Lifestyle Intervention for Healthy Change

Part of paid clinical trials in Augusta, Georgia.

Sponsor
Augusta University
Study ID
NCT05956574
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 40 Years
Healthy Volunteers
Accepted

Interventions

  • Nutrigenomix, personalized dietary plan — BEHAVIORAL
    Personalized dietary plan.
  • Physical Activity — BEHAVIORAL
    Participate in an exercise program to work up to 300 min/week of moderate-intensity activity.
  • Behavioral counseling — BEHAVIORAL
    Review behavioral counseling videos and participate in worksheets to assist with behavioral change.
  • Standard Dietary plan — BEHAVIORAL
    Receive a standard dietary plan

Study Details

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.

Key Dates

Start date
Apr 30, 2025
Status verified
Feb 2025
Primary completion
Dec 31, 2026
Completion
May 31, 2027

Study Design

Enrollment
125 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

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.

Primary Outcome Measure

Total body weight [ Time Frame: 6-months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Augusta UniversityAugustaGeorgia30909
Madison Kindred, PhD
Madison Kindred, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Augusta, GA

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Augusta University· Augusta, GA

Related Studies