Weight Loss in Chronic Disease Patient Population

NCT01155050 | Completed Results DMC

• 1 other identifier: PBRC 29032
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 3

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.

Conditions

Overweight; Obesity; Diabetes; Hypertension

Keywords

overweight; obese; type II diabetes; hypertension

Outcome Measures

Primary Outcomes (2)

• Change in Body Weight

  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

  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 Outcomes (6)

• Change in Systolic Blood Pressure

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

• Change in Diastolic Blood Pressure

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

• Change in HbA1c

  five months

• Change in Triglycerides

  five months

• Change in Total Cholesterol

  five months

Study Arms (4)

Tele-health Home Monitoring

ACTIVE COMPARATOR

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

Device: Tele-health Home Monitoring

Self-Directed Group

NO INTERVENTION

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

TrestleTree Telephone Coaching

ACTIVE COMPARATOR

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

Home monitoring + telephone coach

ACTIVE COMPARATOR

System to track stage of change in weight loss.

Device: Tele-health Home Monitoring Plus Trestle Telephone Coaching

Interventions

Tele-health Home Monitoring DEVICE

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

Also known as: Home Monitoring

Tele-health Home Monitoring

TrestleTree Telephone Coaching BEHAVIORAL

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

Also known as: Telephone Coaching

TrestleTree 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.

Also known as: Home Monitoring and telephone coaching

Home monitoring + telephone coach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead

Study Sites (3)

Earl K. Long Medical Center

Baton Rouge, Louisiana, 70806, United States

Location

Leonard J. Chabert Medical Center

Houma, Louisiana, 70363, United States

Location

WO Moss Regional Medical Center

Lake Charles, Louisiana, 70607, United States

Location

MeSH Terms

Conditions

Overweight; Obesity; Diabetes Mellitus; Hypertension; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Ronald Horswell
• Organization: PenningtonBRC

Ronald.Horswell@pbrc.edu

225-763-2931

Study Officials

• Timothy S. Church, MD, MPH, PhD

  Pennington Biomedical Research Center

  STUDY CHAIR

• Donna H. Ryan, MD

  Pennington Biomedical Research Center

  STUDY CHAIR

• Valerie H. Myers, PhD

  Pennington Biomedical Research Center

  STUDY CHAIR

• Ronald W. Horswell, PhD

  Pennington Biomedical Research Center

  STUDY CHAIR

• Monisha Chadha, MD

  Louisiana State University Health Care Services Division

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: June 29, 2010
• First Posted: July 1, 2010
• Study Start: January 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: January 25, 2024
• Results First Posted: December 29, 2020

Record last verified: 2024-01

Locations

US (3)