Results of a 2-year lifestyle intervention for type 2 diabetes: the Reach Ahead for Lifestyle and Health-Diabetes randomized controlled trial.

OBJECTIVE: The Reach Ahead for Lifestyle and Health (REAL HEALTH)-Diabetes study assessed the comparative effectiveness of two Look AHEAD (Action for Health in Diabetes)-adapted lifestyle intervention (LI) arms targeting weight loss in type 2 diabetes compared with medical nutrition therapy (MNT) referral. At 1 year, LI had greater weight loss than MNT. This study reports outcomes at 24 (end of LI) and 36 months. METHODS: Participants (N = 211) with type 2 diabetes and BMI > 25 kg/m2 were randomly assigned to in-person LI, telephone conference call LI, or MNT. The primary outcome was percentage weight change. Secondary outcomes included 5% and 10% weight loss, glycated hemoglobin (HbA1c), and patient-reported outcomes. RESULTS: Participants were 61.7 (SD 10.2) years old; 55% were female; 77% were non-Hispanic White; and had mean (SD) weight of 98 (18.9) kg and mean (SD) HbA1c of 7.7% (1.2%). Mean (SD) weight change at 24 and 36 months was -4.4% (5.9%) and -4.4% (5.4%) in in-person LI, -4.0% (5.8%) and -5.3% (6.4%) in telephone LI, and -3.1% (5.2%) and -5.8% (7.1%) in MNT, with no statistically significant difference in weight or HbA1c at 24 and 36 months. Compared with MNT, LI arms had favorable changes in patient-reported outcomes related to learned dietary skills. CONCLUSIONS: There were no differences in weight outcomes among LI participants compared with referral to MNT at the end of intervention or 1 year after its conclusion.

Intensive Weight Loss Intervention and Cancer Risk in Adults with Type 2 Diabetes: Analysis of the Look AHEAD Randomized Clinical Trial.

OBJECTIVE: This study was designed to determine whether intensive lifestyle intervention (ILI) aimed at weight loss lowers cancer incidence and mortality. METHODS: Data from the Look AHEAD trial were examined to investigate whether participants randomized to ILI designed for weight loss would have reduced overall cancer incidence, obesity-related cancer incidence, and cancer mortality, as compared with the diabetes support and education (DSE) comparison group. This analysis included 4,859 participants without a cancer diagnosis at baseline except for nonmelanoma skin cancer. RESULTS: After a median follow-up of 11 years, 684 participants (332 in ILI and 352 in DSE) were diagnosed with cancer. The incidence rates of obesity-related cancers were 6.1 and 7.3 per 1,000 person-years in ILI and DSE, respectively, with a hazard ratio (HR) of 0.84 (95% CI: 0.68-1.04). There was no significant difference between the two groups in total cancer incidence (HR, 0.93; 95% CI: 0.80-1.08), incidence of nonobesity-related cancers (HR, 1.02; 95% CI: 0.83-1.27), or total cancer mortality (HR, 0.92; 95% CI: 0.68-1.25). CONCLUSIONS: An ILI aimed at weight loss lowered incidence of obesity-related cancers by 16% in adults with overweight or obesity and type 2 diabetes. The study sample size likely lacked power to determine effect sizes of this magnitude and smaller.

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

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, practice-based 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/m2 (> 23 kg/m2 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/m2 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.

Effective recruitment for practice-based research: Lessons from the REAL HEALTH-Diabetes Study.

BACKGROUND: Aims: The REAL HEALTH Diabetes Study is a practice-based randomized clinical trial that compares the effectiveness of lifestyle intervention aimed at weight reduction to medical nutrition therapy in primary care patients with type 2 diabetes. This paper describes a tiered approach to recruitment, the resultant enrollment rates of sequentially more intensive recruitment strategies, and identifies barriers to participation. METHODS: Potential participants were identified using patient health registries and classified by recruitment site. Four recruitment strategies were used to achieve target enrollment: (1) mail/telephone outreach; (2) direct referral from providers; (3) orientation sessions; and (4) media/advertising. Reasons for ineligibility and non-participation were tracked. RESULTS: Fifteen thousand two hundred sixty-nine (15,269) potential participants were identified from all sources, with the clear majority coming from patient registries. Mail/telephone outreach alone had the lowest enrollment rate (1.2%). Direct referral and orientation sessions superimposed on mail/telephone outreach was used for fewer participants but had greater enrollment rates (27% and 52%.) Media/advertising was ineffective. The most commonly reported reasons for non-participation were not wanting to be in a research (30%) or a weight loss program (22%); time commitment (20%); and distance/transportation (14%). CONCLUSIONS: The use of population registries to identify potential participants coupled with successively more intensive recruitment strategies, executed in a tiered approach moving toward personal engagement to establish trust and credibility, maximized recruitment enrollment rates. Our findings regarding facilitators and barriers to recruitment could be used to inform other practice-based research or to engage patients in group interventions in usual care settings. CLINICAL TRIAL REGISTRATION: NCT02320253.

Design and participant characteristics of a primary care adaptation of the Look AHEAD Lifestyle Intervention for weight loss in type 2 diabetes: The REAL HEALTH-diabetes study.

BACKGROUND/AIMS: The REAL HEALTH -Diabetes Study is a practice-based clinical trial that adapted the Look AHEAD lifestyle intervention for implementation in primary care settings. The trial will compare the effectiveness and cost-effectiveness of in-person group lifestyle intervention, telephone group lifestyle intervention, and individual medical nutrition therapy (MNT), the current recommended standard of care in type 2 diabetes. The primary outcome is percent weight loss at 6 months with outcomes also measured at 12, 18, 24 (intervention completion), and 36 months. Here, we describe the adaptation, trial design, implementation strategies, and baseline characteristics of enrolled participants. METHODS: The study is a three-arm, patient-level, randomized trial conducted in three community health centers (CHCs) and one diabetes practice affiliated with one academic medical center. RESULTS: The study used existing clinical infrastructure to recruit participants from study sites. Strategies for successful conduct of the trial included partnering with health-center based co-investigator clinicians, engaging primary care providers, and accommodating clinical workflows. Of 248 eligible patients who attended a screening visit, 211 enrolled, with 70 randomly assigned to in-person group lifestyle intervention, 72 to telephone group lifestyle intervention, and 69 to MNT. The cohort was 55% female, 29% non-white, with mean age 62 years and mean BMI 35 kg/m2. Enrollment rates were higher at CHC sites. CONCLUSIONS: A practice-based randomized trial of a complex behavioral lifestyle intervention for type 2 diabetes can be implemented in community health and usual clinical settings. Participant and provider engagement was higher at local CHC sites reflecting the study implementation focus. CLINICAL TRIAL REGISTRATION: NCT02320253.

Improving diabetes outcomes through lifestyle change--A randomized controlled trial.

OBJECTIVE: To compare a diabetes group lifestyle intervention (GLI) with dietitian referral for medical nutrition therapy (RD) for weight loss in the usual care setting. METHODS: Randomized clinical trial was conducted with 57 primary care patients with type 2 diabetes and body mass index (BMI) >25 kg/m(2) who received either a dietitian-led 19-week GLI adapted from the Look AHEAD study or RD. Outcome measures include 6-month and 1-year weight loss, changes in medications, glycemic control, cardiac risk factors, and cost analysis. RESULTS: Patients were mean age 61, 59% male, and 32% non-white, and they weighed 97 kg with mean HbA1c 8.2%. At 6 months, 46% of GLI vs. 21% of RD lost ≥5% body weight (P = 0.04), with mean weight loss 6.6 (SD 7.0) kg with GLI and 2.1 (3.5) kg in RD (P = 0.004). HbA1c improved by 0.70 (1.13) vs. 0.39 (1.51) in GLI vs. RD (P = 0.4), respectively, and 82% vs. 38% stopped or reduced diabetes medications (P < 0.001). Weight loss remained significantly greater in GLI compared to RD at 1 year. GLI program cost was $578 per participant. CONCLUSIONS: An affordable GLI achieved significantly more weight loss and medication reduction than RD in primary care patients with type 2 diabetes.

Cognitive Behavioral Therapy for Adherence and Depression (CBT-AD) in Type 2 Diabetes.

Depression is one of the most common psychological problems among individuals diabetes, and it is associated with worse treatment adherence and clinical outcomes. As part of a program of treatment research aimed at integrating interventions for depression and treatment nonadherence, five depressed patients with suboptimally controlled type 2 diabetes were treated with 10-12 sessions of individual cognitive behavioral therapy for adherence and depression (CBT-AD) in a case-series design. The intervention was delivered in a hospital setting by a collaborative team consisting of a psychologist, a nurse educator, and a dietitian. Post-treatment, all participants demonstrated a decrease in depression severity and demonstrated improvements in diabetes self-care. Four of the five demonstrated improved glycemic control. These preliminary results provide evidence for the acceptability, feasibility, and potential utility of CBT-AD for patients with type 2 diabetes and depression.