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Type 2 DiabetesLIFTDiabetesNCT01806727

Lifestyle Intervention for Treatment of Diabetes

A study testing Community Lifestyle Weight Loss (LWL) and Diabetes Self Management (DSM) in people with Type 2 Diabetes and Overweight, run by Wake Forest University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Type 2 Diabetes, Overweight, Obesity
What is being tested?
Community Lifestyle Weight Loss (LWL) and Diabetes Self Management (DSM)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
260 participants
Where
1 siteUnited States
Study dates
Apr 2013to 30 Mar 2017
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 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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).
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

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.

Read the 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.

Being tested
Community Lifestyle Weight Loss (LWL), Diabetes Self Management (DSM)
Keywords
Diabetes, Diabetes Self Management, LIFT Diabetes, Weight Loss, Diet, Physical Activity, Overweight, Obese
Medical subject headings
Diabetes Mellitus, Type 2, Overweight, Obesity, Diabetes Mellitus, Weight Loss, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Community Lifestyle Weight Loss (LWL)Behavioural

    Changing dietary and physical activity behavior to promote weight loss

  • Diabetes Self Management (DSM)Behavioural

    Changing diet, physical activity, self monitoring, and medication related behaviors to improve diabetes control

Study groups in NCT01806727
Study groupRoleWhat they receive
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.
Receives: Behavioral: Community Lifestyle Weight Loss (LWL)
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.
Receives: Behavioral: Diabetes Self Management (DSM)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 months

Secondary outcomes (5)

  1. Hemoglobin A1c

    Change (from baseline) in HbA1c at 12 and 24 months between groups will be assessed

    Measured: 12, 24 months

  2. Blood Pressure

    Systolic and Diastolic Blood Pressure change from baseline at 12 and 24 months between groups will be assessed

    Measured: 12, 24 months

  3. Lipids

    Changes in the lipid profile (Total Cholesterol, HDL-Cholesterol, LDL-Cholesterol, Triglycerides) from baseline to 12 and 24 months between groups will be determined

    Measured: 12, 24 months

  4. Weight Change

    Change in weight from baseline at 12 and 24 months will be ascertained

    Measured: 12, 24 months

  5. Predicted Cardiovascular Risk

    24 month change in UKPDS score will be determined and compared across arms.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2013 (estimated)
  2. Study startApr 2013
  3. Primary completion30 Mar 2017
  4. Study completion30 Mar 2017

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
260 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01806727
Sponsor's protocol ID
IRB00022613
Other IDs
1P60MD006917-01
Acronym
LIFTDiabetes
Status last verified
Aug 2018
First submitted
5 Mar 2013
Last updated
15 Aug 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 30291086

  • 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.

    PubMed 27733193

Questions about this trial

What is this clinical trial studying?

A study testing Community Lifestyle Weight Loss (LWL) and Diabetes Self Management (DSM) in people with Type 2 Diabetes and Overweight, run by Wake Forest 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 10 inclusion and 10 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 15 Aug 2018. 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?

Predicted Cardiovascular Risk (time frame: 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 NCT01806727, 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 15 Aug 2018.

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