Preventing Diabetes

PreDiabetes Clinical Trial

— PD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05395377
• Other study ID #: 2017-0394
• Status: Completed
• Phase: N/A
• Start date: December 18, 2017
• Est. completion date: November 16, 2021

Study information

• Verified date: May 2022
• Source: Geisinger Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: November 16, 2021
• Est. primary completion date: June 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• PreDiabetes
• Prediabetic State

Intervention

Behavioral:
• Registered Dietitian/Nutritionist
Participants received a FitBit Flex and Intensive Lifestyle Intervention coaching via telephone with Registered Dietitian/Nutritionist.
• Diabetes Prevention Program
Modified DPP group classes lead by a Registered Dietitian and Exercise Physiologist.
• Weight Watchers, Reimagined
Participants in this group were provided with an online access code to enroll in WW and could choose the format of their choice- group, online, and/or smartphone app.
• DPP or RDN Counseling + Medication
Participants met with a weight management specialist to receive weight loss medications, as well as, receiving either the DPP or Registered Dietitian coaching. Medications utilized in this study were Phentermine and Metformin. Metformin was prescribed if the participant could not tolerate Phentermine.

Other:
• Bariatric Surgery Evaluation
Participants (BMI > 40) were offered a consultation with the bariatric surgical program that requires lifestyle weight management during the first 6 months. Participants were also able to choose to receive one of the other 4 intervention options in the first six months prior to consideration for bariatric surgery.

Locations

Country	Name	City	State
United States	Geisinger Health System	Danville	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Geisinger Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demographics	Race, ethnicity, education level, marital status, household income, and weight management history.	Baseline
Primary	Body Weight	The study's primary outcome is change in body mass index (in kg) from baseline to 12-month follow-up.	12 Months
Primary	Pre-Diabetes Indicator	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.	12 months
Primary	Patient-Centered Outcomes	Treatment satisfaction and patient involvement in care survey	12 months