OverweightNCT01155050
Weight Loss in Chronic Disease Patient Population
A study testing Tele-health Home Monitoring, TrestleTree Telephone Coaching and Tele-health Home Monitoring Plus Trestle Telephone Coaching in people with Overweight and Obesity, run by Pennington Biomedical Research Center at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overweight, Obesity, Diabetes
- What is being tested?
- Tele-health Home Monitoring, TrestleTree Telephone Coaching and Tele-health Home Monitoring Plus Trestle Telephone Coaching
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2010to Dec 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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 locations and contacts
3 sites in 1 country.
United States3 sites
Earl K. Long Medical Center
Baton Rouge, Louisiana, 70806
Leonard J. Chabert Medical Center
Houma, Louisiana, 70363
WO Moss Regional Medical Center
Lake Charles, Louisiana, 70607
About this study
Official title: 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.
Read the 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.
- Conditions
- Overweight, Obesity, Diabetes, Hypertension
- Being tested
- Tele-health Home Monitoring, TrestleTree Telephone Coaching, Tele-health Home Monitoring Plus Trestle Telephone Coaching
- Keywords
- overweight, obese, type II diabetes, hypertension
- Medical subject headings
- Overweight, Obesity, Diabetes Mellitus, Hypertension, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-health Home MonitoringDevice
Also called Home Monitoring
Daily tele-health monitoring data will be collected from randomized participants.
TrestleTree Telephone CoachingBehavioural
Also called Telephone Coaching
Weekly or bi-weekly phone calls from TrestleTree health coaches with a focus on weight loss.
Tele-health Home Monitoring Plus Trestle Telephone CoachingDevice
Also called Home Monitoring and telephone coaching
Daily collection of data through the tele-health home monitor and weekly or bi-weekly phone calls with a Trestletree Health Coach.
| Study group | Role | What they receive |
|---|---|---|
| Tele-health Home Monitoring | Active comparator | Participants will use the tele-health monitoring equipment to measure daily weight. Receives: 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. Receives: Behavioral: TrestleTree Telephone Coaching |
| Home monitoring + telephone coach | Active comparator | System to track stage of change in weight loss. Receives: Device: Tele-health Home Monitoring Plus Trestle Telephone Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Weight
Body weight at five-month follow-up minus baseline body weight. Body weight is measured in pounds
Measured: 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.
Measured: five-month follow-up compared to baseline
Secondary outcomes (6)
Change in Systolic Blood Pressure
Change is systolic blood pressure (mmHg) from baseline to five-month follow-up.
Measured: Systolic blood pressure (mmHg) at five months minus systolic blood pressure at baseline.
Change in Diastolic Blood Pressure
Change in diastolic blood pressure (mmHg) from baseline to follow-up.
Measured: Diastolic blood pressure (mmHg) at five months minus diastolic blood pressure at baseline.
Change in HbA1c
Change in HbA1c value from baseline to five-month follow-up among those completing the study through five months.
Measured: five months
Change in Triglycerides
Change from baseline to five month follow-up in triglyceride level.
Measured: five months
Change in Total Cholesterol
Change in total cholesterol level from baseline to five-month follow-up.
Measured: five months
Change in Fasting Plasma Glucose
Change from baseline to five-month follow-up in fasting plasma glucose level.
Measured: five months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2010 (estimated)
- Study startJan 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study randomized consenting subjects to four arms for evaluation of different weight loss strategies.
- Masking
- None (open label)
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Timothy S. Church, MD, MPH, PhD, Study chair, Pennington Biomedical Research CenterDonna H. Ryan, MD, Study chair, Pennington Biomedical Research CenterValerie H. Myers, PhD, Study chair, Pennington Biomedical Research CenterRonald W. Horswell, PhD, Study chair, Pennington Biomedical Research CenterMonisha Chadha, MD, Principal investigator, Louisiana State University Health Care Services Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01155050
- Sponsor's protocol ID
- PBRC 29032
- Status last verified
- Jan 2024
- First submitted
- 29 Jun 2010
- Last updated
- 25 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Louisiana State University Health Care Services Division (LSUHCSD) Tele-Health Projects: Weight Loss in Chronic Disease Patient Population
- ClinicalTrials.gov ID
- NCT01155050
- Acronym / sponsor ID
- PBRC 29032
- Conditions
- Overweight, Obesity, Diabetes, Hypertension
- Keywords
- overweight, obese, type II diabetes, hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 1 Jul 2010 (estimated)
- Results
- Posted 29 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The study randomized consenting subjects to four arms for evaluation of different weight loss strategies.
| Arm | Type | Receives |
|---|---|---|
| Tele-health Home Monitoring | Active comparator | Device: Tele-health Home MonitoringParticipants will use the tele-health monitoring equipment to measure daily weight. |
| 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 | Behavioral: TrestleTree Telephone CoachingParticipants 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. |
| Home monitoring + telephone coach | Active comparator | Device: Tele-health Home Monitoring Plus Trestle Telephone CoachingSystem to track stage of change in weight loss. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tele-health Home MonitoringAlso: Home MonitoringDaily tele-health monitoring data will be collected from randomized participants. | Device | Tele-health Home Monitoring |
| TrestleTree Telephone CoachingAlso: Telephone CoachingWeekly or bi-weekly phone calls from TrestleTree health coaches with a focus on weight loss. | Behavioural | TrestleTree Telephone Coaching |
| Tele-health Home Monitoring Plus Trestle Telephone CoachingAlso: Home Monitoring and telephone coachingDaily collection of data through the tele-health home monitor and weekly or bi-weekly phone calls with a Trestletree Health Coach. | Device | Home monitoring + telephone coach |
Primary outcome
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
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.
6 secondary outcomes
Change in Systolic Blood Pressure
Time frame: 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 HbA1c
Time frame: five months
Change in Triglycerides
Time frame: five months
Change in Total Cholesterol
Time frame: five months
Change in Fasting Plasma Glucose
Time frame: five months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy S. Church, MD, MPH, PhD study chair
Pennington Biomedical Research Center
Donna H. Ryan, MD study chair
Pennington Biomedical Research Center
Valerie H. Myers, PhD study chair
Pennington Biomedical Research Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele-health Home Monitoring, TrestleTree Telephone Coaching and Tele-health Home Monitoring Plus Trestle Telephone Coaching in people with Overweight and Obesity, run by Pennington Biomedical Research Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Weight (time frame: five-month follow-up compared to baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2024.