Weight Loss in Chronic Disease Patient Population

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01155050
• Other study ID #: PBRC 29032
• Status: Completed
• Phase: N/A
• Start date: January 2010
• Est. completion date: December 2010

Study information

• Verified date: January 2024
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Chronic Disease
• Diabetes
• Hypertension
• Obesity
• Overweight
• Weight Loss

Intervention

Device:
• Tele-health Home Monitoring
Daily tele-health monitoring data will be collected from randomized participants.

Behavioral:
• TrestleTree Telephone Coaching
Weekly or bi-weekly phone calls from TrestleTree health coaches with a focus on 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.

Locations

Country	Name	City	State
United States	Earl K. Long Medical Center	Baton Rouge	Louisiana
United States	Leonard J. Chabert Medical Center	Houma	Louisiana
United States	WO Moss Regional Medical Center	Lake Charles	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.
Secondary	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.
Secondary	Change in HbA1c	Change in HbA1c value from baseline to five-month follow-up among those completing the study through five months.	five months
Secondary	Change in Triglycerides	Change from baseline to five month follow-up in triglyceride level.	five months
Secondary	Change in Total Cholesterol	Change in total cholesterol level from baseline to five-month follow-up.	five months
Secondary	Change in Fasting Plasma Glucose	Change from baseline to five-month follow-up in fasting plasma glucose level.	five months