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Lifestyle Intervention for Healthy Change

NCT05956574 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2025-02-19

No results posted yet for this study

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.

Conditions

  • Overweight and Obesity

Interventions

BEHAVIORAL

Nutrigenomix, personalized dietary plan

Personalized dietary plan.

BEHAVIORAL

Physical Activity

Participate in an exercise program to work up to 300 min/week of moderate-intensity activity.

BEHAVIORAL

Behavioral counseling

Review behavioral counseling videos and participate in worksheets to assist with behavioral change.

BEHAVIORAL

Standard Dietary plan

Receive a standard dietary plan

Sponsors & Collaborators

  • Augusta University

    lead OTHER

Principal Investigators

  • Madison Kindred, PhD · Augusta University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-04-30
Primary Completion
2026-12-31
Completion
2027-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05956574 on ClinicalTrials.gov