NCT05956574

Lifestyle Intervention for Healthy Change

Healthy Living: Incorporating Lifestyle Interventions to Encourage a Reduction in Body Weight.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 125 (estimated)
• Sponsor: Augusta University · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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

Interventions

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

Timeline

• Start date: 2025-04-01
• Primary completion: 2026-12-01
• Completion: 2027-05-01
• First posted: 2023-07-21
• Last updated: 2025-02-19

Locations

1 site across 1 country: United States