Weight Loss in Chronic Disease Patient Population

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Obesity; Diabetes; Overweight
• Intervention / Treatment: Device: Tele-health Home Monitoring; Behavioral: TrestleTree Telephone Coaching; Device: Tele-health Home Monitoring Plus Trestle Telephone Coaching

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.

• Study Type: Interventional
• Enrollment (Actual): 202
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70806
      • Earl K. Long Medical Center
    • Houma, Louisiana, United States, 70363
      • Leonard J. Chabert Medical Center
    • Lake Charles, Louisiana, United States, 70607
      • WO Moss Regional Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

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

Collaborators and Investigators

• Sponsor: Pennington Biomedical Research Center
• Collaborators: Louisiana State University Health Care Services Division
• Investigators: Study Chair: Timothy S. Church, MD, MPH, PhD, Pennington Biomedical Research Center; Study Chair: Valerie H. Myers, PhD, Pennington Biomedical Research Center; Study Chair: Donna H. Ryan, MD, Pennington Biomedical Research Center; Study Chair: Ronald W. Horswell, PhD, Pennington Biomedical Research Center; Principal Investigator: Monisha Chadha, MD, Louisiana State University Health Care Services Division

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: June 29, 2010
• First Submitted That Met QC Criteria: June 30, 2010
• First Posted (Estimated): July 1, 2010

Study Record Updates

• Last Update Posted (Estimated): January 25, 2024
• Last Update Submitted That Met QC Criteria: January 23, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: overweight; hypertension; obese; type II diabetes
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Disease Attributes; Overnutrition; Nutrition Disorders; Body Weight; Body Weight Changes; Hypertension; Weight Loss; Chronic Disease; Overweight
• Other Study ID Numbers: PBRC 29032