N/A
N=211
REAL HEALTH-Diabetes: Reach Ahead for Lifestyle and Health-Diabetes
Type 2 Diabetes Mellitus · Obesity
Bottom Line
View on ClinicalTrials.gov: NCT02320253 ↗Enrolled (actual)
211
Serious AEs
22.1%
Results posted
Sep 2021
Primary outcome: Primary: Percent Weight Change From Baseline — -1.1; -5.6; -4.6; -2.0 percentage of weight
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- In Person Group (IP) (Behavioral); Telephone Conference Call Group (TCC) (Behavioral); Medical Nutrition Therapy (MNT) (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Sep 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Weight Change From Baseline |
-1.1; -5.6; -4.6; -2.0; -4.5; -4.8 | — |
| SECONDARY Hemoglobin A1c: Change From Baseline |
-0.3; -0.6; -0.5; -0.4; -0.4; -0.2 | — |
| SECONDARY Systolic Blood Pressure: Change From Baseline |
0; -4.0; -2.3; 1.8; -1.8; -1.0 | — |
| SECONDARY Triglyceride Levels: Change From Baseline |
12.5; -56.0; -21.3; 7.9; -57.4; -1.1 | — |
| SECONDARY Diet Self-efficacy: Change From Baseline |
-0.2; 0.3; 0.1; -0.3; 0.2; -0.1 | — |
| SECONDARY Fat-related Diet Behavior: Change From Baseline. |
-0.1; -0.4; -0.3; -0.2; -0.4; -0.3 | — |
| SECONDARY Dietary Restraint: Change From Baseline |
0.4; 0.6; 0.6; 0.5; 0.5; 0.5 | — |
| SECONDARY Diabetes Distress: Change From Baseline |
-7.0; -12.4; -14.1; -5.8; -14.4; -15.1 | — |
| SECONDARY Depression Score: Change From Baseline. |
-0.6; -1.0; -0.7; -0.9; -1.2; -0.4 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02320253). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.