Lifestyle Intervention for Treatment of Diabetes

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.

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.