NCT03694652

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2018

Completed
15 days until next milestone

Study Start

First participant enrolled

October 18, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2019

Completed
4 years until next milestone

Results Posted

Study results publicly available

May 26, 2023

Completed
Last Updated

May 26, 2023

Status Verified

February 1, 2023

Enrollment Period

8 months

First QC Date

October 1, 2018

Results QC Date

August 17, 2022

Last Update Submit

May 23, 2023

Conditions

Overweight and Obesity

Keywords

Text messagingPAD

Outcome Measures

Primary Outcomes (1)

  • Walking Distance

    Walking distance as measured by the 6 minute walk test.

    Month 3

Secondary Outcomes (4)

  • Weight Loss

    Month 3

  • Quality of Life (QoL)

    Month 3

  • Physical Activity

    Month 3

  • Dietary Habits

    Month 3

Study Arms (2)

PACE+DApp

EXPERIMENTAL

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

Behavioral: PACEBehavioral: DietOther: App

PACE+Dface-to-face

ACTIVE COMPARATOR

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

Behavioral: PACEBehavioral: DietOther: Face-to-face

Interventions

PACEBEHAVIORAL

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

PACE+DAppPACE+Dface-to-face
DietBEHAVIORAL

Motivating healthy dietary habits

PACE+DAppPACE+Dface-to-face
AppOTHER

Using an app to deliver communication to the participant.

PACE+DApp
Face-to-faceOTHER

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

PACE+Dface-to-face

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas School of Medicine

Wichita, Kansas, 67214, United States

Location

Related Publications (1)

  • 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.

    PMID: 35113020DERIVED

MeSH Terms

Conditions

OverweightObesity

Interventions

DietAmyloid

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaMultiprotein ComplexesMacromolecular SubstancesProteinsAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Dr. Tracie Collins
Organization
University of New Mexico
tccollins@salud.unm.edu
505-272-4979

Study Officials

  • Tracie C Collins, MD, MPH, MHCDS

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2018

First Posted

October 3, 2018

Study Start

October 18, 2018

Primary Completion

June 5, 2019

Study Completion

June 5, 2019

Last Updated

May 26, 2023

Results First Posted

May 26, 2023

Record last verified: 2023-02

Locations

US(1)