Weight Loss in Chronic Disease Patient Population

Not Applicable

Completed

Interventions: Device: Tele-health Home Monitoring
Device: Tele-health Home Monitoring Plus Trestle Telephone Coaching
Behavioral: TrestleTree Telephone Coaching

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Tele-health Home Monitoring	Tele-health Home Monitoring	Participants will use the tele-health monitoring equipment to measure daily weight.
Home monitoring + telephone coach	Tele-health Home Monitoring Plus Trestle Telephone Coaching	System to track stage of change in weight loss.
TrestleTree Telephone Coaching	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.

Primary Outcome Measures

Name	Time	Method
Change in Waist Circumference	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 Body Weight	five-month follow-up compared to baseline	Body weight at five-month follow-up minus baseline body weight. Body weight is measured in pounds

Secondary Outcome Measures

Name	Time	Method
Change in Diastolic Blood Pressure	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 Systolic Blood Pressure	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 HbA1c	five months	Change in HbA1c value from baseline to five-month follow-up among those completing the study through five months.
Change in Triglycerides	five months	Change from baseline to five month follow-up in triglyceride level.
Change in Total Cholesterol	five months	Change in total cholesterol level from baseline to five-month follow-up.
Change in Fasting Plasma Glucose	five months	Change from baseline to five-month follow-up in fasting plasma glucose level.

Locations (3): WO Moss Regional Medical Center
🇺🇸
Lake Charles, Louisiana, United States
Earl K. Long Medical Center
🇺🇸
Baton Rouge, Louisiana, United States
Leonard J. Chabert Medical Center
🇺🇸
Houma, Louisiana, United States