- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05956574
Lifestyle Intervention for Healthy Change (LIVE WELL)
July 13, 2023 updated by: Madison Kindred, Augusta University
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.
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.
Study Overview
Status
Not yet recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
125
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Madison Kindred, PhD
- Phone Number: 774-238-0591
- Email: mkindred@augusta.edu
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
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.
|
Personalized dietary plan.
Participate in an exercise program to work up to 300 min/week of moderate-intensity activity.
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.
|
Participate in an exercise program to work up to 300 min/week of moderate-intensity activity.
Review behavioral counseling videos and participate in worksheets to assist with behavioral change.
Receive a standard dietary plan
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total body weight
Time Frame: 6-months
|
Use of scale to measure total body weight
|
6-months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
October 1, 2023
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)
July 21, 2023
Last Update Submitted That Met QC Criteria
July 13, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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