Randomized trial examining the effect of exercise and wellness interventions on preventing postpartum depression and perceived stress.

BACKGROUND: Approximately 13-19% of postpartum women experience postpartum depression and a majority report at least some stress during the postpartum phase. Traditional interventions such as psychotherapy and antidepressant medications are often not feasible or desirable. The purpose of this study was to examine two low cost, brief, accessible interventions designed to prevent postpartum depression and perceived stress among women at high risk. METHODS: Participants (n = 450) who were on average four weeks postpartum, had a history of depression before pregnancy, and exercised less than 60 min per week were randomly assigned to one of the following three conditions: (1) 6-month telephone-based exercise intervention; (2) 6-month telephone-based wellness/support intervention (e.g., healthy eating, sleep, and perceived stress); or (3) usual care. RESULTS: Overall, 2.4% of participants met criteria for depression at 6 months and 3.6% at 9 months with no differences between groups. At 6 months following randomization, median symptoms of depression were significantly lower among wellness participants compared to usual care participants (b = - 1.00, SE = 0.46, p = .03). Perceived stress at 6 months post-randomization was significantly lower among exercise vs. usual care participants (b = - 2.00, SE = .98, p = .04) and exercise vs. wellness participants (b = - 2.20, SE = 1.11, p = .04). CONCLUSIONS: The wellness intervention was efficacious for preventing symptoms of depression; however, postpartum depression that met the diagnostic criteria was surprisingly low in all conditions among this at risk sample of postpartum women. Exercise interventions may have a protective effect on perceived stress among women at risk for postpartum depression. Practitioners should consider integrating exercise and wellness interventions into postpartum care. TRIAL REGISTRATION: Clinical Trials Number: NCT01883479 (06/21/2013).

Feasibility trial of an unsupervised, facility-based exercise programme for depressed outpatients.

This pilot study examined feasibility of an unsupervised, facility-based exercise programme for promoting exercise adherence among depressed adult outpatients. The potential effect of adding physical activity counselling on depressive symptoms and physical activity was also explored. Participants were randomly assigned to a 12-week programme comprising an orientation and access to fitness centre resources (control, n = 18) or that programme plus 6 physical activity counselling sessions (intervention, n = 18). Outcome measures were feasibility (fitness centre attendance over 12 weeks); Beck Depression Inventory (BDI-II) and International Physical Activity Questionnaire (IPAQ) completed at baseline and week 12; and qualitative programme feedback. Fitness centre attendance averaged only 12 days (14% of all possible days) with no differences between study groups. No group differences were found on IPAQ or BDI-II scores at week 12. Increases from baseline in IPAQ moderate/vigorous activity minutes were associated with decreases in BDI-II scores at week 12 (p < 0.001). The most helpful programme aspect reported was connecting participants to fitness centre resources. In this pilot study of depressed outpatients, an unsupervised fitness centre based program was not feasible for promoting exercise adherence and adding physical activity counselling was not useful for increasing physical activity levels or reducing depression.

The effect of sleep pattern changes on postpartum depressive symptoms.

BACKGROUND: Research indicates that poor sleep is associated with postpartum depression; however, little is known regarding this relationship among postpartum women who are at high for postpartum depression. This study examined the relationship between changes in self-reported sleep patterns (from six weeks to seven months postpartum) and depressive symptoms at seven months postpartum among women who were at high risk for postpartum depression. METHODS: Participants (n = 122) were postpartum women who were at an increased risk for postpartum depression (personal or maternal history of depression) and had participated in a randomized exercise intervention trial. For the current trial, participants completed the Pittsburgh Sleep Quality Index and Patient Health Questionnaire-9 (PHQ-9; assessed depression) at six weeks and seven months postpartum. RESULTS: Overall, sleep problems significantly improved from six weeks to seven months postpartum. However, linear regression analyses indicated that worsening or minimal improvement of sleep problems were associated with higher depressive symptoms at seven month postpartum. Regarding the specific types of sleep problems, self-reported changes in sleep latency (i.e., how long it takes to fall asleep at night), daytime dysfunction (i.e., difficulty staying awake during the day), and sleep quality (i.e., subjective rating of sleep quality) were associated with higher levels of depressive symptoms. CONCLUSIONS: Sleep problems typically improve during the postpartum phase. However, postpartum women who are at high risk for postpartum depression are at an increased risk for depressive symptoms later in the postpartum phase if sleep problems worsen or show only minimal improvement over time. Therefore, at the six-week postpartum clinic visit, women should receive education regarding potential worsening of sleep patterns and strategies for preventing sleep-related problems. TRIAL REGISTRATION: Registered with ClinicalTrials.gov ( NCT00961402 ) on August 18, 2009 prior to the start of the trial.

Future directions in physical activity intervention research: expanding our focus to sedentary behaviors, technology, and dissemination.

Despite the increased health risks of a sedentary lifestyle, only 49 % of American adults participate in physical activity (PA) at the recommended levels. In an effort to move the PA field forward, we briefly review three emerging areas of PA intervention research. First, new intervention research has focused on not only increasing PA but also on decreasing sedentary behavior. Researchers should utilize randomized controlled trials, common terminology, investigate which behaviors should replace sedentary behaviors, evaluate long-term outcomes, and focus across the lifespan. Second, technology has contributed to an increase in sedentary behavior but has also led to innovative PA interventions. PA technology research should focus on large randomized trials with evidence-based components, explore social networking and innovative apps, improve PA monitoring, consider the lifespan, and be grounded in theory. Finally, in an effort to maximize public health impact, dissemination efforts should address the RE-AIM model, health disparities, and intervention costs.

Effect of Intrapersonal and Interpersonal Behavior Change Strategies on Physical Activity Among Older Adults: A Randomized Clinical Trial.

Importance: Despite guidelines that recommend physical activity (PA), little is known about which types of behavior change strategies (BCSs) effectively promote sustained increases in PA in older adults who are insufficiently active. Objective: To determine whether intrapersonal BCSs (eg, goal setting) or interpersonal BCSs (eg, peer-to-peer sharing or learning) combined with the Otago Exercise Program (17 strength and balance exercises and a walking program that are learned and individually tailored, with instruction to perform 3 times per week at home or location of choice) and a wearable PA monitor help older adults sustain increases in their PA. Design, Setting, and Participants: This 2 × 2 factorial randomized clinical trial (Community-Based Intervention Effects on Older Adults' Physical Activity) of community-dwelling older adults 70 years or older with PA levels below minimum national PA guidelines was conducted in urban community centers. Dates of enrollment were from November 17, 2017, to June 15, 2021, with final follow-up assessments completed on September 2, 2022. Interventions: Participants were randomized to intrapersonal (eg, goal setting) BCSs, interpersonal (eg, problem-solving with peer-to-peer sharing and learning) BCSs, intrapersonal and interpersonal BCSs, or an attention control group. All interventions included a PA monitor and 8 weekly small-group meetings with discussion, practice, and instructions to implement the exercise program and relevant BCSs independently between meetings and after the intervention. Main Outcomes and Measures: The primary outcome was daily minutes of objectively measured total PA (light, moderate, or vigorous intensities) averaged over 7 to 10 days, measured at baseline and after the intervention at 1 week, 6 months, and 12 months. Results: Among 309 participants (mean [SD] age, 77.4 [5.0] years; 240 women [77.7%]), 305 (98.7%) completed the intervention, and 302 (97.7%) had complete data. Participants receiving PA interventions with interpersonal BCS components exhibited greater increases in total PA than did those who did not at 1 week (204 vs 177 PA minutes per day; adjusted difference, 27.1 [95% CI, 17.2-37.0]; P < .001), 6 months (195 vs 175 PA minutes per day; adjusted difference, 20.8 [95% CI, 10.0-31.6]; P < .001), and 12 months (195 vs 168 PA minutes per day; adjusted difference, 27.5 [95% CI, 16.2-38.8]; P < .001) after the intervention. Compared with participants who did not receive interventions with intrapersonal BCS components, participants who received intrapersonal BCSs exhibited no significant changes in total PA at 1 week (192 vs 190 PA minutes per day; adjusted difference, 1.8 [95% CI, -8.6 to 12.2]; P = .73), 6 months (183 vs 187 PA minutes per day; adjusted difference, -3.9 [95% CI, -15.0 to 7.1]; P = .49), or 12 months (177 vs 186 PA minutes per day; adjusted difference, -8.8 [95% CI, -20.5 to 2.9]; P = .14) after the intervention. Interactions between intrapersonal and interpersonal BCSs were not significant. Conclusions and Relevance: In this randomized clinical trial, older adults with low levels of PA who received interpersonal BCSs, the exercise program, and a PA monitor exhibited significant increases in their PA for up to 12 months after the intervention. Intrapersonal BCSs elicited no significant PA changes and did not interact with interpersonal BCSs. Our findings suggest that because effects of a PA intervention on sustained increases in older adults' PA were augmented with interpersonal but not intrapersonal BCSs, approaches to disseminating and implementing the intervention should be considered. Trial Registration: ClinicalTrials.gov Identifier: NCT03326141.

Supervised exercise versus primary stenting for claudication resulting from aortoiliac peripheral artery disease: six-month outcomes from the claudication: exercise versus endoluminal revascularization (CLEVER) study.

BACKGROUND: Claudication is a common and disabling symptom of peripheral artery disease that can be treated with medication, supervised exercise (SE), or stent revascularization (ST). METHODS AND RESULTS: We randomly assigned 111 patients with aortoiliac peripheral artery disease to receive 1 of 3 treatments: optimal medical care (OMC), OMC plus SE, or OMC plus ST. The primary end point was the change in peak walking time on a graded treadmill test at 6 months compared with baseline. Secondary end points included free-living step activity, quality of life with the Walking Impairment Questionnaire, Peripheral Artery Questionnaire, Medical Outcomes Study 12-Item Short Form, and cardiovascular risk factors. At the 6-month follow-up, change in peak walking time (the primary end point) was greatest for SE, intermediate for ST, and least with OMC (mean change versus baseline, 5.8±4.6, 3.7±4.9, and 1.2±2.6 minutes, respectively; P<0.001 for the comparison of SE versus OMC, P=0.02 for ST versus OMC, and P=0.04 for SE versus ST). Although disease-specific quality of life as assessed by the Walking Impairment Questionnaire and Peripheral Artery Questionnaire also improved with both SE and ST compared with OMC, for most scales, the extent of improvement was greater with ST than SE. Free-living step activity increased more with ST than with either SE or OMC alone (114±274 versus 73±139 versus -6±109 steps per hour), but these differences were not statistically significant. CONCLUSIONS: SE results in superior treadmill walking performance than ST, even for those with aortoiliac peripheral artery disease. The contrast between better walking performance for SE and better patient-reported quality of life for ST warrants further study. CLINICAL TRIAL REGISTRATION: URL: http://clinicaltrials.gov/ct/show/NCT00132743?order=1. Unique identifier: NCT00132743.

Healthy for life: a randomized trial examining physical activity outcomes and psychosocial mediators.

BACKGROUND: Researchers theorize that interventions increase physical activity by influencing key theory-based mediators (e.g., behavioral processes). However, few studies have been adequately powered to examine the importance of mediators. PURPOSE: This study examined both physical activity behavior and psychosocial mediators in a randomized trial specifically powered to detect mediation. METHODS: Healthy, sedentary adults (n = 448; 70 % Caucasian, 87 % women, mean age was 43) were randomly assigned to either a 6-month print-based theory tailored physical activity intervention (n = 224) or a 6-month health/wellness contact control arm (n = 224). RESULTS: The print intervention arm exhibited greater increases in physical activity than the control arm at 6 and 12 months (p < .05). Additionally, behavioral processes were found to be an important mediator of physical activity behavior. CONCLUSIONS: It is important for researchers and practitioners to focus on increasing behavioral strategies for physical activity adoption. Future studies should examine other potential mediators of physical activity.

Evaluating the feasibility and efficacy of a home-based combined high intensity interval and moderate intensity training program for increasing physical activity among low-active adults: A randomized pilot trial.

BACKGROUND: High intensity interval training (HIIT), which includes short bursts of high-intensity physical activity (PA) followed by recovery, can increase PA by addressing time barriers and improving PA enjoyment. The purpose of this pilot study was to examine the feasibility and preliminary efficacy of a home-based HIIT intervention on PA. METHODS: Low active adults (n = 47) were randomly assigned to a home-based HIIT intervention or wait-list control lasting 12 weeks. Participants in the HIIT intervention received motivational phone sessions based on Self-Determination Theory and accessed a website that included workout instructions and videos demonstrating proper form. RESULTS: The HIIT intervention appears feasible based on retention, recruitment, adherence to the counseling sessions, follow-up rates, and the consumer satisfaction survey. HIIT participants reported more minutes of vigorous intensity PA at six weeks relative to control (no differences at 12 weeks). HIIT participants reported higher levels of self-efficacy for PA, enjoyment of PA, outcome expectations related to PA, and positive engagement with PA than the control. CONCLUSIONS: This study provides evidence for feasibility and possible efficacy of a home-based HIIT intervention for vigorous intensity PA; however, additional studies are needed with larger samples sizes to confirm efficacy of home-based HIIT interventions. TRIAL REGISTRATION: Clinical Trials Number: NCT03479177.

Technical Assistance Received by Older Adults to Use Commercially Available Physical Activity Monitors (Ready Steady 3.0 Trial): Ad-Hoc Descriptive Longitudinal Study.

Background: Despite evidence that regular physical activity (PA) among older adults confers numerous health and functional benefits, PA participation rates are low. Using commercially available wearable PA monitors (PAMs) is one way to augment PA promotion efforts. However, while expert recommendations exist for the specific information needed at the beginning of PAM ownership and the general ongoing need for structures that support as-needed technical troubleshooting, information is lacking about the type, frequency, and modes of assistance needed during initial and long-term ownership. Objective: This paper describes problems reported and technical assistance received by older adults who used PAMs during the 18 months they participated in a community-based PA trial: Ready Steady 3.0 (RS3). Methods: This was an ad-hoc longitudinal analysis of process variables representing technical problems reported and assistance received by 113 RS3 study participants in the 18 months after their orientation to PAMs. Variables included date of contact, problem(s) reported, mode of technical assistance, and whether the equipment was replaced. The descriptive analysis included frequencies and incidence rates of distinct contacts, types of problems, and technical assistance modes. Results: On average, participants were aged 77 (SD 5.2) years. Most identified as female (n=87, 77%), reported experience using smartphones (n=92, 81.4%), and used the PAM between 2 and 18 months. Eighty-two participants (72.6%) reported between 1 to 9 problems with using PAMs, resulting in a total of 150 technical assistance contacts with a mean of 1.3 (SD 1.3) contacts. The incidence rate of new, distinct contacts for technical assistance was 99 per 100 persons per year from 2018 to 2021. The most common problems were wearing the PAM (n=43, 28.7%), reading its display (n=23, 15.3%), logging into its app (n=20, 13.3%), charging it (n=18, 12%), and synchronizing it to the app (n=16, 10.7%). The modalities of technical assistance were in person (n=53, 35.3%), by telephone (n=51, 34%), by email (n=25, 16.7%), and by postal mail (n=21, 14%). Conclusions: In general, the results of this study show that after receiving orientation to PAMs, problems such as uncomfortable wristbands, difficulty using the PAM or its related app, and obtaining or interpreting relevant personal data were occasionally reported by participants in RS3. Trained staff helped participants troubleshoot and solve these technical problems primarily in person or by phone. Results also underscore the importance of involving older adults in the design, usability testing, and supportive material development processes to prevent technical problems for the initial and ongoing use of PAMs. Clinicians and researchers should further assess technical assistance needed by older adults, accounting for variations in PAM models and wear time, while investigating additional assistance strategies, such as proactive support, short GIF videos, and video calls.

Rethinking how and when to report descriptions of behavior change content within interventions: a case study of an ongoing physical activity trial (ready steady 3.0).

Specifications of what and how much health behavior change (BC) content within research interventions are needed to advance BC science, its implementation, and dissemination. We analyzed the types and dosages of the smallest potentially active BC ingredients and associated behavioral prescriptions intended to be delivered in an ongoing physical activity optimization trial for older adults (Ready Steady 3.0 [RS3]). We defined BC types as behavior change techniques (BCT) and behavioral prescriptions. Our protocol integrated the BCT Taxonomy coding procedures with BCT roles (primary or secondary) and, when relevant, linkages to behavioral prescriptions. Primary BCTs targeted theoretical mechanisms of action, whereas secondary BCTs supported primary BCT delivery. Behavioral prescriptions represented what participants were encouraged to do with each primary BCT in RS3 (ascertain, practice, implement). We assessed dosage parameters of duration, frequency, and amount in each BCT and prescription. Results provided a catalog of in-depth, multidimensional content specifications with 12 primary BCTs, each supported by 2-7 secondary BCTs, with dosages ranging from 2 to 8 weeks, 1 to 8 contacts, and 5 to 451 minutes. Minutes spent on behavioral prescriptions varied: ascertain (1 to 41), practice (5 to 315), and implement (0 to 38). Results can be organized and summarized in varied ways (e.g., by content component) to strengthen future assessments of RS3 fidelity and intervention refinement. Results highlight potential benefits of this early, integrated approach to analyzing BC content and frames questions about how such information might be incorporated and disseminated with reporting research outcomes.

The focus of this case study was to assess what and how much behavior change content was within an intervention still under development­by integrating existing frameworks for classifying behavior change techniques, dosages, and behavioral prescriptions. Findings provide the first set of procedures available for collecting, coding, and analyzing data representing the types of behavior change techniques in an intervention, their durations, frequencies, and amounts, and their linkages to what participants are asked to do. Applying these procedures to the protocol and materials in an ongoing study (Ready Steady 3.0) yielded a detailed, multidimensional catalog of the smallest potentially active behavior change ingredients in its intervention, including behavior change techniques, intended uses, and intended dosages. Findings also showcased how this information can be summarized and organized in various ways to strengthen fidelity evaluations and future intervention development. Researchers can use and adapt these new procedures for reporting behavior change content within individual intervention studies. Findings also highlight the potential benefits of this early, integrated approach to analyzing behavior change content and frame questions about how such information might be incorporated and disseminated with reporting research outcomes.