Clinical trial

Lifestyle Intervention for Healthy Change

Recruiting now · Not applicable · 1 countries · Registry ID NCT05956574

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 40 Years
SexAll
Healthy volunteersAccepted
ConditionOverweight and Obesity

Full registry 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

Treatments and study arms

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

Total body weight6-months

Use of scale to measure total body weight

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Augusta University🇺🇸 Augusta, Georgia, United States
Madison Kindred, PhDContact
Madison Kindred, PhDPrincipal Investigator