Clinical trial NCT01888133: Adopting a Physically Active Lifestyle Through Organized Walk Events Among Joslin Clinic Patients
Official title: Adopting a Physically Active Lifestyle Through Organized Walk Events Among Joslin Clinic Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes
Physical Activity
Lead sponsor: Joslin Diabetes Center
Sponsor class: OTHER
First posted: 2013-06-27
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in steps/day
timeFrame: Baseline, Week 3, Week 6, Week 9, Week 12
Secondary outcomes:
measure: Change in BMI
timeFrame: Baseline, Week 3, Week 6, Week 9, Week 12
measure: Change in Blood Pressure
timeFrame: Baseline, Week 3, Week 6, Week 9, Week 12
measure: Change in Waist Circumference
timeFrame: Baseline, Week 3, Week 6, Week 9, Week 12
measure: Hip Circumference
timeFrame: Baseline, Week 3, Week 6, Week 9, Week 12
measure: Change in Physical Activity Pattern
timeFrame: Baseline, Week 6, Week 12
measure: Change in Food Consumption
timeFrame: Baseline, Week 6, Week 12
measure: Change in Fructosamine
timeFrame: Baseline, Week 6, Week 12
measure: Change in Pulse
timeFrame: Baseline, Week 3, Week 6, Week 9, Week 12
measure: Change in Height
timeFrame: Baseline, Week 3, Week 6, Week 9, Week 12
measure: Change in Weight
timeFrame: Baseline, Week 3, Week 6, Week 9, Week 12
measure: Change in A1c
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
Study officials:
affiliation: Joslin Diabetes Center
name: William Hsu, MD
role: PRINCIPAL_INVESTIGATOR
References:
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