Diabetes, Hypertension, Obesity, Overweight
Conditions
Keywords
overweight, obese, type II diabetes, hypertension
Brief summary
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.
Detailed description
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.
Interventions
DEVICETele-health Home Monitoring
Daily tele-health monitoring data will be collected from randomized participants.
BEHAVIORALTrestleTree Telephone Coaching
Weekly or bi-weekly phone calls from TrestleTree health coaches with a focus on weight loss.
DEVICETele-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.
Sponsors
Pennington Biomedical Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
The study randomized consenting subjects to four arms for evaluation of different weight loss strategies.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 yrs old * BMI ≥ 25 kg/m2 and waist circumference \> 40 inches (men)/ 35 inches (women) * Weight ≤ 500lbs * At least one of the following: * Fasting blood sugar \> 100 mg/dL at any point and/or taking medications for diabetes And/Or * Resting blood pressure \> 130/90 mm Hg at any point and/or taking medications for hypertension * Not involved in regular physical activity or weight loss management programs * Capable of being physically active * Physically able to use in-home equipment (or presence of a household member who can assist the subject in equipment use) * Currently-working conventional telephone line at primary residence * Grounded electrical power supply at primary residence * Have been in LSU HCSD system for 6 months and anticipate remaining in the LSU HCSD patient population for the next 6 months
Exclusion criteria
* A history of drug abuse in the last year, or excess alcohol consumption (40g/day)6 * Currently dieting or engaging in any activity with the goal of losing weight * Significant weight loss or weight gain in the past year (\> 50 lbs) or current use of weight loss medications * History of gastrointestinal bypass or other bariatric surgery in the last 3 years * Diagnosis of congestive heart failure * Under treatment for end-stage renal disease or end-stage liver disease * History of major organ transplant * History of cancers requiring treatment in the past 5 years with anything but excellent prognosis * Current diagnosis of schizophrenia, bipolar disorder, or other psychotic disorders * Pregnant or plan on becoming pregnant in the next 12 months. * Lack support from health care provider or family members. * Current member of household participating in study * Factors that may limit adherence to intervention or affect conduct of the trial. * Unable or unwilling to communicate with staff, to provide written informed consent, or accept the randomized assignment. * Any other condition, which, in the opinion of the investigators would impede competence or compliance or possibly hinder completion of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight | five-month follow-up compared to baseline | Body weight at five-month follow-up minus baseline body weight. Body weight is measured in pounds |
| Change in Waist Circumference | five-month follow-up compared to baseline | Waist circumference at five-month follow-up minus waist circumference at baseline. Waist circumference is measured in centimeters. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c | five months | Change in HbA1c value from baseline to five-month follow-up among those completing the study through five months. |
| Change in Triglycerides | five months | Change from baseline to five month follow-up in triglyceride level. |
| Change in Systolic Blood Pressure | Systolic blood pressure (mmHg) at five months minus systolic blood pressure at baseline. | Change is systolic blood pressure (mmHg) from baseline to five-month follow-up. |
| Change in Fasting Plasma Glucose | five months | Change from baseline to five-month follow-up in fasting plasma glucose level. |
| Change in Total Cholesterol | five months | Change in total cholesterol level from baseline to five-month follow-up. |
| Change in Diastolic Blood Pressure | Diastolic blood pressure (mmHg) at five months minus diastolic blood pressure at baseline. | Change in diastolic blood pressure (mmHg) from baseline to follow-up. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
Potential subjects were screened for eligibility and then randomized within site to the four treatment arms.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 50 |
| Self-Directed Group Participants will receive information on physical activity recommendations and guidelines on nutrition aimed at promoting weight loss. | 51 |
| 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. | 52 |
| 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. | 49 |
| Total | 202 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 15 | 20 | 19 | 22 |
Baseline characteristics
| Characteristic | Tele-health Home Monitoring | Home Monitoring + Telephone Coach | Total | TrestleTree Telephone Coaching | Self-Directed Group |
|---|---|---|---|---|---|
| Age, Continuous | 51.04 years STANDARD_DEVIATION 9.74 | 49.55 years STANDARD_DEVIATION 10.37 | 50.80 years STANDARD_DEVIATION 10.41 | 50.62 years STANDARD_DEVIATION 9.87 | 51.94 years STANDARD_DEVIATION 11.73 |
| Body Mass Index | 41 kg/m^2 STANDARD_DEVIATION 9 | 42 kg/m^2 STANDARD_DEVIATION 10 | 41 kg/m^2 STANDARD_DEVIATION 9 | 42 kg/m^2 STANDARD_DEVIATION 7 | 41 kg/m^2 STANDARD_DEVIATION 9 |
| Diagnosis of diabetes | 26 Participants | 21 Participants | 95 Participants | 23 Participants | 25 Participants |
| Diagnosis of hypertension | 49 Participants | 47 Participants | 193 Participants | 50 Participants | 47 Participants |
| diastolic blood pressure | 80 mm Hg STANDARD_DEVIATION 16 | 83 mm Hg STANDARD_DEVIATION 13 | 80 mm Hg STANDARD_DEVIATION 13 | 78 mm Hg STANDARD_DEVIATION 11 | 81 mm Hg STANDARD_DEVIATION 12 |
| High-density lipoprotein | 41 mg/dL STANDARD_DEVIATION 12 | 44 mg/dL STANDARD_DEVIATION 22 | 44 mg/dL STANDARD_DEVIATION 16 | 48 mg/dL STANDARD_DEVIATION 18 | 43 mg/dL STANDARD_DEVIATION 10 |
| Low-density lipoprotein | 118 mg/dL STANDARD_DEVIATION 32 | 117 mg/dL STANDARD_DEVIATION 36 | 118 mg/dL STANDARD_DEVIATION 35 | 117 mg/dL STANDARD_DEVIATION 41 | 120 mg/dL STANDARD_DEVIATION 33 |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 3 Participants | 9 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 32 Participants | 25 Participants | 111 Participants | 28 Participants | 26 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 15 Participants | 21 Participants | 82 Participants | 23 Participants | 23 Participants |
| Region of Enrollment United States | 50 participants | 49 participants | 202 participants | 52 participants | 51 participants |
| Sex: Female, Male Female | 46 Participants | 43 Participants | 186 Participants | 48 Participants | 49 Participants |
| Sex: Female, Male Male | 4 Participants | 6 Participants | 16 Participants | 4 Participants | 2 Participants |
| systolic blood pressure | 136 mm Hg STANDARD_DEVIATION 22 | 142 mm Hg STANDARD_DEVIATION 21 | 138 mm Hg STANDARD_DEVIATION 20 | 135 mm Hg STANDARD_DEVIATION 20 | 140 mm Hg STANDARD_DEVIATION 16 |
| Triglycerides | 121 mg/dL STANDARD_DEVIATION 74 | 153 mg/dL STANDARD_DEVIATION 145 | 123 mg/dL STANDARD_DEVIATION 88 | 112 mg/dL STANDARD_DEVIATION 51 | 111 mg/dL STANDARD_DEVIATION 57 |
| Use anti-depression medication | 12 Participants | 15 Participants | 60 Participants | 19 Participants | 14 Participants |
| Use blood pressure medication | 47 Participants | 41 Participants | 179 Participants | 47 Participants | 44 Participants |
| Use cholesterol medication | 20 Participants | 15 Participants | 87 Participants | 22 Participants | 30 Participants |
| Use diabetes medication | 24 Participants | 21 Participants | 82 Participants | 19 Participants | 18 Participants |
| Waist circumference | 119 cm STANDARD_DEVIATION 16 | 115 cm STANDARD_DEVIATION 21 | 118 cm STANDARD_DEVIATION 17 | 120 cm STANDARD_DEVIATION 14 | 118 cm STANDARD_DEVIATION 16 |
| Weight | 111 kg STANDARD_DEVIATION 25 | 113 kg STANDARD_DEVIATION 25 | 110 kg STANDARD_DEVIATION 24 | 112 kg STANDARD_DEVIATION 21 | 106 kg STANDARD_DEVIATION 26 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 51 | 0 / 52 | 0 / 49 |
| other Total, other adverse events | 1 / 50 | 3 / 51 | 6 / 52 | 3 / 49 |
| serious Total, serious adverse events | 14 / 50 | 20 / 51 | 22 / 52 | 19 / 49 |
Outcome results
Primary
Change in Body Weight
Body weight at five-month follow-up minus baseline body weight. Body weight is measured in pounds
Time frame: five-month follow-up compared to baseline
Population: Analysis was based on those completing the five-month program and not lost to follow-up after five months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tele-health Home Monitoring | Change in Body Weight | -1.7 pounds | Standard Error 1.1 |
| Self-Directed Group | Change in Body Weight | -.2 pounds | Standard Error 1.9 |
| TrestleTree Telephone Coaching | Change in Body Weight | -4.3 pounds | Standard Error 1.4 |
| Home Monitoring + Telephone Coach | Change in Body Weight | -3.0 pounds | Standard Error 1.9 |
Comparison: The null hypothesis is that there are no differences in the outcome across groups.p-value: 0.296ANOVA
Primary
Change in Waist Circumference
Waist circumference at five-month follow-up minus waist circumference at baseline. Waist circumference is measured in centimeters.
Time frame: five-month follow-up compared to baseline
Population: Analysis was done using those who completed the five-month programs and were not lost to follow-up at five months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tele-health Home Monitoring | Change in Waist Circumference | -.1 centimeters | Standard Error 0.7 |
| Self-Directed Group | Change in Waist Circumference | -.5 centimeters | Standard Error 0.8 |
| TrestleTree Telephone Coaching | Change in Waist Circumference | -1.5 centimeters | Standard Error 0.9 |
| Home Monitoring + Telephone Coach | Change in Waist Circumference | -.6 centimeters | Standard Error 1.6 |
Comparison: The null hypothesis is that there are no differences in the outcome across groups.p-value: 0.787ANOVA
Secondary
Change in Diastolic Blood Pressure
Change in diastolic blood pressure (mmHg) from baseline to follow-up.
Time frame: Diastolic blood pressure (mmHg) at five months minus diastolic blood pressure at baseline.
Population: Analysis is based on those who completed the study through five months and were not lost to follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tele-health Home Monitoring | Change in Diastolic Blood Pressure | -2.5 mm Hg | Standard Error 1.9 |
| Self-Directed Group | Change in Diastolic Blood Pressure | -1.3 mm Hg | Standard Error 1.6 |
| TrestleTree Telephone Coaching | Change in Diastolic Blood Pressure | -1.6 mm Hg | Standard Error 2 |
| Home Monitoring + Telephone Coach | Change in Diastolic Blood Pressure | -5.3 mm Hg | Standard Error 2.2 |
Comparison: The null hypothesis is that there are no differences in the outcome across groups.p-value: 0.502ANOVA
Secondary
Change in Fasting Plasma Glucose
Change from baseline to five-month follow-up in fasting plasma glucose level.
Time frame: five months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tele-health Home Monitoring | Change in Fasting Plasma Glucose | 13.6 mg/dL | Standard Error 9.8 |
| Self-Directed Group | Change in Fasting Plasma Glucose | 4.1 mg/dL | Standard Error 5.9 |
| TrestleTree Telephone Coaching | Change in Fasting Plasma Glucose | 5.9 mg/dL | Standard Error 20.1 |
| Home Monitoring + Telephone Coach | Change in Fasting Plasma Glucose | 10.9 mg/dL | Standard Error 9.4 |
Secondary
Change in HbA1c
Change in HbA1c value from baseline to five-month follow-up among those completing the study through five months.
Time frame: five months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tele-health Home Monitoring | Change in HbA1c | -.01 change in HbA1c percentage | Standard Error 0.21 |
| Self-Directed Group | Change in HbA1c | .19 change in HbA1c percentage | Standard Error 0.13 |
| TrestleTree Telephone Coaching | Change in HbA1c | .11 change in HbA1c percentage | Standard Error 0.19 |
| Home Monitoring + Telephone Coach | Change in HbA1c | -.01 change in HbA1c percentage | Standard Error 0.08 |
Comparison: The null hypothesis is that the outcome does not differ across the four groups.p-value: 0.86ANOVA
Secondary
Change in Systolic Blood Pressure
Change is systolic blood pressure (mmHg) from baseline to five-month follow-up.
Time frame: Systolic blood pressure (mmHg) at five months minus systolic blood pressure at baseline.
Population: Outcome results are for those who completed the study through five-months and were not lost to follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tele-health Home Monitoring | Change in Systolic Blood Pressure | -4.7 mm Hg | Standard Error 2.9 |
| Self-Directed Group | Change in Systolic Blood Pressure | -1.6 mm Hg | Standard Error 2.5 |
| TrestleTree Telephone Coaching | Change in Systolic Blood Pressure | -3.4 mm Hg | Standard Error 3.2 |
| Home Monitoring + Telephone Coach | Change in Systolic Blood Pressure | -9.6 mm Hg | Standard Error 3.6 |
Comparison: The null hypothesis is that there are no differences in the outcome across groups.p-value: 0.34ANOVA
Secondary
Change in Total Cholesterol
Change in total cholesterol level from baseline to five-month follow-up.
Time frame: five months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tele-health Home Monitoring | Change in Total Cholesterol | -10.1 mg/dL | Standard Error 9.1 |
| Self-Directed Group | Change in Total Cholesterol | -6.1 mg/dL | Standard Error 4.8 |
| TrestleTree Telephone Coaching | Change in Total Cholesterol | -.8 mg/dL | Standard Error 11 |
| Home Monitoring + Telephone Coach | Change in Total Cholesterol | -6.9 mg/dL | Standard Error 4.7 |
Comparison: The null hypothesis is that there is no difference in the outcome across the four treatment groups.p-value: 0.879ANOVA
Secondary
Change in Triglycerides
Change from baseline to five month follow-up in triglyceride level.
Time frame: five months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tele-health Home Monitoring | Change in Triglycerides | -5.3 mg/dL | Standard Error 8.9 |
| Self-Directed Group | Change in Triglycerides | 3.8 mg/dL | Standard Error 7.2 |
| TrestleTree Telephone Coaching | Change in Triglycerides | 12 mg/dL | Standard Error 9.2 |
| Home Monitoring + Telephone Coach | Change in Triglycerides | 2 mg/dL | Standard Error 10.1 |
Comparison: The null hypothesis is that the outcome does not differ across the four groups.p-value: 0.634ANOVA