NCT05956574Recruiting
Lifestyle Intervention for Healthy Change
Healthy Living: Incorporating Lifestyle Interventions to Encourage a Reduction in Body Weight.
Source: ClinicalTrials.gov · Last updated 19 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 125 (estimated)
- First submitted
- 13 Jul 2023
- Start date
- Apr 2025
- Primary completion date
- Dec 2026
- Lead sponsor
- Augusta University
- Diseases
- Obesity
- NCT number
- NCT05956574
What you commit to
- Study type: Interventional
- Planned participants: 125
- From Apr 2025 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- Under the age of 18 years
Other
- 40 years and older
- Unable to participate in an exercise program
- Currently pregnant
Who the study is looking for
- 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
Age in the registry: 18 years to 40 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Augusta University Coordinator of this site? Confirm its status | Augusta | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.