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

Sponsor

Joslin Diabetes Center (Other)

Overall Status

Terminated

CT.gov ID

NCT01888133

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

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 :

Apr 1, 2013

Actual Primary Completion Date :

Apr 1, 2014

Actual Study Completion Date :

Apr 1, 2014

Arms and Interventions

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)

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

Behavioral: Individual Walk

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

Outcome Measures

Primary Outcome Measures

Change in steps/day [Baseline, Week 3, Week 6, Week 9, Week 12]

Secondary Outcome Measures

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]
Change in Food Consumption [Baseline, Week 6, Week 12]
Change in Fructosamine [Baseline, Week 6, Week 12]
Change in Pulse [Baseline, Week 3, Week 6, Week 9, Week 12]
Change in Height [Baseline, Week 3, Week 6, Week 9, Week 12]
Change in Weight [Baseline, Week 3, Week 6, Week 9, Week 12]
Change in A1c [Baseline, Week 12]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Joslin Diabetes Center	Boston	Massachusetts	United States	02215

Sponsors and Collaborators

Joslin Diabetes Center

Investigators

Principal Investigator: William Hsu, MD, Joslin Diabetes Center

Study Documents (Full-Text)

None provided.

More Information

Publications

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:

Jun 27, 2013

Last Update Posted:

Apr 3, 2014

Last Verified:

Apr 1, 2014

Study Results

No Results Posted as of Apr 3, 2014