Weight Loss in Chronic Disease Patient Population

January 23, 2024 updated by: Pennington Biomedical Research Center

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
202

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
five-month follow-up compared to baseline
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.
five-month follow-up compared to baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Systolic blood pressure (mmHg) at five months minus systolic blood pressure at baseline.
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.
Diastolic blood pressure (mmHg) at five months minus diastolic blood pressure at baseline.
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.
five months
Change in Triglycerides
Time Frame: five months
Change from baseline to five month follow-up in triglyceride level.
five months
Change in Total Cholesterol
Time Frame: five months
Change in total cholesterol level from baseline to five-month follow-up.
five months
Change in Fasting Plasma Glucose
Time Frame: five months
Change from baseline to five-month follow-up in fasting plasma glucose level.
five months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pennington Biomedical Research Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Louisiana State University Health Care Services Division

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 29, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2010

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 1, 2010

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 25, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PBRC 29032

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings