant
- Breastfeeding
- Wears a pacemaker or other internal medical device
- Chronic kidney disease in the past 2 years
- Active cancer or cancer treatment within the past 6 months
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 |
|---|---|---|
| GLP-1 Receptor Agonist TherapyParticipants receive semaglutide or tirzepatide as prescribed by their own medical provider prior to study enrollment. Dosing and titration followed the prescribing provider's clinical judgment and are not controlled by the study team. Both medications are GLP-1 receptor agonists approved for weight management and glycemic control; tirzepatide additionally acts on the glucose-dependent insulinotropic polypeptide (GIP) receptor. | Drug | GLP-1 Receptor Agonist (Semaglutide or Tirzepatide) |
| Structured Lifestyle InterventionA reduced-calorie diet providing a 500 kcal daily deficit from individually calculated total energy expenditure, combined with a goal of 150 to 300 minutes of moderate-intensity physical activity per week. Total energy expenditure is estimated by multiplying each participant's measured resting metabolic rate (MedGem indirect calorimetry) by a standard physical activity factor. Meal plans are based on the Academy of Nutrition and Dietetics Nutrition Care Manual. Three individual counseling sessions are delivered over three months in person or via a HIPAA-secured video platform. | Behavioural | Lifestyle Comparator Arm |
Primary outcome
Change in Fasting Blood Glucose
Time frame: Baseline and 3 months
Fasting serum blood glucose measured from venipuncture sample and analyzed as part of the basal metabolic panel. Used as the reference outcome for power estimation; a between-group difference of 4.71 mg/dL was the minimum detectable effect based on a prior semaglutide meta-analysis (SD = 9.9 mg/dL).
Change in LDL Cholesterol
Time frame: Baseline and 3 months
Serum LDL cholesterol measured from a fasting venipuncture sample. A decrease of 10% or more from baseline is considered clinically meaningful.
Change in Triglycerides
Time frame: Baseline and 3 months
Serum triglycerides measured from fasting venipuncture sample. A decrease of 30% or more from baseline is considered clinically meaningful.
Change in Fasting Insulin
Time frame: Baseline and 3 months
Serum fasting insulin measured from venipuncture sample. Used alongside fasting glucose to characterize insulin resistance.
Change in Blood Pressure
Time frame: Baseline and 3 months
Systolic and diastolic blood pressure measured using a digital monitor after a five-minute rest period. The average of two readings taken five minutes apart is recorded.
Change in Disordered Eating
Time frame: Baseline and 3 months
Disordered eating characteristics including dietary restraint, eating concern, shape concern, and weight concern assessed using the Eating Disorder Examination Questionnaire (EDE-Q) administered via Qualtrics.
Change in Food Addiction
Time frame: Baseline and 3 months
Food addiction symptom count and severity assessed using the Modified Yale Food Addiction Scale Version 2.0 (mYFAS 2.0) administered via Qualtrics.
Change in Alcohol Use
Time frame: Time Frame: Baseline and 3 months
Alcohol use frequency, quantity, and disorder risk assessed using the Alcohol Use Disorders Identification Test (AUDIT) and a 30-day frequency and quantity measure administered via Qualtrics.
Change in Substance Use
Time frame: Time Frame: Baseline and 3 months
Tobacco and other substance use assessed using the Lifetime Smoking Questionnaire and a 30-day frequency and quantity of substance use measure administered via Qualtrics.
Change in Depressive Symptoms and Suicidal Ideation
Time frame: Time Frame: Baseline and 3 months
Depressive symptom severity and suicidal ideation assessed using the Patient Health Questionnaire-9 (PHQ-9) administered via Qualtrics.
Change in Anxiety
Time frame: Baseline and 3 months
Generalized anxiety symptom severity assessed using the Generalized Anxiety Disorder-7 (GAD-7) administered via Qualtrics.
Change in Perceived Stress
Time frame: Baseline and 3 months
Perceived psychological stress assessed using the Perceived Stress Scale (PSS) administered via Qualtrics.
Change in Fatigue
Time frame: Baseline and 3 months
Fatigue severity assessed using the Fatigue Assessment Scale (FAS) administered via Qualtrics.
9 secondary outcomes
Differential Gene Expression Profiles
Time frame: Baseline and 3 months
Change in Plasma Metabolomic Signatures
Time frame: Baseline and 3 months
Association Between Gene Expression Changes and Cardiometabolic Outcome Changes
Time frame: Baseline and 3 months
Change in Dietary Intake
Time frame: Baseline and 3 months
Change in Physical Activity
Time frame: Baseline and 3 months
Change in Sleep Duration
Time frame: Baseline and 3 months
Change in Health-Related Quality of Life
Time frame: Baseline and 3 months
Change in Liver Enzymes
Time frame: Baseline and 3 months
Change in Renal and Hepatic Markers
Time frame: Baseline and 3 months
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 31 Jul 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.
Nutrition Metabolic Health Initiative (NMHI)
Lubbock, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GLP-1 Receptor Agonist Therapy and Structured Lifestyle Intervention in people with Obesity & Overweight and Cardiometabolic Health Indicators, run by Texas Tech University at 1 site in United States.
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 8 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: looking for participants now, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fasting Blood Glucose (time frame: Baseline and 3 months). The study lists 13 primary outcomes in all. 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 31 Jul 2026.