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Completed

NCT Number: NCT03694652

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

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas School of Medicine

Wichita, Kansas, 67214, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PACE

Behavioral

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

Diet

Behavioral

Motivating healthy dietary habits

App

Other

Using an app to deliver communication to the participant.

Face-to-face

Other

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

Primary outcomes

  1. Walking Distance

    Time frame: Month 3

    Walking distance as measured by the 6 minute walk test.

Secondary outcomes

  1. Weight Loss

    Time frame: Month 3

    Change in weight, collected at two time points.

  2. 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.

  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.

  4. 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)

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 3, 2018
Registry last updated
May 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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