NCT05956574 · Augusta University
Lifestyle Intervention for Healthy Change
(LIVE WELL)
What this study is 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.
View original scientific description
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.
Interventions
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
Primary outcome measures
Total body weight
Time frame: 6-months
Use of scale to measure total body weight
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Augusta, Georgia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 19, 2025 · Source of record for eligibility and locations