Integrated Lifestyle Intervention to Promote Weight Loss Study (COMIRB 23-1154)

Primary Objective

The purpose of this study is to evaluate the 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.

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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
Age

18 to 65 years

Eligibility

Between the ages of 18 and 65 years BMI between 25 and 45kg/m2 Generally healthy with no diabetes, heart disease, or other medical conditions that may limit physical activity Have access to a computer and/or smart phone, and Wi-Fi Not currently exercising regularly (<150 minutes/week) No plans to relocate in the next 16 months No nicotine use (current or past 6 months) No current alcohol or substance abuse No regular use of prescription or over-the-counter medications known to significantly impact appetite, weight, sleep, or energy metabolism (e... g., appetite suppressants, lithium, stimulants, anti-psychotics, tricyclic antidepressants) No regular use of obesity pharmacotherapeutic agents within the last 6 months. Not currently participating in or planning to participate in any formal weight loss, dietary modification, or physical activity/exercise programs or clinical trials. Females who are currently pregnant or lactating, were pregnant within the past 3 months, or planning to become pregnant in the next 5 months will be excluded

Compensation

Compensation provided

Locations

Anschutz Health and Wellness
Outpatient CTRC
University of Colorado Hospital

Principal Investigator
Photograph of Danielle Ostendorf

Danielle Ostendorf

Resources
Study ID

Protocol Number: 23-1154

More information available at ClinicalTrials.gov: NCT06116435

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