Skip to main content
OpenTrials
Completed

NCT Number: NCT01155050

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Earl K. Long Medical Center, Baton Rouge, Louisiana, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tele-health Home Monitoring

Device

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

Other names: Home Monitoring

TrestleTree Telephone Coaching

Behavioral

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

Other names: Telephone Coaching

Tele-health Home Monitoring Plus Trestle Telephone Coaching

Device

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

Primary outcomes

  1. Change in Body Weight

    Time frame: five-month follow-up compared to baseline

    Body weight at five-month follow-up minus baseline body weight. Body weight is measured in pounds

  2. Change in Waist Circumference

    Time frame: five-month follow-up compared to baseline

    Waist circumference at five-month follow-up minus waist circumference at baseline. Waist circumference is measured in centimeters.

Secondary outcomes

  1. Change in Systolic Blood Pressure

    Time frame: Systolic blood pressure (mmHg) at five months minus systolic blood pressure at baseline.

    Change is systolic blood pressure (mmHg) from baseline to five-month follow-up.

  2. Change in Diastolic Blood Pressure

    Time frame: Diastolic blood pressure (mmHg) at five months minus diastolic blood pressure at baseline.

    Change in diastolic blood pressure (mmHg) from baseline to follow-up.

  3. Change in HbA1c

    Time frame: five months

    Change in HbA1c value from baseline to five-month follow-up among those completing the study through five months.

  4. Change in Triglycerides

    Time frame: five months

    Change from baseline to five month follow-up in triglyceride level.

  5. Change in Total Cholesterol

    Time frame: five months

    Change in total cholesterol level from baseline to five-month follow-up.

  6. Change in Fasting Plasma Glucose

    Time frame: five months

    Change from baseline to five-month follow-up in fasting plasma glucose level.

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jul 1, 2010
Registry last updated
Jan 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.