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Clinical Trials/NCT05956574
NCT05956574
Recruiting
N/A

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

Augusta University1 site in 1 country125 target enrollmentApril 2025

Overview

Phase
N/A
Intervention
Not specified
Conditions
Overweight and Obesity
Sponsor
Augusta University
Enrollment
125
Locations
1
Primary Endpoint
Total body weight
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2025
End Date
May 2027
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Madison Kindred

Assistant Professor

Augusta University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Total body weight

Time Frame: 6-months

Use of scale to measure total body weight

Study Sites (1)

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