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
|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)|
|Actual Enrollment :||202 participants|
|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|
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
- 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
- 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.
- 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.
- 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.
- 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.
- Change in Triglycerides [ Time Frame: five months ]Change from baseline to five month follow-up in triglyceride level.
- Change in Total Cholesterol [ Time Frame: five months ]Change in total cholesterol level from baseline to five-month follow-up.
- Change in Fasting Plasma Glucose [ Time Frame: five months ]Change from baseline to five-month follow-up in fasting plasma glucose level.
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
|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|
|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|