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

Not Applicable

Terminated

• Conditions: Diabetes; Physical Activity
• Interventions: Behavioral: Group Walk; Behavioral: Individual Walk

• Registration Number: NCT01888133
• Lead Sponsor: Joslin Diabetes Center

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 available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-02
• Study First Submitted QC: 2013-06-25
• Study First Posted: 2013-06-27
• Status Verified: 2014-04
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Last Update Submitted: 2014-04-01
• Last Update Posted: 2014-04-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 22

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group Walk First	Individual Walk	Participants attend a weekly walking group session from weeks 1-6 and are not required to attend from weeks 7-12.
Individual Walk First	Group Walk	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.
Individual Walk First	Individual Walk	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.
Group Walk First	Group Walk	Participants attend a weekly walking group session from weeks 1-6 and are not required to attend from weeks 7-12.

Primary Outcome Measures

Name	Time	Method
Change in steps/day	Baseline, Week 3, Week 6, Week 9, Week 12

Secondary Outcome Measures

Name	Time	Method
Change in Weight	Baseline, Week 3, Week 6, Week 9, Week 12
Change in A1c	Baseline, 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 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

Trial Locations

Locations (1)

Joslin Diabetes Center; 🇺🇸 Boston, Massachusetts, United States