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

NCT ID: NCT03694652

Last Updated: 2023-05-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-18

Study Completion Date

2019-06-05

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Overweight and Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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PACE+DApp

Participants in this group will receive combined intervention and a mobile phone app.

Group Type EXPERIMENTAL

PACE

Intervention Type BEHAVIORAL

Patient-centered Assessment and Counseling for Exercise \[PACE\] program

Diet

Intervention Type BEHAVIORAL

Motivating healthy dietary habits

App

Intervention Type OTHER

Using an app to deliver communication to the participant.

PACE+Dface-to-face

Participants in this group will receive combined intervention and in person/phone communication.

Group Type ACTIVE_COMPARATOR

PACE

Intervention Type BEHAVIORAL

Patient-centered Assessment and Counseling for Exercise \[PACE\] program

Diet

Intervention Type BEHAVIORAL

Motivating healthy dietary habits

Face-to-face

Intervention Type OTHER

Using in person meetings and/or phone communication with the participant.

Interventions

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PACE

Patient-centered Assessment and Counseling for Exercise \[PACE\] program

Intervention Type BEHAVIORAL

Diet

Motivating healthy dietary habits

Intervention Type BEHAVIORAL

App

Using an app to deliver communication to the participant.

Intervention Type OTHER

Face-to-face

Using in person meetings and/or phone communication with the participant.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tracie C Collins, MD, MPH, MHCDS

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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University of Kansas School of Medicine

Wichita, Kansas, United States

Site Status

Countries

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United States

References

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Collins T, Geana M, Overton K, Benton M, Lu L, Khan F, Rohleder M, Ahluwalia J, Resnicow K, Zhu Y. Use of a Smartphone App Versus Motivational Interviewing to Increase Walking Distance and Weight Loss in Overweight/Obese Adults With Peripheral Artery Disease: Pilot Randomized Trial. JMIR Form Res. 2022 Feb 3;6(2):e30295. doi: 10.2196/30295.

Reference Type DERIVED
PMID: 35113020 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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1R56HL138244

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00141458

Identifier Type: -

Identifier Source: org_study_id

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