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

NCT01888133 | Terminated DMC

• 1 other identifier: CHS 2012-12
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Physical Activity

Outcome Measures

Primary Outcomes (1)

• Change in steps/day

  Baseline, Week 3, Week 6, Week 9, Week 12

Secondary Outcomes (11)

• Change in BMI

  Baseline, Week 3, Week 6, Week 9, Week 12

• Change in Blood Pressure

  Baseline, Week 3, Week 6, Week 9, Week 12

• Change in Waist Circumference

  Baseline, Week 3, Week 6, Week 9, Week 12

• Hip Circumference

  Baseline, Week 3, Week 6, Week 9, Week 12

• Change in Physical Activity Pattern

  Baseline, Week 6, Week 12

Study Arms (2)

Group Walk First

EXPERIMENTAL

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

Individual Walk First

EXPERIMENTAL

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

Group Walk BEHAVIORAL

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)

Group Walk First; Individual Walk First

Individual Walk BEHAVIORAL

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

Group Walk First; Individual Walk First

Eligibility Criteria

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

You may qualify if:

• Joslin Clinic patients
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Joslin Diabetes Center: lead

Study Sites (1)

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (13)

• 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.

  PMID: 14569279 BACKGROUND

• 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.

  PMID: 7698044 BACKGROUND

• 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.

  PMID: 10332670 BACKGROUND

• 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.

  PMID: 11098158 BACKGROUND

• 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.

  PMID: 10460816 BACKGROUND

• 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.

  PMID: 19791652 BACKGROUND

• 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.

  PMID: 17303369 BACKGROUND

• 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.

  PMID: 11985936 BACKGROUND

• 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.

  PMID: 22187471 BACKGROUND

• 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.

  PMID: 22024285 BACKGROUND

• 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.

  PMID: 2053559 BACKGROUND

• 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.

  PMID: 15820844 BACKGROUND

• 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.

  PMID: 14715035 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; Motor Activity

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Study Officials

• William Hsu, MD

  Joslin Diabetes Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Asian Clinic at Joslin Diabetes Center

Study Record Dates

• First Submitted: April 2, 2013
• First Posted: June 27, 2013
• Study Start: April 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: April 3, 2014

Record last verified: 2014-04

Locations

US (1)