Augmented Care at Worksite for Diabetes Prevention
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Prediabetes
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: The proposed translational study applies an innovative experimental approach, an adaptive design, to optimize treatment for weight loss and weight loss maintenance in individuals with prediabetes. All participants will begin a standard lifestyle intervention to promote weight loss. Those who do not achieve >2.5% weight loss during the first month of the intervention will transition to augmented care to enhance weight loss during the intensive intervention phase. Following the intensive phase, participants will be randomly assigned to either the standard intervention or the enhanced intervention for the maintenance study phase. By randomly assigning participants to either the standard maintenance phase of the intervention or the innovative maintenance phase of the intervention following the initial core phase, the impact of extended training in self-regulation for weight loss maintenance will be evaluated.Masking: Single (Outcomes Assessor)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 21 years and 125 years
- Gender
- Both males and females
Description
Employees at The Ohio State University (OSU) with prediabetes will participate in a standard lifestyle intervention for diabetes prevention. Participants who do not achieve >2.5% weight loss by week 5 of the intervention will transition into augmented care with an enhanced training program that addr...
Employees at The Ohio State University (OSU) with prediabetes will participate in a standard lifestyle intervention for diabetes prevention. Participants who do not achieve >2.5% weight loss by week 5 of the intervention will transition into augmented care with an enhanced training program that addresses values clarification, decision making, planning, and problem solving. The impact of the enhanced intervention will be evaluated at 4, 12 and 18 months from baseline to determine if implementing early enhanced training helps participants achieve and maintain weight loss similar to those who received the standard intervention.
Tracking Information
- NCT #
- NCT03382873
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Carla Miller, Ph.D. Ohio State University