Completed
Evaluation of a Lifestyle Intervention for Employees With Prediabetes
What is being tested
Lifestyle counseling
Behavioral
Who is being recruted
Behavior+12
+ Body Weight
+ Diabetes Mellitus
From 18 to 65 Years
+7 Eligibility Criteria
How is the trial designed
Prevention Study
Interventional
Study Start: November 2012
Summary
Principal SponsorOhio State University
Last updated: October 30, 2014
Sourced from a government-validated database.Claim as a partner
Study start date: November 1, 2012
Actual date on which the first participant was enrolled.The lifestyle intervention includes a 16-week group-based program which targets weight reduction through the adoption of a lower fat diet and greater physical activity.
Principal SponsorOhio State University
Last updated: October 30, 2014
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
78 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
BehaviorBody WeightDiabetes MellitusEndocrine System DiseasesMetabolic DiseasesNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionGlucose Metabolism DisordersObesityPrediabetic StateRisk Reduction BehaviorOverweight
Criteria
3 inclusion criteria required to participate
18-65 years old
overweight or obese
prediabetes with elevated glucose value
4 exclusion criteria prevent from participating
concurrent participation in a structured weight loss program
pregnant or lactating
recent cardiovascular event
use of corticosteroids
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalDiabetes Prevention Program lifestyle intervention
Group II
No InterventionUsual care from primary care physician
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
CompletedOne Study Center