REAL HEALTH-Diabetes: Reach Ahead for Lifestyle and Health-Diabetes
Completed · Not applicable
Conditions studied: Type 2 Diabetes Mellitus, Obesity
In brief
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.
Key facts
- Study ID
- NCT02320253
- Run by
- Massachusetts General Hospital
- People needed
- 211
- Starts
- 2014-11-01
- Expected to finish
- 2021-07-01
- Last updated by the study team
- 2021-09-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Charlestown HealthCare Center — Charlestown, Massachusetts, United States
- Chelsea HealthCare Center — Chelsea, Massachusetts, United States
- Revere HealthCare Center — Revere, Massachusetts, United States
Full record on ClinicalTrials.gov
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