Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE April 2, 2013
First Posted Date  ICMJE June 27, 2013
Last Update Posted Date April 3, 2014
Study Start Date  ICMJE April 2013
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2013)
Change in steps/day [ Time Frame: Baseline, Week 3, Week 6, Week 9, Week 12 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2013)
  • Change in BMI [ Time Frame: Baseline, Week 3, Week 6, Week 9, Week 12 ]
  • Change in Blood Pressure [ Time Frame: Baseline, Week 3, Week 6, Week 9, Week 12 ]
  • Change in Waist Circumference [ Time Frame: Baseline, Week 3, Week 6, Week 9, Week 12 ]
  • Hip Circumference [ Time Frame: Baseline, Week 3, Week 6, Week 9, Week 12 ]
  • Change in Physical Activity Pattern [ Time Frame: Baseline, Week 6, Week 12 ]
  • Change in Food Consumption [ Time Frame: Baseline, Week 6, Week 12 ]
  • Change in Fructosamine [ Time Frame: Baseline, Week 6, Week 12 ]
  • Change in Pulse [ Time Frame: Baseline, Week 3, Week 6, Week 9, Week 12 ]
  • Change in Height [ Time Frame: Baseline, Week 3, Week 6, Week 9, Week 12 ]
  • Change in Weight [ Time Frame: Baseline, Week 3, Week 6, Week 9, Week 12 ]
  • Change in A1c [ Time Frame: Baseline, Week 12 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adopting a Physically Active Lifestyle Through Organized Walk Events Among Joslin Clinic Patients
Official Title  ICMJE Adopting a Physically Active Lifestyle Through Organized Walk Events Among Joslin Clinic Patients
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE
  • Diabetes
  • Physical Activity
Intervention  ICMJE
  • 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)
Study Arms  ICMJE
  • 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.
    Interventions:
    • Behavioral: Group Walk
    • Behavioral: Individual Walk
  • 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.
    Interventions:
    • Behavioral: Group Walk
    • Behavioral: Individual Walk
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 1, 2014)
22
Original Estimated Enrollment  ICMJE
 (submitted: June 25, 2013)
44
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01888133
Other Study ID Numbers  ICMJE CHS 2012-12
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party William Hsu, Joslin Diabetes Center
Study Sponsor  ICMJE Joslin Diabetes Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: William Hsu, MD Joslin Diabetes Center
PRS Account Joslin Diabetes Center
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP