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Lifestyle Intervention for Healthy Change

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05956574
Acronym
LIVE WELL
Enrollment
125
Registered
2023-07-21
Start date
2025-04-30
Completion date
2027-05-31
Last updated
2025-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight and Obesity

Keywords

physical activity, dietary intervention

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.

Interventions

BEHAVIORALNutrigenomix, personalized dietary plan

Personalized dietary plan.

BEHAVIORALPhysical Activity

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.

BEHAVIORALStandard Dietary plan

Receive a standard dietary plan

Sponsors

Augusta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Total body weight6-monthsUse of scale to measure total body weight

Countries

United States

Contacts

Primary ContactMadison Kindred, PhD
mkindred@augusta.edu774-238-0591

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026