Pilot Testing an Innovative Physical Activity Intervention for Parents
Phase: NA
Conditions: Physical Inactivity
Sponsor: Brown University

SA1. Community Advisory Board (CAB). We will engage a CAB of 6-8 Mount Hope Cowboys 
(MHC) coaches and mothers to partner with us and guide decisions about intervention 
adaptation and refinement, including content and structure. Information will be solicited to guide 
the development of the in-person physical activity (PA) sessions (types of fitness activities, 
duration, etc.) before the intervention begins. Once underway, the CAB will provide input on 
issues related to intervention implementation and ideas for future refinement. Feedback will be 
provided via biweekly in-person or virtual meetings facilitated by Dr. von Ash and a bilingual 
staff member. CAB meetings will be audio-recorded and detailed notes will be taken. CAB 
members will be incentivized $200 ($25 per meeting) for their time. 
 
SA2. Open Pilot Trial. After modifying the intervention content and structure, we will then test it 
in an 8-week open pilot with a single group of 45 mothers (all receiving the intervention). The 
intervention will consist of in-person PA sessions (offered 3 times/week, with participants 
encouraged to participate at least twice), 2 goal setting sessions, and weekly written materials 
(e.g., brochures and tip sheets). Participants will complete 4 assessments (baseline, 4-weeks, 
8-weeks (i.e., intervention end), and 1-month follow-up), the last of which will include an exit 
interview; 15 participants, chosen at random, will also be invited to complete an in-depth 
interview. Pre and post assessments and interviews will allow us to assess feasibility and 
acceptability (SA2a) and identify the potential impact of the intervention on mothers’ PA (SA2b). 
 
Intervention Description. While the final content and structure of the intervention will be 
informed by Specific Aim 1, participants will receive a culturally adapted, Social Cognitive 
Theory (SCT) and Transtheoretical Model- (TTM) based PA intervention. The evidence-
based, theory guided aerobic PA intervention will systematically builds upon our prior 
studies and includes the following components: Goal setting. At baseline, participants will 
complete an in-person or Zoom goal-setting session based on motivational interviewing where 
they will learn about the benefits of MVPA, key behavior change techniques such as goal-
setting and self-monitoring and establish personal PA goals. They will be assisted in developing 
a plan for gradually building up to 150 minutes of MVPA per week over 8 weeks and will discuss 
potential barriers and learn problem solving skills. Any participants already meeting the 150 
min/week MVPA guideline will be assisted in developing a plan for sustaining their PA and 
achieving other PA goals. Midway through the intervention, participants will complete a second 
goal-setting session. In-person PA sessions. Participants will be invited to participate in PA 
sessions during their child’s practice. Sessions will be offered 3 days/week, and participants 
will be encouraged to attend at least 2 sessions/week during the 8-week intervention. 
Sessions will last for 50 minutes, with the intention that attending all 3 sessions per week 
would allow participants to meet the recommended 150 minutes of MVPA per week. The time 
of the sessions (i.e., whether in the middle, first, or second of hour of practice) will be informed 
by the CAB, with all sessions including aerobic activities that encourage MVPA (jogging, 
jumping jacks, etc.). Participants will learn about proper form, movement techniques, safety, and 
injury prevention, and be given demonstrations on how to properly do each exercise using their 
own body weight or basic equipment that will be provided (e.g., resistance bands, jump ropes, 
small weights). Childcare, with age-appropriate movement activities, will provided for mothers 
with additional children not practicing. The PA equipment will be gifted to the MHC at the end of 
the intervention for continued use by mothers during practice. Written materials. Participants 
will be emailed brochures and tip sheets weekly throughout the intervention. Materials 
include motivation-matched PA manuals (based on baseline and week 4 assessments), tip 
sheets (on stretching, boredom, places to be active, etc.) and computer expert system-
tailored PA feedback reports which draw from a bank of over 330 messages targeting 
different levels of SCT and TTM constructs (motivational readiness, self-efficacy, self-

regulation, processes of change, social support, outcome expectancies, and enjoyment for 
PA). 
 
Overview of Procedures. Prior to the intervention, participants will be screened for 
eligibility, consented, and complete the baseline assessment. A goal-setting session will 
also be completed prior to beginning the in-person PA sessions and receiving print-based 
materials. Additional assessments will be conducted at 4-week (including a second goal 
setting session), 8-week (intervention end), and at 1-month follow-up. The purpose of the 1-
month follow-up assessment is to see if the intervention has a sustained impact on parent 
PA (e.g., they continue to utilize the PA equipment and practice time to be active). 
 
Measures. Assessments, conducted at practice, will be used to examine intervention 
feasibility, acceptability, and satisfaction, and effects, and to provide data for the tailoring 
expert system to function.Intervention feasibility, acceptability, usability, and satisfaction. 
Feasibility will be determined based on whether enrollment (i.e., 10-12 participants per week), 
retention (i.e., >80% of participants through 8 weeks), and assessment (i.e., obtain usable PA 
data from >80% of participants) targets are achieved. Acceptability will be determined based on 
participant engagement with the intervention during the study period (i.e., >80% of participants 
attended at least 2 in-person sessions per week) and by assessing the degree to which 
participants find the intervention beneficial using Likert-type scales. Satisfaction will be 
assessed using an adapted version of the Consumer Satisfaction Measure, used by our 
research team in past trials and adapted for this study, and the Client Satisfaction 
Questionnaire. The intervention will be deemed satisfactory if >80% of participants report a 
“good” acceptability or higher. Participants will complete an exit interview to assess the 
acceptability of the intervention components, duration, and structure. They will also be asked 
which components they found most/least helpful, whether they would recommend the 
intervention to others if offered again, and if they felt the intervention had an impact. Primary 
outcome for examining intervention effects on PA. Participants will complete a 7-Day PAR 
Interview at each assessment (baseline, 4-weeks, at the end of the intervention, and at 1-
month follow-up) to assess minutes of MVPA per week. This self-report instrument provides 
an estimate of total weekly minutes of MVPA and has been used across many studies. It 
has consistently demonstrated acceptable reliability, internal consistency, and congruent 
validity with other more objective PA measures  along with sensitivity to changes in both 
moderate and intensive levels of PA. Our team has extensive experience with administering 
this instrument, which requires annual recertification. Potential moderators and mediators. 
Demographics, assessed at baseline, include age, education, income, race, marital status, 
employment and occupation, country of birth, and length of residence in U.S. Other 
potential moderators and mediators include SCT and TTM constructs, which will also be 
assessed for the purposes of tailoring print materials. Stages of Change for Physical 
Activity measure has successfully been used to stage-match treatment in our trials and 
has shown acceptable reliability (Kappa = 0.78; intraclass correlation r = 0.84) and 
concurrent validity with measures of self-efficacy and current PA levels. Processes of 
Change for Physical Activity (POC) measure contains 10 subscales that address a 
variety of cognitive/behavioral processes related to PA behavior change. Internal 
consistency of the subscales range from .62 to .96. Self-Efficacy For Physical Activity 
(SE) measures self-efficacy to become physically active across diverse contexts. The 
internal consistency is acceptable (alpha = .82). Social Support for Exercise (SSE) has 
three subscales (Family, Friends, Rewards/ Punishments) and acceptable internal 
consistency (alphas .61-.91) and criterion validity. Physical Activity Enjoyment Scale 
(PACES) assesses level of personal satisfaction from PA. The measure has high internal 

consistency (alpha = 0.96) and test-retest reliability. Outcome Expectations Scale 
assesses beliefs regarding the consequences of PA participation will be examined by 9 
items with internal consistency (alpha=.89) and validity based on confirmatory factor 
analysis and positive correlations with PA and self-efficacy.  
 
Data Analysis. Dr. Dunsiger, the study biostatistician, will provide guidance and oversee data 
analysis. 
SA 2a. We will descriptively (means, proportions) analyze the post-intervention feasibility, 
acceptability, and satisfaction data. The qualitative exit interviews with participants will be audio 
recorded, transcribed, coded, and analyzed to determine how the intervention can be 
strengthened. The mixed methods findings will be used to refine the intervention content, 
structure, and assessments for future iterations of the intervention. SA 2b. Consistent with Aim 
2b we will first examine within-person changes over time in PA outcomes (self-reported 
min/week of MVPA and a binary indicator of meeting national PA guidelines). Specifically, a 
longitudinal mixed effects model will regress min/week MVPA at end of treatment (8 weeks) and 
1-month follow-up on baseline MVPA, time, and confounders identified a priori (e.g., age). 
Contrasts can be used to examine changes from baseline to 8 weeks in PA behavior, as well as 
changes 8 weeks to 1 month-follow up (to understand potential maintenance of behavior). 
Models will include a subject specific intercept to account for repeated measures within person 
over time. Next, a longitudinal model implemented with Generalized Estimating Equations with 
robust standard errors will be used to examine changes in meeting the national guideline of 
more than 150 min/week of MVPA over time controlling for baseline value of the indicator and 
potential confounders. This model will be specified to allow us to estimate whether the odds of 
meeting guidelines changed over time. In both cases (continuous and binary PA outcomes), 
interest is in estimating effect sizes rather than strict statistical hypothesis testing. Finally, a 
similar analytic strategy will be used to examine dose effects on both PA outcomes (by including 
a predictor in the model which counts the number of sessions attended/week).  Models will be 
run using the fully enrolled sample under various assumptions of missing data and effects 
compared between models (for example, a multiple imputation approach vs. a likelihood-based 
approach to estimation).