Preventing Diabetes (PD)

May 24, 2022 updated by: Geisinger Clinic

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Registered Dietitian/Nutritionist
Behavioral: Registered Dietitian/Nutritionist
Participants received a FitBit Flex and Intensive Lifestyle Intervention coaching via telephone with Registered Dietitian/Nutritionist.
Active Comparator: DPP Group Classes
Behavioral: Diabetes Prevention Program
Modified DPP group classes lead by a Registered Dietitian and Exercise Physiologist.
Active Comparator: Weight Watchers, Reimagined
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.
Active Comparator: Pharmacological Treatment
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.
Active Comparator: Bariatric Surgery Evaluation
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Geisinger Clinic

Investigators

  • Principal Investigator: Lisa Bailey-Davis, DEd, Geisinger Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2017

Primary Completion (Actual)

June 28, 2019

Study Completion (Actual)

November 16, 2021

Study Registration Dates

First Submitted

May 24, 2022

First Submitted That Met QC Criteria

May 24, 2022

First Posted (Actual)

May 27, 2022

Study Record Updates

Last Update Posted (Actual)

May 27, 2022

Last Update Submitted That Met QC Criteria

May 24, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-0394

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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