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| ID | Type | Description | Link |
|---|---|---|---|
| 1R56HL138244 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PACE+DApp | Experimental | Participants in this group will receive combined intervention and a mobile phone app. |
|
| PACE+Dface-to-face | Active Comparator | Participants in this group will receive combined intervention and in person/phone communication. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PACE | Behavioral | Patient-centered Assessment and Counseling for Exercise [PACE] program |
|
| Measure | Description | Time Frame |
|---|---|---|
| Walking Distance | Walking distance as measured by the 6 minute walk test. | Month 3 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tracie C Collins, MD, MPH, MHCDS | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas School of Medicine | Wichita | Kansas | 67214 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35113020 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 promote physical activity Diet: Motivating healthy dietary habits App: Using an app to deliver communication to the participant. |
| FG001 | Motivational Interviewing | Participants in this group will receive motivational interviewing - in-person and via telephone. Motivational Interviewing: Motivational interviewing counseling is used to promote physical activity and healthy dietary habits. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Walking Distance | Walking distance as measured by the 6 minute walk test. | Posted | Mean | Standard Deviation | meters | Month 3 |
|
three months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PACE+DApp | Participants in this group will receive combined intervention via a mobile phone app. PACE: Patient-centered Assessment and Counseling for Exercise [PACE] program was used to motivate physical activity Diet: health dietary habits (reducing sodium, increasing fruits and vegetables, increasing whole grains, mindful eating, decreasing sugary drinks) App: The app was used to deliver both physical activity and healthy dietary habits. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Tracie Collins | University of New Mexico | 505-272-4979 | tccollins@salud.unm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 1, 2022 | Nov 29, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D004032 | Diet |
| D000682 | Amyloid |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D046912 | Multiprotein Complexes |
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| 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. |
|
| 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 |
| 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) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Weight Loss | Change in weight, collected at two time points. | Posted | Mean | 95% Confidence Interval | lbs. | 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. | Posted | Mean | Standard Deviation | units on a scale; | 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. | Posted | Mean | Standard Deviation | units on a scale | 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 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) | Posted | Mean | Standard Deviation | score on a scale | Month 3 |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Motivational Interviewing | Participants in this group will receive counseling (motivational interviewing) an initial face-to-face session followed by four phone sessions. Motivational interviewing was used to promote physical activity and healthy dietary habits. | 0 | 16 | 0 | 16 | 0 | 16 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D046911 | Macromolecular Substances |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |