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Overweight and ObesityNCT03694652

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

A study testing PACE, Diet and App in people with Overweight and Obesity, run by University of Kansas Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Overweight and Obesity
What is being tested?
PACE, Diet and App
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
1 siteUnited States
Study dates
18 Oct 2018to 5 Jun 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Kansas School of Medicine

    Wichita, Kansas, 67214

Other trials in United States

About this study

Official title: Text Messaging to Promote 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.

Read the 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.

Being tested
PACE, Diet, App, Face-to-face
Keywords
Text messaging, PAD
Medical subject headings
Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PACEBehavioural

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

  • DietBehavioural

    Motivating healthy dietary habits

  • AppOther

    Using an app to deliver communication to the participant.

  • Face-to-faceOther

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

Study groups in NCT03694652
Study groupRoleWhat they receive
PACE+DAppExperimentalParticipants in this group will receive combined intervention and a mobile phone app.
Receives: Behavioral: PACE; Behavioral: Diet; Other: App
PACE+Dface-to-faceActive comparatorParticipants in this group will receive combined intervention and in person/phone communication.
Receives: Behavioral: PACE; Behavioral: Diet; Other: Face-to-face

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Walking Distance

    Walking distance as measured by the 6 minute walk test.

    Measured: Month 3

Secondary outcomes (4)

  1. Weight Loss

    Change in weight, collected at two time points.

    Measured: Month 3

  2. 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.

    Measured: Month 3

  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.

    Measured: Month 3

  4. 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)

    Measured: Month 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2018
  2. Study start18 Oct 2018
  3. Primary completion5 Jun 2019
  4. Study completion5 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03694652
Sponsor's protocol ID
STUDY00141458
Other IDs
1R56HL138244
Status last verified
Feb 2023
First submitted
1 Oct 2018
Last updated
26 May 2023
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhu Y, Collins T. The Moderating Effects of Race and Ethnicity on a Motivational Interviewing Intervention for Improving Physical Health Among Patients With Peripheral Artery Disease: Secondary Analysis of a Pilot Randomized Trial. JMIR Form Res. 2026 Oct 15;10:e82926. doi: 10.2196/82926.

    PubMed 42879766

  • 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.

    PubMed 35113020

Questions about this trial

What is this clinical trial studying?

A study testing PACE, Diet and App in people with Overweight and Obesity, run by University of Kansas Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Walking Distance (time frame: Month 3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03694652, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2023.

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