Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
84 participants
INTERVENTIONAL
2017-12-18
2021-11-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Registered Dietitian/Nutritionist
Registered Dietitian/Nutritionist
Participants received a FitBit Flex and Intensive Lifestyle Intervention coaching via telephone with Registered Dietitian/Nutritionist.
DPP Group Classes
Diabetes Prevention Program
Modified DPP group classes lead by a Registered Dietitian and Exercise Physiologist.
Weight Watchers, Reimagined
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.
Pharmacological Treatment
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.
Bariatric Surgery Evaluation
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.
Interventions
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Registered Dietitian/Nutritionist
Participants received a FitBit Flex and Intensive Lifestyle Intervention coaching via telephone with Registered Dietitian/Nutritionist.
Diabetes Prevention Program
Modified DPP group classes lead by a Registered Dietitian and Exercise Physiologist.
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.
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.
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.
Eligibility Criteria
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Inclusion 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
* Contraindications to weight change (e.g., cancer, pregnancy)
* Prior bariatric surgery
* Weight loss medication use or orders within 5 years prior to the project.
18 Years
89 Years
ALL
No
Sponsors
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Geisinger Clinic
OTHER
Responsible Party
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Principal Investigators
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Lisa Bailey-Davis, DEd
Role: PRINCIPAL_INVESTIGATOR
Geisinger Clinic
Locations
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Geisinger Health System
Danville, Pennsylvania, United States
Countries
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Other Identifiers
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2017-0394
Identifier Type: -
Identifier Source: org_study_id
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