Obesity PreventionORFNCT07341841
Assessing Obesity Related Risk Factors in Adult Population: A Genetic and Behavioral Study
A study testing Diet and exercise, Lifestyle Intervention and Exercise in people with Obesity Prevention, run by Augusta University at 1 site in United States.
Trial summary
This study aims to explore the association between Melanocortin-4 Receptor (MC4R) polymorphisms, eating habits, and social determinants of health in a heterogeneous adult population in Georgia, USA. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity Prevention
- What is being tested?
- Diet and exercise, Lifestyle Intervention and Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2026to 1 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults 18-70 years old are included in the study.
- Target populations are 4 groups:
- Group 1 - overweight (not obese), if BMI is 25.0-29.9 Kg/m2;
- Group 2 - Class 1 (lower-risk) obesity, if BMI is 30.0-34.9 Kg/m2;
- Group 3 - Class 2 (moderate-risk) obesity, if BMI is 35-39.9 Kg/m2 and
- Group 4 - Class 3 (high-risk) obesity, if BMI is equal or greater than 40 Kg/m2.
- Males and females will participate in the study.
Who cannot join
- Children younger than 18 years old and adults over 70 are excluded from the study. Non-English speakers and individuals with impaired decision-making capacity to consent are excluded from the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Assessing Obesity Related Risk Factors in Burke, Columbia, Richmond (BCR) Adult Population: A Genetic and Behavioral Study
This study aims to explore the association between Melanocortin-4 Receptor (MC4R) polymorphisms, eating habits, and social determinants of health in a heterogeneous adult population in Georgia, USA.
Read the detailed description
The study has three aims.
Aim 1: Genotyping and Participant Stratification To assess the genetic variation of the MC4R gene in the Burke-Columbia-Richmond (BCR) population using Targeted DNA sequencing technology and stratify participants into genotype-based intervention groups (e.g., risk vs. non-risk variants). We anticipate seeing differences in MC4R gene polymorphisms within the BCR residents.
Aim 2: Genotype-Informed Lifestyle Intervention To evaluate the effects of an 8-week personalized dietary and physical activity intervention and association with the frequency distribution of the MC4R variants in the BCR using modified Diet History Questionnaire II (DHQ II) and bicycle ergometer, respectively. In addition, the association between body composition and the subject's age group will be measured using BOD POD instrument. We expect to find associations between food intake and the MC4R variants within the residents of the BCR area. We also expect to see the difference between age groups and the MC4R variant based on body composition.
Primary outcome: change in body composition, primarily body fat percentage Secondary outcomes: changes in dietary patterns, physical activity, and BMI
Aim 3: Socioeconomic and environmental factors To assess whether socio-economic status and environmental inequalities influence diet quality and obesity status of the BCR residents. Data will be collected through a structured questionnaire and secondary sources, such as the U.S. Census Bureau. We expect to find differences in the obesity profiles in the BCR adult population due to socio-economic and environmental inequalities. We hypothesize that the MC4R variants, socio-economic, and environmental inequalities are correlated with eating habits and obesity status within BCR residents.
- Conditions
- Obesity Prevention
- Being tested
- Diet and exercise, Lifestyle Intervention, Exercise
- Keywords
- MC4R, gene variant. obesity, diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet and exerciseBehavioural
Diet intervention: Participants will be randomly divided into a control group (n=50) and a training group (n=50) using the simplest method of assigning participants to different treatment groups: a coin toss. They will be surveyed using the modified DHII questionnaire to assess their caloric intake. The baseline calorie intake will be evaluated during the first visit. Participants will be instructed to reduce their portion sizes by half of what they typically consume. The commitment of participants will be for 8 weeks.
Exercise intervention: In the first visit, subjects will be familiarized with exercise on a bicycle ergometer to eliminate the novel effects of a new experience. The subjects in the training group will then come to our laboratory to participate in an 8-week exercise program; the control group will not undergo training during this experimental period. The training group will train on a bicycle ergometer for 30 minutes, 3 days a week, for 8 weeks.
Lifestyle InterventionBehavioural
8-week personalized diet using a personalized low-calorie diet based on the caloric intake baseline using modified Diet History Questionnaire II (DHQ II)
ExerciseBehavioural
8-week personalized physical activity- subjects will be doing 30-minute exercise three times a week using a bicycle ergometer
| Study group | Role | What they receive |
|---|---|---|
| Screening | Other | Diet and exercise baseline Receives: Behavioral: Diet and exercise; Behavioral: Lifestyle Intervention; Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diet and exercise
Calorie intake, BMI, % fat, % lean mass.
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 posted14 Jan 2026
- Study start1 Jan 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion1 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 PreventionStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07341841
- Sponsor's protocol ID
- SPH
- Acronym
- ORF
- Status last verified
- Jan 2026
- First submitted
- 13 Jun 2025
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a pilot study
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Obesity Related Risk Factors in Burke, Columbia, Richmond (BCR) Adult Population: A Genetic and Behavioral Study
- ClinicalTrials.gov ID
- NCT07341841
- Acronym / sponsor ID
- ORF / SPH
- Conditions
- Obesity Prevention
- Keywords
- MC4R, gene variant. obesity, diet
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 14 Jan 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 aims to explore the association between Melanocortin-4 Receptor (MC4R) polymorphisms, eating habits, and social determinants of health in a heterogeneous adult population in Georgia, USA.
Detailed description
The study has three aims.
Aim 1: Genotyping and Participant Stratification To assess the genetic variation of the MC4R gene in the Burke-Columbia-Richmond (BCR) population using Targeted DNA sequencing technology and stratify participants into genotype-based intervention groups (e.g., risk vs. non-risk variants). We anticipate seeing differences in MC4R gene polymorphisms within the BCR residents.
Aim 2: Genotype-Informed Lifestyle Intervention To evaluate the effects of an 8-week personalized dietary and physical activity intervention and association with the frequency distribution of the MC4R variants in the BCR using modified Diet History Questionnaire II (DHQ II) and bicycle ergometer, respectively. In addition, the association between body composition and the subject's age group will be measured using BOD POD instrument. We expect to find associations between food intake and the MC4R variants within the residents of the BCR area. We also expect to see the difference between age groups and the MC4R variant based on body composition.
Primary outcome: change in body composition, primarily body fat percentage Secondary outcomes: changes in dietary patterns, physical activity, and BMI
Aim 3: Socioeconomic and environmental factors To assess whether socio-economic status and environmental inequalities influence diet quality and obesity status of the BCR residents. Data will be collected through a structured questionnaire and secondary sources, such as the U.S. Census Bureau. We expect to find differences in the obesity profiles in the BCR adult population due to socio-economic and environmental inequalities. We hypothesize that the MC4R variants, socio-economic, and environmental inequalities are correlated with eating habits and obesity status within BCR residents.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening | Other | Behavioral: Diet and exercise, Behavioral: Lifestyle Intervention, Behavioral: ExerciseDiet and exercise baseline |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults 18-70 years old are included in the study.
- Group 1 - overweight (not obese), if BMI is 25.0-29.9 Kg/m2;
- Group 2 - Class 1 (lower-risk) obesity, if BMI is 30.0-34.9 Kg/m2;
- Group 3 - Class 2 (moderate-risk) obesity, if BMI is 35-39.9 Kg/m2 and
- Group 4 - Class 3 (high-risk) obesity, if BMI is equal or greater than 40 Kg/m2.
Key exclusion criteria (1 listed)
- Children younger than 18 years old and adults over 70 are excluded from the study. Non-English speakers and individuals with impaired decision-making capacity to consent are excluded from the study.
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 |
|---|---|---|
| Diet and exerciseDiet intervention: Participants will be randomly divided into a control group (n=50) and a training group (n=50) using the simplest method of assigning participants to different treatment groups: a coin toss. They will be surveyed using the modified DHII questionnaire to assess their caloric intake. The baseline calorie intake will be evaluated during the first visit. Participants will be instructed to reduce their portion sizes by half of what they typically consume. The commitment of participants will be for 8 weeks. Exercise intervention: In the first visit, subjects will be familiarized with exercise on a bicycle ergometer to eliminate the novel effects of a new experience. The subjects in the training group will then come to our laboratory to participate in an 8-week exercise program; the control group will not undergo training during this experimental period. The training group will train on a bicycle ergometer for 30 minutes, 3 days a week, for 8 weeks. | Behavioural | Screening |
| Lifestyle Intervention8-week personalized diet using a personalized low-calorie diet based on the caloric intake baseline using modified Diet History Questionnaire II (DHQ II) | Behavioural | Screening |
| Exercise8-week personalized physical activity- subjects will be doing 30-minute exercise three times a week using a bicycle ergometer | Behavioural | Screening |
Primary outcome
Diet and exercise
Time frame: 8 weeks
Calorie intake, BMI, % fat, % lean mass.
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 14 Jan 2026.
- Individual participant dataSharing planned: No. This is a pilot study
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet and exercise, Lifestyle Intervention and Exercise in people with Obesity Prevention, run by Augusta 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 7 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 14 Jan 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diet and exercise (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 14 Jan 2026.