RecruitingNot ApplicableNCT05956574

Lifestyle Intervention for Healthy Change

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


Sponsor

Augusta University

Enrollment

125 participants

Start Date

Apr 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 40 Years

Inclusion Criteria9

  • 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 Criteria4

  • Under the age of 18 years
  • years and older
  • Unable to participate in an exercise program
  • Currently pregnant

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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.

BEHAVIORALBehavioral counseling

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

BEHAVIORALStandard Dietary plan

Receive a standard dietary plan


Locations(1)

Augusta University

Augusta, Georgia, United States

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NCT05956574


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