Recruiting

Lifestyle Intervention

Sponsor:

Augusta University

Code:

NCT05956574

Conditions

Overweight and Obesity

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Interventions

Nutrigenomix, personalized dietary plan

Physical Activity

Behavioral counseling

Standard Dietary plan

Study Details

Brief summary:

The purpose of this study is to determine the effectiveness of a physician led, multi-disciplinary approach to treating obesity that incorporates nutrition (mainly, using genetics to identify appropriate food intake), exercise, and motivational counseling. The investigators plan to recruit overweight/obese (BMI>25) males and females to participate. Participants will be randomized to receive a personalized diet plan, or a standard care diet plan; both groups will participate in the exercise intervention. For a 6-month duration, both groups will be asked to improve their diet according to their dietary plan and participate in moderate-to-vigorous physical activity (gradual increase up to 300 min/week). The investigators intend to evaluate standard outcomes of weight loss, and assess for any predictors of positive outcomes. Following the six-month intervention, participants will complete a 3-month no contact phase. This no contact phase will provide insight into the effects of the study on weight loss maintenance. Our team also plans to address acceptability by providing evaluations to study participants and conducting interviews with a small subset of participants to improve the intervention for the future.

Conditions

Overweight and Obesity

Study ID

NCT05956574

Start date

Apr, 2025

Status verified date

Feb, 2025

Completion date

May, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Age 18-40 years
  • BMI > 25 kg/m2
  • No cardiopulmonary disease
  • stable on medications for 3 months
  • weight stable (+/-5 pounds) for the past 3 months
  • Not pregnant or trying to get pregnant
  • Owns a smartphone
  • Able to walk unassisted
  • Not on supplemental oxygen

Exclusion Criteria:

  • Under the age of 18 years
  • 40 years and older
  • Unable to participate in an exercise program
  • Currently pregnant

Study Design

Enrollment

125 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Nutrigenomix

Participants in this group will be asked to complete an oral swab at baseline. This swab will indicate their dietary needs based on their genetic composition. These personalized dietary needs will be shared with the participant; the participant will be encouraged to follow their dietary plan for the duration of the study. Participants in this group will also gradually increase their physical activity up to 300 min/week at 6 months.

active comparator: Control

Participants in this group will receive a standard care dietary plan. They will also be asked to gradually increase their activity up to 300 min/week by 6 months.

Interventions

Nutrigenomix, personalized dietary plan

Personalized dietary plan.

Physical Activity

Participate in an exercise program to work up to 300 min/week of moderate-intensity activity.

Behavioral counseling

Review behavioral counseling videos and participate in worksheets to assist with behavioral change.

Standard Dietary plan

Receive a standard dietary plan

Primary outcome measure

  • Total body weight [ Time Frame: 6-months ]

Central Contacts and Locations

Central contacts

Locations

Augusta University

Recruiting

Augusta, Georgia, United States, 30909

Principal Investigator:

Madison Kindred, PhD

More Information

Sponsor

Augusta University

Last update posted

Feb 19, 2025

Last verified

Feb, 2025

Keywords

  • physical activity
  • dietary intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Augusta University on 2025-02-19.