Physical Activity and Sedentary Behavior Change; Impact on Lifestyle

NCT02467881 | Completed DMC

• 2 other identifiers: STUDY20050105R18DK100933-02
• Study Type: interventional
• Target: 308
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sedentary Lifestyle; Physical Activity

Keywords

Physical Activity; Sedentary; Lifestyle Intervention

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (16)

• Gait Speed

  Change in Gait Speed between Baseline and 6 months

• Gait Speed

  Change in Gait Speed between Baseline and 12 months

• Fasting glucose test

  Change in Fasting glucose between Baseline and 6 months

• Fasting glucose test

  Change in Fasting glucose between Baseline and 12 months

• Fasting lipid profile test

  Change in Fasting lipid profile between Baseline and 6 months

Study Arms (3)

Physical Activity Increase (GLB-MOD)

ACTIVE COMPARATOR

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.

Behavioral: Physical Activity Increase (GLB-MOD)

Sedentary Time Decrease (GLB-SED)

ACTIVE COMPARATOR

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.

Behavioral: Sedentary Time Decrease (GLB-SED)

6-month delayed (DELAYED)

OTHER

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.

Other: 6-month delayed (DELAYED)

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.

Physical Activity Increase (GLB-MOD)

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.

Sedentary Time Decrease (GLB-SED)

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.

6-month delayed (DELAYED)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Waist circumference (\>40 inches men, \>35 inches women);
• Blood pressure \>130 mmHg (systolic) or \>85 mmHg (diastolic) OR history of diagnosed hypertension
• Low HDL level (\<40mg/dL men, \<50 mg/dL women)
• Elevated triglyceride level \>150 mg/dL
• Fasting glucose \>100mg/dL and \<126mg/dL
• Individuals attending screening with hyperlipidemia plus one additional component of the metabolic syndrome are also eligible.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Pittsburgh, Epidemiology Department

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (8)

• 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.

  PMID: 15793191 BACKGROUND

• 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.

  PMID: 11832527 BACKGROUND

• 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.

  PMID: 15838067 BACKGROUND

• 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.

  PMID: 19944916 BACKGROUND

• 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.

  PMID: 16672833 BACKGROUND

• 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.

  PMID: 22151909 BACKGROUND

• 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.

  PMID: 22866941 BACKGROUND

• Devaraj SM, Napoleone JM, Miller RG, Rockette-Wagner B, Arena VC, Mitchell-Miland C, Saad MB, Kriska AM. The role of Sociodemographic factors on goal achievement in a community-based diabetes prevention program behavioral lifestyle intervention. BMC Public Health. 2021 Oct 2;21(1):1783. doi: 10.1186/s12889-021-11844-z.

  PMID: 34600527 DERIVED

Related Links

• Diabetes Prevention Support Center of the University of Pittsburgh

MeSH Terms

Conditions

Sedentary Behavior; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Andrea M Kriska, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: June 3, 2015
• First Posted: June 10, 2015
• Study Start: September 1, 2015
• Primary Completion: July 31, 2019
• Study Completion: November 30, 2019
• Last Updated: November 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)