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Recruiting

NCT Number: NCT05956574

Lifestyle Intervention for Healthy Change

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.

Recruiting

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Augusta University

Augusta, Georgia, 30909, United States

Location status: Recruiting

Location contact

Madison Kindred, PhD

CONTACT

Madison Kindred, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutrigenomix, personalized dietary plan

Behavioral

Personalized dietary plan.

Physical activity

Behavioral

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

Behavioral Counseling

Behavioral

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

Standard Dietary plan

Behavioral

Receive a standard dietary plan

Primary outcomes

  1. Total body weight

    Time frame: 6-months

    Use of scale to measure total body weight

Study contacts

Contact information is provided by the study sponsor or research team.

Madison Kindred, PhD

CONTACT

[email protected]

774-238-0591

Sponsors and collaborators

Lead sponsor

Augusta University

Other

Registry information

Official study title

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

Acronym: LIVE WELL

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jul 21, 2023
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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