Lifestyle Intervention for Treatment of Diabetes
LIFTDiabetes
2 other identifiers
interventional
260
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable type-2-diabetes
Started Apr 2013
Longer than P75 for not_applicable type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2013
CompletedFirst Posted
Study publicly available on registry
March 7, 2013
CompletedStudy Start
First participant enrolled
April 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2017
CompletedAugust 15, 2018
August 1, 2018
4 years
March 5, 2013
August 13, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Predicted Cardiovascular Risk
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 Outcomes (5)
Hemoglobin A1c
12, 24 months
Blood Pressure
12, 24 months
Lipids
12, 24 months
Weight Change
12, 24 months
Predicted Cardiovascular Risk
24 months
Other Outcomes (1)
Health Costs
12, 24 months
Study Arms (2)
Diabetes Self Management (DSM)
ACTIVE COMPARATORDiabetes Self Management education, delivered in the clinics, using group-based visits and targeting improved control of hemoglobin A1c and related risk factors.
Community Lifestyle Weight Loss (LWL)
EXPERIMENTALParticipants 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.
Interventions
Changing dietary and physical activity behavior to promote weight loss
Changing diet, physical activity, self monitoring, and medication related behaviors to improve diabetes control
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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)
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157, United States
Related Publications (2)
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.
PMID: 30291086DERIVEDEffoe 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.
PMID: 27733193DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alain G Bertoni, MD MPH
Wake Forest University Health Sciences
- PRINCIPAL INVESTIGATOR
Jeffrey Katula, PhD
Wake Forest University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2013
First Posted
March 7, 2013
Study Start
April 1, 2013
Primary Completion
March 30, 2017
Study Completion
March 30, 2017
Last Updated
August 15, 2018
Record last verified: 2018-08