Testing diet and exercise plans for weight loss in adults with obesity
Compares a genetics-guided diet with a standard diet, both with exercise, in adults with overweight.
Key facts
- Who runs it
- Augusta University
- Where
- Augusta, United StatesSee the site
- Trial code
- Registry title
- Lifestyle Intervention for Healthy Change
- Status
- Recruiting
- People taking part
- 125 people, planned
- Started
- Apr 2025
- Expected to end
- May 2027
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Nutrigenomix, personalized dietary plan
- Physical Activity
- Behavioral counseling
- Standard Dietary plan
- Record updated
- 19 February 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 40 who are overweight or obese. It tests a diet, exercise and counseling program for weight loss.
- Age
- 18 to 40 years
- Sex
- Men and women can join.
- Disease stage
- BMI above 25 kg/m2 (overweight or obese).
- Earlier treatment
- Medications must have been stable for the past 3 months.
Main reasons for not taking part
- Cardiopulmonary disease
- Weight change of more than 5 pounds (2 kg) in the past 3 months
- Currently pregnant or trying to get pregnant
- Unable to walk unassisted or take part in an exercise program
- On supplemental oxygen
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- 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
Who cannot take part
- Under the age of 18 years
- 40 years and older
- Unable to participate in an exercise program
- Currently pregnant
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 40 years old?
Where in United States
- Augusta UniversityAugusta, United StatesContact: Madison Kindred, PhDTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- NutrigenomixTreatment being tested
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.
Treatment: Nutrigenomix, personalized dietary plan, Physical Activity, and Behavioral counseling
- ControlExisting treatment, for comparison
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.
Treatment: Physical Activity, Behavioral counseling, and Standard Dietary plan
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Healthy Living: Incorporating Lifestyle Interventions to Encourage a Reduction in Body Weight.
- Plain-language title
- Testing diet and exercise plans for weight loss in adults with obesityGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT05956574, who can take part
- Record updated
- 19 February 2025