Precision Nutrition for Obesity and Prediabetes Prevention in Under-supported Communities

NCT07850531 | Not Yet Recruiting DMC

• 1 other identifier: 2022-027
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity & Overweight; Prediabetes

Keywords

Precision Nutrition; Personalized Nutrition; Weight Loss; Diabetes Prevention; Nutrition Counseling; Physical Activity; Culturally Sensitive Intervention; African American Adults; Hispanic/Latino Adults; Prediabetes; Obesity

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Baseline, 6 weeks, and 12 weeks

Secondary Outcomes (14)

• Change in Hemoglobin A1C (HbA1C)

  Baseline, 6 weeks, and 12 weeks

• Change in Body Fat Percentage

  Baseline, 6 weeks, and 12 weeks

• Change in Skeletal Muscle Mass

  Baseline, 6 weeks, and 12 weeks

• Change in Waist Circumference

  Baseline, 6 weeks, and 12 weeks

• Change in Body Mass Index (BMI)

  Baseline, 6 weeks, and 12 weeks

Study Arms (2)

Precision Nutrition Intervention

EXPERIMENTAL

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

Standard Nutrition Counseling Control

ACTIVE COMPARATOR

Participants will receive standard nutrition counseling and dietary education materials without individualized precision nutrition recommendations.

Behavioral: Standard Nutrition Counseling

Interventions

Precision Nutrition Intervention BEHAVIORAL

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.

Precision Nutrition Intervention

Standard Nutrition Counseling BEHAVIORAL

Standard nutrition counseling and educational materials are delivered in accordance with usual nutrition education practices.

Also known as: Standard Nutrition Counseling Control

Standard Nutrition Counseling Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Hemoglobin A1C (HbA1C) between 5.7% and 6.4%
• Daily access to a cell phone and the internet
• Able to participate in moderate-to-vigorous physical activity
• Able and willing to provide informed consent

You may not qualify if:

• Following a prescribed diet for any reason, including weight loss, within the previous 3 months
• Diagnosed diabetes mellitus
• Cardiovascular disease
• Eating disorders
• Lung disease
• Liver disease
• Thyroid disease
• Crohn's disease
• Pregnant
• Lactating

Sponsors & Collaborators

• Prairie View A&M University: lead
• United States Department of Agriculture (USDA): collaborator

Study Sites (1)

integrated Nutrition Intervention for Community and Health Enhancement Laboratory (iNICHE Lab)

Prairie View, Texas, 77446, United States

Location

Related Publications (5)

• de Toro-Martin J, Arsenault BJ, Despres JP, Vohl MC. Precision Nutrition: A Review of Personalized Nutritional Approaches for the Prevention and Management of Metabolic Syndrome. Nutrients. 2017 Aug 22;9(8):913. doi: 10.3390/nu9080913.

  PMID: 28829397 BACKGROUND

• Jinnette R, Narita A, Manning B, McNaughton SA, Mathers JC, Livingstone KM. Does Personalized Nutrition Advice Improve Dietary Intake in Healthy Adults? A Systematic Review of Randomized Controlled Trials. Adv Nutr. 2021 Jun 1;12(3):657-669. doi: 10.1093/advances/nmaa144.

  PMID: 33313795 BACKGROUND

• Livingstone KM, Ramos-Lopez O, Perusse L, Kato H, Ordovas JM, Martinez JA. Precision nutrition: A review of current approaches and future endeavors. Trends in Food Science and Technology. 2022.

  BACKGROUND

• Ordovas JM, Ferguson LR, Tai ES, Mathers JC. Personalised nutrition and health. BMJ. 2018 Jun 13;361:bmj.k2173. doi: 10.1136/bmj.k2173.

  PMID: 29898881 BACKGROUND

• Celis-Morales C, Livingstone KM, Marsaux CF, Macready AL, Fallaize R, O'Donovan CB, Woolhead C, Forster H, Walsh MC, Navas-Carretero S, San-Cristobal R, Tsirigoti L, Lambrinou CP, Mavrogianni C, Moschonis G, Kolossa S, Hallmann J, Godlewska M, Surwillo A, Traczyk I, Drevon CA, Bouwman J, van Ommen B, Grimaldi K, Parnell LD, Matthews JN, Manios Y, Daniel H, Martinez JA, Lovegrove JA, Gibney ER, Brennan L, Saris WH, Gibney M, Mathers JC; Food4Me Study. Effect of personalized nutrition on health-related behaviour change: evidence from the Food4Me European randomized controlled trial. Int J Epidemiol. 2017 Apr 1;46(2):578-588. doi: 10.1093/ije/dyw186.

  PMID: 27524815 BACKGROUND

Related Links

• Prairie View A\&M University

MeSH Terms

Conditions

Obesity; Overweight; Prediabetic State; Weight Loss; Motor Activity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Body Weight Changes; Behavior

Study Officials

• Janet Antwi, B.Pharm, M.S, Ph.D, RPh, RD,

  Prairie View A&M University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Janet Antwi, B.Pharm, M.S, Ph.D, RPh, RD,

CONTACT

9362612536; jaantwi@pvamu.edu

Obed Akwaa Harrison, PhD, MSc(R), RNutr.

CONTACT

9362612522; oaharrison@pvamu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will be informed that they would follow a healthy eating pattern, however the type of diet of each arm will not be revealed. Given the behavioral and educational nature of the intervention, only personnel providing education and counseling will be aware of the study group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will be randomized to either a precision nutrition intervention group or a control group receiving standard nutrition counseling and educational materials. Both groups will be followed concurrently throughout the study, and outcomes will be compared between groups.

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 30, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Beginning 12 months following publication of the primary study results. Data will be available for up to 5 years following publication of the primary study results.
• Access Criteria: De-identified data will be made available to qualified researchers whose proposed use of the data has been approved by the study investigators. Requests should include a methodologically sound research proposal. Data sharing may require execution of an institutional data use agreement and compliance with applicable ethical and regulatory requirements.

Locations

US (1)