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

NCT04420936 | Completed

• 2 other identifiers: IRB_001328021R18DK123372-01A1
• Study Type: interventional
• Target: 269
• Locations: 1 country
• Sites: 1

Brief 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 (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.

Conditions

Diabetes; Weight Loss; Diet Habit

Keywords

diabetes; weight loss; diet

Outcome Measures

Primary Outcomes (1)

• Change in body weight

  24 months

Secondary Outcomes (9)

• Change in BMI percentage

  24 months

• Change in physical activity as measured in daily steps

  24 months

• Change in physical activity as measured in minutes

  24 months

• Change in dietary habits as measured by grams of fat

  24 months

• Change in dietary habits as measured in calories

  24 months

Study Arms (2)

Lifestyle coaching

EXPERIMENTAL

Behavioral: MAINTAIN PRIME Lifestyle Coaching

Control tracking

ACTIVE COMPARATOR

Behavioral: Control tracking

Interventions

MAINTAIN PRIME Lifestyle Coaching BEHAVIORAL

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.

Lifestyle coaching

Control tracking BEHAVIORAL

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.

Control tracking

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• University of Utah: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Utah Health Sciences Center

Salt Lake City, Utah, 84132, United States

Location

Related Publications (1)

• 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.

  PMID: 38745592 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Weight Loss; Feeding Behavior

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Internal Medicine

Model Details: Pragmatic randomized clinical Trial with percent weight change at 24 months

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 9, 2020
• Study Start: September 8, 2021
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: October 29, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)