Louisiana State University Health Care Services Division (LSUHSCD) Tele-Health Projects: Weight Loss in Chronic Disease Patient Population
|ClinicalTrials.gov Identifier: NCT01155050|
Recruitment Status : Completed
First Posted : July 1, 2010
Last Update Posted : November 1, 2011
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (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|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2010|
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
- Improvement or comparable changes in weight loss and waist circumference. [ Time Frame: 5 months ]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.
- Evaluating effects on resting blood pressure, fasting blood sugar, HbA1c, and metabolic measures including serum cholesterol and triglyceride. [ Time Frame: 5 months ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01155050
|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|
|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|