Lifestyle Intervention for Healthy Change

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorAugusta University

About this trial

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 criteria

Qualifiers

Age 18-40 years

BMI > 25 kg/m2

No cardiopulmonary disease

stable on medications for 3 months

Disqualifiers

Under the age of 18 years

40 years and older

Unable to participate in an exercise program

Currently pregnant

Trial design

Treatments tested in this trial

  • Nutrigenomix, personalized dietary plan
  • Physical Activity
  • Behavioral counseling
  • Standard Dietary plan

Treatment groups

125 Participants
are divided into 2 treatment groups

Sponsors and collaborators