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TerminatedNCT01888133Updated Apr 3, 2014

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

An interventional study of Group Walk and Individual Walk in Diabetes and Physical Activity, sponsored by Joslin Diabetes Center. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-04-03.

Sponsored by Joslin Diabetes Center · Not applicable and Interventional

Why this study was terminated
Lack of funding
Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Diabetes
  • Physical Activity
03

In context

Diabetes Mellitus

11,090 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 22 is below the median of 80 across 8,491 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Joslin Diabetes Center is the lead sponsor of 80 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
22 participants (actual)

Study arms

  • 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 · 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.

    Behavioral: Group Walk · Behavioral: Individual Walk

Interventions

  • BehavioralGroup 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)

  • BehavioralIndividual Walk

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

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What researchers measure

Primary outcomes

  1. Change in steps/day

    Time frame: Baseline, Week 3, Week 6, Week 9, Week 12

Secondary outcomes

  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

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Study locations

1 site
  • Joslin Diabetes Center
    Boston, Massachusetts 02215, United States
08

References and documents

Publications

  • Tudor-Locke C, Bell RC, Myers AM, Harris SB, Ecclestone NA, Lauzon N, Rodger NW. Controlled outcome evaluation of the First Step Program: a daily physical activity intervention for individuals with type II diabetes. Int J Obes Relat Metab Disord. 2004 Jan;28(1):113-9. doi: 10.1038/sj.ijo.0802485. PubMed 14569279 ↗
  • Ford ES, Herman WH. Leisure-time physical activity patterns in the U.S. diabetic population. Findings from the 1990 National Health Interview Survey--Health Promotion and Disease Prevention Supplement. Diabetes Care. 1995 Jan;18(1):27-33. doi: 10.2337/diacare.18.1.27. PubMed 7698044 ↗
  • Hays LM, Clark DO. Correlates of physical activity in a sample of older adults with type 2 diabetes. Diabetes Care. 1999 May;22(5):706-12. doi: 10.2337/diacare.22.5.706. PubMed 10332670 ↗
  • Tudor-Locke CE, Bell RC, Meyers AM. Revisiting the role of physical activity and exercise in the treatment of type 2 diabetes. Can J Appl Physiol. 2000 Dec;25(6):466-92. doi: 10.1139/h00-031. PubMed 11098158 ↗
  • Manson JE, Hu FB, Rich-Edwards JW, Colditz GA, Stampfer MJ, Willett WC, Speizer FE, Hennekens CH. A prospective study of walking as compared with vigorous exercise in the prevention of coronary heart disease in women. N Engl J Med. 1999 Aug 26;341(9):650-8. doi: 10.1056/NEJM199908263410904. PubMed 10460816 ↗
  • Kang M, Marshall SJ, Barreira TV, Lee JO. Effect of pedometer-based physical activity interventions: a meta-analysis. Res Q Exerc Sport. 2009 Sep;80(3):648-55. doi: 10.1080/02701367.2009.10599604. No abstract available. PubMed 19791652 ↗
  • Merom D, Rissel C, Phongsavan P, Smith BJ, Van Kemenade C, Brown WJ, Bauman AE. Promoting walking with pedometers in the community: the step-by-step trial. Am J Prev Med. 2007 Apr;32(4):290-7. doi: 10.1016/j.amepre.2006.12.007. Epub 2007 Feb 15. PubMed 17303369 ↗
  • Kahn EB, Ramsey LT, Brownson RC, Heath GW, Howze EH, Powell KE, Stone EJ, Rajab MW, Corso P. The effectiveness of interventions to increase physical activity. A systematic review. Am J Prev Med. 2002 May;22(4 Suppl):73-107. doi: 10.1016/s0749-3797(02)00434-8. PubMed 11985936 ↗
  • American Diabetes Association. Executive summary: Standards of medical care in diabetes--2012. Diabetes Care. 2012 Jan;35 Suppl 1(Suppl 1):S4-S10. doi: 10.2337/dc12-s004. No abstract available. PubMed 22187471 ↗
  • Januszewski AS, Karschimkus C, Davis KE, O'Neal D, Ward G, Jenkins AJ. Plasma 1,5 anhydroglucitol levels, a measure of short-term glycaemia: assay assessment and lower levels in diabetic vs. non-diabetic subjects. Diabetes Res Clin Pract. 2012 Jan;95(1):e17-9. doi: 10.1016/j.diabres.2011.09.032. Epub 2011 Oct 22. PubMed 22024285 ↗
  • Barrett-Connor E. Nutrition epidemiology: how do we know what they ate? Am J Clin Nutr. 1991 Jul;54(1 Suppl):182S-187S. doi: 10.1093/ajcn/54.1.182S. PubMed 2053559 ↗
  • Lowe B, Kroenke K, Grafe K. Detecting and monitoring depression with a two-item questionnaire (PHQ-2). J Psychosom Res. 2005 Feb;58(2):163-71. doi: 10.1016/j.jpsychores.2004.09.006. PubMed 15820844 ↗
  • Tudor-Locke C, Bassett DR Jr. How many steps/day are enough? Preliminary pedometer indices for public health. Sports Med. 2004;34(1):1-8. doi: 10.2165/00007256-200434010-00001. PubMed 14715035 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2013, a primary completion of Apr 2014 and a completion of Apr 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 2, 2013
First posted
Jun 27, 2013
Start
Apr 2013
Primary completionActual
Apr 2014
CompletionActual
Apr 2014
Last update
Apr 3, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 3, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01888133
Lead sponsor
Joslin Diabetes Center
Responsible party
William Hsu (Director, Asian Clinic at Joslin Diabetes Center, Joslin Diabetes Center) — Principal investigator
First posted
Jun 27, 2013
Start date
Apr 2013
Primary completion
Apr 2014
Completion
Apr 2014
Last update
Apr 3, 2014

Study contacts

William Hsu, MD
principal investigator · Joslin Diabetes Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.

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