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Weight Loss in Chronic Disease Patient Population

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01155050
Recruitment Status : Completed
First Posted : July 1, 2010
Results First Posted : December 29, 2020
Last Update Posted : December 29, 2020
Sponsor:
Collaborator:
Louisiana State University Health Care Services Division
Information provided by (Responsible Party):
Ronald Horswell, Pennington Biomedical Research Center

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
Overweight Obesity Diabetes Hypertension Device: Tele-health Home Monitoring Behavioral: TrestleTree Telephone Coaching Device: Tele-health Home Monitoring Plus Trestle Telephone Coaching Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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.
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 : January 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: Home Monitoring and telephone coaching




Primary Outcome Measures :
  1. Change in Body Weight [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: five months ]
    Change from baseline to five month follow-up in triglyceride level.

  5. Change in Total Cholesterol [ Time Frame: five months ]
    Change in total cholesterol level from baseline to five-month follow-up.

  6. Change in Fasting Plasma Glucose [ Time Frame: five months ]
    Change from baseline to five-month follow-up in fasting plasma glucose level.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01155050


Locations
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United States, Louisiana
Earl K. Long Medical Center
Baton Rouge, Louisiana, United States, 70806
Leonard J. Chabert Medical Center
Houma, Louisiana, United States, 70363
WO Moss Regional Medical Center
Lake Charles, Louisiana, United States, 70607
Sponsors and Collaborators
Ronald Horswell
Louisiana State University Health Care Services Division
Investigators
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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
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Responsible Party: Ronald Horswell, Professor, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT01155050    
Other Study ID Numbers: PBRC 29032
First Posted: July 1, 2010    Key Record Dates
Results First Posted: December 29, 2020
Last Update Posted: December 29, 2020
Last Verified: December 2020
Keywords provided by Ronald Horswell, Pennington Biomedical Research Center:
overweight
obese
type II diabetes
hypertension
Additional relevant MeSH terms:
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Hypertension
Overweight
Weight Loss
Chronic Disease
Vascular Diseases
Cardiovascular Diseases
Body Weight
Body Weight Changes
Disease Attributes
Pathologic Processes