Client Report Follow-Up to November 3, 20I5 Consultation Meeting Mindfulness and Eating Behavior Tammy Turner, Ph.D. Department of Nutritional Sciences University of Arizona Consultants: Jessika Ava, Kyle Carter, Yifei Yuan Advisor: Dr. Dean Billheimer Client Report 2 1 Executive Summary Dr. Tammy Turner, University of Arizona Department of Nutritional Sciences, visited the Statistical Consulting Lab free student session to receive advice on the most effective analytical methods for an upcoming intervention based pilot study. Suggested methods, with sample analyses using simulated data, are presented in this report. 2 Detailed Summary 2.1 Overview of Study A pilot study will consist of 30 adolescents participating in a single-arm non-randomized mindfulness video intervention. Each video, varying in lengths up to 20 minutes will be viewed once a day for six weeks. Video content will focus on mindfulness skills related to eating, physical activity, sleep, stress, and general techniques (e.g. meditation). The impact of the intervention on change in dietary behavior, intrinsic motivation, perceived stress, and mindfulness will be assessed. Secondary outcomes included acceptability, feasibility, adherence, usefulness, likelihood of adoption, and technical feasibility. 2.2 Research Question To determine if a significant difference occurs in mindfulness, stress, motivation, and eating behaviors, as measured by questionnaires, between pre- and post- intervention, in adolescents. 2.3 Client’s Needs This report will answer Dr. Turner’s following questions: 1) How to analyze repeated measures over 6 time points? 2a) Is there a more robust way than paired t-test to measure the changes in a single treatment group with pre-post questionnaire data? 2b) and/or is there a better way to do subgroup analysis on this data besides stratifying by covariates and re-running paired t-tests if I use this as the primary analysis 2.4 Study Design Pre Treatment Baseline Scores: Mindfulness, Stress, Eating Behavior, Motivation, (each as measured by separate questionaires), Prior Mindfulness Knowledge, age, BMI, race, other demographics Intervention Healthy Eating Videos: 1 Video/Day for 6 weeks “Dose” can be measured by number of videos watched Client Report 3 Table 1: Measurement of Mindfulness Scale Week 1 2 3 4 5 6 Video Length 3 min 6 min + + + 15 min # times NOT mindful X1 X2 X3 X4 X5 X6 Mindful scale= length/times not mindful 3/X1 Post Treatment Outcome: Mindfulness, Stress, Eating Behavior, Motivation, each as measured by separate questionnaires 3 Suggested Methods 3.1 Random Mixed Effects Model to Assess Mean Mindfulness Score Values over Time To assess mean mindfulness score values over time, we define mindfulness score as ππ. ππ π‘ππππ πππ‘ ππππππ’π ππππππ’ππππ π πππππ = π‘ππ‘ππ π£ππππ πππππ‘β ππ ππππ’π‘ππ (Please note this figure is the inverse of the original analysis plan, explanation below). A linear mixed effects model with random intercept and unstructured covariance matrix will provide an adequate model. Time is modelled linear and the random effects allow for the subject specific heterogeneity. Data was simulated using a random number generator within Excel software, taking random values 0-10 for number of times not mindful divided by video length measured 3, 6, 9, 12, and 15 minutes. SAS Statistical Software is used to assess the simulated data. The random mixed effects model is: Mindfulness_Scoreij=B1 +B 2(timeij) + b1i + eij , where: i=subject 1,2,….,30; j=time 1, 2, …., 6 B1 = fixed intercept B 2 = fixed time effect b1i = subject-specific random effect of intercept for subject i The simulated data provides this model: Mindfulness_Scoreij=1.34 – 0.20(timeij) + b1i + eij Using simulated data, the results show a negative association with time; this is what would be expected if intervention is successful and number of non-mindful moments decrease with time. Client Report 4 The assumptions for linear mixed effects model are: 1) Linearity 2) Homoskedasticity 3) Normality of residuals 4) Absence of collinearity 5) Absence of influential outliers 6) (Note: Independence is NOT an assumption due to repeated measures) An SPSS manual providing instructions for this analysis is found here: http://www.spss.ch/upload/1126184451_Linear%20Mixed%20Effects%20Modeling%20in%20SPSS.pdf 3.2 Linear Regression Model to Assess Pre-Post Comparison A linear regression model for pre-post comparison may be used to determine potentially influential covariates for change-in-test-scores, run a series of linear regression models cycling through our covariates of interest may be conducted. We suggest to center the covariate in order to provide an easier interpretation and to avoid extrapolation. The regression model is: ΔScorei=B1 +B 2(covariate*i) + ei , where: i=subject 1,2,….,30 B1 = mean change score B 2 = covariate effect 1) 2) 3) 4) The assumptions for the linear regression model are: Linearity Homoskedasticity Normality of residuals Independence of observations Demographic information and test scores were simulated using R. The details of the data generation process may be found in the supplementary file. The following tables detail the results of the simulated study, including the estimated effects, true effects, and p-values. p-values less than 0.05 are considered significant. Table 2: Mindfulness Results Covariate Estimated Value Mean 1.8667 Baseline Mindfulness 0.0762 Age -0.4994 Gender ~0 Prior Knowledge 0.6667 Dose 0.0395 *correct conclusion; !incorrect conclusion True Value 0 0 0 0.2 0.02 p-value 3.27x10^-9 * 0.533 * 0.0234 ! ~1 * 0.155 ! 0.0002 * Client Report 5 Table 3: Stress Results Covariate Estimated Value Mean -1.9667 Baseline Mindfulness 0.0360 Age -0.4994 Gender 0.6 Prior Knowledge -0.6825 Dose -0.02 *correct conclusion; !incorrect conclusion Table 4: Eating Behavior Results Covariate Estimated Value Mean 0.90 Baseline Mindfulness -0.0346 Age 0.4413 Gender 0.2 Prior Knowledge 0.1429 Dose 0.0082 *correct conclusion; !incorrect conclusion Table 5: Motivation Results Covariate Estimated Value Mean 0.6333 Baseline Mindfulness 0.0968 Age 0.0729 Gender 0.8667 Prior Knowledge 0.8413 Dose 0.0082 *correct conclusion; !incorrect conclusion True Value 0 0 0 -0.2 -0.02 True Value 0 0 0 0.1 0.01 p-value 3.05x10^-9 * 0.783 * 0.924 * 0.192 * 0.173 ! 0.119 ! p-value 6.76x10^-4 * 0.7953 * 0.0700 * 0.674 * 0.7833 ! 0.5310 ! True Value 0 0 0 0.1 0.01 p-value 0.0072 * 0.4360 * 0.314 * 0.0427 ! 0.0750 ! 0.6387 ! This model does identify differences between post- and pre- measurements, however, it does not seem to be accurate at determining important covariates. This is likely due to the variance in the data overshadowing the effects. An SPSS manual providing instructions for this analysis is found here: https://statistics.laerd.com/spss-tutorials/linear-regression-using-spss-statistics.php 3.3 Further Analyses to Assess Effect of Intervention Data The intervention can also be evaluated by “Mindfulness State Time” which is obtained based on bellowing equations: πππ‘πππ = πππ‘ππ ππππ πππ − ππππππ’ππππ π πππ’ππ‘ The above equation is reasonable to represents the intervention in the experiment. However, sometimes the self-reported Non-Mindfulness count might be 0, and the MStime will goes to infinity. Thus instead of using MStime directly, Here a new parameter is defined: Client Report 6 λ(t): average non-mindfulness count per mins at week t. t Ο΅{1,2,3,4,5,6} It is further assumed that individual’s Non-mindfulness count follows a Poisson distribution: πΎπ (π‘)~ππππ π ππ (π(π‘) ∗ ππ (π‘)), t Ο΅{1,2,3,4,5,6}, i = 1,2, … , N where πΎπ (π‘) is individual i’s Non-mindfulness count at experiment on week t, ππ (π‘) is total time the individual spent on the intervention at week t. Particularly in this case study, ππ (π‘) is same for each individual i, i.e. π1 (1) = π2 (1) = β― = π30 (1) = 3. In other words, individual 1 to 30 spent equal time watching the intervention videos. And further ππ (1)=3, ππ (2)=5, ππ (3)=8, ππ (4)=10, ππ (5)=12, ππ (6)=15. Based on the Poisson assumption, the maximum-likelihood estimator of π(π‘) can be obtained by: πΜ(π‘) = ∑π π=1 πΎπ (π‘) ∑π π=1 ππ (π‘) Furthermore, because ππ (π‘) is fixed for each individual. The estimator can be rewrite as: πΜ(π‘) = ∑π π=1 πΎπ (π‘) ππ(π‘) Based on factorization theorem, it can be proved that this estimator is sufficient and complete. In addition the estimator is unbiased and the variance achieves Cramér–Rao lower bound. Thus it is a best unbiased estimator. The confidence interval for this estimator can be obtained from chi-square distribution: πΌ π 2 ( 2 , 2 ∑π π=1 πΎπ (π‘)) 2ππ(π‘) ≤ π(π‘) ≤ πΌ π 2 (1 − 2 , 2 ∑π π=1 πΎπ (π‘) + 2) 2ππ(π‘) Based on this confidence interval and point estimator, the estimation of the simulation study is shown in the bellowing figure: Client Report 7 From the figure, the average non-mindfulness count shows significant decrease along the time. Further, based on the Poisson assumption, the “Mindfulness State Time” follows an exponential distribution as: 1 ππ π‘πππ ~ πΈπ₯ππππππ‘πππ( ) π(π‘) Then the confidence interval of MStime is shown as bellowing: The results show that MStime increases from week 1 to week 6 significantly. Correlation between intervention and questionnaire result In the above section, the intervention data is analyzed and it is concluded that the average mindfulness performance increased along time. The previous section focused on population scope (average), while this section focuses on individual scope. For one particular individual, what is concerned is that, the correlation between increase of intervention performance and questionnaire scores. The increase of questionnaire scores can be modeled easily by post questionnaire scores minus baseline questionnaire scores. While the increase of intervention performance can be measured by a linear model: ππ (π‘) = −ππ π‘ + ππ,0 where ππ (π‘) is the average non-mindfulness count for individual i at time t. ππ is the increasing rate of intervention performance. If ππ is high, it means the non-mindfulness count will decrease along time significantly. Based on this model, the increase of intervention performance for each individual can be modeled by ππ . Furthermore, denote the change of mindfulness questionnaire score as ππ . The correlation between ππ and ππ can be modeled by: πΆππ = πΆππ£(ππ , ππ ) √πππ(ππ ) πππ(ππ ) Client Report 8 Based on the simulation data, cor = 0.12503. It is concluded that the increase of intervention performance and increase of questionnaire scores are positively correlated. In addition, the correlation is not significantly high. It indicates in this sample, the major variation of mindfulness questionnaire score does not comes from intervention. 4. Conclusion and Discussion The above analytical methods will provide robust statistical analyses of both the effects of intervention as well as change in mindfulness score over time. However, the study design could be strengthened by a larger sample size and/or comparison group.