- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01806727
Lifestyle Intervention for Treatment of Diabetes (LIFTDiabetes)
August 13, 2018 updated by: Wake Forest University
This study is evaluating two approaches to improving the control blood sugar, and other risk factors for heart disease in overweight and obese adults with type 2 diabetes.
The first approach has participants focus on weight loss via reducing food intake and increasing physical activity, while attending weekly group sessions led by trained community health workers for 12 months.
The second approach has participants receive education on diabetes self management, which focuses primarily on glucose control, while attending monthly group sessions led by a study staff member for 12 months.
We are recruiting persons with type 2 diabetes who live in the Winston-Salem/Forsyth County area of North Carolina who are willing to attend sessions at the Downtown Health Plaza of Wake Forest Baptist Health.
We will measure risk factors for heart disease (glucose control, blood pressure, blood cholesterol) and calculate the predicted risk of heart disease, and see which intervention lowers risk to a greater extent at 12 months, as well as 24 months.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The Look AHEAD trial has demonstrated improved risk factor control among overweight or obese diabetes patients who received an intensive lifestyle intervention at both one and four years after enrollment.
Translating such findings into accessible and effective weight loss programs is a major public health challenge.
We are conducting "Lifestyle Interventions for Treatment of Diabetes" (LIFT Diabetes).
The overall goal is to investigate two approaches to improving risk factor control; one which is modeled after Look AHEAD and is designed to achieve 7% weight loss and increase physical activity to > 175 minutes per week among minority and lower income diabetes patients via a 12-month, group based lifestyle intervention, using community health workers supervised by an interventionist.
Participants will have up to 4 group visits/month and up to 12 individual contacts/year.
The other approach will promote Diabetes Self Management (DSM) by educating participants regarding health behaviors which lead to improved diabetes control; this arm is also 12 months, and is delivered in the clinic by intervention staff via monthly group visits and up to 12 individual contacts/year.
We will randomize 260 overweight or obese adults with diabetes to either intervention, and determine the impact on outcomes (UKPDS-estimated CVD risk, risk factor control), weight, cost, resource utilization, and safety at 12 months, and after transitioning back to usual care, at 24 months.
The hypotheses are that the community based intervention results in 10% relative reduction in CVD risk compared to clinic-based intervention; the interventions are equivalent with respect to adherence and participant satisfaction; and the community based intervention is associated with lower cost than the clinic based intervention.
Translating evidence based, lifestyle strategies, and targeting minority and underserved patients, will yield, if successful, models for addressing diabetes-related health disparities.
Study Type
Interventional
Enrollment (Actual)
260
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
-
Winston-Salem, North Carolina, United States, 27157
- Wake Forest Baptist Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Men and women 21 years of age and older residing in the Forsyth County, North Carolina region.
- Disease: Type 2 diabetes mellitus.
- Overweight or obese: defined as body mass index (BMI) greater than 25 kg/m2 (>27 if on insulin).
- If not on diabetes medication, persons with hemoglobin A1c greater than or equal to 6.5% and less than 11.0%
- If on diabetes medication, hemoglobin A1c greater than or equal to 5.0% and less than 11.0%
- Blood pressure: BP ≤ 160/100 mmHg.
- A usual source of medical care: The intervention may induce hypoglycemia and have other risks, and weight loss and increased physical activity may modify the need for drugs used to treat diabetes, high blood pressure, and lipids. Patients must have a source for ongoing care. Usual source of care will be documented via a "medical clearance" form with physician signature verifying that MD is aware their patient is participating in this trial.
- Able to exercise: Increasing moderate intensity physical activity is an integral part of this intervention. Must be able to walk 1/4 mile without assistance.
- Able to communicate in English
- Other: Willing to give consent to participate in this research program, including random allocation to either study arm.
Exclusion Criteria:
- Poorly controlled diabetes: defined by hemoglobin A1c>11%
- Cardiovascular disease: Clinical history of cardiovascular disease, or newly diagnosed at screening. This includes myocardial infarction, heart failure, ischemic heart disease, stroke and other vascular disease. Persons suspected of having angina (chest pain) or other potentially ischemic symptoms will be required to be evaluated by their health care provider.
- Weight Loss: Currently involved in a supervised medical or surgical weight loss program or with a history of prior weight loss surgery.
- Age: We will exclude children (<21 years)
- Pregnancy: Diabetes during pregnancy has specific management criteria, and the role of weight loss via caloric restriction and increased physical activity is of uncertain efficacy and safety. Among women of child-bearing potential, planning to become pregnant within 12 months will be an exclusion criteria. Women who have recently given birth and are breast feeding are also excluded
- Serious Illness with anticipated decreased life expectancy during the 2 year (24 month) time frame of the intervention, such as cancer diagnosis or treatment within the past 5 years (with the exception of non-melanoma skin cancer).
- Inability to exercise: Patients who are wheel chair bound, have had an amputation, are undergoing treatment for lower extremity infections, or who self report being unable to ambulate 400 meters (1/4 mile) without assistance.
- Participation in another clinical trial involving intervention(s) which affect any component of cardiovascular risk. Potential participants who are enrolled in purely observational studies remain eligible.
- Renal disease: Persons with stage 3 chronic renal disease (estimated glomerular filtration rate <60ml/min by the chronic kidney disease formula used by Wake Forest Baptist) will be excluded.
- Other: Conditions/criteria likely to interfere with participation and acceptance of randomized assignment, including the following: inability/unwillingness to give informed consent, major psychiatric or cognitive problems (schizophrenia, dementia), self-reported active illegal substance or alcohol abuse, and clinical judgment.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Diabetes Self Management (DSM)
Diabetes Self Management education, delivered in the clinics, using group-based visits and targeting improved control of hemoglobin A1c and related risk factors.
|
Changing dietary and physical activity behavior to promote weight loss
|
Experimental: Community Lifestyle Weight Loss (LWL)
Participants with type 2 diabetes will be enrolled in a 12 month lifestyle intervention designed to achieve a mean >7% weight loss induced through caloric restriction and increased physical activity.
The intervention will be delivered via supervised Community Health Workers (CHWs).
Most meetings will be at a community location.
|
Changing diet, physical activity, self monitoring, and medication related behaviors to improve diabetes control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Predicted Cardiovascular Risk
Time Frame: 12 months
|
Cardiovascular risk will be estimated by the United Kingdom Prospective Diabetes Study (UKPDS) risk score, which is based on age, gender, diabetes duration, hemoglobin A1c, blood pressure, lipids, and smoking status.
The study will compare the mean changes in UKDPS scores between groups at 12 months.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hemoglobin A1c
Time Frame: 12, 24 months
|
Change (from baseline) in HbA1c at 12 and 24 months between groups will be assessed
|
12, 24 months
|
Blood Pressure
Time Frame: 12, 24 months
|
Systolic and Diastolic Blood Pressure change from baseline at 12 and 24 months between groups will be assessed
|
12, 24 months
|
Lipids
Time Frame: 12, 24 months
|
Changes in the lipid profile (Total Cholesterol, HDL-Cholesterol, LDL-Cholesterol, Triglycerides) from baseline to 12 and 24 months between groups will be determined
|
12, 24 months
|
Weight Change
Time Frame: 12, 24 months
|
Change in weight from baseline at 12 and 24 months will be ascertained
|
12, 24 months
|
Predicted Cardiovascular Risk
Time Frame: 24 months
|
24 month change in UKPDS score will be determined and compared across arms.
|
24 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health Costs
Time Frame: 12, 24 months
|
Costs and resource utilization will be measured
|
12, 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Alain G Bertoni, MD MPH, Wake Forest University Health Sciences
- Principal Investigator: Jeffrey Katula, PhD, Wake Forest University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Claudel SE, Bertoni AG. Exploring the Use of Personal Technology in Type 2 Diabetes Management Among Ethnic Minority Patients: Cross-Sectional Analysis of Survey Data from the Lifestyle Intervention for the Treatment of Diabetes Study (LIFT Diabetes). JMIR Diabetes. 2018 Feb 22;3(1):e5. doi: 10.2196/diabetes.8934.
- Effoe VS, Katula JA, Kirk JK, Pedley CF, Bollhalter LY, Brown WM, Savoca MR, Jones ST, Baek J, Bertoni AG; LIFT Diabetes Research Team. The use of electronic medical records for recruitment in clinical trials: findings from the Lifestyle Intervention for Treatment of Diabetes trial. Trials. 2016 Oct 13;17(1):496. doi: 10.1186/s13063-016-1631-7.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2013
Primary Completion (Actual)
March 30, 2017
Study Completion (Actual)
March 30, 2017
Study Registration Dates
First Submitted
March 5, 2013
First Submitted That Met QC Criteria
March 5, 2013
First Posted (Estimate)
March 7, 2013
Study Record Updates
Last Update Posted (Actual)
August 15, 2018
Last Update Submitted That Met QC Criteria
August 13, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00022613
- 1P60MD006917-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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