Actively Recruiting

Phase Not Applicable
Age: 18Years - 40Years
All Genders
Healthy Volunteers
NCT05956574

Lifestyle Intervention for Healthy Change

Led by Augusta University · Updated on 2025-02-19

125

Participants Needed

1

Research Sites

108 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Lifestyle Intervention for Healthy Change

Who Can Participate

Age: 18Years - 40Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 to 40 years
  • Body Mass Index (BMI) over 25 kg/m2
  • No cardiopulmonary disease
  • Stable on medications for at least 3 months
  • Weight stable within plus or minus 5 pounds for the past 3 months
  • Not pregnant or trying to become pregnant
  • Owns a smartphone
  • Able to walk without assistance
  • Not using supplemental oxygen
Not Eligible

You will not qualify if you...

  • Under 18 years of age
  • 40 years old or older
  • Unable to participate in an exercise program
  • Currently pregnant

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Augusta University

Augusta, Georgia, United States, 30909

Actively Recruiting

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Research Team

M

Madison Kindred, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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