Overweight and ObesityLIVE WELLNCT05956574
Lifestyle Intervention for Healthy Change
A study testing Nutrigenomix, personalized dietary plan, Physical Activity and Behavioral counseling in people with Overweight and Obesity, run by Augusta University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Nutrigenomix, personalized dietary plan, Physical Activity and Behavioral counseling
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2025to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- Owns a smartphone
- Able to walk unassisted
- Not on supplemental oxygen
Who cannot join
- Under the age of 18 years
- 40 years and older
- Unable to participate in an exercise program
- Currently pregnant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Augusta University
Augusta, Georgia, 30909
Madison Kindred, PhD
Madison Kindred, PhD
About this study
Official title: 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.
- Conditions
- Overweight and Obesity
- Being tested
- Nutrigenomix, personalized dietary plan, Physical Activity, Behavioral counseling, Standard Dietary plan
- Keywords
- physical activity, dietary intervention
- Medical subject headings
- Overweight, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrigenomix, personalized dietary planBehavioural
Personalized dietary plan.
Physical ActivityBehavioural
Participate in an exercise program to work up to 300 min/week of moderate-intensity activity.
Behavioral counselingBehavioural
Review behavioral counseling videos and participate in worksheets to assist with behavioral change.
Standard Dietary planBehavioural
Receive a standard dietary plan
| Study group | Role | What they receive |
|---|---|---|
| Nutrigenomix | Experimental | 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. Receives: Behavioral: Nutrigenomix, personalized dietary plan; Behavioral: Physical Activity; Behavioral: Behavioral counseling |
| Control | Active comparator | 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. Receives: Behavioral: Physical Activity; Behavioral: Behavioral counseling; Behavioral: Standard Dietary plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total body weight
Use of scale to measure total body weight
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study startApr 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Madison Kindred, Augusta University
- Investigators
- Madison Kindred, PhD, Principal investigator, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05956574
- Sponsor's protocol ID
- 2020021-2
- Acronym
- LIVE WELL
- Status last verified
- Feb 2025
- First submitted
- 13 Jul 2023
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Living: Incorporating Lifestyle Interventions to Encourage a Reduction in Body Weight.
- ClinicalTrials.gov ID
- NCT05956574
- Acronym / sponsor ID
- LIVE WELL / 2020021-2
- Conditions
- Overweight and Obesity
- Keywords
- physical activity, dietary intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- Apr 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 21 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutrigenomix | Experimental | Behavioral: Nutrigenomix, personalized dietary plan, Behavioral: Physical Activity, Behavioral: Behavioral counselingParticipants 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. |
| Control | Active comparator | Behavioral: Physical Activity, Behavioral: Behavioral counseling, Behavioral: Standard Dietary planParticipants 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- Under the age of 18 years
- 40 years and older
- Unable to participate in an exercise program
- Currently pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrigenomix, personalized dietary planPersonalized dietary plan. | Behavioural | Nutrigenomix |
| Physical ActivityParticipate in an exercise program to work up to 300 min/week of moderate-intensity activity. | Behavioural | Control, Nutrigenomix |
| Behavioral counselingReview behavioral counseling videos and participate in worksheets to assist with behavioral change. | Behavioural | Control, Nutrigenomix |
| Standard Dietary planReceive a standard dietary plan | Behavioural | Control |
Primary outcome
Total body weight
Time frame: 6-months
Use of scale to measure total body weight
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Madison Kindred, PhD principal investigator
Augusta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrigenomix, personalized dietary plan, Physical Activity and Behavioral counseling in people with Overweight and Obesity, run by Augusta University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Madison Kindred, PhD (774-238-0591, mkindred@augusta.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total body weight (time frame: 6-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025; AzTrials last refreshed its copy on 31 Oct 2026.