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

Overweight and Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03694652
• Other study ID #: STUDY00141458
• Secondary ID: 1R56HL138244
• Status: Completed
• Phase: N/A
• Start date: October 18, 2018
• Est. completion date: June 5, 2019

Study information

• Verified date: February 2023
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: June 5, 2019
• Est. primary completion date: June 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity
• Peripheral Arterial Disease

Intervention

Behavioral:
• PACE
Patient-centered Assessment and Counseling for Exercise [PACE] program
• Diet
Motivating healthy dietary habits

Other:
• App
Using an app to deliver communication to the participant.
• Face-to-face
Using in person meetings and/or phone communication with the participant.

Locations

Country	Name	City	State
United States	University of Kansas School of Medicine	Wichita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Walking Distance	Walking distance as measured by the 6 minute walk test.	Month 3
Secondary	Weight Loss	Change in weight, collected at two time points.	Month 3
Secondary	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
Secondary	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
Secondary	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 ?ve 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