Lifestyle Intervention for Healthy Change

NCT ID: NCT05956574

Last Updated: 2025-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-30

Study Completion Date

2027-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Overweight and Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Nutrigenomix, personalized dietary plan

Intervention Type BEHAVIORAL

Personalized dietary plan.

Physical Activity

Intervention Type BEHAVIORAL

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

Behavioral counseling

Intervention Type BEHAVIORAL

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

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.

Group Type ACTIVE_COMPARATOR

Physical Activity

Intervention Type BEHAVIORAL

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

Behavioral counseling

Intervention Type BEHAVIORAL

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

Standard Dietary plan

Intervention Type BEHAVIORAL

Receive a standard dietary plan

Interventions

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Nutrigenomix, personalized dietary plan

Personalized dietary plan.

Intervention Type BEHAVIORAL

Physical Activity

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

Intervention Type BEHAVIORAL

Behavioral counseling

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

Intervention Type BEHAVIORAL

Standard Dietary plan

Receive a standard dietary plan

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Augusta University

OTHER

Sponsor Role lead

Responsible Party

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Madison Kindred

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Madison Kindred, PhD

Role: PRINCIPAL_INVESTIGATOR

Augusta University

Locations

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Augusta University

Augusta, Georgia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Madison Kindred, PhD

Role: CONTACT

774-238-0591

Facility Contacts

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Madison Kindred, PhD

Role: primary

Other Identifiers

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2020021-2

Identifier Type: -

Identifier Source: org_study_id

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