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Physical Activity & Sedentary Behavior Modification for Sedentary Lifestyle
N/A
Waitlist Available
Led By Andrea M Kriska, PhD
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Individuals attending screening who are found to have prediabetes AND/OR the metabolic syndrome are eligible to participate in the intervention. Pre-diabetes is defined as having a fasting glucose >100 mg/dL and <126mg/dL and/or a hemoglobin A1C of 5.7%-6.4%.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change in hemoglobin a1c between baseline and 12 months
Awards & highlights
Study Summary
This trial will study the effects of reducing sedentary/sitting behaviors on weight and modifying diabetes and CVD risk factors.
Who is the study for?
This trial is for adults with metabolic syndrome or prediabetes, defined by specific measurements like waist size, blood pressure, cholesterol levels, triglycerides, and fasting glucose. They must be able to read/write English at a 6th-grade level and get doctor's approval to participate in physical activities.Check my eligibility
What is being tested?
The study tests the impact of increasing physical activity (GLB-MOD), decreasing sedentary behavior (GLB-SED), compared to a delayed intervention group (DELAYED). It aims to validate the role of these lifestyle changes using objective measures.See study design
What are the potential side effects?
Since this trial involves lifestyle interventions such as increased physical activity and reduced sitting time rather than medication, side effects are minimal but may include muscle soreness or fatigue due to new exercise routines.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have prediabetes or metabolic syndrome based on my screening results.
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 moreTrial 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?
University of PittsburghLead Sponsor
1,719 Previous Clinical Trials
16,342,033 Total Patients Enrolled
6 Trials studying Sedentary Lifestyle
420 Patients Enrolled for Sedentary Lifestyle
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,357 Previous Clinical Trials
4,314,878 Total Patients Enrolled
5 Trials studying Sedentary Lifestyle
1,114 Patients Enrolled for Sedentary Lifestyle
Andrea M Kriska, PhDPrincipal InvestigatorUniversity of Pittsburgh
1 Previous Clinical Trials
223 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have prediabetes or metabolic syndrome based on my screening results.I have high cholesterol and one other metabolic syndrome condition.
Research Study Groups:
This trial has the following groups:- Group 1: 6-month delayed (DELAYED)
- Group 2: Physical Activity Increase (GLB-MOD)
- Group 3: Sedentary Time Decrease (GLB-SED)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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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