Weight Loss in Chronic Disease Patient Population
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Tele-health Home Monitoring Participants will use the tele-health monitoring equipment to measure daily weight. |
Device: Tele-health Home Monitoring
Daily tele-health monitoring data will be collected from randomized participants.
Other Names:
|
No Intervention: Self-Directed Group Participants will receive information on physical activity recommendations and guidelines on nutrition aimed at promoting weight loss. |
|
Active Comparator: 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. |
Behavioral: TrestleTree Telephone Coaching
Weekly or bi-weekly phone calls from TrestleTree health coaches with a focus on weight loss.
Other Names:
|
Active Comparator: Home monitoring + telephone coach System to track stage of change in weight loss. |
Device: 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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 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.
- 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 Total Cholesterol [five months]
Change in total cholesterol level 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.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Earl K. Long Medical Center | Baton Rouge | Louisiana | United States | 70806 |
2 | Leonard J. Chabert Medical Center | Houma | Louisiana | United States | 70363 |
3 | WO Moss Regional Medical Center | Lake Charles | Louisiana | United States | 70607 |
Sponsors and Collaborators
- Ronald Horswell
- Louisiana State University Health Care Services Division
Investigators
- Study Chair: 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
- Principal Investigator: Monisha Chadha, MD, Louisiana State University Health Care Services Division
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PBRC 29032
Study Results
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 Detail | Potential subjects were screened for eligibility and then randomized within site to the four treatment arms. |
Arm/Group Title | Tele-health Home Monitoring | Self-Directed Group | TrestleTree Telephone Coaching | Home Monitoring + Telephone Coach |
---|---|---|---|---|
Arm/Group Description | 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. | Participants will receive information on physical activity recommendations and guidelines on nutrition aimed at promoting weight loss. | 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. | 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. |
Period Title: Overall Study | ||||
STARTED | 50 | 51 | 52 | 49 |
COMPLETED | 35 | 31 | 33 | 27 |
NOT COMPLETED | 15 | 20 | 19 | 22 |
Baseline Characteristics
Arm/Group Title | Tele-health Home Monitoring | Self-Directed Group | TrestleTree Telephone Coaching | Home Monitoring + Telephone Coach | Total |
---|---|---|---|---|---|
Arm/Group Description | 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. | Participants will receive information on physical activity recommendations and guidelines on nutrition aimed at promoting weight loss. | 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. | 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. | Total of all reporting groups |
Overall Participants | 50 | 51 | 52 | 49 | 202 |
Age (years) [Mean (Standard Deviation) ] | |||||
Mean (Standard Deviation) [years] |
51.04
(9.74)
|
51.94
(11.73)
|
50.62
(9.87)
|
49.55
(10.37)
|
50.80
(10.41)
|
Sex: Female, Male (Count of Participants) | |||||
Female |
46
92%
|
49
96.1%
|
48
92.3%
|
43
87.8%
|
186
92.1%
|
Male |
4
8%
|
2
3.9%
|
4
7.7%
|
6
12.2%
|
16
7.9%
|
Race (NIH/OMB) (Count of Participants) | |||||
American Indian or Alaska Native |
3
6%
|
2
3.9%
|
1
1.9%
|
3
6.1%
|
9
4.5%
|
Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Black or African American |
32
64%
|
26
51%
|
28
53.8%
|
25
51%
|
111
55%
|
White |
15
30%
|
23
45.1%
|
23
44.2%
|
21
42.9%
|
82
40.6%
|
More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Region of Enrollment (participants) [Number] | |||||
United States |
50
100%
|
51
100%
|
52
100%
|
49
100%
|
202
100%
|
Diagnosis of diabetes (Count of Participants) | |||||
Count of Participants [Participants] |
26
52%
|
25
49%
|
23
44.2%
|
21
42.9%
|
95
47%
|
Diagnosis of hypertension (Count of Participants) | |||||
Count of Participants [Participants] |
49
98%
|
47
92.2%
|
50
96.2%
|
47
95.9%
|
193
95.5%
|
Use diabetes medication (Count of Participants) | |||||
Count of Participants [Participants] |
24
48%
|
18
35.3%
|
19
36.5%
|
21
42.9%
|
82
40.6%
|
Use cholesterol medication (Count of Participants) | |||||
Count of Participants [Participants] |
20
40%
|
30
58.8%
|
22
42.3%
|
15
30.6%
|
87
43.1%
|
Use blood pressure medication (Count of Participants) | |||||
Count of Participants [Participants] |
47
94%
|
44
86.3%
|
47
90.4%
|
41
83.7%
|
179
88.6%
|
Use anti-depression medication (Count of Participants) | |||||
Count of Participants [Participants] |
12
24%
|
14
27.5%
|
19
36.5%
|
15
30.6%
|
60
29.7%
|
Low-density lipoprotein (mg/dL) [Mean (Standard Deviation) ] | |||||
Mean (Standard Deviation) [mg/dL] |
118
(32)
|
120
(33)
|
117
(41)
|
117
(36)
|
118
(35)
|
High-density lipoprotein (mg/dL) [Mean (Standard Deviation) ] | |||||
Mean (Standard Deviation) [mg/dL] |
41
(12)
|
43
(10)
|
48
(18)
|
44
(22)
|
44
(16)
|
Triglycerides (mg/dL) [Mean (Standard Deviation) ] | |||||
Mean (Standard Deviation) [mg/dL] |
121
(74)
|
111
(57)
|
112
(51)
|
153
(145)
|
123
(88)
|
systolic blood pressure (mm Hg) [Mean (Standard Deviation) ] | |||||
Mean (Standard Deviation) [mm Hg] |
136
(22)
|
140
(16)
|
135
(20)
|
142
(21)
|
138
(20)
|
diastolic blood pressure (mm Hg) [Mean (Standard Deviation) ] | |||||
Mean (Standard Deviation) [mm Hg] |
80
(16)
|
81
(12)
|
78
(11)
|
83
(13)
|
80
(13)
|
Weight (kg) [Mean (Standard Deviation) ] | |||||
Mean (Standard Deviation) [kg] |
111
(25)
|
106
(26)
|
112
(21)
|
113
(25)
|
110
(24)
|
Body Mass Index (kg/m^2) [Mean (Standard Deviation) ] | |||||
Mean (Standard Deviation) [kg/m^2] |
41
(9)
|
41
(9)
|
42
(7)
|
42
(10)
|
41
(9)
|
Waist circumference (cm) [Mean (Standard Deviation) ] | |||||
Mean (Standard Deviation) [cm] |
119
(16)
|
118
(16)
|
120
(14)
|
115
(21)
|
118
(17)
|
Outcome Measures
Title | Change in Body Weight |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
Analysis was based on those completing the five-month program and not lost to follow-up after five months. |
Arm/Group Title | Tele-health Home Monitoring | Self-Directed Group | TrestleTree Telephone Coaching | Home Monitoring + Telephone Coach |
---|---|---|---|---|
Arm/Group Description | 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. | Participants will receive information on physical activity recommendations and guidelines on nutrition aimed at promoting weight loss. | 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. | 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. |
Measure Participants | 35 | 31 | 33 | 27 |
Mean (Standard Error) [pounds] |
-1.7
(1.1)
|
-.2
(1.9)
|
-4.3
(1.4)
|
-3.0
(1.9)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Tele-health Home Monitoring, Self-Directed Group, TrestleTree Telephone Coaching, Home Monitoring + Telephone Coach |
---|---|---|
Comments | The null hypothesis is that there are no differences in the outcome across groups. | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | .296 |
Comments | ||
Method | ANOVA | |
Comments |
Title | Change in Waist Circumference |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
Analysis was done using those who completed the five-month programs and were not lost to follow-up at five months. |
Arm/Group Title | Tele-health Home Monitoring | Self-Directed Group | TrestleTree Telephone Coaching | Home Monitoring + Telephone Coach |
---|---|---|---|---|
Arm/Group Description | 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. | Participants will receive information on physical activity recommendations and guidelines on nutrition aimed at promoting weight loss. | 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. | 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. |
Measure Participants | 35 | 31 | 33 | 27 |
Mean (Standard Error) [centimeters] |
-.1
(.7)
|
-.5
(.8)
|
-1.5
(.9)
|
-.6
(1.6)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Tele-health Home Monitoring, Self-Directed Group, TrestleTree Telephone Coaching, Home Monitoring + Telephone Coach |
---|---|---|
Comments | The null hypothesis is that there are no differences in the outcome across groups. | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | .787 |
Comments | ||
Method | ANOVA | |
Comments |
Title | Change in Systolic Blood Pressure |
---|---|
Description | 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. |
Outcome Measure Data
Analysis Population Description |
---|
Outcome results are for those who completed the study through five-months and were not lost to follow-up. |
Arm/Group Title | Tele-health Home Monitoring | Self-Directed Group | TrestleTree Telephone Coaching | Home Monitoring + Telephone Coach |
---|---|---|---|---|
Arm/Group Description | 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. | Participants will receive information on physical activity recommendations and guidelines on nutrition aimed at promoting weight loss. | 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. | 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. |
Measure Participants | 35 | 31 | 33 | 27 |
Mean (Standard Error) [mm Hg] |
-4.7
(2.9)
|
-1.6
(2.5)
|
-3.4
(3.2)
|
-9.6
(3.6)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Tele-health Home Monitoring, Self-Directed Group, TrestleTree Telephone Coaching, Home Monitoring + Telephone Coach |
---|---|---|
Comments | The null hypothesis is that there are no differences in the outcome across groups. | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | .340 |
Comments | ||
Method | ANOVA | |
Comments |
Title | Change in Diastolic Blood Pressure |
---|---|
Description | 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. |
Outcome Measure Data
Analysis Population Description |
---|
Analysis is based on those who completed the study through five months and were not lost to follow-up. |
Arm/Group Title | Tele-health Home Monitoring | Self-Directed Group | TrestleTree Telephone Coaching | Home Monitoring + Telephone Coach |
---|---|---|---|---|
Arm/Group Description | 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. | Participants will receive information on physical activity recommendations and guidelines on nutrition aimed at promoting weight loss. | 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. | 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. |
Measure Participants | 35 | 31 | 33 | 27 |
Mean (Standard Error) [mm Hg] |
-2.5
(1.9)
|
-1.3
(1.6)
|
-1.6
(2.0)
|
-5.3
(2.2)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Tele-health Home Monitoring, Self-Directed Group, TrestleTree Telephone Coaching, Home Monitoring + Telephone Coach |
---|---|---|
Comments | The null hypothesis is that there are no differences in the outcome across groups. | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | .502 |
Comments | ||
Method | ANOVA | |
Comments |
Title | Change in HbA1c |
---|---|
Description | Change in HbA1c value from baseline to five-month follow-up among those completing the study through five months. |
Time Frame | five months |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | Tele-health Home Monitoring | Self-Directed Group | TrestleTree Telephone Coaching | Home Monitoring + Telephone Coach |
---|---|---|---|---|
Arm/Group Description | 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. | Participants will receive information on physical activity recommendations and guidelines on nutrition aimed at promoting weight loss. | 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. | 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. |
Measure Participants | 18 | 14 | 14 | 7 |
Mean (Standard Error) [change in HbA1c percentage] |
-.01
(.21)
|
.19
(.13)
|
.11
(.19)
|
-.01
(.08)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Tele-health Home Monitoring, Self-Directed Group, TrestleTree Telephone Coaching, Home Monitoring + Telephone Coach |
---|---|---|
Comments | The null hypothesis is that the outcome does not differ across the four groups. | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | .860 |
Comments | ||
Method | ANOVA | |
Comments |
Title | Change in Triglycerides |
---|---|
Description | Change from baseline to five month follow-up in triglyceride level. |
Time Frame | five months |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | Tele-health Home Monitoring | Self-Directed Group | TrestleTree Telephone Coaching | Home Monitoring + Telephone Coach |
---|---|---|---|---|
Arm/Group Description | 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. | Participants will receive information on physical activity recommendations and guidelines on nutrition aimed at promoting weight loss. | 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. | 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. |
Measure Participants | 16 | 14 | 8 | 11 |
Mean (Standard Error) [mg/dL] |
-5.3
(8.9)
|
3.8
(7.2)
|
12
(9.2)
|
2
(10.1)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Tele-health Home Monitoring, Self-Directed Group, TrestleTree Telephone Coaching, Home Monitoring + Telephone Coach |
---|---|---|
Comments | The null hypothesis is that the outcome does not differ across the four groups. | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | .634 |
Comments | ||
Method | ANOVA | |
Comments |
Title | Change in Total Cholesterol |
---|---|
Description | Change in total cholesterol level from baseline to five-month follow-up. |
Time Frame | five months |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | Tele-health Home Monitoring | Self-Directed Group | TrestleTree Telephone Coaching | Home Monitoring + Telephone Coach |
---|---|---|---|---|
Arm/Group Description | 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. | Participants will receive information on physical activity recommendations and guidelines on nutrition aimed at promoting weight loss. | 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. | 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. |
Measure Participants | 16 | 14 | 8 | 11 |
Mean (Standard Error) [mg/dL] |
-10.1
(9.1)
|
-6.1
(4.8)
|
-.8
(11.0)
|
-6.9
(4.7)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Tele-health Home Monitoring, Self-Directed Group, TrestleTree Telephone Coaching, Home Monitoring + Telephone Coach |
---|---|---|
Comments | The null hypothesis is that there is no difference in the outcome across the four treatment groups. | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | .879 |
Comments | ||
Method | ANOVA | |
Comments |
Title | Change in Fasting Plasma Glucose |
---|---|
Description | Change from baseline to five-month follow-up in fasting plasma glucose level. |
Time Frame | five months |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | Tele-health Home Monitoring | Self-Directed Group | TrestleTree Telephone Coaching | Home Monitoring + Telephone Coach |
---|---|---|---|---|
Arm/Group Description | 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. | Participants will receive information on physical activity recommendations and guidelines on nutrition aimed at promoting weight loss. | 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. | 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. |
Measure Participants | 19 | 16 | 14 | 14 |
Mean (Standard Error) [mg/dL] |
13.6
(9.8)
|
4.1
(5.9)
|
5.9
(20.1)
|
10.9
(9.4)
|
Adverse Events
Time Frame | Five months from baseline (randomization) through five-month follow-up | |||||||
---|---|---|---|---|---|---|---|---|
Adverse Event Reporting Description | 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. | |||||||
Arm/Group Title | Tele-health Home Monitoring | Self-Directed Group | TrestleTree Telephone Coaching | Home Monitoring + Telephone Coach | ||||
Arm/Group Description | 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. | Participants will receive information on physical activity recommendations and guidelines on nutrition aimed at promoting weight loss. | 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. | 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. | ||||
All Cause Mortality |
||||||||
Tele-health Home Monitoring | Self-Directed Group | TrestleTree Telephone Coaching | Home Monitoring + Telephone Coach | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/50 (0%) | 0/51 (0%) | 0/52 (0%) | 0/49 (0%) | ||||
Serious Adverse Events |
||||||||
Tele-health Home Monitoring | Self-Directed Group | TrestleTree Telephone Coaching | Home Monitoring + Telephone Coach | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 14/50 (28%) | 20/51 (39.2%) | 22/52 (42.3%) | 19/49 (38.8%) | ||||
General disorders | ||||||||
unexpected outpatient clinic visit | 0/50 (0%) | 0 | 2/51 (3.9%) | 2 | 3/52 (5.8%) | 3 | 1/49 (2%) | 1 |
Surgical and medical procedures | ||||||||
Hospitalization and/or emergency department visit | 14/50 (28%) | 20 | 18/51 (35.3%) | 29 | 19/52 (36.5%) | 31 | 19/49 (38.8%) | 27 |
Other (Not Including Serious) Adverse Events |
||||||||
Tele-health Home Monitoring | Self-Directed Group | TrestleTree Telephone Coaching | Home Monitoring + Telephone Coach | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 1/50 (2%) | 3/51 (5.9%) | 6/52 (11.5%) | 3/49 (6.1%) | ||||
General disorders | ||||||||
mild or moderate unanticipated health events | 1/50 (2%) | 1 | 3/51 (5.9%) | 3 | 6/52 (11.5%) | 6 | 3/49 (6.1%) | 3 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Ronald Horswell |
---|---|
Organization | PenningtonBRC |
Phone | 225-763-2931 |
Ronald.Horswell@pbrc.edu |
- PBRC 29032