Assessing Obesity Related Risk Factors in Adult Population: A Genetic and Behavioral Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Diet and exercise, Lifestyle Intervention, Exercise.
- Who it may be relevant to
- Registry conditions: Obesity Prevention. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Assessing Obesity Related Risk Factors in Burke, Columbia, Richmond (BCR) Adult Population: A Genetic and Behavioral Study
Overview
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.
Interventions
- Behavioral Diet and exercise
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 participa - Behavioral Lifestyle Intervention
8-week personalized diet using a personalized low-calorie diet based on the caloric intake baseline using modified Diet History Questionnaire II (DHQ II) - Behavioral Exercise
8-week personalized physical activity- subjects will be doing 30-minute exercise three times a week using a bicycle ergometer
Primary outcome measures
- Diet and exercise [Time frame: 8 weeks]
Eligibility criteria
Inclusion criteria
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.
Exclusion criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Screening
Study locations
United States · 1 center
- Augusta University — Augusta
Identifiers
NCT: NCT07341841 · SPH