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TBM

Overview of the obesity intervention taxonomy and pooled

analysis working group

Steven H. Belle, PhD, MScHyg,

1

June Stevens, MS, PhD,

2

David Cella, PhD,

3

Jennifer L. Foltz, MD, MPH,

4,5

Catherine M. Loria, PhD, MS, MA,

6

David M. Murray, PhD,

7

Susan M. Czajkowski, PhD,

6

S. Sonia Arteaga, PhD,

6

Elizabeth Thom, PhD,

8

Charlotte A. Pratt, PhD

6

Abstract

The National Heart, Lung, and Blood Institute and the National Institutes of Health Office of Disease Prevention convened a meeting on August 29-30, 2013 entitled

BObesity Intervention Taxonomy and Pooled Analysis.^ The overarching goals of the meeting were to understand how to decompose interventions targeting behavior change, and in particular, those that focus on obesity and to combine data from groups of related intervention studies to supplement what can be learned from the individual studies. This paper summarizes the workshop recommendations and provides an overview of the two other papers that originated from the workshop and that address decomposition of behavioral change

interventions and pooling of data across diverse studies within a consortium.

Keywords

Intervention science, Taxonomy, Pooled analysis

INTRODUCTION

The National Institutes of Health (NIH) and the Cen-ters for Disease Control and Prevention (CDC) have each funded consortia of intervention studies. These consortia include multiple studies, each testing distinct interventions but having a common topic or goal. Examples in the arena of obesity research include the Practice-Based Opportunities for WEight Reduc-tion (POWER) Trials [1], the Early Adult Reduction of weight through LifestYle intervention (EARLY) Trials [2], the Childhood Obesity Prevention and Treatment Research (COPTR) consortium [3], the Lifestyle Interventions for Expectant Moms (LIFE-Moms), the Obesity Related Behavioral Intervention Trials (ORBIT) [4], and the Childhood Obesity Re-search Demonstration (CORD) projects [5]. Previous-ly funded multiple study consortia targeted smoking and other behaviors [6, 7] or caregiver burden [8]. These studies are typically funded via the Cooperative Agreement mechanism and include as a goal performing cross-study analyses in an effort to learn more about intervention effects than is possible from individual studies. For example, combining informa-tion across studies would increase sample sizes such

that it may be possible to gain information on sub-groups that are too small in individual studies to ob-tain meaningful results or to examine effects on less common outcomes than are scientifically justified within individual studies due to limited numbers of outcomes. However, inasmuch as these consortia are constructed such that interventions, target popula-tions, and methods differ by site within a consortium, the use of typical methods for combining information across studies (see, for example, Bangdiwala et al. in this issue) needs to be critically examined or, poten-tially, other methods need to be applied. With these methods, attention needs to be paid to homogeneity among the studies to be combined with respect to, e.g., eligibility criteria, data collection, and the partic-ular interventions tested within each study. For the EARLY Trials [2], COPTR [3], CORD [9,10], LIFE-Moms, POWER [1], and REACH [8], substantial effort was put into agreeing upon several protocol issues including common eligibility criteria, measures, and data collection timepoints prior to intervention start with the goal to enhance homogeneity to facilitate cross-study analyses.

Furthermore, by combining information across studies, it may be possible to understand what specific components of a wide variety of complex behavioral interventions lead to favorable outcomes, with the goal to optimize such interventions. One approach

1Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA, USA

2University of North Carolina, Chapel Hill, Chapel Hill, NC, USA 3Feinberg School of Medicine, Northwestern University, Chicago, IL, USA

4Centers for Disease Control and Prevention, Atlanta, GA, USA 5United States Public Health Service, Washington, DC, USA

6

National Heart, Lung, and Blood Institute,

National Institutes of Health, Bethesda, MD, USA 7

Eunice Kennedy Shriver National Institute of Child Health and Human Development,

National Institutes of Health, Rockville, MD, USA

8George Washington University, Washington, DC, USA

Correspondence to: S Belle belle@edc.pitt.edu

Cite this as:TBM2016;6:244–259

doi: 10.1007/s13142-015-0365-5

Implications

Researchers: Use the behavioral change techni-ques (taxonomy approach) that decompose each intervention component and determine interven-tion dose when combining informainterven-tion from stud-ies that employ similar interventions.

Practitioners: Use information from multiple studies rather than individual studies to provide better information regarding behavior change.

Policymakers:Take advantage of information that comes from several studies for data-driven policy decisions.

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has been demonstrated in the past [11,12], and the manuscript by Tate et al. in this issue describes an alternative approach to decomposing interventions in an effort to ascertain whether particular aspects of multi-component interventions that are associated with outcome can be identified. Unlike those methods for which interventions should be similar for combin-ing to be meancombin-ingful, this method accounts for hetero-geneity such that bothBactive^ andBcontrol^ inter-ventions are decomposed.

The context for this meeting, then, was the existence of NIH- and CDC-funded consortia comprised of sev-eral intervention studies with some common features but with different interventions, populations, and hy-potheses under investigation. The meeting, which in-cluded investigators from EARLY, COPTR, ORBIT, LIFE-Moms, and CORD, addressed several research questions including the following:

1. Can a taxonomy be developed across diverse inter-ventions to facilitate analysis of common measures and enable better understanding of how complex multi-component intervention content relates to effectiveness?

2. What analytical approaches can be used and how can data be combined across different interven-tions, populainterven-tions, and settings?

3. Can data be compared for obesity prevention and treatment studies?

4. What are the best methods for testing differences in subgroup responses to interventions?

The consortia represented at the meeting, briefly described below, are comprised of intervention studies with some commonalities, for example, a common theme is that all are complex, behavioral interventions targeting weight (see Tables1,2,3,4, and5).

Early Adult Reduction of weight through LifestYle intervention (EARLY) Trials

This program consists of seven studies that have 17 interventions across the studies, and a Research Coordinating Unit (RCU). The studies are individ-ually funded within a cooperative agreement which includes the NIH. All of the studies are two-phase clinical research studies to refine and test innova-tive behavioral approaches for weight control in young adults 18–35 years of age at high risk for weight gain. There is also a Resource Coordination Unit to facilitate cross-study activities including logistical and analytical activities. During the first phase of the studies, formative research was con-ducted to refine the proposed intervention, recruit-ment, retention, and adherence strategies targeted to young adults. The second phase of each study consisted of a randomized controlled trial to test the efficacy of the interventions. These interven-tions address weight loss, prevention of weight gain, or prevention of excessive weight gain during pregnancy. Specific target populations include

pregnant and postpartum women, community col-lege or university students, and young adults trying to quit smoking. Most of the interventions are technology-driven using novel methods such as mobile phones, social networks, and web-based curricula. EARLY studies are funded by the Na-tional Heart, Lung and Blood Institute (NHLBI) and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

Childhood Obesity Prevention and Treatment Research Consortium

The purpose of this program is to create and test intervention approaches to prevent excess weight gain in non-overweight and overweight youth and to reduce weight in obese youth. Two obesity prevention trials (University of Minnesota and Vanderbilt University), which target preschoolers (2–5 year olds), are developing and testing approaches that target home, community, and pri-mary care settings for preschool children living in low-income and ethnically diverse neighborhoods. Two obesity treatment trials (Stanford University and Case Western Reserve), which target pre-adolescents or pre-adolescents, are examining novel intervention modalities in overweight and obese children 7–15 years old in school and home set-tings in collaboration with local youth organiza-tions or schools. A Coordinating Center at the University of North Carolina, Chapel Hill, coor-dinates the functions of the Consortium. The pri-mary outcome is children’s body mass index (BMI); secondary outcomes include waist circum-ference, body fat, diet, physical activity, psychoso-cial measures, and cost-effectiveness. COPTR studies are funded by the NHLBI, NICHD, and the NIH Office of Behavioral and Social Sciences Research (OBSSR)

Lifestyle Interventions for Expectant Moms

The LIFE-Moms Consortium is targeting appropri-ate gestational weight gain among overweight and obese women and is a collaboration of seven inde-pendent clinical trials, a Research Coordinating Unit, and the NIH. Each trial is testing a lifestyle intervention designed to control gestational weight gain in overweight or obese women. The primary outcome for the LIFE-Moms Consortium is gesta-tional weight gain above the 2009 Institute of Med-icine’s guidelines for overweight and obese preg-nant women. Secondary outcomes include mater-nal and neonatal infant anthropometric measures, physical activity, sleep, and complications of preg-nancy and delivery. In each trial, weight and met-abolic outcomes are being assessed in both moth-ers and offspring for a minimum of 12 months postpartum. LIFE-Moms is funded by several NIH Institutes and Centers, including the National Institute of Diabetes and Digestive and Kidney

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Int e rve n tio n s: Brief Descriptions S tuden ts are ran do mi zed to in te rve n tio n or co n tro l. In te rve n tio n be gins wit h a 1-cre d it colle ge course focused on b ehaviors im po rt an t in w e ig ht co n tr ol . A w eb-ba sed so ci a l ne tw ork si te de si gn ed for thi s re sea rc h an d fo c u si n g o n weight a nd be havioral tr ac king an d go al se tti ng is intr odu ced duri ng the cl ass and continues for 2 4 m onths. T he c o nt ro l g rou p re c ei ve s s ta n d ar d pu bl ic he al th in fo rm a tio n o n m a in ta in in g a he al thy w eight.

Participants are randomiz

ed to one o f three condition s: 1) ce ll ph one ba sed in te rve n tion ; 2) personal co ach i ng pl us cel l pho nes for self mo nit o rin g ; 3) control grou p . The c ell ph o n e technology includes s e lf-monitoring weig ht, d iet an d p hy si ca l ac ti vi ty . Th e coachin g condition includes both gr oup a nd per s on a lized co ac hing. The c ontrol gr oup receives usual care. Pre g na nt wo me n a re randomized to o n e o f th ree

conditions: 1) inte

rven tion only during preg nancy; 2) inte rven tion during preg nancy and p ost partum; a nd 3) contr o l

group. Both inte

rven tion ar ms re ce iv e inte rven tion strategies through c ell phones and in te rn e t. Cont rol group receives non-we igh t related heal th information on a w eb site. P a rt ic ip a n ts a re ra n d o m iz e d to o n e of two conditions: 1) standard b eha vio ral we ig ht co ntro l p rogram (SBWP) and 2) a n enh a nc ed weight loss in te rve n tion (EW LI). Both groups receive a previously te sted b eha vio ral we ig ht loss tr eat ment involving face to fac e m e et in gs a n d supp or tiv e ph one ca ll s. Par t ic ipa n ts ra n do mi zed to the S B W P a ls o re ce iv e text messages a nd a cce ss to a w e b si te to tr ac k b eha vi o rs. Part icip ants in the EWLI receive text me ss ag es , a cc es s to th e w e b s ite a n d aw e a ra b lem o n it o r to assess energ y expenditure a nd ac ti vi ty . St udent s a re rando mize d to one o f two condition s: int e rven tion a nd con trol. Int ervention students rec e iv e th e o ry -based content o n physical a ct ivity, d ie t, cal o ries an d weight managem ent strategies through text m e s s a g ing, em ai ls , Face bo ok, web sites , and ap ps. Con tro l stu dent s rec eiv e ac cess to a study we bsite with general h eal th information. Pa rt ic ipant s are ra n dom ized to one o f three conditions: 1) large ch a nge in te rve n tion ; 2 ) sm a ll ch an ge in te rve n tion ; a n d 3) co ntro l. The g o a l o f La rge C h a n g e si st ol o s e 5 – 10 po und s to buffer a gainst the w eight g ain tha t o ft e n oc curs during young adul tho o d. Sm al l C han g es fo cu ss es on daily small changes in d iet and activity to reduce the ch ance o f w e ig h t gain. Both inte rven tion s b egin w it h 1 0 fa ce to face gro u p s fo llo we d b y a w e b, and mob ile interve n t io n through 3 yea r s. Pa rt ic ip an ts su bm it w e igh t and receive feed back via we b, sms a nd email. Refresher campa igns are delivered o nl ine. Th e co n tr ol gr ou p re ce iv e s usu a l care. Pa rticip ant s are rando mized to e ith er int e rven ti on or control . Those randomiz e d to the in te rv en ti on re ce iv e ac ce ss to a tob acc o quit line pl us a behav io ral ly fo cused w eight g a in pr eve n tion pr og ra m using i nteractive te ch no lo gies th a t inc lu d e ph one calls, iPod touch with smoking c essation apps and b ehavioral tracking, webinars a nd a st u d y w e b si te . Th e c o n tr ol c o n d it io n rece iv es acce ss to the to bacco quit li n e .

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Ta bl e 2 | Descr ipt ion of C hi ld hoo d Ob esit y Preventio n a nd Treat me nt Research (COP TR) st u die s NET-Works G ROW IMPACT G OALS In st it u tio n s , P Is G ra n t # s U n iv e rs it y o f M in n e so ta , S . French HealthP a rtners Institute for Educat ion & Research, N. She rw ood U01 H L 06 8890 Va nde rbilt U niv ers ity, S . B arkin U 01 HL 1 036 20 C a se West ern R eserv e Unive rsit y, E. Borawski, L. C utler, S. Moore U0 1 HL 1 0362 2 St anf o rd Un iv ersit y, T. Ro b inso n U0 1 H L 1 0362 9 P ri m a ry o utc o me BM I B MI BMI s lo p e BM I slo p e Ma jo r inc lus ion cr ite ria BM I ≥ 50th p ercentile 2 – 4y e a rs o ld No se rious m ed ic al pro bl e m s Sp eaks English o r S panish Fam ily inco me <$65 ,000 /year No plans to m ov e w ithin th e n ext 3 6 m on th s 50 th percentil e ≤ BM I <95th p ercentile 3 – 5y e a rs o ld No seriou s m edical problems Speaks En glis h o r S panis h Live in p redefined zip codes No pl ans to m o ve w ithin the n e xt 3 6 m on ths BMI ≥ 85 th percentile Rising 6th g raders (1 0 – 11 years o ld) No serious m edical problems Speaks Englis h o r S pani sh No plans to m o ve w it hin the n e xt 3 6 m onths BMI ≥ 85 th percentile 7 – 11 years o ld No me dica l prob le m s o r m ed ic at ions af fec ting g row th No me dica l, de vel o p m e n tal , or socia l con d itions limitin g parti cipation in intervent ion s o r a ssessmen ts Speaks and reads English o r S panish Live in p redefined low income neighb orho od s No plans to m o ve fro m S F Bay Area w it h in the n e xt 3 6 m on th s. Targ et po pulati o n

Description Sa

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Ta bl e 3 | D esc ript ion o f Li fe style Interv entio n s fo r Exp ect ant M om s (LIFE-M om s) studi es Healthy B egin nings LIFT P EARLS M O M FIT P R E GO Expecting Succe ss LIFE-Moms P hoenix Ins titutions, P Is Gr a n t # s Ca lifornia Polyte chni c In st itu te S ta te U n iv ersity and B row n Un ive rsit y Suza nne P he lan Ren a Wing U 01 H L11 4377 St . Luke ’ s — Ro osev el t Xa vi er Pi ‐ Sun yer Dympna G allagher U 0 1 D K0 944 63 Unive rsity of Puer to Rico Kaumudi Joshipu ra Pa ul Franks U0 1 H L072 834 Northwestern Unive rsity Linda Van H orn Ala n P e ac em an U0 1 H L114 344 Was h in g ton Universi ty in S t. Louis Sam K le in Debra H aire ‐ Joshu Kelle M oley U 01 D K0944 16 Pe nnington Bio m edic al Re sea rch C en ter Le anne Redman Co rby M a rti n U01 D K094 418 P h o e n ix In d ia n M e d ic a l Cen ter William Knowler H S SN27 6201 300 001C Pr im ar y out com e (2 years p o s t ra ndom ization) W e ig h t g a in p e r w e e k w it h in IO M g u id e li n e s Newbo rn p ercent bo dy fa t Weight gain per w eek wit h in IO M g uidel ine s Wei g ht gain Weight gain not exc e eding IOM guidelines Weight g a in per we ek exc e e d ing IOM g uidelines Weight gain Ma jo r in cl u sio n criteria ≥ 18 years Singleton, viable pregnancy BMI ≥ 25 kg/m 2 Ge statio na l a ge 9w e e k s 0d a y st o 15 weeks 6 days 18 – 40 yea rs Single ton, via b le pregnancy 25 kg /m 2 ≤ BM I ≤ 35 kg/m 2 Ge statio na l a ge 9 w eeks 0 days to 15 weeks 6 days ≥ 18 years Sin gle ton, viable pregnancy BMI ≥ 25 kg/m 2 Gestationa l a ge 9 w ee ks 0 days to 15 weeks 6 days 18 – 45 yea rs Singleton, viable pregnancy 25 k g /m 2 ≤ BM I <40 kg/m 2 Ge sta t io nal a ge 9w e e k s 0 d a y st o 15 weeks 6 days 18 – 45 ye a rs Si nglet o n, vi able pr e g nan cy 2 5 kg/m 2 ≤ BMI ≤ 45 kg/m 2 Ge stat iona l a ge 9w e e k s 0d a y st o 15 wee k s 6 da ys Af ri ca n-A m e ric an Socioe conom ically di sad vant a g e d 18 – 40 years Si n gl et on , vi ab le preg nancy 25 kg /m 2≤ BM I <40 kg/m 2 Gesta tional a ge 9w e e k s 0d a ys to 13 wee ks 5d a ys ≥ 18 years Singlet o n, viable pr e g nan cy BMI ≥ 2 5 kg/m 2 Ge s t a t io n a l a ge 9w e e k s 0d a y st o 1 5 we eks 6 d a ys Sampl e si ze 17 5/arm 10 5/arm 20 0/arm 15 0/arm 1 33/ arm 102/ arm 1 00/ arm Recruit m ent Site (s) Va ri o u s O B p ract ice s ser vicing m ajor delivery hospitals in S an Luis Obi spo and Wo m en and Inf a n ts H o spit al Vario u s O B p rac tices an d cl inic s who se pati e n ts del iver a t S t Luke ’ sR o o s e ve lt Unive rsity of Puer to Rico Ho sp ita l Pre n ti ce Am bu la tory Ca re and o the r practices w h o se pa tie n ts del iver a t Pr enti ce Wom e n ’ s Ho spita l Women ’ sH e a lt hC li n ic at Wa shingto n Uni ve rsit y Va ri ou s O B prac tic e s a nd clinics w hos e pa tie nts del iver at Wo me n ’ s Hospital Ba ton Ro u g e Women ’ sC li n ica tP IM C Int e rv en tio ns: Brief de sc ri p tio ns Antep a rtum Indiv idual c o unseling s e ssi on s; meal replacement p roduct pro v id ed; weight graphing with Antep a rtum In di vid u a l co unse ling sessi ons wi th spe cific cur riculum for d iet modification and phy sic al act ivit y, wit h Antepartum Individual and g ro up cou nselin g s e ssi on, pho ne cal ls reg ard ing im pr ovin g d iet a nd pr om oting reg ula r

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(10)

Ta bl e 5 | De scrip tio n of C hildh ood Obe sity R ese arch D emo n strati on (CORD) studies Ca lifornia C O R D [ 13 ] M assachus ett s CORD [ 14 ]T e xa s C O R D [ 15 ] Ins titutions, P Is Gran t # s S an Di e go S tate University an d the Ins titute for B eh avio ral a nd C om m unit y He al th M a s sac huse tt s D e p artm en t of P u b lic He al th Ha rva rd TH Chan School of Pu blic Hea lt h Mass achu set ts G eneral Ho spita l for C hild ren. M ic h a e la n d S u s a nD e llC e n te rf o r Healthy Livi n g a t U niver s ity of Te xa s, U T S ch o ol o f P u b lic He al th , U T He al th Clínicas de Salud d el Pu eblo, Inc., Th omas Land, P hD Children ’ s Nu triti o n Res e arch Cent er, B a ylor College o f M edicine Im pe rial C o unt y Publ ic Hea lt h Dep a rt me nt Elsie M . Tav era s, M D, MP H D e ll C hildre n ’ sH o sp it a l G uadal upe X . A ya la , P hD, M P H K irste n K . Dav iso n, P hD Te xas C hil d re n ’ sH o sp it a l Leticia Ib a rra , M P H Stev en Gor tm a ke r, PhD D e a nna H o e lsch er, P hD, R D A m y B ingge li-Val la rta , MP H , DrPH N a n cyB u tt e , P h D ,M P H ,R D U1 8 D P003 377 U1 8DP0 033 70 U1 8 D P003 367 Prim ary o u tc o m e s H eight, w e ight, B MI H e ig ht , w e ight, BM I H eight, w e ight, B MI Be hav ioral cha n ge s B eha vior a l ch a nges Be hav ioral cha n ge s -F ruit & vegetable consu m ption -Fruit & vegetabl e con sum p ti on -F ru it & vege tab le co nsu m p tio n -Swe et ene d bev e ra ge co nsu m ptio n -Sw ee te ned b e ve rage con sum p ti on -Swe et ene d bev e ra ge co nsu m ptio n -Wat er co nsum ptio n -Wa ter cons u mpti o n -Wat er co nsum ptio n -P hysi ca l a ctivity -Phy sical activity -P hysi ca l a ctivity -S cr e e n tim e -S cr e e n ti m e -S cr e e n tim e -S le ep tim e -Sl e e p ti m e -S le ep tim e Sa tis fa ction w ith he al thca re S a tisfacti o n wit h hea lthcare Sa tis fa ction w ith he al thca re Quality o f life Q uali ty of life Quality o f life Ma jo r in cl u sio n crit eria Chil d, aged 2 – 10 yea rs C hi ld , a g e d 2 – 12 ye ars P ri m a ry P rev en tio n : Pr escho o le rs, 2nd grad ers, an d 5 th grade rs Pa re nt abl e to re spond to int er view s a nd q u estio n na ires in English o r S p a nish. Parent able to resp ond to interviews an d q uest ionnai re s in E n g lish, Span ish, or Portu g uese . Lo w-i n co m e ; C H IP e li gibl e C hi ld h a s o b tai ned w el l-ch il d ca re fro m th e com munity he al th ce nte r for a t lea st the p revious 1 2 m on ths Secondary p revent ion: Childre n, a ged 2 – 12 years, BM I >85 th p ercentile Pa tien t of com mu n ity he al th ce n te r a n d p la n to remain a p atient for the n e xt two years Parents a ble a nd willing to b ring their child ren to the primary healthc a re clinic or YMCA s e ss ion s over the 12 m o nth s. Lo w -in co m e ; C H IP e lig ib le Sample si ze

(11)
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(13)

Disease (NIDDK), NHLBI, NICHD, the Office of Behavioral and Social Sciences Research (OBSSR), the Office of Research in Women’s Health (ORWH), and the National Center for Comple-mentary and Integrative Health (NCCIH).

Obesity Related Behavioral Intervention Trials

The goal of ORBIT is to translate findings from basic research on human behavior into more ef-fective clinical, community, and population inter-ventions to reduce obesity. Investigators are de-veloping innovative obesity-reducing strategies that show promise in small-scale early phase trials. Target populations include children and their fam-ilies, Latino and American adults, African-American adolescents, low-income populations, pregnant women, and women in the menopausal transition. The interventions being developed in-clude creative new approaches to promote aware-ness of specific eating behaviors, decrease respon-siveness to high-calorie foods, reduce stress-related eating, increase motivation to adhere to weight loss strategies, engage individual’s social networks and communities to encourage physical activity, improve sleep patterns, and change habit-ual dietary behaviors. A Resource and Coordina-tion Unit (RCU), located at Northwestern Univer-sity, facilitates collaboration across the studies. ORBIT is funded by NHLBI with co-funding from the National Cancer Institute (NCI), NIDDK, NICHD, and OBSSR.

Childhood Obesity Research Demonstration projects

The CDC Childhood Obesity Research and Dem-onstration (CORD) project builds on existing com-munity efforts to support children’s healthy eating and active living and support obesity prevention. Efforts focus on children 2–12 years old who are eligible for the Children’s Health Insurance Pro-gram (CHIP). Innovative approaches include com-bining changes in preventive care at doctor visits with supportive changes in schools, child care cen-ters, and community venues. Community health workers provide a bridge between families and resources in their communities. Overall, the grant-ees’work focuses on strategies that improve child-ren’s health behaviors by involving the children themselves, their parents and other family mem-bers, and the communities in which they live. Pro-cess, outcome, and sustainability measures are col-lected. Examples are BMI, behavioral change, quality of life, satisfaction with care, and cost. The three CORD research sites are the University of Texas, Houston; San Diego State University; and the Massachusetts State Department of Health. The Evaluation Center is at the University of Houston. CORD is funded by the Centers for Disease Control and Prevention (CDC).

Investigators within each consortium agreed up-on some commup-on features including outcomes and

other measures, inclusion/exclusion criteria, and follow-up timepoints (Tables 1, 2, 3, 4, and 5). However, because the component studies within each consortium were separately designed, several differences remain. While the overall goals of the interventions were similar, there were differences with respect to study-specific design issues (e.g., study-specific inclusion/exclusion criteria), target populations, recruitment strategies, intervention content, data collection, and how the interventions were delivered.

The Working Group built on the experience of the Resources Enhancing Alzheimer’s Caregiver Health (REACH) consortium which addressed the issue of combining information in a meaning-ful way across several related studies. This group published articles on the methodology used [11] and the results of the analysis [12]. REACH was comprised of six randomized controlled studies which tested nine Bactive^ interventions against two types of control conditions for family mem-bers of people with Alzheimer’s Disease or a related disorder with the goal of reducing care-giver burden [8]. Because the REACH interven-tions, like those represented at the Workgroup meeting, were complex behavioral interventions, REACH investigators wondered whether all com-ponents of their multi-faceted interventions were necessary to have an effect on the outcome. This is a question that could be answered across stud-ies, inasmuch as not all interventions had the same components, but not within a study since it is the interventions as a whole that are being compared by each study. The approach adapted by REACH investigators was to decompose the complex interventions, examining who (caregiver, care-recipient, social, or physical environment) and what (knowledge, behavior, skills, affect) the intervention targeted. The combination of the three Bwhos^ and four Bwhats^ resulted in 12 components (e.g., caregiver affect, care-recipient behavior, knowledge about the social environ-ment). Each intervention was Bscored^ on the basis of these 12 components, and relationships between the components and outcome were ex-amined. As a result, a new intervention (REACH II) was designed that emphasized the components identified as being associated with outcome and subsequently tested in a multi-center randomized, controlled trial [16].

In the process of developing the decomposition methodology, the REACH investigators identified a gap in the literature with respect to how inter-ventions are described and information that is needed to enable the decomposition process to proceed. Thus, an expansion of existing taxono-mies for characterizing interventions was pro-posed [17]. Furthermore, it has been long recog-nized that the lack of a common nomenclature to describe techniques for behavior change has lim-ited behavior change intervention science [18].

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There has been substantial progress in attempting to establish a common language in behavior change intervention research which has resulted in identifying and defining 93 techniques devel-oped by international consensus that have been grouped into 16 higher order domains [19].

Thus, substantial groundwork has been laid to facil-itate cross-study intervention research in behavior change, making timely this meeting to discuss the application of a taxonomy and methods for combining information across studies that target obesity. The meeting was initiated with remarks describing re-search priorities at the National Institutes of Health (NIH) and strategic plans. Two keynote speakers dis-cussed methodologies used to combine results across diverse interventions and a taxonomy that had been developed to describe behavior change techniques. The workgroup members were charged with ing recommendations regarding methods for develop-ing intervention taxonomy and analytical methods for combining data across interventions within a consor-tium. Keynote speakers met with the represented con-sortia in breakout groups and the final recommenda-tions were derived by consensus.

The manuscripts that follow address two topics crit-ical for combining information across studies that ad-dress behavior change. Tate et al. describe the ratio-nale for decomposing interventions, issues that arise when applying the decomposition process to behav-ioral interventions, and the need for further develop-ment of a common language or taxonomy. In the manuscript by Bangdiwala et al., analytical approaches for combining data across studies are discussed.

The meeting attendees concluded that an invest-ment of time and personnel for developing and applying decomposition methods for cross-study analyses could lead to important information and crucial insights for developing effective interven-tions. The attendees came to consensus on recom-mendations to address the research questions artic-ulated above. In general, attendees agreed that a common taxonomy for describing interventions would be useful to better understand those inter-ventions, in particular, aspects of interventions that are related to intervention goals. Several analytical approaches for combining information across interventions, both within a consortium and across consortia, or for investigating treatment response in subgroups, were discussed and are the topic of another manuscript in this issue (Bangdiwala et al.). Attendees agreed that by decomposing inter-ventions (see Tate et al. in this issue) and properly selecting measures, it would be possible to com-bine data from obesity prevention and treatment studies. The meeting attendees made the following recommendations:

Taxonomy-related recommendations

&

Decompose and code content of each intervention

utilizing established theory or taxonomy. Examples

of taxonomies include behavior change techniques (BCTs) and more extensive taxonomies that ad-dress other aspects of studies, such as populations studied, mode of intervention administration, train-ing, measures used, timing of measures, interven-tion adaptability, and interveninterven-tionist characteristics.

&

If established theory or taxonomy is amended,

there should be appropriate scientific rigor to jus-tify the change(s), e.g., calculate inter-rater reliability.

&

Determine the intervention components and

dose intended to be delivered (according to pro-tocol) per each intervention component (e.g., BCT).

&

Determine the intervention components and dose

actually delivered per each intervention compo-nent (e.g., BCT).

&

Determine the intervention components (e.g.,

BCTs) and dose actually received by participants.

Analysis methodology related recommendations

The methodology should take into account relevant theory and be driven by the research question(s). Issues to consider include variable selection and interactions.

&

Pooling results across studies, within or among

consortia, must account for heterogeneity among studies.

&

In general, pooling is used for exploratory analyses

to help identify intervention components (e.g., BCTs) that may work better than others and to identify subsets of participants across studies in which particular components work better. As such, these analyses are not to replace the standard anal-ysis plan for each study. If the analyses were not specified in advance, analyses of pooled data are viewed asBpost-hoc^exploratory analyses. If such analyses are to be performed, split-sample or cross-validation techniques should be employed.

&

Pooling may also be performed to test hypotheses

which were specified a priori.

&

Approaches to consider:

– Traditional analysis, with or without meta-regression. Including only study-level covariates in meta-regression limits the number of observa-tions. Using participant level covariates in meta-regression is recommended to the extent possible.

– Ignoring randomization but utilizing intervention components and, potentially, other study or vention level data rather than indicator(s) of inter-vention. Participant level covariates should be in-cluded with this approach.

&

Methodologies to consider

– Linear mixed-effects models (multi-level analysis)

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– Non-linear models and approaches (e.g., classification/regression trees/forests)

– Multi-group structural equation modeling

– Latent class models

In conclusion, this paper presents an overview of the workgroup meeting that was convened to discuss, and make recommendations regarding, a taxonomy for obesity intervention research and issues to consider and methods to employ for cross-study analyses. The other two manuscripts in this series (Tate et al, Bangdiwala et al) elaborate on meeting findings and

recommendations and together provide useful infor-mation to investigators conducting multi-site trials that have different intervention modalities but common primary outcomes.

Acknowledgments:The three manuscripts described in this journal

were supported by the National Heart, Lung, and Blood Institute, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the NIH Office of Behavioral and Social Science Research, the NIH Office of Disease Prevention, National Institute of Digestive, Diabetes, and Kidney Diseases, National Center for Complementary and Integrative Health, National Cancer Institute, Office of Research on Women’s Health, and the Centers for Disease Control and Prevention (CDC). The findings and conclusions are those of the authors and do not Attendees

Co-chairs

Shrikant Bangdiwala, PhD University of North Carolina, Chapel Hill

Steven Belle, PhD University of Pittsburgh

Participants

Jennifer Beaumont, MS Northwestern University

Alok Bhargava, PhD University of Maryland

Dave Cella, PhD Northwestern University

Rebecca Gersnoviez Clifton, PhD George Washington University

Jennifer Foltz, MD, MPH Centers for Disease Control and Prevention

Debra Harie-Joshu, PhD Washington University

Leslie Lytle, PhD University of North Carolina, Chapel Hill

Simon J. Marshall, PhD University of California, San Diego

Paras Mehta, PhD University of Houston

Susan Michie, PhD Sciences University College, London

Shirley Moore, RN, PhD, FAAN Case Western Reserve University

Dan O’Connor, PhD University of Houston

Thomas Robinson, MD, MPH Stanford University School of Medicine

Nancy E. Sherwood, PhD University of Minnesota and Health Partners

Institute for Education and Research

Evan Sommer, MS Vanderbilt University

June Stevens, PhD University of North Carolina

Deborah Tate, PhD University of North Carolina, Chapel Hill

Thomas N. Templin, PhD Wayne State University

Elizabeth Thom, PhD George Washington University

Dianne Ward, EdD University of North Carolina, Chapel Hill

NIH Staff

Sonia Arteaga, PhD Division of Cardiovascular Sciences, NHLBI

Denise Bonds, MD Division of Cardiovascular Sciences, NHLBI

Susan Czajkowski, PhD Division of Cardiovascular Sciences, NHLBI

Layla Esposito, PhD Child Development & Behavioral Branch, NICHD

Mary Evans, PhD Division of Digestive Diseases & Nutrition, NIDDK

Larry Fine, MD, DrPH Division of Cardiovascular Sciences, NHLBI

Mary Horlick, MD Division of Digestive Diseases & Nutrition, NIDDK

Catherine (Cay) Loria, PhD, MS, MA, FAHA Division of Cardiovascular Sciences, NHLBI

David M. Murray, PhD Office of Disease Prevention, NIH

Victoria Pemberton, RNC, MS, CCRC Division of Cardiovascular Sciences, NHLBI

Charlotte Pratt, PhD, RD, FAHA Division of Cardiovascular Sciences, NHLBI

William (Bill) Riley, PhD Division of Cancer Control and Population Sciences, NCI

Caroline Signore, MD, MPH Division of Extramural Research, NICHD

Denise Simons-Morton, MD, PhD Office of Disease Prevention, NIH

Erica L. Spotts, PhD Office of Behavioral and Social Sciences Research, NIH

Sue Yanovski, MD Division of Digestive Disease & Nutrition, NIDDK

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necessarily represent the official position of the National Institutes of Health or the Centers for Disease Control and Prevention.

Compliance with ethical standards

Conflict of interest:Dr. Cella reports funding from the NHLBI. No other

authors reported a potential conflict of interest.

Adherence to ethical principles:This research did not include human

subjects or animals.

References

1. Yeh HC, Clark JM, Emmons KE, et al. Independent but coordinated trials: insights from the practice-based Opportunities for Weight Reduction Trials Collaborative Research Group.Clin Trials. 2010; 7(4): 322-332.

2. Lytle LA, Svetkey LP, Patrick K, et al. The EARLY trials: a consortium of studies targeting weight control in young adults.Transl Behav Med. 2014; 4(3): 304-313.

3. Pratt CA, Boyington J, Esposito L, et al. Childhood Obesity Prevention and Treatment Research (COPTR): interventions addressing multiple influences in childhood and adolescent obesity.Contemp Clin Tri-als. 2013; 36(2): 406-413.

4. Czajkowski SM, Powell LH, Adler N, et al. From ideas to efficacy: the ORBIT model for developing behavioral treatments for chronic dis-eases. Health Psychol. 2 Feb 2015.

5. Dooyema CA, Belay B, Foltz JL, Williams N, Blanck HM. The child-hood obesity research demonstration project: a comprehensive

community approach to reduce childhood obesity.Child Obes.

2013; 9(5): 454-459.

6. Ory MG, Jordan PJ, Bazarre T. The behavior change consortium: setting the stage for a new century of health behavior-change research.Health Educ Res. 2002; 17(5): 500-511.

7. Ory MG, Lee Smith M, Mier N, Wernicke MM. The science of sus-taining health behavior change: the Health Maintenance Consor-tium.Am J Health Behav. 2010; 34(6): 647-659.

8. Schulz R, Belle SH, Czaja SJ, et al. Introduction to the special section on Resources for Enhancing Alzheimer’s

Caregiver Health (REACH).Psychol Aging. 2003; 18(3):

357-360.

9. Foltz JL, Belay B, Dooyema CA, Williams N, Blanck HM. Childhood Obesity Research Demonstration (CORD): the cross-site overview and opportunities for interventions addressing obesity community-wide.Child Obes. 2015; 11(1): 4-10.

10. O’Connor DP, Lee RE, Mehta P, et al. Childhood Obesity Research Demonstration project: cross-site evaluation methods.Child Obes. 2015; 11(1): 92-104.

11. Czaja SJ, Schulz R, Lee CC, Belle SH, Investigators R. A meth-odology for describing and decomposing complex

psychoso-cial and behavioral interventions.Psychol Aging. 2003; 18(3):

385-395.

12. Belle SH, Czaja SJ, Schulz R, et al. Using a new taxonomy to combine the uncombinable: integrating results across diverse interventions. Psychol Aging. 2003; 18(3): 396-405.

13. Ayala GX, Ibarra L, Binggeli-Vallarta A, et al. Our Choice/ Nuestra Opcion: the Imperial County, California, Childhood

Obesity Research Demonstration study (CA-CORD).Child Obes.

2015; 11(1): 37-47.

14. Taveras EM, Blaine RE, Davison KK, et al. Design of the Mas-sachusetts Childhood Obesity Research Demonstration

(MA-CORD) study.Child Obes. 2015; 11(1): 11-22.

15. Hoelscher DM, Butte NF, Barlow S, et al. Incorporating primary and secondary prevention approaches to address childhood obesity prevention and treatment in a low-income, ethnically diverse population: study design and demographic data from the Texas Childhood Obesity Research Demonstration (TX

CORD) study.Child Obes. 2015; 11(1): 71-91.

16. Belle SH, Burgio L, Burns R, et al. Enhancing the quality of life of dementia caregivers from different ethnic or racial groups: a

randomized, controlled trial.Ann Intern Med. 2006; 145(10):

727-738.

17. Schulz R, Czaja SJ, McKay JR, Ory MG, Belle SH. Intervention taxon-omy (ITAX): describing essential features of interventions.Am J Health Behav. 2010; 34(6): 811-821.

18. Michie S, Ashford S, Sniehotta FF, Dombrowski SU, Bishop A, French DP. A refined taxonomy of behaviour change techni-ques to help people change their physical activity and healthy

eating behaviours: the CALO-RE taxonomy. Psychol Health.

2011; 26(11): 1479-1498.

19. Michie S, Richardson M, Johnston M, et al. The behavior change technique taxonomy (v1) of 93 hierarchically clustered techniques: building an international consensus for the

report-ing of behavior change interventions.Ann Behav Med. 2013;

46(1): 81-95.

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