Clinical trial NCT01155050: Weight Loss in Chronic Disease Patient Population
Official title: Louisiana State University Health Care Services Division (LSUHCSD) Tele-Health Projects: Weight Loss in Chronic Disease Patient Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Diabetes
Hypertension
Keywords: overweight
obese
type II diabetes
hypertension
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2010-07-01
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study randomized consenting subjects to four arms for evaluation of different weight loss strategies.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Change in Body Weight
timeFrame: five-month follow-up compared to baseline
measure: Change in Waist Circumference
timeFrame: five-month follow-up compared to baseline
Secondary outcomes:
measure: Change in Systolic Blood Pressure
timeFrame: Systolic blood pressure (mmHg) at five months minus systolic blood pressure at baseline.
measure: Change in Diastolic Blood Pressure
timeFrame: Diastolic blood pressure (mmHg) at five months minus diastolic blood pressure at baseline.
measure: Change in HbA1c
timeFrame: five months
measure: Change in Triglycerides
timeFrame: five months
measure: Change in Total Cholesterol
timeFrame: five months
measure: Change in Fasting Plasma Glucose
timeFrame: five months
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Earl K. Long Medical Center
state: Louisiana
city: Houma
country: United States
facility: Leonard J. Chabert Medical Center
state: Louisiana
city: Lake Charles
country: United States
facility: WO Moss Regional Medical Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Timothy S. Church, MD, MPH, PhD
role: STUDY_CHAIR
affiliation: Pennington Biomedical Research Center
name: Donna H. Ryan, MD
role: STUDY_CHAIR
affiliation: Pennington Biomedical Research Center
name: Valerie H. Myers, PhD
role: STUDY_CHAIR
affiliation: Pennington Biomedical Research Center
name: Ronald W. Horswell, PhD
role: STUDY_CHAIR
affiliation: Louisiana State University Health Care Services Division
name: Monisha Chadha, MD
role: PRINCIPAL_INVESTIGATOR
References: