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Lifestyle Intervention for Healthy Change (LIVE WELL)

Primary Purpose

Overweight and Obesity

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nutrigenomix, personalized dietary plan
Physical Activity
Behavioral counseling
Standard Dietary plan
Sponsored by
Augusta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Overweight and Obesity focused on measuring physical activity, dietary intervention

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Nutrigenomix

    Control

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Total body weight
    Use of scale to measure total body weight

    Secondary Outcome Measures

    Full Information

    First Posted
    July 13, 2023
    Last Updated
    July 13, 2023
    Sponsor
    Augusta University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05956574
    Brief Title
    Lifestyle Intervention for Healthy Change
    Acronym
    LIVE WELL
    Official Title
    Healthy Living: Incorporating Lifestyle Interventions to Encourage a Reduction in Body Weight.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    December 2026 (Anticipated)
    Study Completion Date
    May 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Augusta University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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. We 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). We 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Overweight and Obesity
    Keywords
    physical activity, dietary intervention

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    125 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Nutrigenomix
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Nutrigenomix, personalized dietary plan
    Intervention Description
    Personalized dietary plan.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Physical Activity
    Intervention Description
    Participate in an exercise program to work up to 300 min/week of moderate-intensity activity.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Behavioral counseling
    Intervention Description
    Review behavioral counseling videos and participate in worksheets to assist with behavioral change.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Standard Dietary plan
    Intervention Description
    Receive a standard dietary plan
    Primary Outcome Measure Information:
    Title
    Total body weight
    Description
    Use of scale to measure total body weight
    Time Frame
    6-months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Madison Kindred, PhD
    Phone
    774-238-0591
    Email
    mkindred@augusta.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Lifestyle Intervention for Healthy Change

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