An interventional study of Precision Nutrition Intervention and Standard Nutrition Counseling in Obesity & Overweight and Prediabetes, sponsored by Prairie View A&M University. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Prairie View A&M University · Not applicable, Interventional, and Treatment
This randomized controlled trial will evaluate the effectiveness of a culturally sensitive precision nutrition intervention for improving obesity- and diabetes-related outcomes among African American and Hispanic/Latino adults who are overweight, obese, or have prediabetes. Participants will be randomized to either a precision nutrition intervention group or a control group receiving standard nutrition counseling and educational materials. The intervention incorporates individualized dietary recommendations based on participant characteristics, including dietary habits, physical activity, socioeconomic factors, psychosocial factors, phenotype, and genotype. Outcomes will be assessed at baseline, 6 weeks, and 12 weeks and will include body weight, diet quality, fasting blood glucose, hemoglobin A1C, body composition, physical activity, blood pressure, and metabolic biomarkers. Feasibility, acceptability, and sustainability of the intervention will also be evaluated.
Obesity and prediabetes are major public health concerns and disproportionately affect under-supported populations, including African American and Hispanic/Latino communities. Traditional nutrition interventions often use a one-size-fits-all approach and may not adequately account for individual variability in biological, behavioral, and environmental factors that influence health outcomes. Precision nutrition is an emerging approach that tailors nutrition recommendations to individual characteristics such as dietary intake, physical activity, health status, genotype, phenotype, psychosocial influences, and environmental exposures. Advances in nutrition science, artificial intelligence, and machine learning have created opportunities to integrate these factors and deliver more personalized dietary and lifestyle recommendations. The purpose of this study is to determine whether a culturally sensitive precision nutrition intervention can improve obesity and type 2 diabetes risk factors among African American and Hispanic/Latino adults living in Texas. The study will recruit adults aged 18 to 65 years with overweight, obesity, and/or prediabetes. Participants will be randomized to either an intervention group or a control group. The intervention group will receive tailored nutrition counseling, individualized meal planning, physical activity guidance, behavior-change education, and access to a mobile-health platform to support healthy lifestyle modification. The intervention will incorporate motivational interviewing techniques and social support resources. The control group will receive standard nutrition counseling and educational materials. Data collection will occur at baseline, 6 weeks, and 12 weeks. Measures will include sociodemographic information, dietary intake, food security, anthropometric and body composition assessments, physical activity, blood pressure, fasting blood glucose, hemoglobin A1C, lipid profile, genetic markers, gut microbiome measures, inflammatory markers, and cognitive assessments. Qualitative interviews and focus group discussions will be used to explore participant experiences and intervention acceptability. Primary outcomes include changes in body weight, diet quality, and fasting blood glucose. Secondary outcomes include changes in hemoglobin A1C, body composition, blood pressure, lipid profile, physical activity levels, feasibility, acceptability, compliance, and sustainability of intervention effects. Findings from this study will provide preliminary evidence regarding the effectiveness and feasibility of precision nutrition approaches for obesity and diabetes prevention in under-supported populations.
Exclusion Criteria:
Participants will receive a culturally sensitive precision nutrition intervention including individualized nutrition counseling, personalized meal planning, physical activity guidance, health behavior lessons, mobile-health support, motivational interviewing, and social support resources.
Behavioral: Precision Nutrition Intervention
Participants will receive standard nutrition counseling and dietary education materials without individualized precision nutrition recommendations.
Behavioral: Standard Nutrition Counseling
A personalized precision nutrition program tailored to participants' dietary habits, physical activity, socioeconomic characteristics, psychosocial factors, phenotype, and genotype. The intervention includes nutrition counseling, physical activity guidance, behavioral education, mobile-health support, and social support activities.
Standard nutrition counseling and educational materials are delivered in accordance with usual nutrition education practices.
Also known as: Standard Nutrition Counseling Control
Change in Body Weight
Change in measured body weight, expressed in kilograms (kg), from baseline following participation in the precision nutrition intervention or standard nutrition counseling control condition.
Time frame: Baseline, 6 weeks, and 12 weeks
Change in Healthy Eating Index (HEI)-2020 Total Score
Change in Healthy Eating Index (HEI)-2020 total score derived from participants' dietary intake data collected using 24-hour dietary recalls. HEI-2020 scores range from 0 to 100, with higher scores indicating better diet quality and greater adherence to the Dietary Guidelines for Americans.
Time frame: Baseline, 6 weeks, and 12 weeks
Change in Fasting Blood Glucose
Change in fasting blood glucose concentration, expressed in milligrams per deciliter (mg/dL), from baseline following participation in the precision nutrition intervention or standard nutrition counseling control condition.
Time frame: Baseline, 6 weeks, and 12 weeks
Change in Hemoglobin A1C (HbA1C)
Change in haemoglobin A1C concentration, expressed as a percentage of total haemoglobin (%), as a measure of long-term glycemic control.
Time frame: Baseline, 6 weeks, and 12 weeks
Change in Body Fat Percentage
Change in body fat percentage (%) measured using body composition assessment methods.
Time frame: Baseline, 6 weeks, and 12 weeks
Change in Skeletal Muscle Mass
Change in skeletal muscle mass, expressed in kilograms (kg), measured using body composition assessment methods. Change in skeletal muscle mass, expressed in kilograms (kg), measured using body composition assessment methods.
Time frame: Baseline, 6 weeks, and 12 weeks
Change in Waist Circumference
Change in waist circumference, expressed in centimeters (cm), measured using standardized anthropometric procedures.
Time frame: Baseline, 6 weeks, and 12 weeks
Change in Body Mass Index (BMI)
Change in body mass index (BMI), calculated as weight in kilograms divided by height in meters squared (kg/m²).
Time frame: Baseline, 6 weeks, and 12 weeks
Change in Average Daily Step Count
Change in average daily step count measured using a pedometer.
Time frame: Baseline, 6 weeks, and 12 weeks
Change in Energy Expenditure
Change in activity-related energy expenditure, expressed in kilocalories per day (kcal/day), measured using a pedometer or activity-monitoring device.
Time frame: Baseline, 6 weeks, and 12 weeks
Change in Blood Pressure
Change in Change in systolic and diastolic blood pressure measurements, expressed in millimeters of mercury (mmHg), measured using standardized procedures.
Time frame: Baseline, 6 weeks, and 12 weeks
Change in Lipid Profile
Change in total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride concentrations, expressed in milligrams per deciliter (mg/dL).
Time frame: Baseline, 6 weeks, and 12 weeks
Program Compliance
Percentage of prescribed nutrition counseling activities, dietary recommendations, and physical activity recommendations completed by participants during the intervention period.
Time frame: Throughout study completion (up to 12 weeks)
Participant Recruitment Rate
Percentage of eligible individuals who enroll in the study among all individuals screened for participation.
Time frame: Throughout study completion (up to 12 weeks)
Participant Retention Rate
Percentage of enrolled participants who complete all study assessments through the end of the intervention period.
Time frame: Throughout study completion (up to 12 weeks)
Participant Satisfaction Questionnaire Score
Participant satisfaction with the intervention measured using a study-specific satisfaction questionnaire. The level of satisfaction will be scored on a likert scale.
Time frame: Throughout study completion (up to 12 weeks)
Program Favorability Questionnaire Score
Participant perceptions of the intervention measured using a study-specific program favorability questionnaire. Scores will be on a likert scale that reflects perceptions of the intervention.
Time frame: Throughout study completion (up to 12 weeks)
Plan to share: Yes — De-identified individual participant data underlying the results reported in publications, including demographic, dietary, anthropometric, physical activity, metabolic, and survey data collected during the study.
Supporting information: Study protocol, Sap, Icf, Analytic code
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Prairie View A&M University