Preventing Diabetes

Not Applicable

Completed

• Conditions: PreDiabetes
• Interventions: Behavioral: Diabetes Prevention Program; Behavioral: Registered Dietitian/Nutritionist; Behavioral: Weight Watchers, Reimagined; Behavioral: DPP or RDN Counseling + Medication; Other: Bariatric Surgery Evaluation

• Registration Number: NCT05395377
• Lead Sponsor: Geisinger Clinic

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.

Study Timeline

• Study Start: 2017-12-18
• Primary Completion: 2019-06-28
• Study Completion: 2021-11-16
• Status Verified: 2022-05
• Study First Submitted: 2022-05-24
• Study First Submitted QC: 2022-05-24
• Last Update Submitted: 2022-05-24
• Study First Posted: 2022-05-27
• Last Update Posted: 2022-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DPP Group Classes	Diabetes Prevention Program	-
Registered Dietitian/Nutritionist	Registered Dietitian/Nutritionist	-
Weight Watchers, Reimagined	Weight Watchers, Reimagined	-
Pharmacological Treatment	DPP or RDN Counseling + Medication	-
Bariatric Surgery Evaluation	Bariatric Surgery Evaluation	-

Primary Outcome Measures

Name	Time	Method
Demographics	Baseline	Race, ethnicity, education level, marital status, household income, and weight management history.
Pre-Diabetes Indicator	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	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	12 months	Treatment satisfaction and patient involvement in care survey

Trial Locations

Locations (1)

Geisinger Health System; 🇺🇸 Danville, Pennsylvania, United States