Lifestyle Intervention for Healthy Change

Overweight and Obesity Clinical Trial

— LIVE WELL  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05956574
• Other study ID #: 2020021-2
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2023
• Est. completion date: May 2027

Study information

• Verified date: July 2023
• Source: Augusta University
• Contact: Madison Kindred, PhD
• Phone: 774-238-0591
• Email: mkindred[@]augusta.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. We 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). We 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 125
• Est. completion date: May 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

Behavioral:
• 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.
• Standard Dietary plan
Receive a standard dietary plan

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Augusta University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total body weight	Use of scale to measure total body weight	6-months