Healthy Living Partnership to Prevent Diabetes

Social forces have promoted adverse behavioral patterns with respect to physical activity and
nutrition resulting in the current epidemics of obesity, the metabolic syndrome and type 2
diabetes mellitus (DM). Results from clinical trials such as the Diabetes Prevention Program
(DPP) have demonstrated a significant potential for prevention of type 2 DM through lifestyle
interventions to promote physical activity, a healthy eating pattern and weight loss. Yet
these approaches are not being applied in practice. In fact, whether these approaches can be
successfully implemented in the community is an unanswered question. The Healthy Living
Partnership to Prevent Diabetes (HELP PD) was designed to address this knowledge gap in a
community setting. It incorporates key translations of prior research to enhance logistical
and fiscal feasibility and long term dissemination, including the use of a group-based,
rather than an individual-based, intensive lifestyle behavioral intervention employing
professionals and community health workers (CHWs), and delivery of the intervention in the
community setting via expansion of an existing Diabetes Education Program (DEP). The trial
has been continued for an additional 5 years, and the primary goal of the continuation is to
test the long-term glucose lowering effects of the HELP PD intervention by randomizing the
lifestyle group to continued group maintenance or a self-directed maintenance condition and
to follow the UC group for additional comparison purposes. Demonstrating the longer term
effectiveness of HELP PD will represent a key step in establishing the value of this approach
to translation of DM prevention into the community. This crucial evidence will be used to
support reimbursement policy for DM prevention, dissemination of the HELP PD CHW approach and
generalization to other behaviorally influenced chronic diseases.

Inclusion Criteria:

- Able to read/understand English at or above a level sufficient to comprehend
recruitment and intervention materials

- BMI greater than or equal to 25 kg/m2 but less than 40 kg/m2

- Fasting blood glucose 95-125 mg/dl (inclusive)

- Willingness to Accept Randomization

Exclusion Criteria:

- Currently involved in a supervised program for weight loss

- Clinical history of DM, or newly diagnosed DM at screening

- Clinical history of cardiovascular disease (CVD) occurring within the past 6 months,
including myocardial infarction, angina, coronary revascularization, stroke, TIA,
carotid revascularization, peripheral arterial disease, and congestive heart failure

- Uncontrolled high blood pressure: BP > 160/100

- Pregnancy, breast feeding, or planning pregnancy within 2 years

- Other chronic disease likely to limit lifespan to less than 2-3 years, including any
cancer requiring treatment in past 5 years except non-melanoma skin cancer

- Chronic use of medicine known to significantly affect glucose metabolism, e.g.,
corticosteroids

- Conditions/criteria likely to interfere with participation and acceptance of
randomized assignment, including the following: inability/unwillingness to give
informed consent, another household member already randomized to HELP PD, major
psychiatric or cognitive problems (schizophrenia, dementia, self-reported active
illegal substance or alcohol abuse), and participation in another research study that
would interfere with HELP PD