Louisiana State University Health Care Services Division (LSUHCSD) Tele-Health Projects: Weight Loss in Chronic Disease Patient Population
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Overweight
- Sponsor
- Pennington Biomedical Research Center
- Enrollment
- 202
- Locations
- 3
- Primary Endpoint
- Change in Waist Circumference
- Status
- Completed
- Last Updated
- 2 years ago
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.
Investigators
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
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.
Outcomes
Primary Outcomes
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 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
Secondary Outcomes
- Change in Systolic Blood Pressure(Systolic blood pressure (mmHg) at five months minus systolic blood pressure at baseline.)
- Change in Diastolic Blood Pressure(Diastolic blood pressure (mmHg) at five months minus diastolic blood pressure at baseline.)
- Change in HbA1c(five months)
- Change in Triglycerides(five months)
- Change in Total Cholesterol(five months)
- Change in Fasting Plasma Glucose(five months)