Weight Loss in Chronic Disease Patient Population

Sponsor
Ronald Horswell (Other)
Overall Status
Completed
CT.gov ID
NCT01155050
Collaborator
Louisiana State University Health Care Services Division (Other)
202
3
4
11
67.3
6.1

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
  • Device: Tele-health Home Monitoring
  • Behavioral: TrestleTree Telephone Coaching
  • Device: Tele-health Home Monitoring Plus Trestle Telephone Coaching
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

Study Type:
Interventional
Actual Enrollment :
202 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The study randomized consenting subjects to four arms for evaluation of different weight loss strategies.The study randomized consenting subjects to four arms for evaluation of different weight loss strategies.
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Louisiana State University Health Care Services Division (LSUHCSD) Tele-Health Projects: Weight Loss in Chronic Disease Patient Population
Study Start Date :
Jan 1, 2010
Actual Primary Completion Date :
Dec 1, 2010
Actual Study Completion Date :
Dec 1, 2010

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:
  • Home Monitoring
  • 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:
  • Telephone Coaching
  • 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:
  • Home Monitoring and telephone coaching
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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

    1. 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.

    2. 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.

    3. Change in HbA1c [five months]

      Change in HbA1c value from baseline to five-month follow-up among those completing the study through five months.

    4. Change in Triglycerides [five months]

      Change from baseline to five month follow-up in triglyceride level.

    5. Change in Total Cholesterol [five months]

      Change in total cholesterol level from baseline to five-month follow-up.

    6. Change in Fasting Plasma Glucose [five months]

      Change from baseline to five-month follow-up in fasting plasma glucose level.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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.

    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.
    Responsible Party:
    Ronald Horswell, Professor, Pennington Biomedical Research Center
    ClinicalTrials.gov Identifier:
    NCT01155050
    Other Study ID Numbers:
    • PBRC 29032
    First Posted:
    Jul 1, 2010
    Last Update Posted:
    Dec 29, 2020
    Last Verified:
    Dec 1, 2020
    Keywords provided by Ronald Horswell, Professor, Pennington Biomedical Research Center
    Additional relevant MeSH terms:

    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

    1. Primary Outcome
    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
    2. Primary Outcome
    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
    3. Secondary Outcome
    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
    4. Secondary Outcome
    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
    5. Secondary Outcome
    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
    6. Secondary Outcome
    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
    7. Secondary Outcome
    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
    8. Secondary Outcome
    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

    [Not Specified]

    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
    Email Ronald.Horswell@pbrc.edu
    Responsible Party:
    Ronald Horswell, Professor, Pennington Biomedical Research Center
    ClinicalTrials.gov Identifier:
    NCT01155050
    Other Study ID Numbers:
    • PBRC 29032
    First Posted:
    Jul 1, 2010
    Last Update Posted:
    Dec 29, 2020
    Last Verified:
    Dec 1, 2020