Lifestyle Intervention for Healthy Change (LIVE WELL)

Augusta University

Status: Enrolling

Conditions: Overweight and Obesity

Treatments: Behavioral: Nutrigenomix, personalized dietary plan; Behavioral: Physical Activity; Behavioral: Behavioral counseling; Behavioral: Standard Dietary plan

Study type: Interventional

Funder types: Other

Identifiers

NCT05956574

2020021-2

Details and patient eligibility

About

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.

Enrollment: 125 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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125 participants in 2 patient groups

Nutrigenomix

Experimental group

Description:

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.

Treatment:

Behavioral: Behavioral counseling

Behavioral: Physical Activity

Behavioral: Nutrigenomix, personalized dietary plan

Control

Active Comparator group

Description:

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.

Treatment:

Behavioral: Standard Dietary plan

Behavioral: Behavioral counseling

Behavioral: Physical Activity