ObesityNCT00743756
Study of a Home Delivered Meal Program on Obese Elderly African American Subjects With Type 2 Diabetes Mellitus (DM)
A study testing home-delivered meals and diabetes education for 12 months in people with Obesity and Diabetes, run by Emory University at 1 site in United States.
Trial summary
The purpose of this study is to assess the impact of home-delivered Medical Nutrition Therapy on clinical outcomes for persons with diabetes. The primary outcomes of this studies include A1c (A1C), blood glucose, blood pressure, Body Mass Index, lipid levels and other measures of disease progression and management as… Read more about this study
- Who is it for?
- Ages 65 to 85 years
- What is being tested?
- home-delivered meals and diabetes education for 12 months
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- African-American subjects
- Males or females 65 - 85 years of age
- Body mass index (BMI) equal to or greater than 30 kg/m2
- Fasting blood glucose less than 300 mg/dL and HbA1c less than 9.0%
- Ability to understand and be willing to adhere to the study protocol
- A known history of type 2 diabetes mellitus greater than 3 months, receiving either diet alone or oral antidiabetic agents (sulfonylureas, metformin, thiazolidinediones).
Who cannot join
- Subjects with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state.
- Patients with clinically relevant hepatic disease or impaired renal function, as shown by a serum creatinine greater than 3.0 mg/dL.
- Mental condition rendering the subject unable to understand the scope of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of a Home Delivered Meal Program on Obese Elderly African American Subjects With T2Dm
The purpose of this study is to assess the impact of home-delivered Medical Nutrition Therapy on clinical outcomes for persons with diabetes. The primary outcomes of this studies include A1c (A1C), blood glucose, blood pressure, Body Mass Index, lipid levels and other measures of disease progression and management as well as costs of medical care provided throughout the intervention period.
Read the detailed description
Data collected as a result of this project will be evaluated in aggregate to demonstrate the potential impacts on health and medical costs available through this type of intervention, with long-term goals of reducing disability and deaths due to chronic disease.
- Being tested
- home-delivered meals, diabetes education for 12 months
- Keywords
- obesity, diabetes, endothelial function, insulin sensitivity
- Medical subject headings
- Obesity, Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
home-delivered mealsDietary supplement
3 diabetic meals per day, 7 days per week for 12 months
home-delivered mealsDietary supplement
diabetic meals 3 times per day, 7 days a week for six months
diabetes education for 12 monthsBehavioural
subjects in this group received diabetes education for 12 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | A total of 20 African-American patients with type 2 diabetes will be randomized to receive home-delivered meals for twelve consecutive months. In addition, the subjects received diabetes education at every visit (8 clinic visits and 8 phone calls) Receives: Dietary Supplement: home-delivered meals |
| 2 | Experimental | A total of 20 African-American patients with type 2 diabetes will be randomized to receive home-delivered meals for six consecutive months. In addition, the subjects received diabetes education for up to twelve months(8 clinic visits and 8 phone calls) Receives: Dietary Supplement: home-delivered meals |
| 3 | Other | 20 subjects received 12 months of diabetes education (8 clinic visits and 8 phone calls) Receives: Behavioral: diabetes education for 12 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Loss in the elderly african american population
Measured: 6 months to 1 year
Secondary outcomes (1)
Endothelial Function (assessed by pulse-wave analysis); sympathetic activity; insulin sensitivity
Measured: 6 months to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2008 (estimated)
- Study startApr 2006
- Primary completionFeb 2009
- Study completionDec 2009
Why it stopped: slow patient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guillermo Umpierrez, Emory University
- Investigators
- Guillermo E Umpierrez, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00743756
- Sponsor's protocol ID
- 1404-2005
- Status last verified
- Jun 2014
- First submitted
- 27 Aug 2008
- Last updated
- 10 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of a Home Delivered Meal Program on Obese Elderly African American Subjects With T2Dm
- ClinicalTrials.gov ID
- NCT00743756
- Acronym / sponsor ID
- 1404-2005
- Keywords
- obesity, diabetes, endothelial function, insulin sensitivity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow patient enrollment
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Feb 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 29 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the impact of home-delivered Medical Nutrition Therapy on clinical outcomes for persons with diabetes. The primary outcomes of this studies include A1c (A1C), blood glucose, blood pressure, Body Mass Index, lipid levels and other measures of disease progression and management as well as costs of medical care provided throughout the intervention period.
Detailed description
Data collected as a result of this project will be evaluated in aggregate to demonstrate the potential impacts on health and medical costs available through this type of intervention, with long-term goals of reducing disability and deaths due to chronic disease.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: home-delivered mealsA total of 20 African-American patients with type 2 diabetes will be randomized to receive home-delivered meals for twelve consecutive months. In addition, the subjects received diabetes education at every visit (8 clinic visits and 8 phone calls) |
| 2 | Experimental | Dietary Supplement: home-delivered mealsA total of 20 African-American patients with type 2 diabetes will be randomized to receive home-delivered meals for six consecutive months. In addition, the subjects received diabetes education for up to twelve months(8 clinic visits and 8 phone calls) |
| 3 | Other | Behavioral: diabetes education for 12 months20 subjects received 12 months of diabetes education (8 clinic visits and 8 phone calls) |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- African-American subjects
- Males or females 65 - 85 years of age
- Body mass index (BMI) equal to or greater than 30 kg/m2
- Fasting blood glucose less than 300 mg/dL and HbA1c less than 9.0%
- Ability to understand and be willing to adhere to the study protocol
Key exclusion criteria (3 listed)
- Subjects with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state.
- Patients with clinically relevant hepatic disease or impaired renal function, as shown by a serum creatinine greater than 3.0 mg/dL.
- Mental condition rendering the subject unable to understand the scope of the study.
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 |
|---|---|---|
| home-delivered meals3 diabetic meals per day, 7 days per week for 12 months | Dietary supplement | 1 |
| home-delivered mealsdiabetic meals 3 times per day, 7 days a week for six months | Dietary supplement | 2 |
| diabetes education for 12 monthssubjects in this group received diabetes education for 12 months | Behavioural | 3 |
Primary outcome
Weight Loss in the elderly african american population
Time frame: 6 months to 1 year
1 secondary outcome
Endothelial Function (assessed by pulse-wave analysis); sympathetic activity; insulin sensitivity
Time frame: 6 months to 1 year
Results and safety
The study was stopped early (reason given: slow patient enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2014.
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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.
Guillermo E Umpierrez, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing home-delivered meals and diabetes education for 12 months in people with Obesity and Diabetes, run by Emory University at 1 site 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 6 inclusion and 3 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: stopped early, as of the sponsor's last update on 10 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early (reason given: slow patient enrollment). Results are not available in the source record.
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?
Weight Loss in the elderly african american population (time frame: 6 months to 1 year). 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 10 Jun 2014.