Lifestyle Intervention for Healthy Change

Not Applicable

Recruiting

• Conditions: Overweight and Obesity
• Interventions: Behavioral: Physical Activity; Behavioral: Nutrigenomix, personalized dietary plan; Behavioral: Standard Dietary plan; Behavioral: Behavioral counseling

• Registration Number: NCT05956574
• Lead Sponsor: Augusta University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-13
• Study First Submitted QC: 2023-07-13
• Study First Posted: 2023-07-21
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-17
• Last Update Posted: 2025-02-19
• Study Start: 2025-04
• Primary Completion: 2026-12
• Study Completion: 2027-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 125

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Physical Activity	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.
Control	Standard Dietary plan	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.
Nutrigenomix	Behavioral counseling	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.
Control	Behavioral counseling	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.
Nutrigenomix	Nutrigenomix, personalized dietary plan	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.
Nutrigenomix	Physical Activity	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.

Primary Outcome Measures

Name	Time	Method
Total body weight	6-months	Use of scale to measure total body weight

Trial Locations

Locations (1)

Augusta University; 🇺🇸 Augusta, Georgia, United States