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

Abstract

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

Introduction

Twelve percent of U.S. adults have diabetes, with the vast majority having type 2 diabetes; prevalence will increase to 1 in 3 by 2050, if current trends continue [1,2]. Diabetes significantly impacts overall health, quality of life, and national healthcare costs, with $176 billion in direct medical costs and $69 billion in indirect medical costs, including disability, work loss, and premature mortality [3,4]. Eighty-seven percent of adults with diabetes are overweight or obese, and 40.8% are physically inactive [2]. Moderate weight loss of 5–10% of body weight is a highly effective treatment for type 2 diabetes [5]. Lifestyle intervention, including diet and exercise, to achieve sustainable weight loss of this degree is effective and cost-effective for prevention of diabetes and its sequelae over time, as demonstrated by NIDDK's Diabetes Prevention Program (DPP) and other lifestyle interventions [[6], [7], [8]]. It has also been particularly effective in preventing and treating burdensome and costly diabetes comorbidities that are not impacted by medications, such as impaired mobility, physical function, and sleep apnea as demonstrated in the Look AHEAD trial. [[9], [10], [11], [12], [13]]

The Look AHEAD trial compared a DPP-adapted lifestyle intervention aimed at sustaining a 7% weight loss and 175 min of weekly activity to a program of diabetes support and education (DSE) in people with type 2 diabetes. Look AHEAD demonstrated significantly greater weight loss (8.6% vs. 0.7%) and fitness after 1 year, resulting in improvements in glycemic control, blood pressure, and lipids with simultaneous reductions in medications and health service expenditure to treat these conditions. Improvements persisted at 4 and 8 years [10,[14], [15], [16], [17]].

There is abundant evidence supporting both the DPP and Look AHEAD interventions [5,[18], [19], [20]]. Nevertheless, adoption in clinical practice has been slow. This may be in part due to the complexity of the interventions and possibly due to a concern that outcomes achieved in highly screened clinical trial participants may not be replicable in less motivated participants or using less intensive interventions. The challenge of translational research is to ensure that interventions adapted for clinical practice are practical, effective, and easily delivered. In the case of the DPP, Medicare approved coverage of DPP lifestyle intervention programs [21] only after successful translation was demonstrated [22,23]. Look AHEAD is similar to the DPP in that it is a complex behavioral lifestyle intervention, but it has the added challenge of diabetes medication adjustment as participants alter diet and activity levels. The high intensity intervention used in Look AHEAD has had only limited adaptation for delivery and testing in practice-based settings [24].

The aim of the REAL HEALTH-Diabetes (Reach Ahead for Lifestyle and Health- Diabetes) Study is to implement and test the effectiveness of an adapted Look AHEAD lifestyle intervention in real-world settings, including community health centers. Secondary aims include determining the reach, cost-effectiveness, and sustainability of the program. Two lifestyle intervention formats, in-person group lifestyle intervention or telephone group lifestyle intervention, are being compared in a patient-level randomized controlled trial to referral to a dietitian for individual medical nutrition therapy (MNT), the currently recommended standard of care. REAL HEALTH-Diabetes is a practice-based translational research effort meant to bridge the gap between what has been found to be effective in clinical trials and what is feasible in clinical settings. This paper describes the study design, interventions, enrolled population, and implementation challenges and solutions associated with the launch of the project.