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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01888133
• Other study ID #: CHS 2012-12
• Status: Terminated
• Phase: N/A
• First received: April 2, 2013
• Last updated: April 1, 2014
• Start date: April 2013
• Est. completion date: April 2014

Study information

• Verified date: April 2014
• Source: Joslin Diabetes Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes
• Physical Activity

Intervention

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

Locations

Country	Name	City	State
United States	Joslin Diabetes Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Joslin Diabetes Center

Country where clinical trial is conducted

United States, 

References & Publications (13)

American Diabetes Association. Executive summary: Standards of medical care in diabetes--2012. Diabetes Care. 2012 Jan;35 Suppl 1:S4-S10. doi: 10.2337/dc12-s004. — View Citation

Barrett-Connor E. Nutrition epidemiology: how do we know what they ate? Am J Clin Nutr. 1991 Jul;54(1 Suppl):182S-187S. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Löwe B, Kroenke K, Gräfe K. Detecting and monitoring depression with a two-item questionnaire (PHQ-2). J Psychosom Res. 2005 Feb;58(2):163-71. — View Citation

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. — View Citation

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. Epub 2007 Feb 15. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in steps/day		Baseline, Week 3, Week 6, Week 9, Week 12	No
Secondary	Change in BMI		Baseline, Week 3, Week 6, Week 9, Week 12	No
Secondary	Change in Blood Pressure		Baseline, Week 3, Week 6, Week 9, Week 12	No
Secondary	Change in Waist Circumference		Baseline, Week 3, Week 6, Week 9, Week 12	No
Secondary	Hip Circumference		Baseline, Week 3, Week 6, Week 9, Week 12	No
Secondary	Change in Physical Activity Pattern		Baseline, Week 6, Week 12	No
Secondary	Change in Food Consumption		Baseline, Week 6, Week 12	No
Secondary	Change in Fructosamine		Baseline, Week 6, Week 12	No
Secondary	Change in Pulse		Baseline, Week 3, Week 6, Week 9, Week 12	No
Secondary	Change in Height		Baseline, Week 3, Week 6, Week 9, Week 12	No
Secondary	Change in Weight		Baseline, Week 3, Week 6, Week 9, Week 12	No
Secondary	Change in A1c		Baseline, Week 12	No