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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: t
View:

• 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

Locations
United States
Georgia
Augusta University
RECRUITING
Augusta
Contact Information
Primary
Madison Kindred, PhD
mkindred@augusta.edu
774-238-0591
Time Frame
Start Date: 2025-04
Estimated Completion Date: 2027-05
Participants
Target number of participants: 125
Treatments
Experimental: Nutrigenomix
Participants in this group will be asked to complete an oral swab at baseline. This swab will indicate their dietary needs based on their genetic composition. These personalized dietary needs will be shared with the participant; the participant will be encouraged to follow their dietary plan for the duration of the study. Participants in this group will also gradually increase their physical activity up to 300 min/week at 6 months.
Active_comparator: Control
Participants in this group will receive a standard care dietary plan. They will also be asked to gradually increase their activity up to 300 min/week by 6 months.
Related Therapeutic Areas
Sponsors
Leads: Augusta University

This content was sourced from clinicaltrials.gov