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

Mass General Brigham

Status: Completed

Conditions: Type 2 Diabetes Mellitus; Obesity

Treatments: Behavioral: In Person Group (IP); Behavioral: Telephone Conference Call Group (TCC); Behavioral: Medical Nutrition Therapy (MNT)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02320253

2014P002074

1R18DK102737-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 211 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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211 participants in 3 patient groups

Medical Nutrition Therapy (MNT)

Active Comparator group

Description:

Participants in this arm will meet with a dietitian at their respective Health Center, not with a study dietitian. The participant and dietitian will decide how frequently to meet and create an individualized treatment plan. The participant's health insurance will be billed for these dietitian visit(s) and the participant is responsible for any copay(s) or deductible(s) associated with the visit(s).

Treatment:

Behavioral: Medical Nutrition Therapy (MNT)

In Person Group (IP)

Experimental group

Description:

Participants enrolled to the IP arm will meet weekly for 14 weeks, biweekly for 10 weeks, and then monthly for the next 18 months. Each session will be led by a study dietitian that has been assigned to that specific health center and will last 1.5 hours. Participants will be allowed to have one-on-one sessions with their dietitian throughout the first two years, twice in the first year and three times in the second year.

Treatment:

Behavioral: In Person Group (IP)

Telephone Conference Call Group (TCC)

Experimental group

Description:

Participants enrolled in the TCC arm will meet weekly for 14 weeks, biweekly for 10 weeks, and then monthly for the next 18 months. Each session will be led, over-the-phone, by a study dietitian that has been assigned to that specific health center and will last 1.5 hours. Participants will be allowed to have one-on-one sessions with their dietitian throughout the first two years, twice in the first year and three times in the second year.

Treatment:

Behavioral: Telephone Conference Call Group (TCC)