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Adopting a Physically Active Lifestyle Through Organized Walk Events Among Joslin Clinic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01888133
Recruitment Status : Terminated (Lack of funding)
First Posted : June 27, 2013
Last Update Posted : April 3, 2014
Sponsor:
Information provided by (Responsible Party):
William Hsu, Joslin Diabetes Center

Brief Summary:
Can participation in group physical activity, such as a community-based organized group walk, help adult diabetes patients develop a physically active lifestyle? Can such engagement ultimately lead to an improvement in hemoglobin A1c? To address this question, the investigators have designed this pilot study with the aim to investigate the effect of community-based group walks among Joslin adults with diabetes on the development of a physically active lifestyle and glycemic level. The investigators hypothesize that participation in group walking events helps Joslin adults with diabetes engage in physical activity and improves glycemic control.

Condition or disease Intervention/treatment Phase
Diabetes Physical Activity Behavioral: Group Walk Behavioral: Individual Walk Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Adopting a Physically Active Lifestyle Through Organized Walk Events Among Joslin Clinic Patients
Study Start Date : April 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Arm Intervention/treatment
Experimental: Group Walk First
Participants attend a weekly walking group session from weeks 1-6 and are not required to attend from weeks 7-12.
Behavioral: Group Walk
weekly walking club session on Saturday mornings at Boston Common, lasting 30 min - 1 hour and engage in daily physical activity (aiming for 10,000 steps/day or increase number of steps by 500 every 2 weeks)

Behavioral: Individual Walk
engage in daily physical activity (aiming for 10,000 steps/day or increase number of steps by 500 every 2 weeks)

Experimental: Individual Walk First
Participants are not required to attend a weekly group walking sessions from weeks 1-6 and attend a weekly walking group session from weeks 7-12.
Behavioral: Group Walk
weekly walking club session on Saturday mornings at Boston Common, lasting 30 min - 1 hour and engage in daily physical activity (aiming for 10,000 steps/day or increase number of steps by 500 every 2 weeks)

Behavioral: Individual Walk
engage in daily physical activity (aiming for 10,000 steps/day or increase number of steps by 500 every 2 weeks)




Primary Outcome Measures :
  1. Change in steps/day [ Time Frame: Baseline, Week 3, Week 6, Week 9, Week 12 ]

Secondary Outcome Measures :
  1. Change in BMI [ Time Frame: Baseline, Week 3, Week 6, Week 9, Week 12 ]
  2. Change in Blood Pressure [ Time Frame: Baseline, Week 3, Week 6, Week 9, Week 12 ]
  3. Change in Waist Circumference [ Time Frame: Baseline, Week 3, Week 6, Week 9, Week 12 ]
  4. Hip Circumference [ Time Frame: Baseline, Week 3, Week 6, Week 9, Week 12 ]
  5. Change in Physical Activity Pattern [ Time Frame: Baseline, Week 6, Week 12 ]
  6. Change in Food Consumption [ Time Frame: Baseline, Week 6, Week 12 ]
  7. Change in Fructosamine [ Time Frame: Baseline, Week 6, Week 12 ]
  8. Change in Pulse [ Time Frame: Baseline, Week 3, Week 6, Week 9, Week 12 ]
  9. Change in Height [ Time Frame: Baseline, Week 3, Week 6, Week 9, Week 12 ]
  10. Change in Weight [ Time Frame: Baseline, Week 3, Week 6, Week 9, Week 12 ]
  11. Change in A1c [ Time Frame: Baseline, Week 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Joslin Clinic patients
  • 18 years or older
  • A1C between 7.5% - 12.0%
  • Received physician clearance indicating safe to participate in the walk club events
  • Reside within Boston and Greater Boston Area
  • Ability to communicate in English and/or Chinese
  • Agree to participate in the intervention walk club for 6 consecutive weeks

Exclusion Criteria:

  • Pregnant or breast feeding
  • Unstable angina or myocardial infarction within 1 month prior to screening
  • Unstable gait, severe neuropathy, or deformed foot.
  • Enrolled in another investigational study within 1 month prior to screening for this study
  • On medications such as prednisone that will affect blood glucose

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01888133


Locations
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United States, Massachusetts
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Joslin Diabetes Center
Investigators
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Principal Investigator: William Hsu, MD Joslin Diabetes Center
Publications:

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Responsible Party: William Hsu, Director, Asian Clinic at Joslin Diabetes Center, Joslin Diabetes Center
ClinicalTrials.gov Identifier: NCT01888133    
Other Study ID Numbers: CHS 2012-12
First Posted: June 27, 2013    Key Record Dates
Last Update Posted: April 3, 2014
Last Verified: April 2014