Teens Engaged in Exercise Teens Engaged in Exercise and Nutrition (TEEN): A RCT and Nutrition (TEEN): A RCT of a Family-Based Distance of a Family-Based Distance Intervention for Overweight Intervention for Overweight

Rural AdolescentsRural Adolescents

TEEN Health Group

The ProblemThe Problem

Health risks as children and adults Health risks as children and adults early morbidity and mortalityearly morbidity and mortality cardiovascular risk factorscardiovascular risk factors link with adult obesitylink with adult obesity

Over one quarter of rural children overweight/obese, Over one quarter of rural children overweight/obese, compared to 10-25% in the national populationcompared to 10-25% in the national population

Rural children w/ 54.7% increased risk of obesity Rural children w/ 54.7% increased risk of obesity when compared to urban children (McMurray, when compared to urban children (McMurray, Harrell, Bangdiwala & Deng, 1999) Harrell, Bangdiwala & Deng, 1999)

Access to medical and behavioral healthcare is Access to medical and behavioral healthcare is limited in rural areaslimited in rural areas

A Novel SolutionA Novel Solution Efficacious treatments for childhood obesity Efficacious treatments for childhood obesity

already existalready exist Jelalian & Saelens, 1999Jelalian & Saelens, 1999

State-of-the-art Delivery SystemState-of-the-art Delivery System Web TVWeb TV PDA technology with satellite links for PDA technology with satellite links for

feedbackfeedback Immediate, individualized treatment— “electronic Immediate, individualized treatment— “electronic

therapist”therapist” Close the access gap for rural adolescentsClose the access gap for rural adolescents

Family Web-TVFamily Web-TV

Life Coach Life Coach ©©

TEEN Health

Why Kansas?Why Kansas?

Collaborative partners with KDHE and KSDECollaborative partners with KDHE and KSDE HIGH NEED: 15% children/adolescents overweight; HIGH NEED: 15% children/adolescents overweight;

3 in 5 adults are overweight3 in 5 adults are overweight $$$ Obesity-related medical expenditures in Kansas $$$ Obesity-related medical expenditures in Kansas

total $657 million, 5.5 % of the state’s annual health total $657 million, 5.5 % of the state’s annual health care bill (KDHE 2004)care bill (KDHE 2004)

Mandated annual BMI assessment by schoolMandated annual BMI assessment by school 98% access to internet technology in the home 98% access to internet technology in the home

(KAN-ED)(KAN-ED)

OBJECTIVEOBJECTIVE

To reduce BMI of rural To reduce BMI of rural overweight adolescents overweight adolescents using a family-based, multi-using a family-based, multi-component distance component distance interventionintervention

Research ContextResearch Context Previous research has established probably

efficacious interventions for children and adolescents Adaptation of Epstein’s comprehensive family-based

intervention for exercise and diet in overweight and obese children tested in three small randomized trials

Studies link increased fruit and vegetable consumption with decreased overall caloric intake

Our pilot studies used 10 focus groups to establish the acceptability and feasibility of the current intervention

Research Context Research Context Life CoachLife Coach©© Development Development

SBIR Phase I/II studies from NHLBI conducted by SBIR Phase I/II studies from NHLBI conducted by TeamSix, Inc.TeamSix, Inc.

Enhanced PDA featuring:Enhanced PDA featuring: PedometerPedometer Ecological momentary assessment (EMA)Ecological momentary assessment (EMA) Feedback componentFeedback component

Satellite linkSatellite link Feasibility tested in populations 12 years and olderFeasibility tested in populations 12 years and older Preliminary efficacy data in adultsPreliminary efficacy data in adults

Increases Kcal expendedIncreases Kcal expended Decreases Kcal consumedDecreases Kcal consumed Decreases weightDecreases weight

Primary Question and Primary Question and HypothesisHypothesis

Will the TEEN technology-based weight Will the TEEN technology-based weight management program be efficacious in management program be efficacious in reducing BMI in overweight rural adolescents reducing BMI in overweight rural adolescents (grades 7-10)?(grades 7-10)?

Hypothesis: Hypothesis: The TEEN treatment will The TEEN treatment will produce a greater reduction in BMI over produce a greater reduction in BMI over time as compared to controltime as compared to control

Secondary Questions and HypothesesSecondary Questions and Hypotheses

Will reduction in BMI in the treatment group be mediated by Will reduction in BMI in the treatment group be mediated by changes in activity, diet, and parent involvement?changes in activity, diet, and parent involvement?

Hypothesis 2A:Hypothesis 2A: Increase in activity level (LifeCoach) Increase in activity level (LifeCoach) will mediate the effects of treatment on reduction in BMI.will mediate the effects of treatment on reduction in BMI.

Hypothesis 2B:Hypothesis 2B: Increase in self-reported consumption Increase in self-reported consumption of healthy foods (e.g., fruits and vegetables) will mediate of healthy foods (e.g., fruits and vegetables) will mediate the effects of treatment on reduction in BMI.the effects of treatment on reduction in BMI.

Hypothesis 2C:Hypothesis 2C: Increase in parental involvement will Increase in parental involvement will mediate the effects of treatment on reduction in BMI.mediate the effects of treatment on reduction in BMI.

Secondary Questions and HypothesesSecondary Questions and Hypotheses

Will the intervention result in an Will the intervention result in an improved quality of life?improved quality of life?

Hypothesis 3:Hypothesis 3: Adolescents in the Adolescents in the treatment group will show greater treatment group will show greater improvement in quality of life (PEDS-improvement in quality of life (PEDS-QL) as compared to control.QL) as compared to control.

Subgroup AnalysesSubgroup Analyses

Assess potential moderating role of age, Assess potential moderating role of age, gender, race/ethnicity and baseline BMI gender, race/ethnicity and baseline BMI on treatment gains.on treatment gains. Hypothesis 4:Hypothesis 4: No differential change No differential change

in BMI between groups by age, in BMI between groups by age, gender, race/ethnicity, and baseline gender, race/ethnicity, and baseline BMIBMI

OVERVIEW OF OVERVIEW OF STUDYSTUDY

•2 group parallel design

•Clustered randomization

•Assessors are blind to group assignment

•ITT

•Intervention duration=6 months

•Study duration=18 months total

RANDOMIZATION WITHIN RANDOMIZATION WITHIN STRATA (MS VS. HS)STRATA (MS VS. HS)

Unit of randomization: schoolUnit of randomization: school ““Clustered randomized trial”Clustered randomized trial”

Keep arms spatially separateKeep arms spatially separate All eligible grade-level children within school All eligible grade-level children within school

are assigned to same armare assigned to same arm Reduces treatment contaminationReduces treatment contamination Equal treatment of equals within the small Equal treatment of equals within the small

communitiescommunities Nested dataNested data

POPULATION SIZEPOPULATION SIZE

279 rural schools (84 middle, 20 junior, 279 rural schools (84 middle, 20 junior, 175 high school), 47.5% in rural areas175 high school), 47.5% in rural areas

46,642 rural students in 7-1046,642 rural students in 7-10thth grade grade 15% overweight on avg., approx. 7,000 15% overweight on avg., approx. 7,000

potential populationpotential population 10 of 70 students per school are 10 of 70 students per school are

overweight (2 grades sampled/school; overweight (2 grades sampled/school; average grade size=35 students)average grade size=35 students)

POWER CALCULATIONPOWER CALCULATIONutilizing Optimal Design softwareutilizing Optimal Design software

There is a 90% chance of a statistically There is a 90% chance of a statistically significant result w/ 8 (of 10) participating significant result w/ 8 (of 10) participating children/school under the following conditions children/school under the following conditions (p=.05, 2-tail): (p=.05, 2-tail):

Std Effect Size (1 Year, in pop)

Intraclass correlation

.3(2 kg, sd=7.5)

.5(4kg, sd=7.5)

.05 82 total schools 32 total schools

.1 104 total schools 38 total schools

SAMPLE SIZESAMPLE SIZE

Control/Treatment ArmsControl/Treatment Arms26 HS (260 students)26 HS (260 students)26 JH/MS (260 students)26 JH/MS (260 students)

TOTALTOTAL104 schools (52 per arm)104 schools (52 per arm)1,040 students in grades 7-101,040 students in grades 7-10

Inclusion Criteria: Exclusion Criteria:

Children grades 7 – 10 with Children grades 7 – 10 with a BMI > 85a BMI > 85thth percentile percentile

Participation in a weight loss program or loss of more than Participation in a weight loss program or loss of more than 10 lbs (4.5 kg) within the past 6 months10 lbs (4.5 kg) within the past 6 months

No active parent or legal guardian at home who is willing No active parent or legal guardian at home who is willing to participate in this program (e.g., single-parent with to participate in this program (e.g., single-parent with disability or terminal illness)disability or terminal illness)

Resides in a rural area (city population < 20,000)

Any physical symptoms or conditions that would prevent Any physical symptoms or conditions that would prevent them from engaging in daily exercise (e.g., asthma)them from engaging in daily exercise (e.g., asthma)

PregnancyPregnancyMalignancyMalignancyEating disorder diagnosis

English speaking Physical limitation or receives an injury which significantly limits physical mobility

Access to television within the home

Hospitalization for chronic disease within the past year Hospitalization for chronic disease within the past year

Only one child participant/family

Child/parent has significant developmental delay or cognitive impairment; Parent with significant physical or cognitive disability

Recruitment Recruitment

Through collaboration with KDHE, KDE, Through collaboration with KDHE, KDE, school districts, and all principals (see letters school districts, and all principals (see letters of agreement), contact potential familiesof agreement), contact potential families

Principal’s officePrincipal’s office Mails a letter to each identified household Mails a letter to each identified household Each mailing includes a consent form Each mailing includes a consent form

No informed consent received within 3 weeks, No informed consent received within 3 weeks, second mailingsecond mailing

Follow-up recruitment calls from schools for Follow-up recruitment calls from schools for non-responsenon-response

ScreeningScreening

Location – schoolsLocation – schools Staff - LVNsStaff - LVNs

MEASURE INITIAL/BASELINE

Detailed medical history X

BMI (height, weight) X

Fasting blood glucose X

Blood pressure X

Physical activity preparedness questionnaire

X

Tanner staging X

Exercise tolerance activity X

Epstein’s Components

Caregivers and Child:Weight control / preventionTraffic light diet with focus on increasing fruit and vegetablesDeveloping healthy eating environment: situational / contingenciesBehavior change techniquesMaintenance of behavior changes

Caregiver Only: Education on reinforcement of target child behaviors

Intervention emphasizes simple changes: • Eating more fresh fruits vegetables per day• Reducing sedentary behaviors• Increasing activity through low intensity “lifestyle” changes.

WebTV Family WebTV Family InterventionIntervention

WebTV Family WebTV Family InterventionIntervention

Typical mode of administration is through a workbook and 12 individual and family face-to-face sessions.

Adapted to technology-based administration for WebTV for rural access.

Adapted each lesson into an “edutainment” based approach to modeling health behavior through 12 bi-weekly 20-minute “shows” on the WebTV.

This translates into behavioral goals of 5 fresh fruits/veg per day and 10,000 steps/day.

Life CoachLife Coach© Assessment© Assessment

Child/Parents in both groupsChild/Parents in both groups Pedometer (Assessment)Pedometer (Assessment)

Daily upload to server via satelliteDaily upload to server via satellite Ecological Momentary Assessment (EMA) Ecological Momentary Assessment (EMA)

(Assessment)(Assessment) Randomly selects 4 days/weekRandomly selects 4 days/week

Activity/Exercise checklistActivity/Exercise checklist Food intake checklistFood intake checklist

Red/Yellow/Green foodsRed/Yellow/Green foods Barriers to exercise checklistBarriers to exercise checklist Barriers to healthy food intake checklistBarriers to healthy food intake checklist

Life CoachLife Coach© Intervention© Intervention

FeedbackFeedback Weekly/PRNWeekly/PRN Via Life CoachVia Life Coach©©, web, email, mail, web, email, mail Summaries (actual vs. goal)Summaries (actual vs. goal) Tailored suggestions for changeTailored suggestions for change Parent gets embedded suggestions based on child’s Parent gets embedded suggestions based on child’s

assessmentsassessments

Informational ResourcesInformational Resources Event driven/PRNEvent driven/PRN

Kcal for foodsKcal for foods Kcal expenditure for certain exercise/activityKcal expenditure for certain exercise/activity Solutions for barriersSolutions for barriers Request for resources, video modulesRequest for resources, video modules

Control ConditionControl Condition

Written notification on child’s baseline BMIWritten notification on child’s baseline BMI Description of health risks and treatment Description of health risks and treatment

optionsoptions Encouragement to see PCP/healthcare Encouragement to see PCP/healthcare

providerprovider Get Life CoachGet Life Coach©© without feedback without feedback

Treatment Fidelity:Treatment Fidelity:DeliveryDelivery

Date/Time stamp of observation of video Date/Time stamp of observation of video modules (both parent and child)modules (both parent and child)

““Feedback” suggestions viewed (Life Feedback” suggestions viewed (Life CoachCoach©©, web), web)

Life CoachLife Coach© worn (>100 steps/day)© worn (>100 steps/day)

Treatment Fidelity:Treatment Fidelity:ReceiptReceipt

Scavenger HuntScavenger Hunt Videos/Feedback have embedded Videos/Feedback have embedded

words/objects that must be identified after words/objects that must be identified after video/feedbackvideo/feedback

Post-video content quiz (videos)Post-video content quiz (videos)

Treatment Fidelity:Treatment Fidelity:EnactmentEnactment

Daily pedometer readingsDaily pedometer readings Change in daily activity and food Change in daily activity and food

monitoring from EMAmonitoring from EMA Changes in self-report assessment of Changes in self-report assessment of

activity/food measuresactivity/food measures Parent report of child’s behaviorParent report of child’s behavior

Efforts to Increase Treatment Efforts to Increase Treatment ComplianceCompliance

Remuneration for 0, 6, 12, 18 month Remuneration for 0, 6, 12, 18 month assessments ($5.00/$10.00/$20.00/$40.00 assessments ($5.00/$10.00/$20.00/$40.00 worth of gift certificates to vendors)worth of gift certificates to vendors)

Keep Life CoachKeep Life Coach©© upon completion upon completion Points given on scavenger hunt itemsPoints given on scavenger hunt items Prizes/Gift certificates available based on Prizes/Gift certificates available based on

number of points per week/monthnumber of points per week/month

MEASURE INITIAL/BASELINE

6 MONTH 12 MONTH 18 MONTH

BMI (height and weight) X X X X

Parental involvement questionnaire X X X X

PEDS QL X X X X

Enrolled in other weight loss program

X X X X

Assessment of Adverse Events X X X X

CONTINUOUS MEASURES

Life Coach # of steps X X

Life Coach report of physical activity

X X

Life Coach report diet (Fruit/Veg) X X

Primary Data AnalysisPrimary Data Analysis

H1: A multi-level growth curve model will be fit to H1: A multi-level growth curve model will be fit to compare whether average rate of change over compare whether average rate of change over time in BMI differs across treatment and control, time in BMI differs across treatment and control, and whether mean BMI differs at end of and whether mean BMI differs at end of treatment and follow-up across groupstreatment and follow-up across groups

Secondary Data AnalysisSecondary Data Analysis H3: A multi-level growth curve model will be fit to compare H3: A multi-level growth curve model will be fit to compare

whether average rate of change over time in QOL differs whether average rate of change over time in QOL differs across treatment and control, and whether mean QOL differs across treatment and control, and whether mean QOL differs at end of treatment and follow-up across groupsat end of treatment and follow-up across groups

H4 Subgroup: Test whether age, gender, race/ethnicity H4 Subgroup: Test whether age, gender, race/ethnicity covariates interact with the main effect of treatment on covariates interact with the main effect of treatment on intercept (mean BMI at time t) and BMI growth rate (average intercept (mean BMI at time t) and BMI growth rate (average change in BMI over time).change in BMI over time).

Examine the correlation between intercept (initial BMI) and Examine the correlation between intercept (initial BMI) and slope (change in BMI).slope (change in BMI).

Secondary Data Analyses (cont)Secondary Data Analyses (cont)

H2a-c: Conduct separate mediational analyses H2a-c: Conduct separate mediational analyses (Baron & Kenny, 1986) for physical activity, food (Baron & Kenny, 1986) for physical activity, food selection, and parental involvementselection, and parental involvement

DSMB IssuesDSMB Issues

Interim analyses (2)Interim analyses (2) After 333 and 666 adolescents After 333 and 666 adolescents

randomized and completed/drop-outrandomized and completed/drop-out Stopping rulesStopping rules

O’brien-Flemming for efficacy / harmO’brien-Flemming for efficacy / harmStochastic Curtailment for futilityStochastic Curtailment for futility

DSMB Issues (cont)DSMB Issues (cont) SAE/AESAE/AE

A Serious Adverse Event (SAE) is any adverse A Serious Adverse Event (SAE) is any adverse experience occurring during the studyexperience occurring during the study DeathDeath, disability, s, disability, serious medical illnesserious medical illness HospitalizationHospitalization In the absence of medical intervention would have led to In the absence of medical intervention would have led to

any of the aboveany of the above An Adverse Event (AE) is a lesser adverse An Adverse Event (AE) is a lesser adverse

experience occurring during the study (e.g., minor experience occurring during the study (e.g., minor injury, underweight, depression)injury, underweight, depression)

SAE/AEs will be reported verbally and in SAE/AEs will be reported verbally and in writing to the PI.writing to the PI.

All SAEs will be reported to the IRB & DSMB All SAEs will be reported to the IRB & DSMB w/in 24 hours w/in 24 hours

ConclusionConclusion

LimitationsLimitations Costs associated with technologyCosts associated with technology Long-term effects?Long-term effects?

Innovative combination of technology and family Innovative combination of technology and family to overcome access barriersto overcome access barriers

Rural setting but portable to other populations Rural setting but portable to other populations with limited accesswith limited access

Anticipated cost effectivenessAnticipated cost effectiveness Reduced medical costsReduced medical costs Relatively low-costRelatively low-cost

AcknowledgementsAcknowledgements

Thanks to all our mentors, consultants, Thanks to all our mentors, consultants, and peer consultants that made TEEN and peer consultants that made TEEN possible!possible!

Thanks in advance to our future funders Thanks in advance to our future funders and reviewers!!and reviewers!!

ReferencesReferencesMcMurray RG, Harrell JS, Bangdiwala SI, Deng S. Cardiovascular disease risk factors and obesity of rural and urban elementary school children. McMurray RG, Harrell JS, Bangdiwala SI, Deng S. Cardiovascular disease risk factors and obesity of rural and urban elementary school children.

Journal of Rural Health. Journal of Rural Health. 1999;15(4):365-374.1999;15(4):365-374. Epstein LH, Myers MD, Raynor HA, Saelens BE. Treatment of pediatric obesity. Epstein LH, Myers MD, Raynor HA, Saelens BE. Treatment of pediatric obesity. Pediatrics. Pediatrics. 1998;101(Supplement):554-570.1998;101(Supplement):554-570.Troiano, R. & Flegal, K. (1998). Overweight children and adolescents: Description, epidemiology, and demographics. Troiano, R. & Flegal, K. (1998). Overweight children and adolescents: Description, epidemiology, and demographics.

Pediatrics, 101Pediatrics, 101, 497-504., 497-504. Kromeyer, K., Zellner, K., Jaeger, U. & Hoyer, H. (1999). Prevalence of overweight and obesity among school children in Kromeyer, K., Zellner, K., Jaeger, U. & Hoyer, H. (1999). Prevalence of overweight and obesity among school children in

Jena (Germany). Jena (Germany). International Journal of Obesity and Related Metabolic Disorders, 23International Journal of Obesity and Related Metabolic Disorders, 23, 1143-50., 1143-50. Rios, M., Fluiters, E. & Perez, M. (1999). Prevalence of childhood overweight in northwestern Spain: A comparative study of Rios, M., Fluiters, E. & Perez, M. (1999). Prevalence of childhood overweight in northwestern Spain: A comparative study of

two periods with a ten year interval. two periods with a ten year interval. International Journal of Obesity and Related Metabolic Disorders, 23International Journal of Obesity and Related Metabolic Disorders, 23, 1095-8. , 1095-8. Strauss, R. & Pollack, H. (2001). Epidemic increase in childhood overweight, 1986-1998. Strauss, R. & Pollack, H. (2001). Epidemic increase in childhood overweight, 1986-1998. Journal of the American Medical Journal of the American Medical

Association, 286Association, 286, 2845-8., 2845-8. DiPietro, L., Mossberg, H. & Stunkard, A. (1994). A 40-year history of overweight children in Stockholm: Life-time overweight, DiPietro, L., Mossberg, H. & Stunkard, A. (1994). A 40-year history of overweight children in Stockholm: Life-time overweight,

morbidity, and mortality. morbidity, and mortality. International Journal of Obesity and Related Metabolic Disorders, 18,International Journal of Obesity and Related Metabolic Disorders, 18, 585-90. 585-90. Freedman, D., Dietz, W., Srinivasan, S. & Berenson, G. (1999). The relation of overweight to cardiovascular risk factors Freedman, D., Dietz, W., Srinivasan, S. & Berenson, G. (1999). The relation of overweight to cardiovascular risk factors

among children and adolescents: The bogalusa heart study. among children and adolescents: The bogalusa heart study. Pediatrics, 103Pediatrics, 103, 1175-82., 1175-82.Freedman, D., Kettel Khan, L., Dietz, W., Srinivasan, S. & Berenson, G. (2001). Relationship of childhood obesity to coronary Freedman, D., Kettel Khan, L., Dietz, W., Srinivasan, S. & Berenson, G. (2001). Relationship of childhood obesity to coronary

heart disease risk factors in adulthood: The bogalusa heart study. heart disease risk factors in adulthood: The bogalusa heart study. Pediatrics, 108Pediatrics, 108, 712-8., 712-8.Must, A., Jacques, P., Dallal, G., Bajema, C., Dietz, W. (1992). Long-term morbidity and mortality of overweight adolescents: Must, A., Jacques, P., Dallal, G., Bajema, C., Dietz, W. (1992). Long-term morbidity and mortality of overweight adolescents:

A follow-up of the harvard growth study of 1922 to 1935. A follow-up of the harvard growth study of 1922 to 1935. New England Journal of Medicine, 327New England Journal of Medicine, 327, 1350-5., 1350-5.