Preventing Diabetes (PD)
Primary Purpose
PreDiabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Registered Dietitian/Nutritionist
Diabetes Prevention Program
Weight Watchers, Reimagined
DPP or RDN Counseling + Medication
Bariatric Surgery Evaluation
Sponsored by
About this trial
This is an interventional prevention trial for PreDiabetes
Eligibility Criteria
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.
Sites / Locations
- Geisinger Health System
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Registered Dietitian/Nutritionist
DPP Group Classes
Weight Watchers, Reimagined
Pharmacological Treatment
Bariatric Surgery Evaluation
Arm Description
Outcomes
Primary Outcome Measures
Demographics
Race, ethnicity, education level, marital status, household income, and weight management history.
Body Weight
The study's primary outcome is change in body mass index (in kg) from baseline to 12-month follow-up.
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.
Patient-Centered Outcomes
Treatment satisfaction and patient involvement in care survey
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05395377
Brief Title
Preventing Diabetes
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
December 18, 2017 (Actual)
Primary Completion Date
June 28, 2019 (Actual)
Study Completion Date
November 16, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Geisinger Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PreDiabetes
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants enrolled in this study were able to choose from 1 of 5 intervention options based on their weight status.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Registered Dietitian/Nutritionist
Arm Type
Active Comparator
Arm Title
DPP Group Classes
Arm Type
Active Comparator
Arm Title
Weight Watchers, Reimagined
Arm Type
Active Comparator
Arm Title
Pharmacological Treatment
Arm Type
Active Comparator
Arm Title
Bariatric Surgery Evaluation
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Registered Dietitian/Nutritionist
Intervention Description
Participants received a FitBit Flex and Intensive Lifestyle Intervention coaching via telephone with Registered Dietitian/Nutritionist.
Intervention Type
Behavioral
Intervention Name(s)
Diabetes Prevention Program
Intervention Description
Modified DPP group classes lead by a Registered Dietitian and Exercise Physiologist.
Intervention Type
Behavioral
Intervention Name(s)
Weight Watchers, Reimagined
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
DPP or RDN Counseling + Medication
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Bariatric Surgery Evaluation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Demographics
Description
Race, ethnicity, education level, marital status, household income, and weight management history.
Time Frame
Baseline
Title
Body Weight
Description
The study's primary outcome is change in body mass index (in kg) from baseline to 12-month follow-up.
Time Frame
12 Months
Title
Pre-Diabetes Indicator
Description
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.
Time Frame
12 months
Title
Patient-Centered Outcomes
Description
Treatment satisfaction and patient involvement in care survey
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Bailey-Davis, DEd
Organizational Affiliation
Geisinger Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geisinger Health System
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Preventing Diabetes
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