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

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

October 1, 2018

First Posted Date ^ICMJE

October 3, 2018

Last Update Posted Date

October 3, 2018

Actual Study Start Date ^ICMJE

October 2018

Estimated Primary Completion Date

April 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Walking distance[ Time Frame: Change from Baseline to Month 3 ]

Change in walking distance as measured by the 6 minute walk test.

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Weight loss[ Time Frame: Change from Baseline to Month 3 ]
Change in weight
Quality of life (QoL)[ Time Frame: Change from Baseline to Month 3 ]
Change in QoL as measured by the VascQOL.
Physical activity[ Time Frame: Change from Baseline to Month 3 ]
Physical activity to be measured using the Exercise Behaviors Questionnaire.
Dietary habits[ Time Frame: Month 3 ]
Dietary habits tracked using the Diet History Questionnaire.

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Text Messaging to Promote Mobility in Overweight/Obese Adults With Peripheral Artery Disease

Brief Summary

By doing this study, researchers hope to learn about the impact of text messaging to help overweight or obese adults with PAD lose weight and improve their walking distance.

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 Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Prevention

Condition ^ICMJE

Intervention ^ICMJE

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

Study Arms

Experimental: PACE+DApp
Participants in this group will receive combined intervention and a mobile phone app.
Active Comparator: PACE+Dface-to-face
Participants in this group will receive combined intervention and in person/phone communication.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

April 2019

Estimated Primary Completion Date

April 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria: - Overweight or obese (body mass index >=27 kg/m2) - Have symptomatic PAD - English or Spanish 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

Sex/Gender

Sexes Eligible for Study:

All

Ages

21 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

University of Kansas Medical Center

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Traci Collins, MD, MPH University of Kansas Medical Center

PRS Account

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

请使用微信扫码报名