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Clinical Trials/NCT05395377
NCT05395377
Completed
Not Applicable

Preventing Diabetes Among Patients With Pre-Diabetes by Improving Patient-Activation and Enhancing Clinical Decision Support for Weight Management to Lower Costs

Geisinger Clinic1 site in 1 country84 target enrollmentDecember 18, 2017
ConditionsPreDiabetes

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
PreDiabetes
Sponsor
Geisinger Clinic
Enrollment
84
Locations
1
Primary Endpoint
Demographics
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 18, 2017
End Date
November 16, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Demographics

Time Frame: Baseline

Race, ethnicity, education level, marital status, household income, and weight management history.

Pre-Diabetes Indicator

Time Frame: 12 months

At baseline, 6 months,12 months, we will assess HbA1c from the intervention participants. These measures will provide important information about changes in participants' risk and prevention of diabetes.

Body Weight

Time Frame: 12 Months

The study's primary outcome is change in body mass index (in kg) from baseline to 12-month follow-up.

Patient-Centered Outcomes

Time Frame: 12 months

Treatment satisfaction and patient involvement in care survey

Study Sites (1)

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