Preventing Diabetes (PD)

Geisinger Health

Status: Completed

Conditions: PreDiabetes

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05395377

2017-0394

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 5 patient groups

Registered Dietitian/Nutritionist

Active Comparator group

Treatment:

Behavioral: Registered Dietitian/Nutritionist

DPP Group Classes

Active Comparator group

Treatment:

Behavioral: Diabetes Prevention Program

Weight Watchers, Reimagined

Active Comparator group

Treatment:

Behavioral: Weight Watchers, Reimagined

Pharmacological Treatment

Active Comparator group

Treatment:

Behavioral: DPP or RDN Counseling + Medication

Bariatric Surgery Evaluation

Active Comparator group

Treatment:

Other: Bariatric Surgery Evaluation