Effectiveness of Lifestyle Intervention for Type 2 Diabetes in Primary Care: the REAL HEALTH-Diabetes Randomized Clinical Trial

Abstract

BACKGROUND: Intensive lifestyle interventions (LI) improve outcomes in obesity and type 2 diabetes but are not currently available in usual care. OBJECTIVE: To compare the effectiveness and costs of two group LI programs, in-person LI and telephone conference call (telephone LI), to medical nutrition therapy (MNT) on weight loss in primary care patients with type 2 diabetes. DESIGN: A randomized, assessor-blinded, practicebased clinical trial in three community health centers and one hospital-based practice affiliated with a single health system. PARTICIPANTS: A total of 208 primary care patients with type 2 diabetes, HbA1c 6.5 to < 11.5, and BMI > 25 kg/m 2 (> 23 kg/m 2 in Asians). INTERVENTIONS: Dietitian-delivered in-person or telephone group LI programs with medication management or MNT referral. MAIN MEASURES: Primary outcome: mean percent weight change. Secondary outcomes: 5% and 10% weight loss, change in HbA1c, and cost per kilogram lost. KEY RESULTS: Participants' mean age was 62 (SD 10) years, 45% were male, and 77% were White, with BMI 35 (SD 5) kg/m 2 and HbA1c 7.7 (SD 1.2). Seventy were assigned to in-person LI, 72 to telephone LI, and 69 to MNT. The mean percent weight loss (95% CI) at 6 and 12 months was 5.6% (4.4-6.8%) and 4.6% (3.1-6.1%) for in-person LI, 4.6% (3.3-6.0%) and 4.8% (3.3-6.2%) for telephone LI, and 1.1% (0.2-2.0%) and 2.0% (0.9-3.0%) for MNT, with statistically significant differences between each LI arm and MNT (P < 0.001) but not between LI arms (P = 0.63). HbA1c improved in all participants. Compared with MNT, the incremental cost per kilogram lost was $789 for in-person LI and $1223 for telephone LI. CONCLUSIONS: In-person LI or telephone group LI can achieve good weight loss outcomes in primary care type 2 diabetes patients at a reasonable cost. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02320253

Does the effect of lifestyle intervention for individuals with diabetes vary by food insecurity status? A preplanned subgroup analysis of the REAL HEALTH randomized clinical trial

“…Compared with those receiving MNT, those receiving LI lost a greater percentage of bodyweight at 6 months (5.1% lost vs 1.1% lost; p<0.0001) and 12 months (4.7% lost vs 2.0% lost; p=0.0005). 22 The intervention effect in the LI arm was similar regardless of food security status (5.1% bodyweight lost vs 1.1% in food secure participants and 5.1% bodyweight lost vs 1.3% in food insecure participants at 6 months; 4.7% bodyweight lost vs 2.1% in food secure participants and 4.5% bodyweight lost vs 0.9% in food insecure participants at 12 months) ( table 2 , figure 1 ). Interaction terms testing these differences in intervention effect were not statistically significant in either unadjusted (p=0.87) or adjusted (p=0.99) models.…”

“…Compared with those receiving MNT, those receiving LI lost a greater percentage of bodyweight at 6 months (5.1% lost vs 1.1% lost; p<0.0001) and 12 months (4.7% lost vs 2.0% lost; p=0.0005). 22 The intervention effect in the LI arm was similar regardless of food security status figure 1). Interaction terms testing these differences in intervention effect were not statistically significant in either unadjusted (p=0.87) or adjusted (p=0.99) models.…”

“…As previously described, 211 individuals enrolled in the trial and 3 (1.4%) withdrew, leaving 208 participants (98.6%) who were included in the intention-to-treat analyses. 22 The mean age of participants was 61.7 (SD: 10.2) years, 55.3% were women, 76.9% were of non-Hispanic white race/ethnicity, and 8.2% spoke Spanish as their primary language (table 1). Thirteen per cent of participants reported food insecurity, with a similar proportion in the two study arms, as expected in a randomized trial.…”

“…All analyses followed the intention-to-treat approach for intervention arm classification. Because prior analyses found that the inperson and telephone-delivered LI produced similar results, 22 we combined these intervention arms for analysis, comparing those who received either format of LI with those who received MNT. To account for repeated measures within individuals and possible clustering within the study arms in which the LI was delivered, we used three-level mixed effect models with random effects terms for both the individual and intervention group.…”

Associations of Diet Quality and All-Cause Mortality Across Levels of Cardiometabolic Health and Disease: A 7.6-Year Prospective Analysis From the Dutch Lifelines Cohort

“…Because intensive pharmaceutical treatment for type 2 diabetes is controversial, as it could increase mortality risk (27,28), dietary interventions may be a safe and efficacious alternative addition to standard pharmaceutical therapy. This foregrounds the importance of initiatives aimed at the implementation of lifestyle programs in the standard care of patients with type 2 diabetes (29,30).…”