Overweight and Obesity
Conditions
Keywords
Text messaging, PAD
Brief 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.
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.
Interventions
BEHAVIORALPACE
Patient-centered Assessment and Counseling for Exercise \[PACE\] program
BEHAVIORALDiet
Motivating healthy dietary habits
OTHERApp
Using an app to deliver communication to the participant.
OTHERFace-to-face
Using in person meetings and/or phone communication with the participant.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Walking Distance | Month 3 | Walking distance as measured by the 6 minute walk test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight Loss | Month 3 | Change in weight, collected at two time points. |
| Quality of Life (QoL) | 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. |
| Physical Activity | 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. |
| Dietary Habits | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PACE+DApp Participants in this group will receive a physical activity and dietary intervention via a mobile phone app.
PACE: Patient-centered Assessment and Counseling for Exercise \[PACE\] program to motivate physical activity
Diet: Motivating healthy dietary habits
App: Used to deliver the interventions | 13 |
| Motivational Interviewing Participants in this group will receive counseling - motivational interviewing.
Motivational interviewing was used to motivate physical activity and health dietary habits
MI was delivered face-to-face initially followed by telephone for subsequent sessions (total sessions were 5) | 16 |
| Total | 29 |
Baseline characteristics
| Characteristic | Motivational Interviewing | Total | PACE+DApp |
|---|---|---|---|
| Age, Continuous | 68.39 years STANDARD_DEVIATION 7.36 | 66.03 years STANDARD_DEVIATION 8.12 | 63.12 years STANDARD_DEVIATION 8.34 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants | 28 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 14 Participants | 23 Participants | 9 Participants |
| Region of Enrollment United States | 16 participants | 29 participants | 13 participants |
| Sex: Female, Male Female | 11 Participants | 20 Participants | 9 Participants |
| Sex: Female, Male Male | 5 Participants | 9 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 16 |
| other Total, other adverse events | 0 / 13 | 0 / 16 |
| serious Total, serious adverse events | 0 / 13 | 0 / 16 |
Outcome results
Primary
Walking Distance
Walking distance as measured by the 6 minute walk test.
Time frame: Month 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PACE+DApp | Walking Distance | 331.19 meters | Standard Deviation 58.63 |
| Motivational Interviewing | Walking Distance | 298.67 meters | Standard Deviation 101.2 |
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 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)
Time frame: Month 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PACE+DApp | Dietary Habits | 2.61 score on a scale | Standard Deviation 0.32 |
| Motivational Interviewing | Dietary Habits | 2.45 score on a scale | Standard Deviation 0.52 |
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.
Time frame: Month 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PACE+DApp | Physical Activity | 22.73 units on a scale | Standard Deviation 16.56 |
| Motivational Interviewing | Physical Activity | 27.32 units on a scale | Standard Deviation 27.18 |
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.
Time frame: Month 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PACE+DApp | Quality of Life (QoL) | 5.09 units on a scale; | Standard Deviation 1.37 |
| Motivational Interviewing | Quality of Life (QoL) | 5.36 units on a scale; | Standard Deviation 0.75 |
Secondary
Weight Loss
Change in weight, collected at two time points.
Time frame: Month 3
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PACE+DApp | Weight Loss | 2.3 lbs. |
| Motivational Interviewing | Weight Loss | 10.1 lbs. |