PreDiabetes
Conditions
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.
Interventions
BEHAVIORALRegistered Dietitian/Nutritionist
Participants received a FitBit Flex and Intensive Lifestyle Intervention coaching via telephone with Registered Dietitian/Nutritionist.
BEHAVIORALDiabetes Prevention Program
Modified DPP group classes lead by a Registered Dietitian and Exercise Physiologist.
BEHAVIORALWeight 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.
BEHAVIORALDPP 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.
OTHERBariatric 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
Geisinger Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Participants enrolled in this study were able to choose from 1 of 5 intervention options based on their weight status.
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Demographics | Baseline | Race, ethnicity, education level, marital status, household income, and weight management history. |
| Body Weight | 12 Months | The study's primary outcome is change in body mass index (in kg) from baseline to 12-month follow-up. |
| Pre-Diabetes Indicator | 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. |
| Patient-Centered Outcomes | 12 months | Treatment satisfaction and patient involvement in care survey |
Countries
United States
Outcome results
None listed