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This study will assess the effect of in-home tele-health monitoring on health outcomes for LSUHCSD chronic disease, overweight or obese patients diagnosed with type II diabetes or hypertension.
This study will assess the effect of in-home tele-health monitoring on health outcomes for LSUHCSD chronic disease, overweight or obese patients diagnosed with type II diabetes or hypertension. Primary emphasis will be on assessing the effect of tele-health home monitoring combined with motivational telephone coaching on weight loss and waist circumference as compared to self-directed, home monitoring alone, and telephone coaching alone. Secondary outcomes such as blood pressure, Hemoglobin A1c (HbA1c), fasting blood sugar, and cholesterol will be examined as well.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tele-health Home Monitoring | Active Comparator | Participants will use the tele-health monitoring equipment to measure daily weight. |
|
| Self-Directed Group | No Intervention | Participants will receive information on physical activity recommendations and guidelines on nutrition aimed at promoting weight loss. | |
| TrestleTree Telephone Coaching | Active Comparator | Participants will speak to Trestletree health coaches for 15 to 60 minutes each session. During these sessions, the coaches will identify the participant's stage of change and intervene accordingly. The telephone calls will be centered on weight loss. |
|
| Home monitoring + telephone coach | Active Comparator | System to track stage of change in weight loss. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tele-health Home Monitoring | Device | Daily tele-health monitoring data will be collected from randomized participants. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Weight | Body weight at five-month follow-up minus baseline body weight. Body weight is measured in pounds | five-month follow-up compared to baseline |
| Change in Waist Circumference | Waist circumference at five-month follow-up minus waist circumference at baseline. Waist circumference is measured in centimeters. | five-month follow-up compared to baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Systolic Blood Pressure | Change is systolic blood pressure (mmHg) from baseline to five-month follow-up. | Systolic blood pressure (mmHg) at five months minus systolic blood pressure at baseline. |
| Change in Diastolic Blood Pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy S. Church, MD, MPH, PhD | Pennington Biomedical Research Center | Study Chair |
| Donna H. Ryan, MD | Pennington Biomedical Research Center | Study Chair |
| Valerie H. Myers, PhD | Pennington Biomedical Research Center | Study Chair |
| Ronald W. Horswell, PhD | Pennington Biomedical Research Center | Study Chair |
| Monisha Chadha, MD | Louisiana State University Health Care Services Division | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Earl K. Long Medical Center | Baton Rouge | Louisiana | 70806 | United States | ||
| Leonard J. Chabert Medical Center |
Potential subjects were screened for eligibility and then randomized within site to the four treatment arms.
Subjects were recruited between January 1, 2010 and June 30, 2010. Recruitment was done at primary care clinics at three LSU Health Care Services Division locations in three Louisiana cities.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tele-health Home Monitoring | Participants will use the tele-health monitoring equipment to measure daily weight. Tele-health Home Monitoring: Daily tele-health monitoring data will be collected from randomized participants. |
| FG001 | Self-Directed Group | Participants will receive information on physical activity recommendations and guidelines on nutrition aimed at promoting weight loss. |
| FG002 | TrestleTree Telephone Coaching | Participants will speak to Trestletree health coaches for 15 to 60 minutes each session. During these sessions, the coaches will identify the participant's stage of change and intervene accordingly. The telephone calls will be centered on weight loss. TrestleTree Telephone Coaching: Weekly or bi-weekly phone calls from TrestleTree health coaches with a focus on weight loss. |
| FG003 | Home Monitoring + Telephone Coach | System to track stage of change in weight loss. Tele-health Home Monitoring Plus Trestle Telephone Coaching: Daily collection of data through the tele-health home monitor and weekly or bi-weekly phone calls with a Trestletree Health Coach. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tele-health Home Monitoring | Participants will use the tele-health monitoring equipment to measure daily weight. Tele-health Home Monitoring: Daily tele-health monitoring data will be collected from randomized participants. |
| BG001 | Self-Directed Group |
| 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 | Change in Body Weight | Body weight at five-month follow-up minus baseline body weight. Body weight is measured in pounds | Analysis was based on those completing the five-month program and not lost to follow-up after five months. | Posted | Mean | Standard Error | pounds | five-month follow-up compared to baseline |
|
Five months from baseline (randomization) through five-month follow-up
The adverse event data summary includes all adverse events identified for the initially randomized 202 subjects, not just for the 126 subjects who completed the study. That is because adverse events identified over the course of the five-month study include identified adverse events for those who subsequently did not complete the study. For example, a subject may have had an adverse event in the second month but have been lost to follow-up by the end of month five when the study ended.
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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 | Tele-health Home Monitoring | Participants will use the tele-health monitoring equipment to measure daily weight. Tele-health Home Monitoring: Daily tele-health monitoring data will be collected from randomized participants. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization and/or emergency department visit | Surgical and medical procedures | Systematic Assessment | Hospitalization for any reason or an emergency department visit for any reason |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| mild or moderate unanticipated health events | General disorders | Systematic Assessment | Includes (1) unanticipated outpatient clinic visits and (2) significant changes in reported health status not resulting in emergency department visits or hospitalization and deemed unrelated or unlikely to be related to the study interventions. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ronald Horswell | PenningtonBRC | 225-763-2931 | Ronald.Horswell@pbrc.edu |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D003920 | Diabetes Mellitus |
| D006973 | Hypertension |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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The study randomized consenting subjects to four arms for evaluation of different weight loss strategies.
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| TrestleTree Telephone Coaching | Behavioral | Weekly or bi-weekly phone calls from TrestleTree health coaches with a focus on weight loss. |
|
|
| Tele-health Home Monitoring Plus Trestle Telephone Coaching | Device | Daily collection of data through the tele-health home monitor and weekly or bi-weekly phone calls with a Trestletree Health Coach. |
|
|
Change in diastolic blood pressure (mmHg) from baseline to follow-up.
| Diastolic blood pressure (mmHg) at five months minus diastolic blood pressure at baseline. |
| Change in HbA1c | Change in HbA1c value from baseline to five-month follow-up among those completing the study through five months. | five months |
| Change in Triglycerides | Change from baseline to five month follow-up in triglyceride level. | five months |
| Change in Total Cholesterol | Change in total cholesterol level from baseline to five-month follow-up. | five months |
| Change in Fasting Plasma Glucose | Change from baseline to five-month follow-up in fasting plasma glucose level. | five months |
| Houma |
| Louisiana |
| 70363 |
| United States |
| WO Moss Regional Medical Center | Lake Charles | Louisiana | 70607 | United States |
Participants will receive information on physical activity recommendations and guidelines on nutrition aimed at promoting weight loss. |
| BG002 | TrestleTree Telephone Coaching | Participants will speak to Trestletree health coaches for 15 to 60 minutes each session. During these sessions, the coaches will identify the participant's stage of change and intervene accordingly. The telephone calls will be centered on weight loss. TrestleTree Telephone Coaching: Weekly or bi-weekly phone calls from TrestleTree health coaches with a focus on weight loss. |
| BG003 | Home Monitoring + Telephone Coach | System to track stage of change in weight loss. Tele-health Home Monitoring Plus Trestle Telephone Coaching: Daily collection of data through the tele-health home monitor and weekly or bi-weekly phone calls with a Trestletree Health Coach. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Diagnosis of diabetes | Count of Participants | Participants |
|
| Diagnosis of hypertension | Count of Participants | Participants |
|
| Use diabetes medication | Count of Participants | Participants |
|
| Use cholesterol medication | Count of Participants | Participants |
|
| Use blood pressure medication | Count of Participants | Participants |
|
| Use anti-depression medication | Count of Participants | Participants |
|
| Low-density lipoprotein | Mean | Standard Deviation | mg/dL |
|
| High-density lipoprotein | Mean | Standard Deviation | mg/dL |
|
| Triglycerides | Mean | Standard Deviation | mg/dL |
|
| systolic blood pressure | Mean | Standard Deviation | mm Hg |
|
| diastolic blood pressure | Mean | Standard Deviation | mm Hg |
|
| Weight | Mean | Standard Deviation | kg |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Waist circumference | Mean | Standard Deviation | cm |
|
| OG002 | TrestleTree Telephone Coaching | Participants will speak to Trestletree health coaches for 15 to 60 minutes each session. During these sessions, the coaches will identify the participant's stage of change and intervene accordingly. The telephone calls will be centered on weight loss. TrestleTree Telephone Coaching: Weekly or bi-weekly phone calls from TrestleTree health coaches with a focus on weight loss. |
| OG003 | Home Monitoring + Telephone Coach | System to track stage of change in weight loss. Tele-health Home Monitoring Plus Trestle Telephone Coaching: Daily collection of data through the tele-health home monitor and weekly or bi-weekly phone calls with a Trestletree Health Coach. |
|
|
|
| Primary | Change in Waist Circumference | Waist circumference at five-month follow-up minus waist circumference at baseline. Waist circumference is measured in centimeters. | Analysis was done using those who completed the five-month programs and were not lost to follow-up at five months. | Posted | Mean | Standard Error | centimeters | five-month follow-up compared to baseline |
|
|
|
|
| Secondary | Change in Systolic Blood Pressure | Change is systolic blood pressure (mmHg) from baseline to five-month follow-up. | Outcome results are for those who completed the study through five-months and were not lost to follow-up. | Posted | Mean | Standard Error | mm Hg | Systolic blood pressure (mmHg) at five months minus systolic blood pressure at baseline. |
|
|
|
|
| Secondary | Change in Diastolic Blood Pressure | Change in diastolic blood pressure (mmHg) from baseline to follow-up. | Analysis is based on those who completed the study through five months and were not lost to follow-up. | Posted | Mean | Standard Error | mm Hg | Diastolic blood pressure (mmHg) at five months minus diastolic blood pressure at baseline. |
|
|
|
|
| Secondary | Change in HbA1c | Change in HbA1c value from baseline to five-month follow-up among those completing the study through five months. | The analysis was based on those who completed the study through five months and who had both baseline and follow-up lab results available from the electronic medical record. | Posted | Mean | Standard Error | change in HbA1c percentage | five months |
|
|
|
|
| Secondary | Change in Triglycerides | Change from baseline to five month follow-up in triglyceride level. | The analysis was based on those subjects completing the study through five months and for whom triglyceride levels were available in the study sites' electronic medical records. | Posted | Mean | Standard Error | mg/dL | five months |
|
|
|
|
| Secondary | Change in Total Cholesterol | Change in total cholesterol level from baseline to five-month follow-up. | The analysis is based on subjects completing the study through five months and who had total cholesterol lab values available in the study sites' electronic medical records. | Posted | Mean | Standard Error | mg/dL | five months |
|
|
|
|
| Secondary | Change in Fasting Plasma Glucose | Change from baseline to five-month follow-up in fasting plasma glucose level. | The analysis is based on those subjects who completed the study through five months and who had fast plasma glucose lab values available in the study sites' electronic medical record. | Posted | Mean | Standard Error | mg/dL | five months |
|
|
|
| 0 |
| 50 |
| 14 |
| 50 |
| 1 |
| 50 |
| EG001 | Self-Directed Group | Participants will receive information on physical activity recommendations and guidelines on nutrition aimed at promoting weight loss. | 0 | 51 | 20 | 51 | 3 | 51 |
| EG002 | TrestleTree Telephone Coaching | Participants will speak to Trestletree health coaches for 15 to 60 minutes each session. During these sessions, the coaches will identify the participant's stage of change and intervene accordingly. The telephone calls will be centered on weight loss. TrestleTree Telephone Coaching: Weekly or bi-weekly phone calls from TrestleTree health coaches with a focus on weight loss. | 0 | 52 | 22 | 52 | 6 | 52 |
| EG003 | Home Monitoring + Telephone Coach | System to track stage of change in weight loss. Tele-health Home Monitoring Plus Trestle Telephone Coaching: Daily collection of data through the tele-health home monitor and weekly or bi-weekly phone calls with a Trestletree Health Coach. | 0 | 49 | 19 | 49 | 3 | 49 |
|
| unexpected outpatient clinic visit | General disorders | Systematic Assessment | Unexpected/unplanned outpatient clinic visits for emergent conditions. |
|
|
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |