Weight Loss in Chronic Disease Patient Population

Study Overview
=================
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.

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.

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

Conditions
-----------------
Obesity, Overweight, Diabetes, Hypertension

Intervention / Treatment
-----------------
* Device: Tele-health Home Monitoring
* Behavioral: TrestleTree Telephone Coaching
* Device: Tele-health Home Monitoring Plus Trestle Telephone Coaching


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study randomized consenting subjects to four arms for evaluation of different weight loss strategies.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tele-health Home Monitoring<br>Participants will use the tele-health monitoring equipment to measure daily weight. | Device: Tele-health Home Monitoring<br>* Daily tele-health monitoring data will be collected from randomized participants.<br>* Other names: Home Monitoring;|
| No Intervention: Self-Directed Group<br>Participants will receive information on physical activity recommendations and guidelines on nutrition aimed at promoting weight loss. | |
| Active Comparator: TrestleTree Telephone Coaching<br>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<br>* Weekly or bi-weekly phone calls from TrestleTree health coaches with a focus on weight loss.<br>* Other names: Telephone Coaching;|
| Active Comparator: Home monitoring + telephone coach<br>System to track stage of change in weight loss. | Device: Tele-health Home Monitoring Plus Trestle Telephone Coaching<br>* Daily collection of data through the tele-health home monitor and weekly or bi-weekly phone calls with a Trestletree Health Coach.<br>* Other names: Home Monitoring and telephone coaching;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Body Weight | Body weight at five-month follow-up minus baseline body weight. Body weight is measured in pounds | five-month follow-up compared to baseline | 
| Change in Waist Circumference | Waist circumference at five-month follow-up minus waist circumference at baseline. Waist circumference is measured in centimeters. | five-month follow-up compared to baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Systolic Blood Pressure | Change is systolic blood pressure (mmHg) from baseline to five-month follow-up. | Systolic blood pressure (mmHg) at five months minus systolic blood pressure at baseline. | 
| Change in Diastolic Blood Pressure | Change in diastolic blood pressure (mmHg) from baseline to follow-up. | Diastolic blood pressure (mmHg) at five months minus diastolic blood pressure at baseline. | 
| Change in HbA1c | Change in HbA1c value from baseline to five-month follow-up among those completing the study through five months. | five months | 
| Change in Triglycerides | Change from baseline to five month follow-up in triglyceride level. | five months | 
| Change in Total Cholesterol | Change in total cholesterol level from baseline to five-month follow-up. | five months | 
| Change in Fasting Plasma Glucose | Change from baseline to five-month follow-up in fasting plasma glucose level. | five months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
overweight, obese, type II diabetes, hypertension