Lifestyle Intervention for Healthy Change

Study Overview
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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. 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.

Official Title
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Healthy Living: Incorporating Lifestyle Interventions to Encourage a Reduction in Body Weight.

Conditions
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Overweight and Obesity

Intervention / Treatment
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* Behavioral: Nutrigenomix, personalized dietary plan
* Behavioral: Physical Activity
* Behavioral: Behavioral counseling
* Behavioral: Standard Dietary plan


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutrigenomix<br>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<br>* Personalized dietary plan.<br>Behavioral: Physical Activity<br>* Participate in an exercise program to work up to 300 min/week of moderate-intensity activity.<br>Behavioral: Behavioral counseling<br>* Review behavioral counseling videos and participate in worksheets to assist with behavioral change.<br>|
| Active Comparator: Control<br>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<br>* Participate in an exercise program to work up to 300 min/week of moderate-intensity activity.<br>Behavioral: Behavioral counseling<br>* Review behavioral counseling videos and participate in worksheets to assist with behavioral change.<br>Behavioral: Standard Dietary plan<br>* Receive a standard dietary plan<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total body weight | Use of scale to measure total body weight | 6-months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physical activity, dietary intervention