Preventing Diabetes
NCT05395377 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84
Last updated 2022-05-27
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.
Conditions
Interventions
- 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.
Sponsors & Collaborators
-
Geisinger Clinic
lead OTHER
Principal Investigators
-
Lisa Bailey-Davis, DEd · Geisinger Clinic
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 89 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-12-18
- Primary Completion
- 2019-06-28
- Completion
- 2021-11-16
Countries
- United States
Study Locations
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