CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 308 enrolled
Drug / intervention
Physical Activity Increase (GLB-MOD) +2 morebehavioral
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02467881
NCT02467881N/ACompleted

Physical Activity and Sedentary Behavior Change; Impact on Lifestyle Intervention Effects for Diabetes Translation

University of Pittsburgh·interventional·Posted Jun 10, 2015·Updated Nov 15, 2024

In Brief

A clinical study evaluating Physical Activity Increase (GLB-MOD), Sedentary Time Decrease (GLB-SED), and 1 other intervention for Sedentary Lifestyle and Physical Activity. Completed, enrolled 308 participants across 1 site.

Detailed Summary

Diabetes Prevention Program translational efforts, such as the Group Lifestyle Balance Program (GLB), have been shown to be effective in reducing weight and modifying diabetes and CVD risk factors in a variety of diverse community settings. Although one of the two primary goals of these DPP translation programs focuses on increasing physical activity levels, few published DPP translation studies reported results on change in physical activity with only one study reporting activity levels from an objective measurement instrument. In order to completely understand the role that physical activity plays in making healthy lifestyle change, it is critical that we validate the impact of activity using a valid and reliable objective measure. In addition, current studies suggest that decreasing time spent sitting may have a positive health impact separate from the effects of participating in planned bouts of moderate intensity activity. Therefore, we propose to examine the impact of a modified version of the GLB program, which will focus on decreasing sedentary/sitting behaviors. The results of this project will provide information regarding best options for physical activity within lifestyle intervention programs, focusing both on verifying the current role of physical activity in lifestyle intervention using an objective measure and on examining an alternative intervention option for translation efforts.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 10, 2015
Enrollment StartSep 1, 2015
Primary CompletionJul 31, 2019
Study CompletionNov 30, 2019
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 11.1 years ago

Interventions

Physical Activity Increase (GLB-MOD)behavioral

The Group Lifestyle Balance (GLB) program was adapted from the original DPP lifestyle intervention. As in the original DPP lifestyle program, the GLB goals are to achieve and maintain a 7% weight loss, and to safely and progressively increase physical activity to 150 minutes/week of moderately intense physical activity similar to a brisk walk. The curriculum will be administered in intervention groups with an average of 10-15 individuals per group; sessions will be conducted by trained coaches, with participants attending 22 sessions over one year. The two intervention arms will only differ in the aerobic activity portion of the intervention, which is covered in sessions #4, #10 and 19 as well as participant record keeping and goal setting in regards to activity/inactivity progression.

Sedentary Time Decrease (GLB-SED)behavioral

As in the original DPP, the GLB goal for weight is to achieve and maintain a 7% weight loss. For this intervention arm, instead of focusing on increasing moderate physical activity, the GLB curriculum will be adapted to address decreasing sitting time. Participants will have a goal of decreasing sitting time by 45 minutes/day. The curriculum will be administered in intervention groups with an average of 10-15 individuals per group; sessions will be conducted by trained coaches, with participants attending 22 sessions over one year. The two intervention arms will only differ in the aerobic activity portion of the intervention, which is covered in sessions #4, #10 and 19 as well as participant record keeping and goal setting in regards to activity/inactivity progression.

6-month delayed (DELAYED)other

Individuals assigned to 6 month delay will wait for 6 months from baseline to be randomly assigned to one of the two interventions and will begin intervention at that time. During the waiting period they will receive health information newsletters.