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

April 1, 2014 updated by: William Hsu, Joslin Diabetes Center
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Joslin Diabetes Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in steps/day
Time Frame: Baseline, Week 3, Week 6, Week 9, Week 12
Baseline, Week 3, Week 6, Week 9, Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in BMI
Time Frame: Baseline, Week 3, Week 6, Week 9, Week 12
Baseline, Week 3, Week 6, Week 9, Week 12
Change in Blood Pressure
Time Frame: Baseline, Week 3, Week 6, Week 9, Week 12
Baseline, Week 3, Week 6, Week 9, Week 12
Change in Waist Circumference
Time Frame: Baseline, Week 3, Week 6, Week 9, Week 12
Baseline, Week 3, Week 6, Week 9, Week 12
Hip Circumference
Time Frame: Baseline, Week 3, Week 6, Week 9, Week 12
Baseline, Week 3, Week 6, Week 9, Week 12
Change in Physical Activity Pattern
Time Frame: Baseline, Week 6, Week 12
Baseline, Week 6, Week 12
Change in Food Consumption
Time Frame: Baseline, Week 6, Week 12
Baseline, Week 6, Week 12
Change in Fructosamine
Time Frame: Baseline, Week 6, Week 12
Baseline, Week 6, Week 12
Change in Pulse
Time Frame: Baseline, Week 3, Week 6, Week 9, Week 12
Baseline, Week 3, Week 6, Week 9, Week 12
Change in Height
Time Frame: Baseline, Week 3, Week 6, Week 9, Week 12
Baseline, Week 3, Week 6, Week 9, Week 12
Change in Weight
Time Frame: Baseline, Week 3, Week 6, Week 9, Week 12
Baseline, Week 3, Week 6, Week 9, Week 12
Change in A1c
Time Frame: Baseline, Week 12
Baseline, Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Joslin Diabetes Center

Investigators

  • Principal Investigator: William Hsu, MD, Joslin Diabetes Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

April 2, 2013

First Submitted That Met QC Criteria

June 25, 2013

First Posted (Estimate)

June 27, 2013

Study Record Updates

Last Update Posted (Estimate)

April 3, 2014

Last Update Submitted That Met QC Criteria

April 1, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • CHS 2012-12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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