NCT05395377

Preventing Diabetes

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Geisinger Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

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.

Conditions

• PreDiabetes

Interventions

Type	Name	Description
BEHAVIORAL	Registered Dietitian/Nutritionist	Participants received a FitBit Flex and Intensive Lifestyle Intervention coaching via telephone with Registered Dietitian/Nutritionist.
BEHAVIORAL	Diabetes Prevention Program	Modified DPP group classes lead by a Registered Dietitian and Exercise Physiologist.
BEHAVIORAL	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.
BEHAVIORAL	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.

Timeline

• Start date: 2017-12-18
• Primary completion: 2019-06-28
• Completion: 2021-11-16
• First posted: 2022-05-27
• Last updated: 2022-05-27

Locations

1 site across 1 country: United States