beta
Trial Radar AI
Clinical Trial NCT05956574 (LIVE WELL) for Overweight and Obesity is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
One trial matched filter criteria
Card View
Back to Search

Lifestyle Intervention for Healthy Change (LIVE WELL)

Recruiting
Clinical Trial NCT05956574 (LIVE WELL) is an interventional study for Overweight and Obesity that is recruiting. It started on 1 April 2025 with plans to enroll 125 participants. Led by Augusta University, it is expected to complete by 1 May 2027. The latest data from ClinicalTrials.gov was last updated on 19 February 2025.
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.
Official Title

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

Conditions
Overweight and Obesity
Other Study IDs
  • LIVE WELL
  • 2020021-2
NCT ID Number
NCT05956574
Start Date (Actual)
2025-04
Last Update Posted
2025-02-19
Completion Date (Estimated)
2027-05
Enrollment (Estimated)
125
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
physical activity
dietary intervention
Primary Purpose
Other
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalNutrigenomix
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, Personalized Dietary Plan
Personalized dietary plan.
Physical Activity
Participate in an exercise program to work up to 300 min/week of moderate-intensity activity.
Behavioral Counseling
Review behavioral counseling videos and participate in worksheets to assist with behavioral change.
Active ComparatorControl
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.
Physical Activity
Participate in an exercise program to work up to 300 min/week of moderate-intensity activity.
Behavioral Counseling
Review behavioral counseling videos and participate in worksheets to assist with behavioral change.
Standard Dietary Plan
Receive a standard dietary plan
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Total body weight
Use of scale to measure total body weight
6-months
Eligibility Criteria

Eligible Ages
Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
  • 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

  • Under the age of 18 years
  • 40 years and older
  • Unable to participate in an exercise program
  • Currently pregnant
Augusta University logoAugusta University46 active trials to explore
Study Responsible Party
Madison Kindred, Principal Investigator, Assistant Professor, Augusta University
Study Central Contact
Contact: Madison Kindred, PhD, 774-238-0591, [email protected]
1 Study Locations in 1 Countries

Georgia

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