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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Registered Dietitian/Nutritionist | Active Comparator |
| |
| DPP Group Classes | Active Comparator |
| |
| Weight Watchers, Reimagined | Active Comparator |
| |
| Pharmacological Treatment | Active Comparator |
| |
| Bariatric Surgery Evaluation | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Registered Dietitian/Nutritionist | Behavioral | Participants received a FitBit Flex and Intensive Lifestyle Intervention coaching via telephone with Registered Dietitian/Nutritionist. |
| Measure | Description | Time Frame |
|---|---|---|
| Demographics | Race, ethnicity, education level, marital status, household income, and weight management history. | Baseline |
| Body Weight | 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 | 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 | Treatment satisfaction and patient involvement in care survey | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Bailey-Davis, DEd | Geisinger Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geisinger Health System | Danville | Pennsylvania | 17822 | United States |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D064686 | Nutritionists |
| C407547 | dentin sialophosphoprotein |
| D004304 | Dosage Forms |
| ID | Term |
|---|---|
| D006282 | Health Personnel |
| D005159 | Health Care Facilities Workforce and Services |
| D004364 | Pharmaceutical Preparations |
| D013678 | Technology, Pharmaceutical |
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Participants enrolled in this study were able to choose from 1 of 5 intervention options based on their weight status.
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| Diabetes Prevention Program | Behavioral | Modified DPP group classes lead by a Registered Dietitian and Exercise Physiologist. |
|
| Weight Watchers, Reimagined | Behavioral | 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. |
|
| DPP or RDN Counseling + Medication | Behavioral | 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. |
|
| Bariatric Surgery Evaluation | Other | 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. |
|
| D004700 | Endocrine System Diseases |
| D008919 | Investigative Techniques |