Weight Loss in Chronic Disease Patient Population

Pennington Biomedical Research Center

Status: Completed

Conditions: Hypertension; Overweight; Diabetes; Obesity

Treatments: Device: Tele-health Home Monitoring Plus Trestle Telephone Coaching; Behavioral: TrestleTree Telephone Coaching; Device: Tele-health Home Monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT01155050

PBRC 29032

Details and patient eligibility

About

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.

Full 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.

Enrollment: 202 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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202 participants in 4 patient groups

Tele-health Home Monitoring

Active Comparator group

Description:

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

Treatment:

Device: Tele-health Home Monitoring

Self-Directed Group

No Intervention group

Description:

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

TrestleTree Telephone Coaching

Active Comparator group

Description:

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.

Treatment:

Behavioral: TrestleTree Telephone Coaching

Home monitoring + telephone coach

Active Comparator group

Description:

System to track stage of change in weight loss.

Treatment:

Device: Tele-health Home Monitoring Plus Trestle Telephone Coaching