Precision Nutrition for Obesity and Prediabetes Prevention in Under-supported Communities
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorPrairie View A&M University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 to 65 years
African American or Hispanic/Latino adults
Residents of Texas
Body mass index (BMI) ≥ 25 kg/m² and/or fasting blood glucose levels of 100-125 mg/dL
Disqualifiers
Do not meet the inclusion criteria
Following a prescribed diet for any reason, including weight loss, within the previous 3 months
Diagnosed diabetes mellitus
Cardiovascular disease
Trial design
Design model
Parallel
Treatments tested in this trial
Precision Nutrition Intervention
BehavioralA 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
BehavioralStandard nutrition counseling and educational materials are delivered in accordance with usual nutrition education practices.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Precision Nutrition InterventionExperimental treatment 1 intervention
Group B: Standard Nutrition Counseling ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 weeks2
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 weeks3
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 weeksSecondary outcomes
1
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 weeks2
Change in Body Fat Percentage
Change in body fat percentage (%) measured using body composition assessment methods.
Time frame
Baseline, 6 weeks, and 12 weeks3
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 weeks4
Change in Waist Circumference
Change in waist circumference, expressed in centimeters (cm), measured using standardized anthropometric procedures.
Time frame
Baseline, 6 weeks, and 12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Prairie View A&M University
Lead sponsor
United States Department of Agriculture (USDA)
Collaborator
Source ClinicalTrials.gov
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