Louisiana State University Health Care Services Division (LSUHSCD) Tele-Health Projects: Weight Loss in Chronic Disease Patient Population

This study has been completed.
Sponsor:
Collaborator:
Louisiana State University Health Care Services Division
Information provided by (Responsible Party):
Timothy Church, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT01155050
First received: June 29, 2010
Last updated: October 28, 2011
Last verified: April 2011
  Purpose

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 Intervention
Overweight
Obesity
Diabetes
Hypertension
Device: Tele-health Home Monitoring
Behavioral: TrestleTree Telephone Coaching
Device: Tele-health Home Monitoring Plus Trestle Telephone Coaching

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Louisiana State University Health Care Services Division Tele-Health Projects: Weight Loss in Chronic Disease Patient Population

Resource links provided by NLM:


Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:
  • Improvement or comparable changes in weight loss and waist circumference. [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    After 5 months, individuals randomized to the home monitoring plus the telephone intervention aimed at promoting improved physical activity and dietary habits will have a greater average improvement in weight loss and waist circumference than patients on home monitoring alone, telephone intervention alone, or self-directed. After 5 months, individuals randomized in the home monitoring intervention will have comparable changes in weight and waist circumference to those individuals in the telephone intervention.


Secondary Outcome Measures:
  • Evaluating effects on resting blood pressure, fasting blood sugar, HbA1c, and metabolic measures including serum cholesterol and triglyceride. [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    In addition to the primary aims, we will evaluate the effects of home monitoring, telephone intervention, home monitoring plus telephone-based coaching, and self-directed on several important secondary outcomes, including resting blood pressure, fasting blood sugar, HbA1c, and metabolic measures including serum cholesterol and triglyceride. In addition, we will evaluate daily weight measurements during the interventions using the home monitoring device.


Estimated Enrollment: 240
Study Start Date: January 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01155050

Locations
United States, Louisiana
Earl K. Long Medical Center
Baton Rouge, Louisiana, United States
Leonard J. Chabert Medical Center
Houma, Louisiana, United States
WO Moss Regional Medical Center
Lake Charles, Louisiana, United States
Sponsors and Collaborators
Timothy Church
Louisiana State University Health Care Services Division
Investigators
Principal Investigator: Timothy S. Church, MD, MPH, PhD Pennington Biomedical Research Center
Study Chair: Donna H. Ryan, MD Pennington Biomedical Research Center
Study Chair: Valerie H. Myers, PhD Pennington Biomedical Research Center
Study Chair: Ronald W. Horswell, PhD Pennington Biomedical Research Center
Study Chair: Monisha Chadha, MD Louisiana State University Health Care Services Division
  More Information

No publications provided

Responsible Party: Timothy Church, Professor, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT01155050     History of Changes
Other Study ID Numbers: PBRC29032
Study First Received: June 29, 2010
Last Updated: October 28, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Pennington Biomedical Research Center:
overweight
obese
type II diabetes
hypertension

Additional relevant MeSH terms:
Hypertension
Overweight
Weight Loss
Chronic Disease
Vascular Diseases
Cardiovascular Diseases
Body Weight
Signs and Symptoms
Body Weight Changes
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on October 01, 2014