- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03694652
Texting for Mobility in Overweight/Obese Adults With Peripheral Artery Disease
Text Messaging to Promote Mobility in Overweight/Obese Adults With Peripheral Artery Disease
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kansas
-
Wichita, Kansas, United States, 67214
- University of Kansas School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PACE+DApp
Participants in this group will receive combined intervention and a mobile phone app.
|
Patient-centered Assessment and Counseling for Exercise [PACE] program
Motivating healthy dietary habits
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.
|
Patient-centered Assessment and Counseling for Exercise [PACE] program
Motivating healthy dietary habits
Using in person meetings and/or phone communication with the participant.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Walking Distance
Time Frame: Month 3
|
Walking distance as measured by the 6 minute walk test.
|
Month 3
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight Loss
Time Frame: Month 3
|
Change in weight, collected at two time points.
|
Month 3
|
Quality of Life (QoL)
Time Frame: Month 3
|
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.
|
Month 3
|
Physical Activity
Time Frame: Month 3
|
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. |
Month 3
|
Dietary Habits
Time Frame: Month 3
|
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)
|
Month 3
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Tracie C Collins, MD, MPH, MHCDS, University of Kansas Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00141458
- 1R56HL138244 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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