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

Primary Purpose

Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PACE
Diet
App
Face-to-face
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight and Obesity focused on measuring Text messaging, PAD

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Kansas School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PACE+DApp

PACE+Dface-to-face

Arm Description

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

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

Outcomes

Primary Outcome Measures

Walking Distance
Walking distance as measured by the 6 minute walk test.

Secondary Outcome Measures

Weight Loss
Change in weight, collected at two time points.
Quality of Life (QoL)
QoL as measured by the Vascular Quality of Life Questionnaire. There are 25 questions that are each scored 1-7. The total score is determined by all adding the score from each of the 25 questions and dividing by 25. The total range is 1-7 and a higher score indicates a better quality of life.
Physical Activity
Physical activity to be measured using the Exercise Behavior Questionnaire from the Stanford Patient Education Research Center. Scores are for type of activity, length of activity, time spent in aerobic activities, and an assessment of time spent in stretching and strengthening exercises. For the manuscript, we only focused on aerobic activity and we did not include stretching or strengthening exercise scores. Participants were asked how often during the past week they performed aerobic exercises on a scale of 0 (none) to 4 (more than 3 hours per week). Scores were converted by the overall time spent in aerobic exercises per week and range from 0 to 180 with higher scores indicating more time spent doing aerobic exercises.
Dietary Habits
Dietary habits tracked using the Fat-Related Diet Habits Questionnaire. Questions were rated on a 4-point scale, where 1 indicates healthy and 4 less healthy eating habits. The questionnaire included five sections (i) replacing high fat foods with low fat substitutes (score range: 7-28); (ii) modifying high fat foods (range: 3-12); (iii) avoiding high fat cooking methods (score range: 4-16); (iv) consumption of fresh fruit and vegetables as a snack (score range: 3-12); and (v) choosing specially manufactured low fat food (score range: 5-20). The total score is calculated from the sum of section scores divided by 5 (range from 4.4 to 17 with higher scores representing more unhealthy eating habits)

Full Information

First Posted
October 1, 2018
Last Updated
May 23, 2023
Sponsor
University of Kansas Medical Center
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT03694652
Brief Title
Texting for Mobility in Overweight/Obese Adults With Peripheral Artery Disease
Official Title
Text Messaging to Promote Mobility in Overweight/Obese Adults With Peripheral Artery Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
October 18, 2018 (Actual)
Primary Completion Date
June 5, 2019 (Actual)
Study Completion Date
June 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
Text messaging, PAD

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PACE+DApp
Arm Type
Experimental
Arm Description
Participants in this group will receive combined intervention and a mobile phone app.
Arm Title
PACE+Dface-to-face
Arm Type
Active Comparator
Arm Description
Participants in this group will receive combined intervention and in person/phone communication.
Intervention Type
Behavioral
Intervention Name(s)
PACE
Intervention Description
Patient-centered Assessment and Counseling for Exercise [PACE] program
Intervention Type
Behavioral
Intervention Name(s)
Diet
Intervention Description
Motivating healthy dietary habits
Intervention Type
Other
Intervention Name(s)
App
Intervention Description
Using an app to deliver communication to the participant.
Intervention Type
Other
Intervention Name(s)
Face-to-face
Intervention Description
Using in person meetings and/or phone communication with the participant.
Primary Outcome Measure Information:
Title
Walking Distance
Description
Walking distance as measured by the 6 minute walk test.
Time Frame
Month 3
Secondary Outcome Measure Information:
Title
Weight Loss
Description
Change in weight, collected at two time points.
Time Frame
Month 3
Title
Quality of Life (QoL)
Description
QoL as measured by the Vascular Quality of Life Questionnaire. There are 25 questions that are each scored 1-7. The total score is determined by all adding the score from each of the 25 questions and dividing by 25. The total range is 1-7 and a higher score indicates a better quality of life.
Time Frame
Month 3
Title
Physical Activity
Description
Physical activity to be measured using the Exercise Behavior Questionnaire from the Stanford Patient Education Research Center. Scores are for type of activity, length of activity, time spent in aerobic activities, and an assessment of time spent in stretching and strengthening exercises. For the manuscript, we only focused on aerobic activity and we did not include stretching or strengthening exercise scores. Participants were asked how often during the past week they performed aerobic exercises on a scale of 0 (none) to 4 (more than 3 hours per week). Scores were converted by the overall time spent in aerobic exercises per week and range from 0 to 180 with higher scores indicating more time spent doing aerobic exercises.
Time Frame
Month 3
Title
Dietary Habits
Description
Dietary habits tracked using the Fat-Related Diet Habits Questionnaire. Questions were rated on a 4-point scale, where 1 indicates healthy and 4 less healthy eating habits. The questionnaire included five sections (i) replacing high fat foods with low fat substitutes (score range: 7-28); (ii) modifying high fat foods (range: 3-12); (iii) avoiding high fat cooking methods (score range: 4-16); (iv) consumption of fresh fruit and vegetables as a snack (score range: 3-12); and (v) choosing specially manufactured low fat food (score range: 5-20). The total score is calculated from the sum of section scores divided by 5 (range from 4.4 to 17 with higher scores representing more unhealthy eating habits)
Time Frame
Month 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tracie C Collins, MD, MPH, MHCDS
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas School of Medicine
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35113020
Citation
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.
Results Reference
derived

Learn more about this trial

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

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