1. of an Adaptive Intervention in a Weight-management Study of Inner-city Adolescents Application of an Adaptive Intervention in a Weight-management Study of Inner-city Adolescents Shirley M. Moore, RN, PhD Professor and Associate Dean for Research Frances Payne Bolton School of Nursing Case Western Reserve University Cleveland, Ohio

2. Acknowledgements  Funding: supported by Award U01HL103622 from the National Heart, Lung, And Blood Institute, the Eunice Kennedy Shriver National Institute of Child Health and Development and the Office of Behavioral and Social Sciences Research  Co-Principal Investigator: Elaine Borawski, PhD  IMPACT Study Team  The Methodology Corner, Pennsylvania State University

3. Adaptive Intervention The gold standard approach to test an intervention is to standardize or “fix” the composition and level of the intervention components during the trial Therefore, tailoring behavioral interventions to the specific needs of any given participant in a randomized clinical trial presents challenges An Adaptive Intervention Protocol allows for participant-specific modifications to the intervention protocol based on a priori decision rules

4. Adaptive Interventions An adaptive intervention is a sequence of decision rules that specify whether, how and when (timing), and based on which measures, to alter the dosage (duration, frequency or amount), type, or delivery of treatment at decision stages in the course of care/trial Assumes that all individuals do not respond similarly to the same intervention What works for whom, under what conditions

5. Intervention Protocols Many health problems entail a sequential, individualized approach whereby treatment is adapted and readapted over time in response to the specific needs and evolving status of an individual High level of heterogeneity in response to treatment What works for one individual may not work for another Adaptive Interventions provide one way to guide or formalize individual sequences of treatment

6. Adaptive Interventions Also known as:  Dynamic treatment regimens  Adaptive treatment strategies  Stepped-care (stepped-up, stepped-down)

7. Example Using a Weight Management Intervention Protocol

8. IMPACT Trial Design Weight Management Study in Urban Adolescents Design: 3-group RCT; 3-year intervention among 360 6 th graders recruited from urban schools (ages 10-14 at baseline) with BMI at >85th percentile. Measures at baseline,12, 24 & 36 mos. Primary outcome is BMI change.

9. Family-level Interventions  HealthyCHANGE: cognitive-behavioral theory  SystemCHANGE: ecological & process improvement theory Small group face-to-face meetings q 2 weeks for first 12 mos. (25 sessions of 90 min.), followed by rotating monthly face-to-face meetings & phone calls for another 24 mos. Manualized protocols focused on healthy eating, physical activity, stress management, sleep management

10.  Average age 11.6 yrs; 57% female  93% minority (77% AA; 16% Hispanic)  Families economically disadvantaged  67% single parents households  70% on food stamps (SNAP)  49% households live on <$25,000/year  44% of index parent not working  Strength of our study: reaching populations most in need

12. Type of VariableVariableValueReview IntervalChange in Intervention BaselineBinge eating Clinical binge eaters, >4 binge eating episodes on the Youth Eating Disorder Questionnaire Scale Baseline and at 1-year intervals thereafter Counseling (face-to-face or telephone) – first session with child psychologist, followed by interventionist personal counseling with child and parent throughout the study (1-2 hours/mo extra maximum contact)* BaselineObesity level Above the 99.5 th percentile at baseline Baseline and at 1-year intervals thereafter Personal coaching by interventionist with the child and parent throughout the study (1- 2hr./mo. extra maximum contact) Process Parent/Family Involvement If the family member attends less than half of the scheduled sessions at end of Session 8 End of Session 8 and every 4 th session thereafter Personal coaching by interventionist with the child throughout the study (1-2hr./mo. extra maximum contact). Reach out to parent/guardian q 2 months ProcessWeight gain Weight gain of >2 pounds/month for three months in a row Quarterly checks as monitored monthly Compute new BMI to see if wt gain is associated with a growth spurt. If not, additional coaching session of 15 min with interventionist - up to 2 hrs/mo. Process *additional intervention hours are not cumulative across adaption factors. All children will receive a total of no more than 2 hrs total of personal coaching a month

13. (Collins, L. M., Murphy, S. A., & Bierman, K. L., 2004).  Select the tailoring variables  Measure the tailoring variables  Derive the decision rules  Optimally implement the decision rules Intervention Design Principles Adaptive Intervention Design Principles

14. Process in IMPACT Trial Implementation Process in IMPACT Trial Computerized reports alerted interventionists to those participants who met the thresholds for the adapted protocol The adapted protocols consist of a predetermined number of 20-minute individual coaching sessions in addition to the standard protocol Type and dose of adaptation was documented as part of total intervention delivered

15. Required adapted protocol Type of adaptation Binge eating Excessive Weight Gain Morbid Obesity Lack of Parent/Guardian Involvement Subjects who required more than one adaptation

16. Feasibility We will be able to determine the exact dose provided for each child and this will be included in the total intervention dose for analyses. Scheduling “extra” coaching sessions was sometimes problematic. We have been able to deliver ~75% of them. A pilot study is helpful to determine the adaptation variables, thresholds, and feasibility of delivery

17. Conclusions Designing an adaptive intervention requires considerable attention to determine the right variables and thresholds on which to adapt Tailoring research behavioral interventions using an adaptive protocol design requires minimal additional resources to deliver Adaptive intervention designs can be feasibly incorporated into behavioral weight management protocols and still preserve intervention replicability and precise measurement of intervention dose

18. Recommendations 1. Acknowledge the high level of heterogeneity in participant response to treatment by incorporating an adaptive intervention approach 2. Use a pilot study (or a series of pilot studies) to determine the adaptation variables, thresholds, and feasibility of delivery 3. Track the number of contacts and amount of time to deliver the adaptive intervention so that the “dose” can be calculated