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Texting for Mobility in Overweight/Obese Adults With Peripheral Artery Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03694652
Recruitment Status : Completed
First Posted : October 3, 2018
Last Update Posted : June 21, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Kansas Medical Center

Study Description
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Brief Summary:
By doing this study, researchers hope to learn about the feasibility of using a mobile application to help overweight or obese adults with PAD increase their walking distance and lose weight.

Condition or disease Intervention/treatment Phase
Overweight and Obesity Behavioral: PACE Behavioral: Diet Other: App Other: Face-to-face Not Applicable

Detailed Description:
Peripheral artery disease (PAD) or poor leg circulation affects 8 to 12 million Americans including non-Hispanic Whites, African Americans and Latinos. Having PAD can limit how far you can walk. Many patients with PAD are also overweight or obese. Weight loss among overweight or obese adults with PAD may improve walking distance. Given how common obesity or being overweight is among persons with PAD, interventions are needed to address weight loss in this population.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Text Messaging to Promote Mobility in Overweight/Obese Adults With Peripheral Artery Disease
Actual Study Start Date : October 18, 2018
Actual Primary Completion Date : June 5, 2019
Actual Study Completion Date : June 5, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: PACE+DApp
Participants in this group will receive combined intervention and a mobile phone app.
 Behavioral: PACE
Patient-centered Assessment and Counseling for Exercise [PACE] program

Behavioral: Diet
Motivating healthy dietary habits

Other: App
Using an app to deliver communication to the participant.
Active Comparator: PACE+Dface-to-face
Participants in this group will receive combined intervention and in person/phone communication.
 Behavioral: PACE
Patient-centered Assessment and Counseling for Exercise [PACE] program

Behavioral: Diet
Motivating healthy dietary habits

Other: Face-to-face
Using in person meetings and/or phone communication with the participant.


Outcome Measures
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Primary Outcome Measures :
  1. Walking distance [ Time Frame: Change from Baseline to Month 3 ]
    Change in walking distance as measured by the 6 minute walk test.


Secondary Outcome Measures :
  1. Weight loss [ Time Frame: Change from Baseline to Month 3 ]
    Change in weight

  2. Quality of life (QoL) [ Time Frame: Change from Baseline to Month 3 ]
    Change in QoL as measured by the VascQOL.

  3. Physical activity [ Time Frame: Change from Baseline to Month 3 ]
    Physical activity to be measured using the Exercise Behaviors Questionnaire.

  4. Dietary habits [ Time Frame: Month 3 ]
    Dietary habits tracked using the Diet History Questionnaire.


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Overweight or obese (body mass index >=27 kg/m2)
  • Have symptomatic PAD
  • English speaking
  • Have 24 hour access to a cell phone

Exclusion Criteria:

  • Cannot tolerate fruits and vegetables, fiber, and/or a low fat diet, as informed by a physician and/or registered dietician
  • Restricted intake of water
  • Pregnancy
  • Prior major amputation (foot or lower leg) or critical leg ischemia (tissue loss, gangrene, or ulcers)
  • Use of supplemental oxygen
  • Heart attack within preceding 3 months
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03694652


Locations
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United States, Kansas
University of Kansas School of Medicine
Wichita, Kansas, United States, 67214
Sponsors and Collaborators
University of Kansas Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Tracie C Collins, MD, MPH, MHCDS University of Kansas Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT03694652    
Other Study ID Numbers: STUDY00141458
1R56HL138244 ( U.S. NIH Grant/Contract )
First Posted: October 3, 2018    Key Record Dates
Last Update Posted: June 21, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Kansas Medical Center:
Text messaging
PAD
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Overweight
Body Weight
Atherosclerosis
Arteriosclerosis
 Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases