Preventing Diabetes

NCT05395377 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2022-05-27

No results posted yet for this study

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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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05395377 on ClinicalTrials.gov