REAL HEALTH-Diabetes: Reach Ahead for Lifestyle and Health-Diabetes

Participants will be randomly assigned to one of three arms: MNT, IP, or TCC. Participants
will be enrolled in the study for a total of three years. During those three years,
participants will have 5 research visits, at baseline, where randomization occurs, 6 months,
12 months, 24 months, and 36 months. At each research visit, participants will have a lipid
panel and HbA1c sample drawn, their blood pressure, weight, and height, baseline only, taken.
Participants will also answer questionnaires that will address health behaviors,
self-efficacy, measures of self-determination, depression, literacy and numeracy, food
insecurity, health-related quality-of-life and patient satisfaction with quality of care.

For the group-based interventions, dietitians will deliver the adapted Look AHEAD lifestyle
intervention. The first 14 sessions will be delivered weekly and the next 5 sessions
biweekly. In the subsequent 18 months, group sessions will be delivered monthly from 6-24
months. In addition, participants will be offered 2 individual MNT sessions in months 6-12
and 3 in months 13-24. At these individual visits, dietitians will address diabetes-related
issues and discuss tailored goals and behaviors, based on the Look AHEAD model. Dietitians
will provide ongoing feedback to participants' own PCPs about patient progress toward goals
and will encourage PCPs to reinforce weight loss strategies with their patients. Each group
will contain up to 10 participants with type 2 diabetes and will last 1-1.5 hours. The
program curriculum focuses on nutrition, activity, and behavioral topics and incorporates the
use of meal replacements for the first 4-16 weeks to enhance weight loss success.

In addition to the teaching component, participants who are taking insulin or medications
that can cause hypoglycemia will self-monitor blood glucose levels at least 2 times per day
and submit self-monitoring records for review each week, either by delivering them at the
in-person sessions or by mailing, faxing, or emailing them to the study team. Patients on
oral hypoglycemics who are not adjusting medications based on blood sugar will be instructed
to do targeted monitoring to determine the effects of exercise and meals on blood glucose.
The study provider at each health center will review BG records and make any needed
adjustments to insulin or medication doses according to an algorithm to maintain glycemic
control and prevent hypoglycemia as participants lose weight.

A trained member of the study staff will provide MNT referral participants with an
educational handout emphasizing that modest weight loss (5 - 10%) via caloric restriction and
gradual adoption of moderate increases in daily physical activity (equivalent to brisk
walking for 30 minutes daily) is safe and effective in managing diabetes and schedule them
for an appointment with a dietitian from Nutrition Services for follow up.

Inclusion Criteria:

- Diagnosis of type 2 diabetes

- Age 18 years or older

- Overweight or obese (BMI >25 kg/m2)

- HbA1c level 6.5<11.5%

- Systolic blood pressure (SBP) <160 mmHg, diastolic blood pressure (DBP) <100 mmHg

- Taking metformin or have a metformin allergy or intolerance

- Willing to lose 5-7% of body weight

- Willing to increase activity to at least 175 minutes/week

- Willing to commit to random assignment to either attend and participate in the
lifestyle change program in person or on the telephone or be referred to Nutrition
Services for medical nutrition therapy

- Stable health, with no severe comorbidities that might interfere with their ability to
participate in a group intervention that includes increasing activity or decreasing
calories, such as severe psychiatric illness or significant heart disease

- Ability to understand and communicate effectively in English or Spanish

- Willing to self-monitor blood glucose

- Willing to keep a food, exercise, and blood glucose diary

- Have a primary care physician at MGH Chelsea, Charlestown, or Revere Health Centers,
or be willing to attend sessions, in-person or by phone, and have medications adjusted
by a provider based at one of those health centers with communication to the referring
primary care provider

Exclusion Criteria:

- Weight greater than 350 pounds

- Pregnant or planning pregnancy in the next year

- Currently seeing a dietitian (regular scheduled follow up appointments) or
participating in a weight loss program and unwilling to stop

- Weight change of more than 3% of weight in the previous month.

- Currently enrolled in another diabetes intervention study

- Lack of availability of telephone