BACKGROUND

Obesity has reached epidemic proportions in American adults and youth and accounts for nearly 10 % of all annual medical spending [1, 2]. By 2030, between 35 and 51 % of the population will be obese [3, 4]. Young adults (18–35 years) are at higher risk for weight gain than older adults. According to a recent National Health and Examination Survey (NHANES) for US adults ages 25–74, major weight gain over 10 years (a gain in body mass index (BMI) ≥ 5 kg/m2) was highest at ages 25–34 [5]. Between 2004 and 2010, the prevalence of overweight and obesity rates for men ages 20–39 increased from 62.2 to 67.1 % and the prevalence for women in the same age range increased from 51.7 to 55.8 % [6]. The Coronary Artery Risk Development in Young Adults (CARDIA) study, sponsored by the National Heart, Lung, and Blood Institute (NHLBI), showed peak aging-related weight gain over 10 years was highest in the early to mid-twenties [7].

After many years of declining coronary heart disease (CHD) mortality rates, recent national age-specific data suggest a possible increase in the CHD death among young adults. While CHD and its risk factors have been rare at age 20, these new data suggest that these conditions may be increasing, and recent successes in reducing CHD mortality may be reversed in future years [8, 9]. Data from the CARDIA Study suggest that excess weight gain in early adulthood adversely impacts development of multiple CHD risk factors, such as hypertension, dyslipidemia, and diabetes. Mean CHD risk factor levels remained relatively unchanged in adults, initially aged 18–30, who maintained a stable weight over 15 years even if already overweight at baseline, whereas risk factor levels steadily increased in weight gainers [10]. These data suggest that if further weight gain is avoided early in adulthood, risk factor progression may be reduced or prevented and more adults will enter middle age at lower CHD risk. Lower CHD risk status in middle age is linked to lower CHD morbidity and mortality, lower health care costs, increased life expectancy, and higher quality of later life [11].

The prevalence of overweight and obesity in young adults and findings from the CARDIA Study, led the NHLBI to initiate clinical trials of behavioral weight control interventions targeting young adults using a consortium approach. The trials were charged with conducting clinical research studies to, “… develop, refine, and test innovative behavioral and/or environmental approaches for weight control in young adults at high risk for weight gain.” [12]. The consortium approach involves funding multiple studies in a specific research area, each of which conducts a unique intervention, shares a common primary outcome and agrees on a set of common elements and measurement protocol. Testing several approaches simultaneously has the potential to advance knowledge regarding what works and how to engage this high-risk age group in achieving and maintaining a healthy weight more rapidly than independent trials. This approach also facilitates making cross-study and intervention strategy comparisons [13].

In 2009, seven institutions were awarded funds to participate in this research with the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) joining NHLBI to help fund the trials. The investigators and staff from NHLBI and NICHD formed the Early Adult Reduction of weight through LifestYle intervention (EARLY) Trials (www.earlytrials.org). The purpose of this paper is to describe the EARLY trials, including the studies involved, EARLY’s organization, and the development of common elements that are intended to provide cross-study insights into weight control strategies for young adults.

METHODS

Common elements across the trials

The trials include a set of parameters to be consistent across all studies. The interventions are to be 24 months in duration, focusing on weight control defined as weight loss, prevention of weight gain, or prevention of excessive weight gain during pregnancy. The interventions all incorporate media and technologies commonly used by this age group, such as the Internet, chat rooms, iPods, or cell phones, in order to facilitate recruitment and retention and to appeal to young adults. In addition, interventions are designed to be practical, cost-effective, sustainable, and easily disseminated on a broad scale. Change in weight or BMI are the primary outcome. A set of common data elements was agreed upon and included specific protocols for assessing height, weight, waist circumference and blood pressure and the collection and storing of blood samples as well as a common set of questions to describe behavioral, psychosocial, demographic, and clinical factors. The process for identifying the common elements and the final set of common elements are described in a following section. A set of common inclusion and exclusion criteria for participants was also established for the trials (Table 1).

Table 1 EARLY common inclusion and exclusion criteria
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Overview of the research partners

Table 2 identifies the institution and principal investigator, and describes study characteristics. All studies received approval from their institution’s human subjects and internal review boards and are monitored by Data and Safety Monitoring Boards (DSMB). A brief description of each study follows.

Table 2 Description of individual studies in the EARLY trials
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(CHOICES) (Minneapolis-St. Paul, MN)

The goal of the Choosing Healthy Options In College Environment Settings (CHOICES) study is to develop and test innovative strategies to help prevent unhealthy weight gain in students attending 2-year community or technical colleges (www.choicesstudy.org). The CHOICES sample is made up of 441 students randomized to an intervention or control condition. The CHOICES intervention is based on social ecological and social networks models [14]. Students randomized into the intervention condition participate in a one-credit course offered through their 2-year college that focuses on eating, activity, sleep, and stress management as ways to help maintain or achieve a healthy weight. Three course sections (online, face-to-face, and a hybrid course option) are offered to accommodate students’ scheduling needs and learning preferences. A study-designed website component is introduced as part of this course and continues for 20 months following the one-credit course. The goal of the CHOICES website is to reinforce behaviors related to healthy weight maintenance and to encourage exchange and support among all intervention participants. Students track their weight and weight-related behaviors on the website, and intervention staff interact with participants electronically or through phone calls offering encouragement and helping with problem solving. Control students receive their health assessments, existing public health information on maintaining a healthy weight, and information on health services offered on their school’s campus. Change in BMI over 2 years is the primary outcome for this study and secondary outcomes examine the impact of the intervention on behavioral and psychosocial outcomes and on the formation of social networks.

CITY (Durham, NC)

The Cellphone InTervention for You (CITY) study is a randomized control trial (RCT) in which a diverse population of 365 overweight/obese, generally healthy adults are randomly assigned to one of three groups: (1) a behavioral weight loss intervention delivered almost entirely via an interactive “smart” phone application designed by the investigators; (2) a behavioral weight loss intervention delivered via group and individual personal coaching, using cell phones for self-monitoring of weight, dietary intake, and physical activity; or (3) a usual care, advice-only control group. CITY is testing the hypothesis that each active intervention will lead to more weight loss than occurs in the control group. A secondary analysis will compare weight loss in the cell phone intervention to weight loss in the personal contact intervention. Other outcomes to be compared among the three treatment groups include health behaviors (diet and physical activity), obesity-associated risk factors (e.g., blood pressure, insulin resistance), psychosocial variables (e.g., body image), and costs of implementation. Subgroup analyses will determine treatment effects in race, sex, and age subgroups. Other secondary analyses will attempt to identify predictors of successful weight loss in this study population.

E-MomsRoc (Rochester, NY)

The goal of E-MomsRoc is to decrease the prevalence of excessive pregnancy weight gain and excessive weight retention in the first 18 months postpartum in a socioeconomically and racially/ethnically diverse sample of women who are normal weight (BMI 18.5–24.9), overweight (BMI 25–29.9), and obese class 1 (BMI 30–34.9) in early pregnancy (below 14 weeks gestation) using electronically mediated patient intervention programs. The sample of 1,691 women are randomized in the first 20 weeks of pregnancy to one of three groups: (1) receipt of an electronically mediated intervention program only during pregnancy; (2) receipt of an electronically mediated intervention both during pregnancy and for 18 months postpartum; and (3) a control condition in which women receive non-weight-related health information and resources at the project website and through their cell phones. A project website and cell phones are the electronic media that are used for communicating with the women. Analyses will examine if intervention during pregnancy prevents excess weight gain and, additionally, whether intervention during pregnancy and postpartum has a greater effect on overall weight retention than intervention during pregnancy only. Subgroup analyses will examine treatment effects in income and weight subgroups.

IDEA (Pittsburgh, PA)

The primary aim of the Innovative Approaches to Diet, Exercise, and Activity (IDEA) study is to examine whether an enhanced weight loss intervention (EWLI) that includes advanced technology components results in improved weight loss in young adults compared to a standard behavioral weight control program (SBWP) over a period of 24 months. The sample includes 471 overweight and obese young adults. All participants are engaged in a 24-month behavioral weight loss program that includes weekly intervention meetings for the initial 6 months with monthly sessions from months 7–24, and brief monthly intervention-based telephone calls from months 7–24 with a goal to reduce energy intake and increase moderate-to-vigorous intensity exercise. During months 1–6, weekly sessions are conducted in a group format by trained staff. Each session incorporates feedback and problem solving, includes a formal lesson on weight loss, nutrition, physical activity, or behavior change and allows for group interaction. Each session lasts between 30 and 60 min and precedes a weekly weigh-in performed by staff. In addition, participants are randomized to receive one of two additional treatments (SBWP or EWLI). Participants randomized to SBWP also receive modest technology enhancements from months 7–24 that include periodic targeted text messages and access to a study website where the participant can self-monitor diet and activity behaviors. Participants randomized to EWLI also receive text messaging from months 7–24, intervention materials posted to a website from months 7–24, and the BodyMedia Fit System® that includes a wearable monitor and display to provide real-time feedback on energy expenditure, physical activity goals, dietary intake. While the primary outcome is change in body weight, secondary outcomes include examining the interventions’ effect on BMI, body composition, fitness, and behavioral/psychosocial measures that may be predictive of obesity risk.

SMART (San Diego, CA)

Social/Mobile Approach to Reduce weighT (SMART) is a theory-based intervention that utilizes web, cell phone and social media to provide an engaging weight loss program for young adults. Participants are 404 college and university students with BMI between 25 and 34.9 kg/m2 from three institutions in San Diego County. Participants are randomized to the SMART intervention or the comparison arm. SMART is comprised of the following components: (1) a brief (30 min) health educator session at program onset; (2) over the course of 24 months, up to 10 (as needed) brief (5–10 min) phone contacts with the health educator via phone, email, Skype, or instant messaging chats; (3) study-specific smartphone apps (accessible on either Android or iPhone) and interactive text messages that support improved weight-related behaviors; (4) study-specific Facebook campaigns and games supporting improved weight behaviors; and (5) access to the SMART intervention website for updated study-related content and news. For the full 24 months of the study, participants are asked to visit the intervention website on a weekly basis and interact with intervention content via text messages and through Facebook applications several times per week. They are encouraged to engage their social network via Facebook, sharing specific SMART related apps with their friends. Control participants are assigned to a website with general health information for college students. Change in weight is the primary outcome with additional analyses examining influences of SMART intervention components and social network characteristics on weight-related behaviors and other aspects of health important for young adults.

SNAP (Providence, Rhode Island and Raleigh/Durham NC)

The purpose of Study of Novel Approaches to Weight Gain Prevention (SNAP) is to test two interventions to prevent weight gain in young adults. The project involves two clinical centers (The Miriam Hospital/Alpert Medical School of Brown University and the University of North Carolina at Chapel Hill) and a Data Coordinating Center (Wake Forest University School of Medicine). The interventions are based on a self-regulation approach that has been shown to help prevent weight regain in recent weight losers [15]. Key aspects of this approach include daily self-weighing, use of the information from a scale to know when adjustments in eating and activity are needed, behavioral skills to modify these behaviors, and small reinforcements for successful prevention of weight gain. One self-regulation intervention is focused on making small consistent changes in eating and exercise behavior to prevent weight gain; the other emphasizes periodic larger changes in eating and exercise behavior that result in small weight losses. These interventions will be compared to each other and to a control condition in a three-armed RCT. The study involves 600 adults (300 at each clinical site), with a BMI of 23–30, who are randomly assigned to (1) control; (2) self-regulation intervention with small behavior changes or (3) self-regulation with large behavior changes. Both interventions include ten face-to-face group meetings delivered during the initial 4 months; subsequently participants use the Internet, email or cell phones to submit their weight at least monthly and are sent monthly feedback on their weight via email. Both groups are offered periodic refresher classes and assistance (via email, phone or in person) if weight gain is observed. Participants will be followed from randomization until the end of the grant, resulting in 24–48 months of follow-up (mean = 3 years). The primary hypothesis is that the magnitude of weight gain across an average planned follow-up of 3 years will differ among the three groups; the a priori hypothesis is that weight gain will be greatest in control, intermediate in small changes, and least in the large change condition. The trial will also examine the association among changes in behaviors, weight, and cardiovascular disease risk factors and examine potential moderators and mediators.

TARGIT (Memphis, Tennessee)

The purpose of the Treating Adults at Risk for weight Gain with Interactive Technology (TARGIT) study is to develop and test a behavioral weight loss/weight gain prevention intervention delivered through interactive technology. This intervention will be used in conjunction with an efficacious tobacco quit line in young adult smokers to determine if it can prevent weight gain associated with smoking cessation. TARGIT’s primary hypothesis is that the behavioral intervention using interactive technology will significantly attenuate or prevent weight gain associated with smoking cessation at 2 years after enrollment compared to a tobacco quit line in young adult smokers. The TARGIT study also plans to test whether the behavioral intervention using interactive technology combined with a tobacco quit line compared to a tobacco quit line alone results in increased biochemically verified smoking cessation, increased healthy eating, and increased physical activity as secondary outcomes. A total of 330 participants are randomly assigned to the intervention group or the comparison group in a 1:1 ratio and followed for 24 months to assess outcomes. TARGIT offers a variety of interactive technologies including phone calls (quit line), TARGIT study website (www.targitstudy.org), and iPod Touch with a smoking cessation application (app) for both groups and weight loss-related apps for the intervention group.

EARLY trials organizational structure and subcommittees

In addition to the seven trials, one institution (University of Pittsburgh, Steven Belle, PI) was also selected to serve as the Resource and Coordination Unit (RCU). The RCU is responsible for facilitating cross-study activities, such as coordinating meetings and committee work, supporting the identification of common elements (e.g., eligibility criteria and measures) across studies, and serving as a data repository for measures common to all the trials. The EARLY trials are governed by a Steering Committee (SC) comprised of each study’s Principal Investigator (PI), the RCU PI, and NHLBI and NICHD scientists. An Executive Committee, made up of the elected SC Chair and Vice Chair, RCU PI and two NHLBI project scientists, facilitates direction and coordination of the trials. The EARLY trials have three NIH-appointed DSMB that advise the NHLBI on the execution and safety of the trial. DSMB members, with specific expertise relevant to the EARLY trials, are external to the trial. Additional EARLY trials subcommittees include: Design and Analysis (D&A), Safety, Recruitment and Retention (R&R) and Intervention. These subcommittees include investigators from each of the studies as well as NIH program office scientists (Table 3).

Table 3 EARLY subcommittees
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Common elements

Although each of the EARLY studies will publish it own results, the EARLY investigators also plan to engage in cross-study analyses based on a pooled database. Hypothesis testing for primary study aims can only occur in the context of single studies; however, the pooled data can address additional questions of interest with a larger sample. In order to maximize comparability and facilitate cross-study analysis, the SC agreed to measure elements that would be common across studies.

In the first year, working groups were created to establish measures and protocols that would be common across all seven trials. The EARLY working groups included: Physical Measures, Diet Assessment, Physical Activity, and Survey. The working groups’ activities occurred prior to baseline data collection and representation from each study was encouraged on each working group. The chairs of the working groups convened conference calls that reviewed each study’s measurement and evaluation plans put forth in their individual grant application. Similarities and differences in plans were examined and a list of potential common elements was proposed to the SC. The SC amended and approved the list of common elements based on the potential cost, feasibility and impact of adoption.

The EARLY SC made all final decisions on the common elements to be collected by all EARLY studies and on the measurement protocols to be used. In addition, the EARLY SC specified that data collection visits would occur, at a minimum, at baseline, 12, and 24 months; some studies included additional interim data collection visits depending on study design. For E-MomsRoc, the data collection time points are: baseline (enrollment to 28 weeks gestation), 32 weeks gestation to delivery, delivery and 6 weeks postpartum and 6, 12, and 18 months postpartum. Table 4 outlines the common elements related to measurement agreed upon for the EARLY trials, the number of questions included for assessing each construct on survey instruments, and the source of the assessment methodology.

Table 4 Common elements: demographic information, physical and dietary measures and constructs and sources
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DISCUSSION

The EARLY trials are testing seven unique 2-year behavioral interventions in young adults that address weight loss, prevention of weight gain or prevention of excessive weight gain during pregnancy. The trials target a variety of racially- and ethnically diverse populations, including pregnant and postpartum women, community college or university students, and young adults trying to quit smoking. Most of the interventions are technology-driven using novel methods to appeal to young adults. The EARLY trials are some of the first to evaluate the effectiveness and efficacy of a variety of technology-based approaches to reach and engage young adults and to have an impact on health-related outcomes such as obesity treatment and prevention.

The EARLY trials are an example of a research consortium funded by NHLBI. Another example of this type of trial is the POWER trials that included three centers independently evaluating the effectiveness of weight loss interventions in primary care settings. Each of the POWER studies conducted unique interventions but agreed on a common primary outcome and a set of common measures, inclusion and exclusion criteria and a common analysis plan for the primary outcome. Yeh et al.13 identify three advantages to this type of model that includes: (1) the ability to test several interventions simultaneously; (2) the ability to draw on expertise from the larger group of investigators representing each site; and (3) the potential to learn more because of the ability to conduct pooled analyses and to make comparisons across studies.

Another benefit of this approach is the shared expertise of investigators from across the studies. Collaborative trials such as POWER and EARLY are examples of team science in action [16]. In a team science approach researchers who traditionally would work independently come together to form collaborative centers or groups. The advantage of team science is to create opportunities for innovations and advancement that are not possible when investigators work independently. Working as a transdisciplinary team allows researchers to draw on techniques, approaches and perspectives unavailable in any single discipline, providing great potential to impact the most complex health issues that we face.

In EARLY, this team science approach encouraging shared expertise was helpful as we chose the common elements and the most rigorous protocol to use. This approach also facilitates continued problem solving involving a wide range of issues that the individual trials faced including issues related to recruitment, retention and sustaining engagement in the intervention. The pooled sample size of more than 4,200 young adults represented in the EARLY trials greatly increases the generalizability of what we learn and yields greater statistical power. In addition, the EARLY investigators plan to use a process described by Belle et al. [17] that will allow us to compare the efficacy of a wide variety of intervention strategies, by pooling data from each study and using a taxonomy to integrate results across the diverse interventions. For this process, we are using the weight management strategies described by Michie et al. [18, 19] to provide structure for combining diverse interventions.

Yeh et al. [13] also describe challenges faced by the POWER trials in conducting independent but coordinated trials that have been shared by EARLY. Those challenges include: (1) allocating resources for the increased time required and complexity involved in the decision-making process; (2) designing and agreeing on strategies that maximize the potential for pooling data; and (3) monitoring the trial. For the EARLY trials, a great deal of work went into identifying and agreeing upon the set of common elements. Having adequate time in the trial to make these difficult decisions was imperative; studies generally underestimated the resources required for fully participating in coordinating across the studies. Creating the system for pooling data has also been challenging and relies largely on the EARLY’s RCU to create the protocol and process for receiving data from each study. Unlike a multicenter trial with a single coordinating center that provides statistical and data management support, this model requires collaboration and consensus among statisticians and data managers across all studies. In addition, data managers in each study must have the time and expertise to provide the RCU with common data and, at the same time, manage the data that are unique to the study-specific research questions.

Several additional challenges have been encountered with the EARLY trials. One issue has been to make the trials as comparable as possible without overburdening the individual studies and their participants. Coordinating timelines has also been difficult. Individual studies have their own timelines for pilot work, recruitment, measurement and intervention activities that often differ from other studies. Analyzing common elements across studies for any one measurement period requires all studies to wait until the last study has finished data collection and cleaning. A final challenge has been respecting the unique research aims of each study. While all of the EARLY trials focus on weight control in young adults, approaches and samples differ and direct comparisons across studies are not possible. Nevertheless, the EARLY trials will provide the opportunity to test hypotheses from individual trials and to combine results and data to provide a cross-cutting perspective of behavioral weight control approaches that work well for young adults.

CONCLUSION AND IMPLICATIONS

The article describes the development, organization and implementation of the EARLY research consortium that includes seven independent but coordinated research trials funded to evaluate innovative strategies to help young adults achieve and maintain a healthy weight. This type of research consortium represents a useful approach in research areas at an earlier stage of development in which the state-of-the-science has not yet identified a single approach ready to be evaluated through a large single protocol, multicenter trial. By funding multiple independent trials with a common primary outcome that test a variety of potential behavioral interventions using common protocol and measurement tools for at least a subset of measures, the ability to pool data and to make comparisons in efficacy in intervention strategies is greatly increased. If this model is successful in expanding what we can learn from single, smaller intervention studies, this may have implications for the future design of larger behavioral intervention trials that impact research design, clinical practice, and national policy.