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| ID | Type | Description | Link |
|---|---|---|---|
| P30AG044271 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| The Claude D. Pepper Older Americans Independence Centers | OTHER |
| National Institute on Aging (NIA) | NIH |
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The study team want to see if changes in lifestyle and behaviors and self-monitoring of diet and physical activity in older adults who have type 2 Diabetes (T2D) may help to prevent or reduce frailty. Frailty occurs in older adults and leads people to have falls, become disabled, require nursing home placement, and have increased risk of death. T2D is one of the major risk factors for frailty. T2D is a significant problem in older adults and is known to increase the risk of future frailty.
Behavioral lifestyle intervention: Participants (N=40) will be randomized to the mHealth+ group Intervention group (Group A; n=20)and mHealth+ individual intervention group (Group B; n=20) group using a randomization table. (1) The mHealth+ group Intervention group (Group A) will receive a modified Look AHEAD behavior lifestyle intervention with smartphone-based self-monitoring of diet and physical activity. This comprises ten group sessions for lifestyle intervention in 6-months. The group will receive three weekly classes in the first month and then bi-weekly classes for month 2-3, and three monthly session in month four, five, and six. The frequency and layout of these classes will allow participants to master new skills gradually, then eventually wean off, and adopt the modified lifestyle as the part of their daily lives. (2) The mHealth+ individual intervention group (Group B) will receive an abbreviated behavior lifestyle intervention with smartphone-based self-monitoring of diet and physical activity in one face-to-face individual session at the beginning of the study. In addition, participants will receive self-study materials, from Look Ahead modules, and a monthly follow-up phone calls for the duration of the study (6-months). The goal for these follow up phone calls are to assess understanding of the modules, to promote continued engagement with the study material, and to provide clarification on materials as needed. Participants in the mHealth+ group Intervention group (Group A) and mHealth+ individual intervention group (Group B will receive instruction on how to download an app to help them record their diet and physical activity at the beginning of the study.
Fitbit offers a simple, easy-to-use tool for tracking food and physical activity. It helps set daily calorie budget, and set and work towards goals for nutrient intake, weight loss, exercise, and more. https://www.fitbit.com/inspire 04.12.20: Due to SARS-CoV2 (COVID-19) and social distancing order, the study team are adding hemoglobin Hba1c home test.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Behavioral Lifestyle Intervention | Experimental | The participants will receive behavioral lifestyle intervention with a smartphone-based self-monitoring for diet and physical activity. This group also includes a total of 10 Group sessions over 6 months. |
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| Group B control arm | Other | Participants use the smart-phone app to record their daily diet and physical activity, with no group sessions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle App | Behavioral | A mobile app used to assist with lifestyle changes |
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| Measure | Description | Time Frame |
|---|---|---|
| Frailty Scale Using Fried's Phenotype Method Based on Five Frailty Characteristics |
| Baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Glycated Hemoglobin (HbA1c) | Change in HbA1c measured over the study period | Baseline to 6 months |
| Short Physical Performance Battery (SPPB) Balance | The balance test assesses a person's ability to stand with the feet together in side-by-side, semi-tandem, and full-tandem positions for 10 seconds each, responses ranging between 0-4 with a higher score indicating better balance. Three balance tests are performed and scoring is as follows: Side-by-side stand: person attempts to stand with feet together, side-by-side, for 10 seconds.
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rozmin Jiwani, RN, PhD | University of Texas Health at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | United States |
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| Label | URL |
|---|---|
| J. Frailty Aging 2021 April 24: 1-9 | View source |
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Information will be shared with mentors and advisors
Data will be available at study completion
Study Teams plans on publication at completion of data analysis.
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The control group did not recruit any subjects due to the COVID-19 pandemic
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| ID | Title | Description |
|---|---|---|
| FG000 | Behavioral Lifestyle Intervention | This group will receive behavioral lifestyle intervention with a smartphone-based self-monitoring for diet and physical activity. This group also includes a total of 10 Group sessions over 6 months. Lifestyle App: A mobile app used to assist with lifestyle changes |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Oct 20, 2020 |
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| Look AHEAD behavior lifestyle intervention | Behavioral | A modified Look AHEAD behavior lifestyle intervention with smartphone-based self-monitoring of diet and physical activity |
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| Abbreviated Look AHEAD behavior lifestyle intervention | Behavioral | An abbreviated Look AHEAD behavior lifestyle intervention with smartphone-based self-monitoring of diet and physical activity |
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| Baseline to 6 months |
| SPPB Gait Speed | Gait speed at a 4-meter walk is timed in seconds as participants walk at their usual pace. Two trials were administered, time (in seconds) was recorded for each trial. The fastest walk of two trials was recorded. Score is recorded between 0-4 with a higher score indicating a faster gait speed. Scoring is as follows:
| Baseline to 6 months |
| SPPB Chair Stands | Chair stand represents the time to complete five chair rises, sit to stand from a chair, as quickly as possible, without using hands, responses ranging between 0-4. Scoring is as follows:
| Baseline to 6 months |
| Group B - Control Group |
The mHealth+ individual intervention group (Group B) will receive an abbreviated behavior lifestyle intervention with smartphone-based self-monitoring of diet and physical activity in one face-to-face individual session at the beginning of the study. In addition, participants will receive self-study materials, from Look Ahead modules, and a monthly follow-up phone calls for the duration of the study (6-months) |
| COMPLETED |
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| NOT COMPLETED |
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Participants were older adults with Type 2 diabetes. Group B did not enroll any participant due to the COVID-19 pandemic.
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| ID | Title | Description |
|---|---|---|
| BG000 | Behavioral Lifestyle Intervention | This group will receive behavioral lifestyle intervention with a smartphone-based self-monitoring for diet and physical activity. This group also includes a total of 10 Group sessions over 6 months. Lifestyle App: A mobile app used to assist with lifestyle changes |
| BG001 | Group B - Control Group | The mHealth+ individual intervention group (Group B) will receive an abbreviated behavior lifestyle intervention with smartphone-based self-monitoring of diet and physical activity in one face-to-face individual session at the beginning of the study. In addition, participants will receive self-study materials, from Look Ahead modules, and a monthly follow-up phone calls for the duration of the study (6-months) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Frailty Scale Using Fried's Phenotype Method Based on Five Frailty Characteristics |
| The control group did not recruit any subjects due to the COVID-19 pandemic | Posted | Mean | Standard Deviation | score on a scale | Baseline to 6 months |
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| Secondary | Glycated Hemoglobin (HbA1c) | Change in HbA1c measured over the study period | The control group did not recruit any subjects due to the pandemic | Posted | Mean | Standard Deviation | Percentage of glycated hemoglobin | Baseline to 6 months |
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| Secondary | Short Physical Performance Battery (SPPB) Balance | The balance test assesses a person's ability to stand with the feet together in side-by-side, semi-tandem, and full-tandem positions for 10 seconds each, responses ranging between 0-4 with a higher score indicating better balance. Three balance tests are performed and scoring is as follows: Side-by-side stand: person attempts to stand with feet together, side-by-side, for 10 seconds.
| The control group did not recruit any subjects due to the COVID-19 pandemic | Posted | Mean | Standard Deviation | score on a scale | Baseline to 6 months |
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| Secondary | SPPB Gait Speed | Gait speed at a 4-meter walk is timed in seconds as participants walk at their usual pace. Two trials were administered, time (in seconds) was recorded for each trial. The fastest walk of two trials was recorded. Score is recorded between 0-4 with a higher score indicating a faster gait speed. Scoring is as follows:
| Group B did not recruit any subjects due to the COVID-19 pandemic | Posted | Mean | Standard Deviation | score on a scale | Baseline to 6 months |
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| Secondary | SPPB Chair Stands | Chair stand represents the time to complete five chair rises, sit to stand from a chair, as quickly as possible, without using hands, responses ranging between 0-4. Scoring is as follows:
| Group B did not recruit any subjects due to the COVID-19 pandemic | Posted | Mean | Standard Deviation | score on a scale | Baseline to 6 months |
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Adverse events were collected during active study participation, from baseline to 6 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 | Behavioral Lifestyle Intervention | This group will receive behavioral lifestyle intervention with a smartphone-based self-monitoring for diet and physical activity. This group also includes a total of 10 Group sessions over 6 months. Lifestyle App: A mobile app used to assist with lifestyle changes | 0 | 18 | 0 | 18 | 0 | 18 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rozmin Jiwani | University of Texas Health San Antonio | 210-450-8498 | jiwani@uthscsa.edu |
| Apr 23, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000073496 | Frailty |
| D001835 | Body Weight |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Unknown or Not Reported |
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The mHealth+ individual intervention group (Group B) will receive an abbreviated behavior lifestyle intervention with smartphone-based self-monitoring of diet and physical activity in one face-to-face individual session at the beginning of the study. In addition, participants will receive self-study materials, from Look Ahead modules, and a monthly follow-up phone calls for the duration of the study (6-months) |
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