Clinical trial NCT05395377: Preventing Diabetes
Official title: Preventing Diabetes Among Patients With Pre-Diabetes by Improving Patient-Activation and Enhancing Clinical Decision Support for Weight Management to Lower Costs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PreDiabetes
Lead sponsor: Geisinger Clinic
Sponsor class: OTHER
First posted: 2022-05-27
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants enrolled in this study were able to choose from 1 of 5 intervention options based on their weight status.
Primary purpose: PREVENTION

Brief summary: The purpose of this project is to improve the quality of weight management care for patients with pre-diabetes and overweight or obesity. Personalized risk profiles, clinical decision support, and patient-centered decision tools for understanding pre-diabetes risk and the likelihood of preventing diabetes with a modest 5-7% weight loss will be developed. This project will offer patients their choice of effective weight management treatment options, each containing the cornerstone of weight management- intensive lifestyle intervention. Patients and PCPs will be better informed and equipped with information that helps them make weight management treatment decisions that work the best for their lifestyle, and each is expected to produce at least 5-7% weight loss over 6 months.

Detailed description: The primary aim of this study was to demonstrate that an increased recruitment rate for weight loss intervention can be achieved within patients that have pre-diabetes by communicating personalized risk of progression to type 2 diabetes, by estimating risk reduction with weight loss, and by offering program choice. Secondary aims included program participation rate, weight loss, and short term decreased diabetes risk.

Eligibility criteria: Inclusion Criteria:

* At least two weight measures within the last two 24 months, including most recent, that meet the following criteria:
* Prediabetes and BMI \>27: Treatment Option 1, 2, 3, or 4
* Prediabetes and BMI \>40: Treatment Options 1-5
* Most recent laboratory value that meets prediabetes indicators, per American Diabetes Association, 2016
* Hemoglobin A1C ≥5.7% and \<6.5%, or
* Fasting plasma glucose ≥100 mg/dl and \<126 mg/dl, or
* Oral glucose tolerance test ≥140 mg/dl and \<200 mg/dl

Exclusion Criteria:

* History of significant weight loss documented within 5 years,
* Contraindications to weight change (e.g., cancer, pregnancy)
* Prior bariatric surgery
* Weight loss medication use or orders within 5 years prior to the project.

Primary outcomes:
measure: Demographics
timeFrame: Baseline
measure: Body Weight
timeFrame: 12 Months
measure: Pre-Diabetes Indicator
timeFrame: 12 months
measure: Patient-Centered Outcomes
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Danville
country: United States
facility: Geisinger Health System
state: Pennsylvania
Study officials:
affiliation: Geisinger Clinic
name: Lisa Bailey-Davis, DEd
role: PRINCIPAL_INVESTIGATOR
References: