Lifestyle Intervention for Healthy Change
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nutrigenomix, personalized dietary plan, Physical Activity, Behavioral counseling, Standard Dietary plan.
- Who it may be relevant to
- Registry conditions: Overweight and Obesity. Basic parameters: 18 years — 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Healthy Living: Incorporating Lifestyle Interventions to Encourage a Reduction in Body Weight.
Overview
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.
Interventions
- Behavioral Nutrigenomix, personalized dietary plan
Personalized dietary plan. - Behavioral Physical Activity
Participate in an exercise program to work up to 300 min/week of moderate-intensity activity. - Behavioral Behavioral counseling
Review behavioral counseling videos and participate in worksheets to assist with behavioral change. - Behavioral Standard Dietary plan
Receive a standard dietary plan
Primary outcome measures
- Total body weight [Time frame: 6-months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
United States · 1 center
- Augusta University — Augusta
Identifiers
NCT: NCT05956574 · 2020021-2