NCT04420936: MAINTAIN PRIME

Pragmatic Research in Healthcare Settings to Improve Diabetes and Obesity Prevention and Care for Our Program

Completed NA Last updated 29 October 2025

What this trial tests

NA trial testing MAINTAIN PRIME Lifestyle Coaching in Diabetes in 269 participants. Completed in 30 June 2025.

Timeline

8 September 2021

Primary endpoint
30 June 2025

30 June 2025

Quick facts

Lead sponsor	University of Utah
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	269
Start date	8 September 2021
Primary completion	30 June 2025
Estimated completion	30 June 2025
Sites	1 location across United States

Drugs / interventions tested

• MAINTAIN PRIME Lifestyle Coaching
• Control tracking

Conditions studied

• Diabetes — all drugs for Diabetes →
• Weight Loss — all drugs for Weight Loss →
• Diet Habit — all drugs for Diet Habit →

Sponsor

University of Utah

Who can join

Adults 18 to 75, any sex, with Diabetes or Weight Loss. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Implementing weight maintenance with existing staff and electronic health record tools in a primary care setting: Baseline results from the MAINTAIN PRIME trial.
   Conroy MB, Cedillo M, Jordanova K, Zepeda J, et al · · 2024 · cited 1× · PMID 38552870 · DOI 10.1016/j.cct.2024.107520
2. Scalable and successful patient portal lifestyle coaching training for primary care clinical staff.
   Cedillo M, Zepeda J, Kiraly B, Flynn M, et al · · 2024 · PMID 39298682 · DOI 10.1093/tbm/ibae047
3. Design and implementation of electronic health record-based tools to support a weight management program in primary care.
   Kukhareva PV, Weir CR, Cedillo M, Taft T, et al · · 2024 · PMID 38745592 · DOI 10.1093/jamiaopen/ooae038