Design, recruitment and start up of a primary care weight loss trial targeting African American and Hispanic adults

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Abstract

Primary care offices are critical access points for obesity treatment, but evidence for approaches that can be implemented within these settings is limited. The Think Health! (¡Vive Saludable!) Study was designed to assess the feasibility and effectiveness of a behavioral weight loss program, adapted from the Diabetes Prevention Program, for implementation in routine primary care. Recruitment of clinical sites targeted primary care practices serving African American and Hispanic adults. The randomized design compares (a) a moderate-intensity treatment consisting of primary care provider counseling plus additional counseling by an auxiliary staff member (i.e., lifestyle coach), with (b) a low-intensity, control treatment involving primary care provider counseling only. Treatment and follow up duration are 1 to 2 years. The primary outcome is weight change from baseline at 1 and 2 years post-randomization. Between November 2006 and January 2008, 14 primary care providers (13 physicians; 1 physician assistant) were recruited at five clinical sites. Patients were recruited between October 2007 and November 2008. A total of 412 patients were pre-screened, of whom 284 (68.9%) had baseline assessments and 261 were randomized, with the following characteristics: 65% African American; 16% Hispanic American; 84% female; mean (SD) age of 47.2 (11.7) years; mean (SD) BMI of 37.2(6.4) kg/m2; 43.7% with high blood pressure; and 18.4% with diabetes. This study will provide insights into the potential utility of moderate-intensity lifestyle counseling delivered by motivated primary care clinicians and their staff. The study will have particular relevance to African Americans and women.

Introduction

About one-third of U.S. adults are obese (body mass index [BMI] of 30 kg/m2 or above), and another third are overweight (BMI between 25 and 30 kg/m2) [1]. Obesity is clearly linked to the increased occurrence of type 2 diabetes, cardiovascular and pulmonary diseases, certain cancers, and musculoskeletal conditions [2]. Even modest weight loss may help to delay the onset or improve the management of these conditions. Given that obesity requires continuing care, there is a critical need to identify effective, sustainable treatment approaches that are available to affected adults, particularly those with obesity related co-morbidities. An expert panel has recommended that obesity treatment be offered routinely in primary care, directly or by referral [3]. However, evidence for weight loss treatment approaches that can be effectively implemented within primary care offices is lacking. Approaches that are efficacious in specialized research settings are generally not transferable. This is because the higher program intensity and delivery by expert staff, which are common elements of such treatment, are not replicable or feasible in the typical primary care office. Studies are needed to determine how typical practices might offer obesity treatment, as well as justify insurance coverage of such care [4], [5].

Studies of how to provide effective obesity treatment for African American and Hispanic primary care populations are especially lacking [3], [4] and are critically needed. African American and Hispanic adults, particularly women, have higher obesity prevalence than non-Hispanic whites [1], and this contributes to higher prevalence of obesity-related co-morbid conditions [6], [7]. For example, national data for 2007–2008 indicate that 50% of black women and 43% of Hispanic women have a BMI ≥ 30 kg/m2, compared to 33% of white women [1]. The numbers of primary care office visits for African American and Hispanic adults are substantial, in spite of relatively lower rates of health insurance coverage [8], [9].

Recent multi-center efficacy trials of lifestyle modification for obesity have reported clinically significant weight loss results for African American and Hispanic adults [10], [11], [12], presenting an excellent opportunity for translation to practical use. The Think Health! Study addresses this opportunity. Think Health! assesses the feasibility and effectiveness of a behavioral weight loss program by adapting the Diabetes Prevention Program [12], [13] intervention for implementation in routine primary care, with a particular focus on practices reaching African American or Hispanic adults. This article reports the study design, recruitment and preparation of primary care practices, training of primary care providers and auxiliary staff to deliver the program, patient recruitment, and clinical site and patient baseline characteristics. Start-up and recruitment were completed in November 2008.

Section snippets

Aim and hypothesis

The study assesses the feasibility and effectiveness of a moderate-intensity weight loss program compared with a lower intensity version of the same program, implemented in primary care practices over 1 to 2 years. A moderate-intensity intervention is defined as providing approximately monthly treatment contacts [3]. Primary care providers (PCPs) (usually physicians) and auxiliary staff trained to act as lifestyle coaches counsel patients in their own practices. The design is a parallel group,

Participating practices and providers

Table 2 shows selected characteristics of the five practices, including numbers and gender of participating providers. There was a mix of small, medium, and large practices based on number of clinicians, total staff size, or estimated patient volume, with length of operation varying from 4 to 43 years. Across all sites approximately half (14 of 27) of eligible clinicians participated in the study; both eligible clinicians participated at 1 site. Participating clinicians were evenly divided by

Discussion

The hybrid design of the Think Health! Study combines objectives that prioritize internal validity (as in efficacy studies) with those that explore feasibility and give more priority to external validity and potential sustainability (as in effectiveness studies) [36], [37]. This type of trial is a useful precursor to a practical trial that would require full adoption and institutionalization within primary care settings. Clinical site recruitment focused on community-based practices, most of

Acknowledgments

This project is funded, in part, under a grant with the Pennsylvania Department of Health. The Department specifically disclaims responsibility for any analyses, interpretations or conclusions. Partial support was also provided by P60 MD000209 from the National Center for Minority Health and Health Disparities (NCMHD), National Institutes of Health (NIH). Participation of Drs. Tsai and Allison was supported, in part, by K12-HD043459 from the NIH National Institute of Child Health and Human

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      A systematic review of the literature reveals that high-intensity behavioral counseling, which consists of two or more individual or group sessions per month for at least the first 3 months, has greater clinical effectiveness than the 3–6 month interval of traditional counseling in managing obesity (Tsai & Wadden, 2009). Study findings related to specific weight reduction and diet/exercise programs implemented successfully by healthcare providers within primary care office visits are limited in the current literature (Kumanyika et al., 2011; Tsai & Wadden, 2009). The limited findings within natural primary care settings may be due to logistical and feasibility concerns (Kumanyika et al., 2011).

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    1

    Present address: Community Health Collaborative, 2130 N. Palethorpe St., Philadelphia, PA, USA 19122.

    2

    Present address: Polaris Health Directions, Inc.; 444 Oxford Valley Rd., Suite 300; Langhorne, PA, USA, 19047.

    3

    Present address: Division of General Internal Medicine, University of Pennsylvania School of Medicine, Blockley Hall, Philadelphia, PA, USA, 19104.

    4

    Present address: Division of General Internal Medicine & Center for Human Nutrition, University of Colorado Denver, Campus Box C263, North Pavilion, Room 317 Denver, Colorado, USA, 80220.

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