Lifestyle Intervention for Healthy Change (LIVE WELL)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Overweight and Obesity
• Intervention / Treatment: Behavioral: Nutrigenomix, personalized dietary plan; Behavioral: Physical Activity; Behavioral: Behavioral counseling; Behavioral: Standard Dietary plan

• Study Type: Interventional
• Enrollment (Estimated): 125
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Madison Kindred, PhD; Phone Number: 774-238-0591; Email: mkindred@augusta.edu

Study Locations

• United States
  • Georgia
    • Augusta, Georgia, United States, 30909
      • Recruiting
      • Augusta University
      • Contact: Madison Kindred, PhD
      • Principal Investigator: Madison Kindred, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total body weight	Use of scale to measure total body weight	6-months

Collaborators and Investigators

• Sponsor: Augusta University
• Investigators: Principal Investigator: Madison Kindred, PhD, Augusta University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: July 13, 2023
• First Submitted That Met QC Criteria: July 13, 2023
• First Posted (Actual): July 21, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 17, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: physical activity; dietary intervention
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight
• Other Study ID Numbers: 2020021-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No