6-month delayed (DELAYED) for Physical Activity
University of Pittsburgh, Epidemiology Department, Pittsburgh, PA
Targeting 2 different conditions6-month delayed (DELAYED) +2 moreN/AWaitlist AvailableLed by Andrea M Kriska, PhDResearch Sponsored by University of PittsburghEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upchange in hemoglobin a1c between baseline and 12 months
Awards & highlights
No Placebo-Only Group
Study Summary
This trial will study the effects of reducing sedentary/sitting behaviors on weight and modifying diabetes and CVD risk factors.
Eligible Conditions
- Physical Activity
- Sedentary Lifestyle
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change in hemoglobin a1c between baseline and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change in hemoglobin a1c between baseline and 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Actigraph Accelerometry
BMI (Body Mass Index)
Secondary outcome measures
Blood pressure
EQ-5D Quality of Life Survey
Fasting Insulin test
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: 6-month delayed (DELAYED)Experimental Treatment1 Intervention
Those assigned to the DELAYED group at baseline will wait for 6 months to begin intervention. During the delayed time period, these participants will receive periodic health information newsletters. At the end of 6 months, the DELAYED participants will be randomly assigned to GLB-MOD or GLB-SED intervention, and will begin their intervention program at that time.
Group II: Physical Activity Increase (GLB-MOD)Active Control1 Intervention
Participants randomized to this arm will follow the traditional GLB program with an activity goal of 150 minutes per week of moderately intense physical activity similar to a brisk walk. Progression of the activity goal each week is slow and safe with increases of no more than 30 minutes per week. Participants are requested to try and achieve 20-30 minutes per day of moderate activity but, to allow for flexibility, that amount can be split into 10 minute increments. Self-reported monitoring for this group includes keeping track of weight, daily food intake as well the number of minutes each day spent being active as part of their planned activity goal. This is all recorded in the self-monitoring keeping track book.
Group III: Sedentary Time Decrease (GLB-SED)Active Control1 Intervention
The GLB curriculum will be adapted to direct participants to decrease the time they spend sitting in a day rather than to increase moderate+ physical activity as is the case in the current GLB program. In order for the participant to become aware of how much time they spend sitting and where most of their sitting time occurs, they will fill out a "7 Day Sedentary Diary" that consists of daily entry of time spent sitting over the course of one week. Participants will be asked to eliminate a 45 minute sitting bout in a day with non-sitting activity. They will initially be asked to eliminate 45 minutes of sitting for two days in that week. This will increase one day a week until 7 days in a week are met.
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Who is running the clinical trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,262 Previous Clinical Trials
4,200,500 Total Patients Enrolled
University of PittsburghLead Sponsor
1,674 Previous Clinical Trials
16,301,650 Total Patients Enrolled
Andrea M Kriska, PhDPrincipal Investigator
University of Pittsburgh1 Previous Clinical Trials
223 Total Patients Enrolled
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Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Do patients currently have the opportunity to participate in this experiment?
"The available information on clinicaltrials.gov indicates that this medical study is not presently recruiting participants, having been initially posted in September 2015 and recently updated November 2022. However, there are currently 128 other trials which require patient recruitment at the moment."
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