REAL HEALTH-Diabetes: Reach Ahead for Lifestyle and Health-Diabetes
REAL HEALTH-Diabetes: Reach Ahead for Lifestyle and Health-Diabetes
The goal of this project is to translate the Look AHEAD intensive lifestyle intervention for
 type 2 diabetes and obesity into usual care at community health centers, comparing an
 in-person group program (IP), a telephone conference call (TCC) group program, and referral
 to medical nutrition therapy (MNT), the current standard of care.
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 up to 5 individual MNT sessions over the 2
 year intervention period. 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 12 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

 -  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