Rationale and Design of the Women’s Health And Daily Experiences Project: Protocol for an Ecological Momentary Assessment Study to Identify Real-Time Predictors of Midlife Women’s Physical Activity

Background Midlife women are at an elevated risk for cardiovascular disease (CVD) and associated mortality. Those who have additional risk conditions such as obesity or hypertension report specific barriers to engaging in cardioprotective behaviors such as physical activity (PA). Considerable effort has been devoted to understanding PA determinants and designing interventions for midlife women, although with suboptimal success, as increasing PA could meaningfully attenuate CVD risk. An updated approach to understanding PA among midlife women could improve upon existing resources by focusing on novel psychosocial influences on PA in this population (ie, body satisfaction, social interactions, social comparisons, mood state) and within-person relations between these influences and PA in the natural environment. Objective The overarching goal of Project WHADE (Women’s Health And Daily Experiences) is to use an ecological momentary assessment (EMA) approach to capture ecologically valid relations between midlife women’s psychosocial experiences and PA as they engage in their normal daily activities. The primary aim of the study is to identify within-person psychosocial predictors of variability in PA (ie, experiences associated with higher vs lower PA for a given individual). Methods Midlife women (aged 40-60 years) with one or more additional risk markers for CVD (eg, hypertension) will be recruited from primary care clinics and the general community (target n=100). Eligible women will complete an initial survey and a face-to-face baseline session before engaging in a 10-day EMA protocol. Psychosocial experiences will be assessed using a brief self-report via a smartphone 5 times per day, and PA will be assessed throughout waking hours using a research-grade monitor. Participants will return for a brief exit interview at the end of 10 days. Multilevel models that address the nested structure of EMA data will be used to evaluate the study aims. Results Recruitment and enrollment are ongoing, and a total of 75 women have completed the protocol to date. Data collection is expected to be completed in Fall 2020. Conclusions Project WHADE is designed to identify naturally occurring psychosocial experiences that predict short-term variability in midlife women’s PA. As such, the results of this study should advance the current understanding of PA among midlife women by providing further insight into within-person psychosocial influences on PA in this group. In the future, this information could help inform the design of interventions for this population. International Registered Report Identifier (IRRID) DERR1-10.2196/19044


RESUME AND SUMMARY OF DISCUSSION:
This is a resubmission of a K23 from Danielle Arigo, a clinical psychologist, who has proposed to study the psychosocial barriers to physical activity for midlife women and to develop a mobile health app to encourage activity. The Candidate continues to be a major strength of the current submission. While she is located at a university underrepresented in federal research funding, she has been successful in applying for intramural research funding and has recruited mentors from outside her university for the proposed studies (which was a point of discussion, but in the end, was thought to be more of a demonstration of her commitment to doing research rather than a potential weakness). Her Career Development Plan is well developed and she has eliminated training for programming/app development, and states that she will now collaborate with experts from her university. However, the Candidate did not provide assurances that a specific individual will collaborate with her -there is no letter of support provided to attest to this. This uncertainty and lack of specific details regarding app development (and funding) and, importantly, app maintenance/upgrading, was viewed as a serious weakness in the application. While the Candidate has been very responsive to many of the previous concerns, poor planning for the App development significantly decreased reviewer confidence for success, and in this project as a vehicle to help her reach research independence.

DESCRIPTION (provided by applicant):
Cardiovascular risk and mortality is uniquely elevated among midlife women due to factors such as menopause and gender differences in cardiovascular event symptom presentation. Physical activity (PA) is critical to reducing risk in midlife women; however, this group confronts distinctive psychosocial barriers to PA that rarely are addressed by existing interventions. Current evidence and the candidate's pilot data indicate that these barriers are negative mood, body satisfaction, and social comparison (i.e., evaluating one's PA relative to that of peers). Mobile health tools such as smartphone applications have the ability to intervene on these barriers in real time, but developing effective tools requires a sophisticated understanding of (1) when PA occurs and determinants of PA for particular individuals in their natural environments, and (2) the ability to optimize this information for mobile delivery. The proposed K23 training program will address these needs by focusing on the following training goals: ambulatory assessment of PA and its psychosocial determinants, advanced statistical methods, individual tailoring of PA programs (with an emphasis on mobile intervention development), women's health, and cardiovascular physiology. Training will include apprenticeships and tutorials with experts in each of these topics, as well as coursework in intensive ambulatory assessment, mobile application design, and physiology.
To support this plan, the proposed research will investigate PA and its determinants among midlife female primary care patients with cardiovascular risk markers. Aim 1 of this research is to examine relations between real-time psychosocial experiences (i.e., mood, body satisfaction, social comparison)

Research Plan: Strengths
 The candidate is addressing an important public health problem: the contribution of physical inactivity to cardiovascular risk and the determinants of this physical inactivity. In the first Aim, she will investigate the determinants of physical activity in women during midlife and in the second she will refine and pilot test a mobile application in overweight/obese midlife women with one additional CV risk factor.  Aim 2 is not dependent on Aim 1 because she already has pilot data upon which to base the Aim 2 mobile app work.  Has considered potential pitfalls and limitations.  Has thought about how the K23 project could generate preliminary data for an R01 application (in which she would propose a large-scale efficacy trial of her app).  Letter of collaboration from Prime Med Medical Group should help with study subject recruitment.

Weaknesses
 Reviewers of the A0 version of the K23 noted as a weakness that although a main goal of the candidate was to develop a mobile app, she had no training or plan for training in this area. Her response in this A1 application is that she will not be trained in this area but instead will work with software engineer at the University of Scranton, which she states has the expertise and is committed to provide these services. Yet there is no budget item for this, no specific collaborators identified with expertise in this area and no letter of collaboration between a specific software engineer. There is no description of the specific expertise or personnel who could provide this service. The sentence in the Institutional Commitment letter stating that she has "access to cutting-edge software development resources through our Computing Sciences Department and Software Engineering M.S. program, which is committed to supporting this work (e.g. offering consulting services as needed) is helpful but not entirely convincing. Identification of a collaborator who attested to his/her commitment to this project would have been a stronger response and would have gone a long way toward making it clear that the proposed project is feasible.

Candidate: Strengths
 As noted regarding the previous submission, the applicant has excellent potential for developing as an independent and productive researcher focusing on patient-oriented research. The candidate has outlined a logical progression of research, based on previous pilot work, that indicates a commitment to becoming an independent investigator focusing on patient-oriented research. She has done patient-oriented research in several settings. Letters of reference are very strong and indicate the high potential of the candidate for becoming an independent investigator. Weaknesses  None noted.

Career Development Plan/Career Goals & Objectives/Plan to Provide Mentoring: Strengths
 It was previously noted as a minor weakness that mentors are scattered among three institutions. On reflection, this is viewed as a strength: mentors demonstrate an exceptionally strong investment in the applicant, and the applicant demonstrates an exceptionally strong commitment to patient-oriented research.  Weaknesses noted in the previous submission have been adequately addressed. Specifically, the new emphasis on training in the translation of behavioral science principles to mobile health tools is a strength. Weaknesses  None noted.

Research Plan: Strengths
 Overall the research plan articulates a clear question that the candidate is uniquely situated to answer and has been working toward with pilot work. It is a logical next step in a progression that will launch the candidate toward her career objectives.  Most weaknesses noted in the previous submission have been adequately addressed, and the plan is generally strong. Weaknesses  In the pilot intervention, some prompts will require users to input psychosocial factors, and others will provide intervention content selected at random. I'm curious why the applicant didn't consider linking the two, such that intervention messages would be selected based on inputted psychosocial factors. This may increase programming complexity but also takes full advantage of the mobile health platform. The applicant does indicate that specifications are subject to modification based on knowledge developed via career development activities, so this or other options may be considered as the project unfolds.  It has been clarified that the applicant will achieve the software development via collaboration with the computing resources available at the University of Scranton. However, while within the same university, it hasn't been demonstrated that these resources can be feasibly accessed, for example by a Letter of Support from this department. Since there are no budgetary resources for software development, this type of arrangement can often depend heavily on faculty and student interest which is not conclusively demonstrated. There is a statement in the letter from the Dean of the College of Arts and Sciences indicating that the Computing Sciences Department is committed to supporting this work, however, so this is considered a relatively minor concern.