NCT04420936Completed
Pragmatic Research in Healthcare Settings to Improve Diabetes and Obesity Prevention and Care for Our Program
Pragmatic Research in Healthcare Settings to Improve Diabetes and Obesity Prevention and Care for Our Program MAINTAIN PRIME (Promoting Real (World) IMplEmentation Through Care Teams).
Source: ClinicalTrials.gov · Last updated 29 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Many people struggle not only to lose weight through changes in diet and physical activity, but also to maintain weight loss once they have achieved it. In a previous study, our team designed and deployed a weight maintenance intervention that was delivered through the patient portal of an electronic health record (EHR) and found that patients who tracked their weight, diet, and physical activity and also received coaching had better success with maintaining recent intentional weight loss than patients who tracked but did not receive coaching. The investigators propose to repeat the intervention in a new health care system and train routine health care staff (e.g., medical assistants and nurses) to be coaches, a more sustainable model that will allow ongoing intervention delivery after the proposed study ends. This is a pragmatic randomized clinical Trial with percent weight change at 24 months as the primary outcome. This will be a 2-arm randomized trial that compares the MAINTAIN PRIME lifestyle coaching intervention to a control tracking intervention.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 269 (actual)
- First submitted
- 4 Jun 2020
- Start date
- 8 Sept 2021
- Primary completion date
- 30 Jun 2025
- Lead sponsor
- University of Utah
- Diseases
- Obesity
- NCT number
- NCT04420936
What you commit to
- Study type: Interventional
- Participants enrolled: 269
- From 8 Sept 2021 to the primary completion date, 30 Jun 2025
- 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.
Prior treatment
- Bariatric surgery in the last 2 years, or planned during the next 3 years
- Any other underlying reason or concomitant condition, which in the opinion of the principal investigator, could confound the results of the study or put the participant at undue risk.
Other illness
- Medical conditions that might cause unintended weight loss such as cancer or thyroid disease
- Edematous state that interferes with bodyweight assessment (e.g., severe congestive heart failure, end-stage renal disease, or ascites)
Other
- Provider's assessment that patient is unable to safely undertake moderately intense unsupervised physical activity (the equivalent of 30 minutes of brisk walking)
- Current or planned pregnancy in the next 3 years
- Currently breastfeeding
- Perceived lack of basic computer or Internet skills.
- Unable to attend the orientation/baseline visit or comply with the protocol procedures
Who the study is looking for
- Adults aged 18-75
- BMI of ≥ 25 prior to this intended weight loss
- Have experienced and maintained an intentional weight loss of at least 5% of body weight in the past 24 months
- Plan to maintain a University of Utah Health relationship in one of the participating primary care practices
- Have or be willing to get an account with the Epic MyHealth patient portal embedded in the electronic health record (EHR)
Age in the registry: 18 years to 75 years · Sex: All · Does not accept 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 |
|---|---|---|---|
| University of Utah Health Sciences Center Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.