Weight Loss in Chronic Disease Patient Population

NCT ID: NCT01155050

Last Updated: 2024-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 202 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2010-12-31

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.

Conditions

Overweight; Obesity; Diabetes; Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Tele-health Home Monitoring

Participants will use the tele-health monitoring equipment to measure daily weight.

Group Type: ACTIVE_COMPARATOR

Tele-health Home Monitoring

Intervention Type: DEVICE

Daily tele-health monitoring data will be collected from randomized participants.

Self-Directed Group

Participants will receive information on physical activity recommendations and guidelines on nutrition aimed at promoting weight loss.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: ACTIVE_COMPARATOR

TrestleTree Telephone Coaching

Intervention Type: BEHAVIORAL

Weekly or bi-weekly phone calls from TrestleTree health coaches with a focus on weight loss.

Home monitoring + telephone coach

System to track stage of change in weight loss.

Group Type: ACTIVE_COMPARATOR

Tele-health Home Monitoring Plus Trestle Telephone Coaching

Intervention Type: DEVICE

Daily collection of data through the tele-health home monitor and weekly or bi-weekly phone calls with a Trestletree Health Coach.

Interventions

Tele-health Home Monitoring

Daily tele-health monitoring data will be collected from randomized participants.

Intervention Type: DEVICE

TrestleTree Telephone Coaching

Weekly or bi-weekly phone calls from TrestleTree health coaches with a focus on weight loss.

Intervention Type: BEHAVIORAL

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.

Intervention Type: DEVICE

Other Intervention Names

Home Monitoring; Telephone Coaching; Home Monitoring and telephone coaching

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pennington Biomedical Research Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Timothy S. Church, MD, MPH, PhD

Role: STUDY_CHAIR

Pennington Biomedical Research Center

Donna H. Ryan, MD

Role: STUDY_CHAIR

Pennington Biomedical Research Center

Valerie H. Myers, PhD

Role: STUDY_CHAIR

Pennington Biomedical Research Center

Ronald W. Horswell, PhD

Role: STUDY_CHAIR

Pennington Biomedical Research Center

Monisha Chadha, MD

Role: PRINCIPAL_INVESTIGATOR

Louisiana State University Health Care Services Division

Locations

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, United States

Countries

United States

Other Identifiers

PBRC 29032

Identifier Type: -

Identifier Source: org_study_id