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Weight Loss in Chronic Disease Patient Population

Primary Purpose

Overweight, Obesity, Diabetes

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Tele-health Home Monitoring

TrestleTree Telephone Coaching

Tele-health Home Monitoring Plus Trestle Telephone Coaching

About this trial

This is an interventional health services research trial for Overweight focused on measuring overweight, obese, type II diabetes, hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Earl K. Long Medical Center
Leonard J. Chabert Medical Center
WO Moss Regional Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

No Intervention

Active Comparator

Arm Label

Tele-health Home Monitoring

Self-Directed Group

TrestleTree Telephone Coaching

Home monitoring + telephone coach

Arm Description

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

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

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.

System to track stage of change in weight loss.

Outcomes

Primary Outcome Measures

Change in Body Weight

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

Change in Waist Circumference

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

Secondary Outcome Measures

Change in Systolic Blood Pressure

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

Change in Diastolic Blood Pressure

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

Change in HbA1c

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

Change in Triglycerides

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

Change in Total Cholesterol

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

Change in Fasting Plasma Glucose

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

Full Information

NCT ID

NCT01155050

First Posted

June 29, 2010

Last Updated

December 3, 2020

Sponsor

Ronald Horswell

Collaborators

Louisiana State University Health Care Services Division

1. Study Identification

Unique Protocol Identification Number

NCT01155050

Brief Title

Weight Loss in Chronic Disease Patient Population

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

December 2010 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Ronald Horswell

Collaborators

Louisiana State University Health Care Services Division

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overweight, Obesity, Diabetes, Hypertension

Keywords

overweight, obese, type II diabetes, hypertension

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

The study randomized consenting subjects to four arms for evaluation of different weight loss strategies.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

202 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tele-health Home Monitoring

Arm Type

Active Comparator

Arm Description

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

Arm Title

Self-Directed Group

Arm Type

No Intervention

Arm Description

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

Arm Title

TrestleTree Telephone Coaching

Arm Type

Active Comparator

Arm Description

Arm Title

Home monitoring + telephone coach

Arm Type

Active Comparator

Arm Description

System to track stage of change in weight loss.

Intervention Type

Device

Intervention Name(s)

Tele-health Home Monitoring

Other Intervention Name(s)

Home Monitoring

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

TrestleTree Telephone Coaching

Other Intervention Name(s)

Telephone Coaching

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Tele-health Home Monitoring Plus Trestle Telephone Coaching

Other Intervention Name(s)

Home Monitoring and telephone coaching

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Body Weight

Description

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

Time Frame

five-month follow-up compared to baseline

Title

Change in Waist Circumference

Description

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

Time Frame

five-month follow-up compared to baseline

Secondary Outcome Measure Information:

Title

Change in Systolic Blood Pressure

Description

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

Time Frame

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

Title

Change in Diastolic Blood Pressure

Description

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

Time Frame

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

Title

Change in HbA1c

Description

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

Time Frame

five months

Title

Change in Triglycerides

Description

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

Time Frame

five months

Title

Change in Total Cholesterol

Description

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

Time Frame

five months

Title

Change in Fasting Plasma Glucose

Description

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

Time Frame

five months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials: