HealthMatters@24/7 Asynchronous Health Promotion eLearning for People Supporting Adults With Intellectual and Developmental Disabilities
Phase: NA
Conditions: Obesity, Hypertension, Hypercholesterolemia, Hyperglycemia
Sponsor: University of Illinois at Chicago

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HealthMatters@24/7 eLearning for People Supporting Adults with 
Intellectual and Developmental Disabilities 
 
ClinicalTrials.gov ID: NCT03206164 
Study Protocol and Statistical Analysis Plan 
Document Date: June 24, 2020 
 
Study Protocol 
 
Objectives and Hypotheses: 
 
The HealthMatters @ 24/7 eLearning project has three objectives: 
Objective: Test the effectiveness of an on demand e-Learning platform (HealthMatters@24-7) for staff in 
CBOs in one state. 
HO1. More CBOs in the asynchronous training program will have developed Strategic Action Plans for 
Health and Wellness, established Wellness Committees, and have equal or more resources and 
improved culture for health promotion at 3 months compared to CBOS participating in the current live 
HealthMatters TtT Workshop webinar. 
HO2. Staff in the asynchronous training group will have improved level of learner/instructor satisfaction 
toward the training immediately after completing the enhanced mode of training, HM@24/7 compared 
to staff trained using the current live HealthMatters TtT Workshop webinar. 
 
Design. We will utilize two groups (Table 1), random selection, pre-test/post test experimental 
design where Experimental Group receives HealthMatters@24/7 training and Control Group 
receives the usual real-time (live) webinar training (HealthMatters Train the Trainer Workshop). 
 
Table 1. Two groups, Random Selection, Pre-test, Post-test experimental design 
 
Group 
Pre-test 
Treatment 
Post-test 
HealthMatters@24/7 synchronous group 
O 
X 
O 
HealthMatters Train the Trainer 
O 
O 
Workshop (real-time synchronous 
 webinar training) asynchronous group 
 
 
Methods. We will convert the evidence based HealthMatters Train the Trainer Workshop for 
Instructors, real-time synchronous webinar training into HealthMatters@24/7, a continuous, e- 
learning environment to train staff to plan, conduct, and evaluate a 12-Week HealthMatters 
Program for people with IDD in residential and day/employment community-based organizations. 
 
HealthMatters™ Train the Trainer (TtT). is an evidence-based 6-hour training (synchronous 
and asynchronous) provides structured information on how to organize and start a tailored 
physical activity and health education program for people with intellectual and/or developmental 
disabilities (IDD) in community-based residential and day/vocational organizations. The training 
can enhance staff's skills, knowledge, and abilities to work with persons who have disabilities to 
become more physically active, make healthy food choices, and incorporate healthy lifestyle into 
daily living. Support staff will be given the following strategies and resources to improve health 
behaviors and health status of people with IDD: 
 

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o Asynchronous Virtual Coach: HealthMattersTM Program using Google Classroom; 
o paper-based Health Matters Curriculum; and, 
o Program Plan for your Virtual Coach: HealthMatters™ Program. 
 
Participants. A minimum of 20 CBOs with at least 3-member team totaling 60 staff will be 
recruited. CBOs enrolled in either synchronous or asynchronous group. Both groups will receive 
a form of training with an estimated reach of 160 individuals with IDD (not research 
participants). 
 
Measures. HO1, HO2, and HO4 Measures. Process Evaluation (assessment of changes in 
policy and fiscal strategic plans). Throughout the program, process evaluation will be used to 
continuously provide data for program improvement efforts and communicate new information 
through as many channels as possible to reach target audience. Process evaluation questions are 
in Appendix B. HO3 Measures will be collected using an online organizational HealthMatters 
Assessments (oHMA) via Qualtrics. oHMA evaluates organizational needs and capacity for 
developing a health promotion plan including programs, services, environmental support, 
resources, culture, and employee knowledge and skills to do health promoting activities. Please 
see Table 2 for reliability and validity information. Data will be collected from CBO staff before 
at baseline and at 1 year. Staff outcome expectations, barriers to exercise and nutrition, self- 
efficacy for health promotion and health promotion knowledge, and health advocacy will also be 
assessed via online HMAs. The data will be collected before HMP at baseline, 3, 12, and 24 
months after implementation of the HMP intervention. 
 
Table 2. Reliability and Validity of HealthMatters Assessments 
Organizational 
Capacity Checklist 
Reliability coefficients for the Organizational Capacity Checklist subscales 
(e.g., organization commitment, supportive health promotion policies, policies 
supporting staff to do health promotion, and organizational resources) ranged 
from .92 - .81. Test/retest correlations ranged from .83 - .74. 
Employee Capacity 
Checklist 
Reliability coefficients for the Employee Capacity Checklist subscales (e.g., 
confidence doing health promotion, agency policies, agency resources, and 
health promotion knowledge) ranged from a= .90 - .67. Test/retest ranged from 
.74 - .58. 
Exercise and Nutrition Outcome 
Expectations (OE); Barriers to 
Exercising and Nutrition 
OE: Exercise: a=.81; test/retest =.60; Nutrition: a=.81; test/retest 
=.59 
Barriers: Exercise: a= .88; test/retest = .54; Nutrition: a= .80; 
test/retest = .57 
Self-Efficacy for Teaching Exercise Activities 
(a= .94; test/retest = .68) 
 
Statistical Analysis Plan  
Data Analysis. With a minimum of 20 CBOs, 60 employees (30 in each group) and 160 
individuals with IDD (80 in each group) participating in the 12-week HealthMatters Program, 
the proposed project will have a 95% power to detect a small effect size of 0.08 between the 
HealthMatters@24/7 intervention and the HealthMatters Live webinar control groups using a 2- 
sided alpha 0.05 and an estimated intraclass correlation (ICC) of 0.5. While the actual effect size 

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is unknown due to its novel nature, the proposed sample size should be adequate to detect a 
minimum meaningful difference in study outcomes between the two experimental groups as we 
anticipate a small to moderate effect size resulting from the HealthMatters @ 24/7 e-Learning. 
 
Data were electronically collected throughout the project. Descriptive statistics will be obtained 
for all study variables. Tests of significance will be based on an alpha level of .05. Repeated 
measures analysis of variance (RM-ANOVA) will be employed to examine whether outcome 
measures of self-efficacy, barriers, outcome expectations, and health advocacy for DSP will be 
more favorable for the HealthMatters asyncrhonous group compared to syncrhonous group. 
Multi-level hierarchical liner modeling (HLM) analysis will be done to estimate separately the 
variance between DSPs within the same CBO, and the variance between CBOs. We will examine 
group-level and individual-level factors with multilevel analysis to allow for variance in outcome 
variables that can be analyzed at multiple hierarchical levels. 
 
Informed Consent Form. No informed consent form was needed. Per “Study IRB Protocol 
#2020-0754 Exempt Research” was determined under exemption category under 45 CFR 
46.101(b) in that information obtained was recorded in such a manner that no human subjects 
could be identified, directly or through identifiers linked to the study participants.