DiabetesMAINTAIN PRIMENCT04420936
Pragmatic Research in Healthcare Settings to Improve Diabetes and Obesity Prevention and Care for Our Program
A study testing MAINTAIN PRIME Lifestyle Coaching in people with Diabetes and Weight Loss, run by University of Utah at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes, Weight Loss, Diet Habit
- What is being tested?
- MAINTAIN PRIME Lifestyle Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 269 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2021to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Medical conditions that might cause unintended weight loss such as cancer or thyroid disease
- Provider's assessment that patient is unable to safely undertake moderately intense unsupervised physical activity (the equivalent of 30 minutes of brisk walking)
- Edematous state that interferes with bodyweight assessment (e.g., severe congestive heart failure, end-stage renal disease, or ascites)
- Bariatric surgery in the last 2 years, or planned during the next 3 years
- Current or planned pregnancy in the next 3 years
- Currently breastfeeding
Show all 9Show fewer
- Perceived lack of basic computer or Internet skills.
- Unable to attend the orientation/baseline visit or comply with the protocol procedures
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Health Sciences Center
Salt Lake City, Utah, 84132
About this study
Official title: 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).
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.
Read the detailed description
Obesity is a major health problem in the United States and associated with increased risk of diabetes. While many behavioral interventions have led to successful short-term weight loss, very few programs focus on weight loss maintenance after intentional loss, and fewer still are applicable to routine health care settings. There is a great need for interventions that can assist with long-term maintenance of healthy body weight and be sustainably integrated into existing health care teams. The investigators have developed and tested an innovative weight loss maintenance intervention - Maintaining Activity and Nutrition through Technology-Assisted Innovation in Primary Care (MAINTAIN-pc) - delivered through the electronic health record (EHR) to help patients maintain recent intentional weight loss and successful lifestyle strategies.
The investigators have conducted and published a randomized clinical trial of MAINTAIN-pc at the University of Pittsburgh and found that participants who received EHR tracking tools and personalized coaching had significantly lower weight regain at 24 months (primary outcome) than participants who received EHR tracking tools alone. MAINTAIN-pc leveraged commonly available health information technology (HIT) tools to track participant progress and support patients and their providers in ongoing efforts to maintain weight loss. The investigators used an EHR platform (Epic) employed by many health care systems nationwide and integrated many parts of the MAINTAIN-pc protocol (e.g., patient identification, provider updates) with routine clinic workflow.
Despite the success of MAINTAIN-pc, two key questions about the practicality and sustainability of this intervention remain unanswered: (i) whether the HIT could be adapted at other sites and (ii) whether coaching could be delivered leveraging existing staff resources rather than interventionists supported by a research grant. The investigators propose a pragmatic clinical trial to test the implementation and impact of the MAINTAIN-pc protocol in routine health care settings: MAINTAIN PRIME (Promoting Real (World) IMplEmentation). MAINTAIN PRIME will be conducted in 14 primary care practices affiliated with the University of Utah and will capitalize on further advances in HIT (e.g., dashboards to track patient populations) and team-based care models to deliver the intervention with minimal support from research staff. The investigators will measure costs to inform future sustainability, and study workflow and individual, clinical, and organizational attributes to determine facilitators and barriers to successful implementation. With assistance from an External Advisory Board, the investigators will assemble an Implementation Toolkit of HIT and clinical resources to aid further dissemination.
- Conditions
- Diabetes, Weight Loss, Diet Habit
- Being tested
- MAINTAIN PRIME Lifestyle Coaching, Control tracking
- Keywords
- diabetes, weight loss, diet
- Medical subject headings
- Diabetes Mellitus, Weight Loss, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAINTAIN PRIME Lifestyle CoachingBehavioural
Participants will receive two years patient support consisting of supportive coaching via EHR patient portal and tracking tools with EHR. Participants will also receive primary care physician (PCP) support with real time progress reports with counseling tips via EHR prior to visits, notification of weight changes greater or equal to 10 pounds, and annual PCP feedback.
Control trackingBehavioural
Participants will receive two years of patient support consisting of prevention updates via EHR patient portal and tracking tools within the EHR. Participants in this group will not receive primary care physician (PCP) support.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle coaching | Experimental | Not described Receives: Behavioral: MAINTAIN PRIME Lifestyle Coaching |
| Control tracking | Active comparator | Not described Receives: Behavioral: Control tracking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight
Measured: 24 months
Secondary outcomes (9)
Change in BMI percentage
Measured: 24 months
Change in physical activity as measured in daily steps
Measured: 24 months
Change in physical activity as measured in minutes
Measured: 24 months
Change in dietary habits as measured by grams of fat
Measured: 24 months
Change in dietary habits as measured in calories
Measured: 24 months
Change in dietary habits as measured by validated diet habit survey score
Measured: 24 months
Change in quality of life as measured by Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire scores
Measured: 24 months
Change in quality of function as measured by Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire scores
Measured: 24 months
Change in blood pressure
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start8 Sep 2021
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pragmatic randomized clinical Trial with percent weight change at 24 months
- Masking
- None (open label)
- Enrolment
- 269 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Margaret (Molly) B. Conroy, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04420936
- Sponsor's protocol ID
- IRB_00132802
- Other IDs
- 1R18DK123372-01A1
- Acronym
- MAINTAIN PRIME
- Status last verified
- Oct 2025
- First submitted
- 4 Jun 2020
- Last updated
- 29 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kukhareva PV, Weir CR, Cedillo M, Taft T, Butler JM, Rudd EA, Zepeda J, Zheutlin E, Kiraly B, Flynn M, Conroy MB, Kawamoto K. Design and implementation of electronic health record-based tools to support a weight management program in primary care. JAMIA Open. 2024 May 13;7(2):ooae038. doi: 10.1093/jamiaopen/ooae038. eCollection 2024 Jul.
PubMed 38745592
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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).
- ClinicalTrials.gov ID
- NCT04420936
- Acronym / sponsor ID
- MAINTAIN PRIME / IRB_00132802
- Conditions
- Diabetes, Weight Loss, Diet Habit
- Keywords
- diabetes, weight loss, diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 269 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 8 Sep 2021 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Obesity is a major health problem in the United States and associated with increased risk of diabetes. While many behavioral interventions have led to successful short-term weight loss, very few programs focus on weight loss maintenance after intentional loss, and fewer still are applicable to routine health care settings. There is a great need for interventions that can assist with long-term maintenance of healthy body weight and be sustainably integrated into existing health care teams. The investigators have developed and tested an innovative weight loss maintenance intervention - Maintaining Activity and Nutrition through Technology-Assisted Innovation in Primary Care (MAINTAIN-pc) - delivered through the electronic health record (EHR) to help patients maintain recent intentional weight loss and successful lifestyle strategies.
The investigators have conducted and published a randomized clinical trial of MAINTAIN-pc at the University of Pittsburgh and found that participants who received EHR tracking tools and personalized coaching had significantly lower weight regain at 24 months (primary outcome) than participants who received EHR tracking tools alone. MAINTAIN-pc leveraged commonly available health information technology (HIT) tools to track participant progress and support patients and their providers in ongoing efforts to maintain weight loss. The investigators used an EHR platform (Epic) employed by many health care systems nationwide and integrated many parts of the MAINTAIN-pc protocol (e.g., patient identification, provider updates) with routine clinic workflow.
Despite the success of MAINTAIN-pc, two key questions about the practicality and sustainability of this intervention remain unanswered: (i) whether the HIT could be adapted at other sites and (ii) whether coaching could be delivered leveraging existing staff resources rather than interventionists supported by a research grant. The investigators propose a pragmatic clinical trial to test the implementation and impact of the MAINTAIN-pc protocol in routine health care settings: MAINTAIN PRIME (Promoting Real (World) IMplEmentation). MAINTAIN PRIME will be conducted in 14 primary care practices affiliated with the University of Utah and will capitalize on further advances in HIT (e.g., dashboards to track patient populations) and team-based care models to deliver the intervention with minimal support from research staff. The investigators will measure costs to inform future sustainability, and study workflow and individual, clinical, and organizational attributes to determine facilitators and barriers to successful implementation. With assistance from an External Advisory Board, the investigators will assemble an Implementation Toolkit of HIT and clinical resources to aid further dissemination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pragmatic randomized clinical Trial with percent weight change at 24 months
| Arm | Type | Receives |
|---|---|---|
| Lifestyle coaching | Experimental | Behavioral: MAINTAIN PRIME Lifestyle Coaching |
| Control tracking | Active comparator | Behavioral: Control tracking |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (9 listed)
- Medical conditions that might cause unintended weight loss such as cancer or thyroid disease
- Provider's assessment that patient is unable to safely undertake moderately intense unsupervised physical activity (the equivalent of 30 minutes of brisk walking)
- Edematous state that interferes with bodyweight assessment (e.g., severe congestive heart failure, end-stage renal disease, or ascites)
- Bariatric surgery in the last 2 years, or planned during the next 3 years
- Current or planned pregnancy in the next 3 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MAINTAIN PRIME Lifestyle CoachingParticipants will receive two years patient support consisting of supportive coaching via EHR patient portal and tracking tools with EHR. Participants will also receive primary care physician (PCP) support with real time progress reports with counseling tips via EHR prior to visits, notification of weight changes greater or equal to 10 pounds, and annual PCP feedback. | Behavioural | Lifestyle coaching |
| Control trackingParticipants will receive two years of patient support consisting of prevention updates via EHR patient portal and tracking tools within the EHR. Participants in this group will not receive primary care physician (PCP) support. | Behavioural | Control tracking |
Primary outcome
Change in body weight
Time frame: 24 months
9 secondary outcomes
Change in BMI percentage
Time frame: 24 months
Change in physical activity as measured in daily steps
Time frame: 24 months
Change in physical activity as measured in minutes
Time frame: 24 months
Change in dietary habits as measured by grams of fat
Time frame: 24 months
Change in dietary habits as measured in calories
Time frame: 24 months
Change in dietary habits as measured by validated diet habit survey score
Time frame: 24 months
Change in quality of life as measured by Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire scores
Time frame: 24 months
Change in quality of function as measured by Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire scores
Time frame: 24 months
Change in blood pressure
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2025.
- Derived from this study: PubMed 38745592Kukhareva PV, Weir CR, Cedillo M, Taft T, Butler JM, Rudd EA, Zepeda J, Zheutlin E, Kiraly B, Flynn M, Conroy MB, Kawamoto K. Design and implementation of electronic health record-based tools to support a weight management program in primary care. JAMIA Open. 2024 May 13;7(2):ooae038. doi: 10.1093/jamiaopen/ooae038. eCollection 2024 Jul.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MAINTAIN PRIME Lifestyle Coaching in people with Diabetes and Weight Loss, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04420936, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2025.