Lifestyle Intervention for Healthy Change

NCT05956574 | Recruiting

• 1 other identifier: 2020021-2
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity

Keywords

physical activity; dietary intervention

Outcome Measures

Primary Outcomes (1)

• Total body weight

  Use of scale to measure total body weight

  6-months

Study Arms (2)

Nutrigenomix

EXPERIMENTAL

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.

Behavioral: Nutrigenomix, personalized dietary plan; Behavioral: Physical Activity; Behavioral: Behavioral counseling

Control

ACTIVE COMPARATOR

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.

Behavioral: Physical Activity; Behavioral: Behavioral counseling; Behavioral: Standard Dietary plan

Interventions

Nutrigenomix, personalized dietary plan BEHAVIORAL

Personalized dietary plan.

Nutrigenomix

Physical Activity BEHAVIORAL

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

Control; Nutrigenomix

Behavioral counseling BEHAVIORAL

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

Control; Nutrigenomix

Standard Dietary plan BEHAVIORAL

Receive a standard dietary plan

Control

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Under the age of 18 years
• years and older
• Unable to participate in an exercise program
• Currently pregnant

Sponsors & Collaborators

• Augusta University: lead

Study Sites (1)

Augusta University

Augusta, Georgia, 30909, United States

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity; Motor Activity

Interventions

Exercise; Behavior Therapy

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Madison Kindred, PhD

  Augusta University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Madison Kindred, PhD

CONTACT

774-238-0591; mkindred@augusta.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: July 21, 2023
• Study Start: April 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)