Type 2 DiabetesLIFENCT01901952
Lifestyle Improvement Through Food and Exercise (LIFE)Study
A study testing Intensive education and lifestyle support in people with Type 2 Diabetes, run by Rush University Medical Center at 1 site in United States.
Trial summary
The primary aim of the LIFE study is to compare low-income African American diabetes patients in a lifestyle intervention group with those in a standard of care control group on change in glycemic control at 12-months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Intensive education and lifestyle support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 211 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to 2 Dec 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of type 2 diabetes mellitus (T2DM) and HbA1c > 7%;
- Patients must identify themselves as African American;
- Patients must be patients of Cook County Hospital ambulatory clinics;
- Primary care physician gives clearance for patient to participate in study and engage in moderate level physical activity.
Who cannot join
- BMI<18.5;
- Patient not on diabetes medication and with a HbA1c reading less than 7%
- End-stage renal disease, stroke with paresis, congestive heart failure (NYHA class 2-4), or other major end-organ complication of diabetes;
- Comorbid conditions limiting probable life span to <4 years (e.g. cancer, AIDS) or indication of end-stage complications of diabetes (kidney dialysis, or transplant, blindness, or lower extremity amputation);
- Receiving treatment for a major psychiatric disorder (i.e. schizophrenia);
- Unable to give informed consent;
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- Under the age of 18;
- Has no access to a telephone (Phone contact is a critical component of the intervention).
- Cannot walk 2 blocks without stopping and resting.
- Impaired cognitive function as determined by mini-mental test.
- Lives in the same household as an active LIFE participant.
- Presence of sickle cell trait
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lifestyle Improvement Through Food and Exercise (LIFE) Study
The primary aim of the LIFE study is to compare low-income African American diabetes patients in a lifestyle intervention group with those in a standard of care control group on change in glycemic control at 12-months. We hypothesize that, on average, participants in the intervention group will achieve greater glycemic control at 12-months relative to their baseline A1c, than those in the control group.
Read the detailed description
This project is a randomized controlled trial to test an innovative lifestyle intervention to achieve sustained improvements in glycemic control among low-income African American diabetes patients. The LIFE (Lifestyle Improvement through Food and Exercise) program is a diabetes self-management program focused on diet and exercise, informed by anthropological research on models of food and health among low-income African-Americans. Pilot work demonstrated that the LIFE Program is effective in improving glycemic control among low-income African Americans at 6-months. The main goal of the current study is to determine whether the LIFE Program can achieve sustained improvements in glycemic control for 12 months. The trial will randomize low-income African American adults with diabetes to a control group, which receives standard diabetes education, or an intervention group, which receives the LIFE Program (28 group meetings with peer support telephone calls) followed by a 6-month maintenance phase (quarterly group sessions with monthly peer support phone calls). The primary aim of the proposed research is to compare low-income African American diabetes patients receiving the LIFE Program with those in a standard of care control group on change in glycemic control at 12 months. Our primary hypothesis is that patients in the intervention group will achieve a change in A1c from baseline that is less than patients in the control group. Secondary aims are to compare low-income African American diabetes patients receiving the LIFE Program with those in a standard of care control group on (a) change in glycemic control at 18 months; (b) change in physical activity and total energy intake at 12 months; (c) change in physical activity and total energy intake at 18 months; and (d) to obtain estimates needed for a subsequent trial, including weight, blood pressure, and diabetes-related hospitalizations. For secondary aims we hypothesize that a) the intervention group will achieve a mean 18-month change in A1C that is less than the change in the control group; b) at 12 months, a greater proportion of intervention patients will have achieved the activity goal of 150 minutes of moderate activity per week, and the intervention group will achieve a greater reduction from baseline in mean total energy intake than the control group; and c) at 18 months, a greater proportion of intervention patients will have achieved the activity goal of 150 minutes of moderate activity per week, and the intervention group will achieve a greater reduction from baseline in mean total energy intake than the control group.
- Conditions
- Type 2 Diabetes
- Being tested
- Intensive education and lifestyle support, Standard of Care control group
- Keywords
- Self management diabetes intervention
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive education and lifestyle supportBehavioural
Group classes for 12 months (weekly for 4 months, biweekly for 4 months, monthly for 4 months), weekly peer supporter telephone calls, and diabetes education newsletters every 2 months.
Standard of Care control groupBehavioural
Participants receive 2 diabetes education classes taught by a Certified Diabetes Educator. They also receive diabetes education newsletters every 2 months.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | Active comparator | Not described Receives: Behavioral: Standard of Care control group |
| Intensive education and support | Experimental | Not described Receives: Behavioral: Intensive education and lifestyle support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c
Finger prick on Afinion machine
Measured: change from baseline to 12 months
Secondary outcomes (4)
Physical Activity
An accelerometer is worn by participants for seven days. International-Physical Activity Questionnaire is administered at baseline, 6 months, 1 year, and 18 months.
Measured: change from baseline to 12 months
Total Energy Intake
24-hour dietary food recalls
Measured: change from baseline to 12 months
Physical Measures
Measurements of weight, waist circumference, and blood pressure.
Measured: change from baseline to 12 months
Medications
Participants bring all medications to the clinic visit and medication and dosage is recorded.
Measured: change from baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2013 (estimated)
- Study startMar 2012
- Primary completion25 Nov 2015
- Study completion2 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Cook County Health
- Responsible party
- Sponsor
- Investigators
- Elizabeth Lynch, PhD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01901952
- Sponsor's protocol ID
- 1R01DK092271-01
- Other IDs
- R01DK092271-01
- Acronym
- LIFE
- Status last verified
- May 2017
- First submitted
- 12 Jul 2013
- Last updated
- 10 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lynch EB, Mack L, Avery E, Wang Y, Dawar R, Richardson D, Keim K, Ventrelle J, Appelhans BM, Tahsin B, Fogelfeld L. Randomized Trial of a Lifestyle Intervention for Urban Low-Income African Americans with Type 2 Diabetes. J Gen Intern Med. 2019 Jul;34(7):1174-1183. doi: 10.1007/s11606-019-04894-y. Epub 2019 Apr 8.
PubMed 30963440Lynch EB, Liebman R, Ventrelle J, Keim K, Appelhans BM, Avery EF, Tahsin B, Li H, Shapera M, Fogelfeld L. Design of the Lifestyle Improvement through Food and Exercise (LIFE) study: a randomized controlled trial of self-management of type 2 diabetes among African American patients from safety net health centers. Contemp Clin Trials. 2014 Nov;39(2):246-55. doi: 10.1016/j.cct.2014.09.003. Epub 2014 Sep 22.
PubMed 25245954
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle Improvement Through Food and Exercise (LIFE) Study
- ClinicalTrials.gov ID
- NCT01901952
- Acronym / sponsor ID
- LIFE / 1R01DK092271-01
- Conditions
- Type 2 Diabetes
- Keywords
- Self management diabetes intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Cook County Health
- Study start
- Mar 2012
- Primary completion
- 25 Nov 2015 (actual)
- Study completion
- 2 Dec 2015 (actual)
- First posted
- 17 Jul 2013 (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 primary aim of the LIFE study is to compare low-income African American diabetes patients in a lifestyle intervention group with those in a standard of care control group on change in glycemic control at 12-months. We hypothesize that, on average, participants in the intervention group will achieve greater glycemic control at 12-months relative to their baseline A1c, than those in the control group.
Detailed description
This project is a randomized controlled trial to test an innovative lifestyle intervention to achieve sustained improvements in glycemic control among low-income African American diabetes patients. The LIFE (Lifestyle Improvement through Food and Exercise) program is a diabetes self-management program focused on diet and exercise, informed by anthropological research on models of food and health among low-income African-Americans. Pilot work demonstrated that the LIFE Program is effective in improving glycemic control among low-income African Americans at 6-months. The main goal of the current study is to determine whether the LIFE Program can achieve sustained improvements in glycemic control for 12 months. The trial will randomize low-income African American adults with diabetes to a control group, which receives standard diabetes education, or an intervention group, which receives the LIFE Program (28 group meetings with peer support telephone calls) followed by a 6-month maintenance phase (quarterly group sessions with monthly peer support phone calls). The primary aim of the proposed research is to compare low-income African American diabetes patients receiving the LIFE Program with those in a standard of care control group on change in glycemic control at 12 months. Our primary hypothesis is that patients in the intervention group will achieve a change in A1c from baseline that is less than patients in the control group. Secondary aims are to compare low-income African American diabetes patients receiving the LIFE Program with those in a standard of care control group on (a) change in glycemic control at 18 months; (b) change in physical activity and total energy intake at 12 months; (c) change in physical activity and total energy intake at 18 months; and (d) to obtain estimates needed for a subsequent trial, including weight, blood pressure, and diabetes-related hospitalizations. For secondary aims we hypothesize that a) the intervention group will achieve a mean 18-month change in A1C that is less than the change in the control group; b) at 12 months, a greater proportion of intervention patients will have achieved the activity goal of 150 minutes of moderate activity per week, and the intervention group will achieve a greater reduction from baseline in mean total energy intake than the control group; and c) at 18 months, a greater proportion of intervention patients will have achieved the activity goal of 150 minutes of moderate activity per week, and the intervention group will achieve a greater reduction from baseline in mean total energy intake than the control group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | Active comparator | Behavioral: Standard of Care control group |
| Intensive education and support | Experimental | Behavioral: Intensive education and lifestyle support |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of type 2 diabetes mellitus (T2DM) and HbA1c > 7%;
- Patients must identify themselves as African American;
- Patients must be patients of Cook County Hospital ambulatory clinics;
- Primary care physician gives clearance for patient to participate in study and engage in moderate level physical activity.
Key exclusion criteria (12 listed)
- BMI<18.5;
- Patient not on diabetes medication and with a HbA1c reading less than 7%
- End-stage renal disease, stroke with paresis, congestive heart failure (NYHA class 2-4), or other major end-organ complication of diabetes;
- Comorbid conditions limiting probable life span to <4 years (e.g. cancer, AIDS) or indication of end-stage complications of diabetes (kidney dialysis, or transplant, blindness, or lower extremity amputation);
- Receiving treatment for a major psychiatric disorder (i.e. schizophrenia);
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 |
|---|---|---|
| Intensive education and lifestyle supportGroup classes for 12 months (weekly for 4 months, biweekly for 4 months, monthly for 4 months), weekly peer supporter telephone calls, and diabetes education newsletters every 2 months. | Behavioural | Intensive education and support |
| Standard of Care control groupParticipants receive 2 diabetes education classes taught by a Certified Diabetes Educator. They also receive diabetes education newsletters every 2 months. | Behavioural | Standard of care |
Primary outcome
Hemoglobin A1c
Time frame: change from baseline to 12 months
Finger prick on Afinion machine
4 secondary outcomes
Physical Activity
Time frame: change from baseline to 12 months
Total Energy Intake
Time frame: change from baseline to 12 months
Physical Measures
Time frame: change from baseline to 12 months
Medications
Time frame: change from baseline to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2017.
- Derived from this study: PubMed 30963440Lynch EB, Mack L, Avery E, Wang Y, Dawar R, Richardson D, Keim K, Ventrelle J, Appelhans BM, Tahsin B, Fogelfeld L. Randomized Trial of a Lifestyle Intervention for Urban Low-Income African Americans with Type 2 Diabetes. J Gen Intern Med. 2019 Jul;34(7):1174-1183. doi: 10.1007/s11606-019-04894-y. Epub 2019 Apr 8.
- Derived from this study: PubMed 25245954Lynch EB, Liebman R, Ventrelle J, Keim K, Appelhans BM, Avery EF, Tahsin B, Li H, Shapera M, Fogelfeld L. Design of the Lifestyle Improvement through Food and Exercise (LIFE) study: a randomized controlled trial of self-management of type 2 diabetes among African American patients from safety net health centers. Contemp Clin Trials. 2014 Nov;39(2):246-55. doi: 10.1016/j.cct.2014.09.003. Epub 2014 Sep 22.
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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.
Elizabeth Lynch, PhD principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive education and lifestyle support in people with Type 2 Diabetes, run by Rush University Medical Center 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 4 inclusion and 12 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 10 May 2017. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Hemoglobin A1c (time frame: change from baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01901952, which also lists 2 linked publications.
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 May 2017.