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

Study Overview
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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.

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

Conditions
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Overweight and Obesity

Intervention / Treatment
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* Behavioral: PACE
* Behavioral: Diet
* Other: App
* Other: Face-to-face


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PACE+DApp<br>Participants in this group will receive combined intervention and a mobile phone app. | Behavioral: PACE<br>* Patient-centered Assessment and Counseling for Exercise [PACE] program<br>Behavioral: Diet<br>* Motivating healthy dietary habits<br>Other: App<br>* Using an app to deliver communication to the participant.<br>|
| Active Comparator: PACE+Dface-to-face<br>Participants in this group will receive combined intervention and in person/phone communication. | Behavioral: PACE<br>* Patient-centered Assessment and Counseling for Exercise [PACE] program<br>Behavioral: Diet<br>* Motivating healthy dietary habits<br>Other: Face-to-face<br>* Using in person meetings and/or phone communication with the participant.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Walking Distance | Walking distance as measured by the 6 minute walk test. | Month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Loss | Change in weight, collected at two time points. | Month 3 | 
| 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. | Month 3 | 
| 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. | Month 3 | 
| 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) | Month 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Text messaging, PAD