Designing with dissemination in mind: Development and evaluation of a theory-based physical activity intervention using the Multiphase Optimization Strategy: Aim 2
Primary Objective
The purpose of this study is to evaluate an integrated lifestyle intervention program. We want to learn whether patients like the program, if it easy for them to participate in it and how the program impacts their health.
Description
If you join the study, you will undergo 2-3 screening visits to see if you are eligible to be in the study. If you are eligible to be in the study, you will receive a 6-month integrated lifestyle intervention program. This integrated program includes PreventT2 (formally known as the Diabetes Prevention Program), as well as a physical activity support program. The integrated program will involve weekly group-based classes for the first 12 weeks, followed by group-based classes occurring every other week from weeks 13-26, delivered by a trained, Registered Dietitian (RD). You will be asked to restrict your calorie intake and to build up your physical activity levels up to 300 minutes/week. You may receive up to three, additional physical activity support program components: 1) 3-5, 45-minute individualized physical activity support sessions, 2) Access to an online fitness membership over 6 months, 3) Weekly mental guided imagery sessions over 6 months. These three additional program components will be assigned to you by chance. This means that you do not get to decide which treatment you receive. Your participation in the study will last approximately 13-16 months to complete all study measures including study screening, baseline testing, and outcome measures at 6 and 12 months after the start of the intervention.
Details
Locations
Anschutz Health and Wellness
Outpatient CTRC
University of Colorado Hospital
Principal Investigator
Danielle Ostendorf
Study ID
Protocol Number: 23-1154
More information available at ClinicalTrials.gov: NCT06116435
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