Physical Activity and Sedentary Behavior Change; Impact on Lifestyle

Physical Activity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02467881
• Other study ID #: STUDY20050105
• Secondary ID: R18DK100933-02
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 2015
• Est. completion date: October 2024

Study information

• Verified date: February 2024
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Translation efforts based upon the successful Diabetes Prevention Program (DPP) have shown that this behavioral lifestyle intervention model is effective in a variety of diverse community settings. Despite the fact that physical activity is a key part of the DPP lifestyle intervention as one of the two intervention goals, activity change in the DPP, and/or the resulting translation studies modeled after it, has not been adequately verified with an accurate objective measure. In addition, previous research has shown that, in many subgroups of the general population, moderate and vigorous physical activity is non-existent. Individuals with activity only at the low end of the intensity spectrum may have a difficult time increasing their levels of moderate+ intensity physical activity for various reasons such as limited function or lack of motivation. For these individuals, interventions with a movement goal of increasing planned bouts of moderate intensity activity may not be as effective and therefore not as beneficial as interventions with a movement goal of decreasing time spent sitting.

The purpose of this proposal is to understand the impact of movement, specifically physical activity and sitting time, in a DPP-adapted community lifestyle intervention, Group Lifestyle Balance (GLB).

Aim 1: To determine if the GLB lifestyle intervention, shown to be effective in translation efforts in decreasing weight and increasing self-reported activity, has significant changes in physical activity levels determined by a validated objective measure, the accelerometer. It is hypothesized that participants randomized to the conventional lifestyle intervention arm (GLB-MOD) will have significant improvements in our primary endpoints of weight and physical activity (measured objectively) compared to a delayed-intervention control at 6 months and will have reductions in several secondary outcome measures (fasting glucose, insulin, blood pressure, waist, lipids, physical function, and quality of life).

Aim 2: To determine if a lifestyle intervention program similar to the one described above, with the only change being that the activity focus is now replaced with an inactivity focus (GLB-SED), is also effective. It is hypothesized that participants randomized to GLB-SED will have a significant improvement in the primary endpoints of weight and decreased inactivity (measured objectively) compared to a delayed-intervention control at 6 months and will have significant reductions in several of the secondary endpoints (fasting glucose, insulin, blood pressure, waist circumference, lipids, physical function, quality of life).

Secondary Aims: To examine the pre-post change in participants for weight, physical activity (objective and subjective), and sedentary time from baseline to 6 and 12 months of intervention for each randomized arm and to understand the inter-relationships of these behavioral factors over time. It is hypothesized that those GLB-MOD participants who achieve significant weight loss will also have significant increases in their moderate+ intensity activity levels. Similarly, we hypothesize those GLB-SED participants who achieve significant weight loss will also have significant decreases in the amount of time they spent sedentary/sitting. An estimate of the difference in participant cost between the two versions of the lifestyle intervention programs will also be determined.

Aim #1 addresses an important remaining gap in the prevention literature; does objectively measured activity improve as a result of the existing intervention that is being used in DPP-based translation efforts and does this change in activity have an impact on weight change? Aim #2 examines the impact of replacing the conventional physical activity goal of increasing planned and relatively brief bouts of moderate physical activity with one focusing on decreasing sedentary time within the framework of a successful translation lifestyle intervention adapted from the DPP, the Group Lifestyle Balance (GLB) program.

The study design is a prospective, six month delayed-control intervention in which 321 subjects (age 50 and older with a BMI of ≥24 kg/m2 and with prediabetes and/or metabolic syndrome) will be recruited from community centers and randomly assigned to one of three groups: the standard GLB program which includes the conventional moderate activity goal (GLB-MOD), the GLB program with a focus on decreasing sedentary behavior (GLB-SED), or delayed intervention. Subjects assigned to GLB-MOD and GLB-SED will each, separately be compared at 6 months to the delayed-control group after which time, the delayed group will be randomly assigned to either GLB-MOD or GLB-SED. Participants will complete baseline, 6, and 12 month assessment visits. Change in weight, objectively measured activity, and time spent sedentary are the primary outcomes with secondary outcomes including change in self-reported physical activity, HbA1c, fasting glucose, lipids, blood pressure, waist circumference, quality of life and physical function.

It is hypothesized that physical activity assessed by accelerometry in GLB-MOD will significantly increase (mostly moderate intense activity) and that there will be a significant decrease in weight, which will partly be related to change in activity levels. The 2nd hypothesis is that the GLB-SED intervention will significantly decrease time spent sitting as measured by accelerometry and that this change will also be related to a significant decrease in weight. The information that will be gained from this entire effort is important, innovative, and will allow us to obtain a complete and accurate understanding of both ends of the physical activity/inactivity spectrum and their impact in community prevention intervention programs. If shown to be effective, the innovative, modified sedentary-focused translation intervention program would provide a valuable future translation option.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 308
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

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%.

Metabolic syndrome is defined as having at least 3 of the 5 following risk factors:

1. Waist circumference (>40 inches men, >35 inches women);

2. Blood pressure >130 mmHg (systolic) or >85 mmHg (diastolic) OR history of diagnosed hypertension

3. Low HDL level (<40mg/dL men, <50 mg/dL women)

4. Elevated triglyceride level >150 mg/dL

5. Fasting glucose >100mg/dL and <126mg/dL

Individuals attending screening with hyperlipidemia plus one additional component of the metabolic syndrome are also eligible.

Exclusion Criteria:

Individuals who are identified as having diabetes as a result of the screening are not eligible. All individuals enrolled in the study should have at least 6th grade English reading/writing ability. Physician approval will be requested to clear for the activity portion of the program.

Related Conditions & MeSH terms

• Physical Activity
• Sedentary Lifestyle

Intervention

Behavioral:
• Physical Activity Increase (GLB-MOD)
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)
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.

Other:
• 6-month delayed (DELAYED)
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.

Locations

Country	Name	City	State
United States	University of Pittsburgh, Epidemiology Department	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (7)

Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512. — View Citation

Kramer MK, Kriska AM, Venditti EM, Miller RG, Brooks MM, Burke LE, Siminerio LM, Solano FX, Orchard TJ. Translating the Diabetes Prevention Program: a comprehensive model for prevention training and program delivery. Am J Prev Med. 2009 Dec;37(6):505-11. doi: 10.1016/j.amepre.2009.07.020. — View Citation

Kriska AM, Edelstein SL, Hamman RF, Otto A, Bray GA, Mayer-Davis EJ, Wing RR, Horton ES, Haffner SM, Regensteiner JG. Physical activity in individuals at risk for diabetes: Diabetes Prevention Program. Med Sci Sports Exerc. 2006 May;38(5):826-32. doi: 10.1249/01.mss.0000218138.91812.f9. — View Citation

Orchard TJ, Temprosa M, Goldberg R, Haffner S, Ratner R, Marcovina S, Fowler S; Diabetes Prevention Program Research Group. The effect of metformin and intensive lifestyle intervention on the metabolic syndrome: the Diabetes Prevention Program randomized trial. Ann Intern Med. 2005 Apr 19;142(8):611-9. doi: 10.7326/0003-4819-142-8-200504190-00009. — View Citation

Ratner R, Goldberg R, Haffner S, Marcovina S, Orchard T, Fowler S, Temprosa M; Diabetes Prevention Program Research Group. Impact of intensive lifestyle and metformin therapy on cardiovascular disease risk factors in the diabetes prevention program. Diabetes Care. 2005 Apr;28(4):888-94. doi: 10.2337/diacare.28.4.888. — View Citation

Steeves JA, Bassett DR, Fitzhugh EC, Raynor HA, Thompson DL. Can sedentary behavior be made more active? A randomized pilot study of TV commercial stepping versus walking. Int J Behav Nutr Phys Act. 2012 Aug 6;9:95. doi: 10.1186/1479-5868-9-95. — View Citation

Wilmot EG, Davies MJ, Edwardson CL, Gorely T, Khunti K, Nimmo M, Yates T, Biddle SJ. Rationale and study design for a randomised controlled trial to reduce sedentary time in adults at risk of type 2 diabetes mellitus: project stand (Sedentary Time ANd diabetes). BMC Public Health. 2011 Dec 8;11:908. doi: 10.1186/1471-2458-11-908. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI (Body Mass Index)	BMI will be calculated as average weight divided by average height squared (kg/m2).	Change in BMI between Baseline and 6 months
Primary	BMI (Body Mass Index)	BMI will be calculated as average weight divided by average height squared (kg/m2).	Change in BMI between Baseline and 12 months
Primary	Actigraph Accelerometry	Physical activity level objectively measured using Actigraph Accelerometry. This will be worn on the waist and will passively record physical activity and sedentary behavior.	Change in Physical Activity Level between Baseline and 6 months
Primary	Actigraph Accelerometry	Physical activity level objectively measured using Actigraph Accelerometry. This will be worn on the waist and will passively record physical activity and sedentary behavior.	Change in Physical Activity Level between Baseline and 12 months
Secondary	Gait Speed	Gait Speed (m/s over 4 m) will be used to measure change in physical function.	Change in Gait Speed between Baseline and 6 months
Secondary	Gait Speed	Gait Speed (m/s over 4 m) will be used to measure change in physical function.	Change in Gait Speed between Baseline and 12 months
Secondary	Fasting glucose test	Blood sample	Change in Fasting glucose between Baseline and 6 months
Secondary	Fasting glucose test	Blood sample	Change in Fasting glucose between Baseline and 12 months
Secondary	Fasting lipid profile test	Blood sample	Change in Fasting lipid profile between Baseline and 6 months
Secondary	Fasting lipid profile test	Blood sample	Change in Fasting lipid profile between Baseline and 12 months
Secondary	Fasting Insulin test	Blood test	Change in Fasting Insulin between Baseline and 6 months
Secondary	Fasting Insulin test	Blood test	Change in Fasting Insulin between Baseline and 12 months
Secondary	Hemoglobin A1c test	Blood sample	Change in Hemoglobin A1c between Baseline an 6 months
Secondary	Hemoglobin A1c test	Blood sample	Change in Hemoglobin A1c between Baseline and 12 months
Secondary	Blood pressure		Change in Blood Pressure between Baseline and 6 months
Secondary	Blood pressure		Change in Blood Pressure between Baseline and 12 months
Secondary	Modifiable Activity Questionnaire	The Modified Activity Questionnaire is a self-report of physical activity level and sedentary behavior.	Change in self-reported Modifiable Activity Questionnaire between Baseline and 6 months
Secondary	Modifiable Activity Questionnaire	The Modified Activity Questionnaire is a self-report of physical activity level and sedentary behavior.	Change in self-reported Modifiable Activity Questionnaire between Baseline and 12 months
Secondary	EQ-5D Quality of Life Survey	The EQ-5D quality of life survey measures health status and outcomes.	Change in Quality of Life between Baseline and 6 months
Secondary	EQ-5D Quality of Life Survey	The EQ-5D quality of life survey measures health status and outcomes.	Change in Quality of Life between Baseline and 12 months

External Links

•   Diabetes Prevention Support Center of the University of Pittsburgh