Attention Control Arm Research Articles

Impact of the Physical Activity Environment on Change in Body Mass Index Percentile in Child Care Centers Serving Children with Disabilities.

Childcare centers (CCCs) can provide opportunities to implement physical activity (PA) via health promotion interventions to prevent obesity and associated chronic disease risk factors in young children. This study evaluated the impact of the Healthy Caregivers-Healthy Children (HC2) intervention on body mass index percentile (PBMI) and the PA environment in CCCs serving children with disabilities (CWD) over one school year. Ten CCCs were cluster-randomized to either (1) an intervention arm that received the HC2 curriculum adapted for CWD or (2) an attention control arm. Mixed-effect linear regression models analyzed the relationship between change in child PBMI and CCC childcare center PA environment by experimental condition and child disability status over one school year. Findings showed a significant decrease in PBMI among children in the HC2 centers (-6.74, p = 0.007) versus those in control centers (-1.35, p = 0.74) over one school year. Increased PA staff behaviors (mean change 3.66, p < 0.001) and PA policies (mean change 6.12, p < 0.001) were shown in intervention centers during the same period. Conversely, there was a significant increase in sedentary opportunities (mean change 4.45, p < 0.001) and a decrease in the portable play environment (mean change -3.16, p = 0.03) and fixed play environment (mean change -2.59, p = 0.04) in control centers. No significant differences were found in PBMI changes between CWD and children without disabilities (beta = 1.62, 95% CI [-7.52, 10.76], p = 0.73), suggesting the intervention's efficacy does not differ by disability status. These results underscore the importance of (1) including young CWD and (2) PA and the supporting environment in CCC health promotion and obesity prevention interventions.

Sociodemographic predictors of successful screening and subsequent randomization in a digital health hypertension intervention.

Clinical trials often enroll nonrepresentative participant samples, limiting generalizability of trial findings. The current analysis explores the influences of remote recruitment and screening protocols on participation in a digital health intervention (DHI) to promote the evidence-based Dietary Approaches to Stop Hypertension (DASH) eating pattern. Nourish was a 12-month randomized controlled trial comparing the effectiveness of a DHI to an attention control arm among US adults with hypertension. Participants were recruited using digital approaches; eligible individuals completed several screening steps. We examined associations between sociodemographics and mobile technology use and completion of each screening step and compared those characteristics between randomized and nonrandomized participants (those consented but were screened out before randomization). A total of 678 adults consented to participate in Nourish; 44% of those consented were randomized (n = 301). Those randomized possessed a higher education level (p < 0.0001); were more likely to use health-related apps (p < 0.0001) and wearables (p < 0.0001); and were older (p = 0.01) than nonrandomized individuals. Randomized adults were more likely to use a desktop/laptop/tablet for Internet access (vs mobile phones) (p = 0.01). No significant association was observed existed between sex, race, ethnicity, income, or geographic density of residence and subsequent randomization. Participants with lower education levels or limited experience in using mobile technologies may require additional support to participate in DHIs. Future research is needed to evaluate remote clinical trial procedures and impacts on generalizability to achieve equitable clinical trial participation.

Ensuring Intervention Fidelity of an Attention Control Arm in a Multisite Randomized Controlled Trial.

Intervention fidelity is a critical element of randomized controlled trials, yet reporting of intervention fidelity among attention control arms is limited. Lack of fidelity to attention control procedures can affect study outcomes by either overestimating or underestimating the efficacy of the intervention under examination. This brief report describes the approach researchers took to promote fidelity to the attention control arm of a pediatric palliative care randomized controlled trial funded by the National Institutes of Health. The Informational Meetings for Planning and Coordinating Treatment trial aims to determine the efficacy of a communication intervention that uses care team dyads (i.e., physicians partnered with nurses or advanced practice providers) to engage parents of children with cancer who have a poor prognosis in structured conversations about prognostic information, goals of care, and care planning. The intervention is compared with an attention control arm, which provides parents with structured conversations on common pediatric cancer education topics, such as talking to their child about their cancer, clinical trials, cancer treatment, side effects, and so forth. National Institutes of Health guidelines for assessing and implementing strategies to promote intervention fidelity were used to design (a) the attention control arm of a randomized controlled trial, (b) related attention control arm training, and (c) quality assurance monitoring. Attention control study procedures were designed to mirror that of the intervention arm (i.e., same number, frequency, and time spent in study visits). Cluster randomization was used to allocate care team dyads to one arm of the randomized controlled trial. Care team dyads assigned to the attention control arm participated in online training sessions to learn attention control procedures, the different roles of research team members, and quality assurance methods. Fidelity to attention control procedures is assessed by both the interveners themselves and a quality assurance team. Study design, training, and delivery are all critical to attention control fidelity. Baseline training often needs to be supplemented with booster training when time gaps occur between study start-up and implementation. Quality assurance procedures are essential to determine whether interveners consistently deliver attention control procedures correctly.

Secure Messaging Intervention in Patients Starting New Antidepressant to Promote Adherence: Pilot Randomized Controlled Trial.

There are a range of effective pharmacological and behavioral treatments for depression. However, approximately one-third of patients discontinue antidepressants within the first month of treatment and 44% discontinue them by the third month of treatment. The major reasons reported for discontinuation were side effect burden, patients experiencing that the medications were not working, and patients wanting to resolve their depression without using medication. This study tested the acceptability, feasibility, and preliminary effectiveness of an SMS messaging intervention designed to improve antidepressant adherence and depression outcomes in veterans. The intervention specifically targeted the key reasons for antidepressant discontinuation. For example, the secure message included reminders that it can take up to 6 weeks for an antidepressant to work, or prompts to call their provider should the side effect burden become significant. This pilot was a 3-armed randomized controlled trial of 53 veterans undergoing depression treatment at the Iowa City Veterans Affairs Health Care System. Veterans starting a new antidepressant were randomized to secure messaging only (SM-Only), secure messaging with coaching (SM+Coach), or attention control (AC) groups. The intervention lasted 12 weeks with follow-up assessments of key outcomes at 6 and 12-weeks. This included a measure of antidepressant adherence, depressive symptom severity, and side effect burden. The 2 active interventions (SM-Only and SM+Coach) demonstrated small to moderate effect sizes (ESs) in improving antidepressant adherence and reducing side effect burden. They did not appear to reduce the depressive symptom burden any more than in the AC arm. Veteran participants in the SM arms demonstrated improved medication adherence from baseline to 12 weeks on the Medication Adherence Rating Scale compared with those in the AC arm, who had a decline in adherence (SM-Only: ES=0.09; P=.19; SM+Coach: ES=0.85; P=.002). Depression scores on the 9-Item Patient Health Questionnaire decreased for all 3 treatment arms, although the decline was slightly larger for the SM-Only (ES=0.32) and the SM+Coach (ES=0.24) arms when compared with the AC arm. The 2 intervention arms indicated a decrease in side effects on the Frequency, Intensity, and Burden of Side Effects Ratings, whereas the side effect burden for the AC arm increased. These differences indicated moderate ES (SM-Only vs AC: ES=0.40; P=.07; SM+Coach: ES=0.54; P=.07). A secure messaging program targeting specific reasons for antidepressant discontinuation had small-to-moderate ES in improving medication adherence. Consistent with prior research, the intervention that included brief synchronic meetings with a coach appeared to have a greater benefit than the SMS-alone intervention. Veterans consistently engaged with the SMS messaging in both treatment arms throughout the study period. They additionally provided feedback on which texts were most helpful, tending to prefer messages providing overall encouragement rather than specific wellness recommendations. ClinicalTrials.gov NCT03930849; https://clinicaltrials.gov/study/NCT03930849.

A blended preconception lifestyle programme for couples undergoing IVF: lessons learned from a multicentre randomized controlled trial.

What is the effect of a blended preconception lifestyle programme on reproductive and lifestyle outcomes of couples going through their first 12 months of IVF as compared to an attention control condition? This randomized controlled trial (RCT) was stopped prematurely because of the coronavirus disease 2019 (Covid-19) pandemic but the available data did not suggest that a blended preconception lifestyle programme could meaningfully affect time to ongoing pregnancy or other reproductive and lifestyle outcomes. Increasing evidence shows associations between a healthy lifestyle and IVF success rates. Lifestyle programmes provided through a mobile phone application have yet to be evaluated by RCTs in couples undergoing IVF. A multicentre RCT (1:1) was carried out. The RCT started in January 2019 and was prematurely stopped because of the Covid-19 pandemic, leading to a reduced sample size (211 couples initiating IVF) and change in primary outcome (cumulative ongoing pregnancy to time to ongoing pregnancy). Heterosexual couples initiating IVF in five fertility clinics were randomized between an attention control arm and an intervention arm for 12 months. The attention control arm received treatment information by mobile phone in addition to standard care. The intervention arm received the blended preconception lifestyle (PreLiFe)-programme in addition to standard care. The PreLiFe-programme included a mobile application, offering tailored advice and skills training on diet, physical activity and mindfulness, in combination with motivational interviewing over the telephone. The primary outcome was 'time to ongoing pregnancy'. Secondary reproductive outcomes included the Core Outcome Measures for Infertility Trials and IVF discontinuation. Changes in the following secondary lifestyle outcomes over 3 and 6 months were studied in both partners: diet quality, fruit intake, vegetable intake, total moderate to vigorous physical activity, sedentary behaviour, emotional distress, quality of life, BMI, and waist circumference. Finally, in the intervention arm, acceptability of the programme was evaluated and actual use of the mobile application part of the programme was tracked. Analysis was according to intention to treat. A total of 211 couples were randomized (105 control arm, 106 intervention arm). The hazard ratio of the intervention for time to ongoing pregnancy was 0.94 (95% CI 0.63 to 1.4). Little to no effect on other reproductive or lifestyle outcomes was identified. Although acceptability of the programme was good (6/10), considerable proportions of men (38%) and 9% of women did not actively use all the modules of the mobile application (diet, physical activity, or mindfulness). The findings of this RCT should be considered exploratory, as the Covid-19 pandemic limited its power and the actual use of the mobile application was low. This is the first multicentre RCT evaluating the effect of a blended preconception lifestyle programme for women and their partners undergoing IVF on both reproductive and lifestyle outcomes. This exploratory RCT highlights the need for further studies into optimal intervention characteristics and actual use of preconception lifestyle programmes, as well as RCTs evaluating effectiveness. Supported by the Research foundation Flanders (Belgium) (FWO-TBM; reference: T005417N). No competing interests to declare. ClinicalTrials.gov Identifier: NCT03790449. 31 December 2018. 2 January 2019.

Effect of Exercise on Chemotherapy-Induced Peripheral Neuropathy Among Patients Treated for Ovarian Cancer

Chemotherapy-induced peripheral neuropathy (CIPN), one of the most common and severe adverse effects of chemotherapy, is associated with worse quality of life among survivors of ovarian cancer. Currently, there is no effective treatment for CIPN. To evaluate the effect of a 6-month aerobic exercise intervention vs attention-control on CIPN among women treated for ovarian cancer in the Women's Activity and Lifestyle Study in Connecticut (WALC) to provide evidence to inform the guidelines and recommendations for prevention or treatment of CIPN. This prespecified secondary analysis evaluated the Women's Activity and Lifestyle Study in Connecticut (WALC), a multicentered, open-label, population-based, phase 3 randomized clinical trial of an aerobic exercise intervention vs attention control for CIPN in patients who were diagnosed with ovarian cancer. Only WALC participants who received chemotherapy were included in this analysis. Participants were randomized 1:1 to either a 6-month aerobic exercise intervention or to attention control. All analyses were conducted between September 2022 and January 2023. The exercise intervention consisted of home-based moderate-intensity aerobic exercise facilitated by weekly telephone counseling from an American College of Sports Medicine/American Cancer Society-certified cancer exercise trainer. Attention control involved weekly health education telephone calls from a WALC staff member. Change in CIPN was the primary outcome in this secondary analysis. This outcome was represented by CIPN severity, which was self-measured by participants at baseline and 6 months using the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity scale, with a score range of 0 to 44. A mixed-effects model was used to assess the 6-month change in CIPN between the exercise intervention and attention control arms. Of the 134 participants (all females; mean [SD] age, 57.5 [8.3] years) included in the analysis, 69 were in the exercise intervention arm and 65 were in the attention control arm. The mean (SD) time since diagnosis was 1.7 (1.0) years. The mean (SD) baseline CIPN scores were 8.1 (5.6) in the exercise intervention arm and 8.8 (7.9) in the attention control arm (P = .56). At 6 months, the self-reported CIPN score was reduced by 1.3 (95% CI, -2.3 to -0.2) points in the exercise intervention arm compared with an increase of 0.4 (95% CI, -0.8 to 1.5) points in the attention control arm. The between-group difference was -1.6 (95% CI, -3.1 to -0.2) points. The point estimate was larger among the 127 patients with CIPN symptoms at enrollment (-2.0; 95% CI, -3.6 to -0.5 points). Findings of this secondary analysis of the WALC trial indicate that a 6-month aerobic exercise intervention vs attention control significantly improved self-reported CIPN among patients who were treated for ovarian cancer. While replication of the findings in other studies is warranted, incorporating referrals to exercise programs into standard oncology care could reduce CIPN symptoms and increase quality of life in patients with ovarian cancer. ClinicalTrials.gov Identifier: NCT02107066.

A Mobile App to Support Self-Management in Patients with Multiple Myeloma or Chronic Lymphocytic Leukemia: Pilot Randomized Controlled Trial.

Patients with blood cancer experience serious physical and emotional symptoms throughout their cancer journey. Building on previous work, we aimed to develop an app designed to help patients with multiple myeloma and chronic lymphocytic leukemia self-manage symptoms and test it for acceptability and preliminary efficacy. We developed our Blood Cancer Coach app with input from clinicians and patients. Our 2-armed randomized controlled pilot trial recruited participants from Duke Health and nationally in partnerships with the Association of Oncology Social Work, Leukemia and Lymphoma Society, and other patient groups. Participants were randomized to the attention control (Springboard Beyond Cancer website) arm or the Blood Cancer Coach app intervention arm. The fully automated Blood Cancer Coach app included symptom and distress tracking with tailored feedback, medication reminders and adherence tracking, multiple myeloma and chronic lymphocytic leukemia education resources, and mindfulness activities. Patient-reported data were collected at baseline, 4 weeks, and 8 weeks for both arms through the Blood Cancer Coach app. Outcomes of interest were global health (Patient Reported Outcomes Measurement Information System Global Health), posttraumatic stress (Posttraumatic Stress Disorder Checklist for DSM-5), and cancer symptoms (Edmonton Symptom Assessment System Revised). Among participants in the intervention arm, satisfaction surveys and usage data were used to evaluate acceptability. Among 180 patients who downloaded the app, 49% (89) of them consented to participate and 40% (72) of them completed baseline surveys. Of those who completed baseline surveys, 53% (38) of them completed week 4 surveys (16 intervention and 22 control) and 39% (28) of them completed week 8 surveys (13 intervention and 15 control). Most participants found the app at least moderately effective at helping manage symptoms (87%), feeling more comfortable seeking help (87%), increasing awareness of resources (73%), and reported being satisfied with the app overall (73%). Participants completed an average of 248.5 app tasks over the 8-week study period. The most used functions within the app were medication log, distress tracking, guided meditations, and symptom tracking. There were no significant differences between the control and intervention arms at week 4 or 8 on any outcomes. We also saw no significant improvement over time within the intervention arm. The results of our feasibility pilot were promising in which most participants found the app to be helpful in managing their symptoms, reported satisfaction with the app, and that it was helpful in several important areas. We did not, however, find significantly reduced symptoms or improved global mental and physical health over 2 months. Recruitment and retention were challenging for this app-based study, an experience echoed by others. Limitations included a predominantly White and college educated sample. Future studies would do well to include self-efficacy outcomes, target those with more symptoms, and emphasize diversity in recruitment and retention. ClinicalTrials.gov NCT05928156; https://clinicaltrials.gov/study/NCT05928156.

Randomised controlled trial of the Caring Connections intervention to reduce loneliness and perceived social isolation in persons with spinal cord injuries and disorders: study protocol

IntroductionPerceived social isolation and loneliness are understudied in individuals with spinal cord injuries and disorders (SCI/D). The few existing studies reported that they are common, yet poorly treated, in persons...

Correlates of Engagement Within an Online HIV Prevention Intervention for Single Young Men Who Have Sex With Men: Randomized Controlled Trial.

BackgroundDigital HIV interventions (DHI) have been efficacious in reducing sexual risk behaviors among sexual minority populations, yet challenges in promoting and sustaining users’ engagement in DHI persist. Understanding the correlates of DHI engagement and their impact on HIV-related outcomes remains a priority. This study used data from a DHI (myDEx) designed to promote HIV prevention behaviors among single young men who have sex with men (YMSM; ages 18-24 years) seeking partners online.ObjectiveThe goal of this study is to conduct a secondary analysis of the myDex project data to examine whether YMSM’s online behaviors (eg, online partner-seeking behaviors and motivations) are linked to participants’ engagement (ie, the number of log-ins and the number of sessions viewed).MethodsWe recruited 180 YMSM who were randomized into either myDEx arm or attention-control arm using a stratified 2:1 block randomization. In the myDEx arm, we had 120 YMSM who had access to the 6-session intervention content over a 3-month period. We used Poisson regressions to assess the association between YMSM’s baseline characteristics on their DHI engagement. We then examined the association between the participants’ engagement and their self-reported changes in HIV-related outcomes at the 3-month follow-up.ResultsThe mean number of log-ins was 5.44 (range 2-14), and the number of sessions viewed was 6.93 (range 0-22) across the 3-month trial period. In multivariable models, the number of log-ins was positively associated with high education attainment (estimated Poisson regression coefficient [β]=.22; P=.045). The number of sessions viewed was associated with several baseline characteristics, including the greater number of sessions viewed among non-Hispanic YMSM (β=.27; P=.002), higher education attainment (β=.22; P=.003), higher perceived usefulness of online dating for hookups (β=.13; P=.002) and perceived loneliness (β=.06; P=.004), as well as lower experienced online discrimination (β=–.01; P=.007) and limerence (β=–.02; P=.004). The number of sessions viewed was negatively associated with changes in internalized homophobia (β=–.06; P<.001) and with changes in perceived usefulness of online dating for hookups (β=–.20; P<.001). There were no significant associations between the number of log-ins and changes in the participants’ behaviors at the 90-day follow-up.ConclusionsDHI engagement is linked to participants’ sociodemographic and online behaviors. Given the importance of intervention engagement in the intervention’s effectiveness, DHIs with personalized intervention components that consider the individuals’ differences could increase the overall engagement and efficacy of DHIs.Trial RegistrationClinicalTrials.gov NCT02842060; https://clinicaltrials.gov/ct2/show/NCT02842060.

Communication and Activation in Pain to Enhance Relationships and Treat Pain with Equity (COOPERATE): Rationale, study design, methods, and sample characteristics

BackgroundChronic pain is associated with profound negative effects, and racial disparities are well-documented in chronic pain treatment. In addition, Black patients report poorer communication with providers and exhibit lower levels of patient activation (self-management self-efficacy) than White patients. Although the causes of healthcare disparities are complex and require intervention at multiple levels, empowering patients is one critical path to achieving health equity. The current study is a coaching intervention focused on increasing patient activation and building communication skills for Black patients with chronic pain. MethodsIn this randomized controlled trial, 250 Black patients with chronic pain were randomized to either the coaching intervention or an attention control arm. Intervention patients attended 6 telephone-delivered individual coaching sessions over 12 weeks. Coaching focused on clarifying and prioritizing goals and on communication skills, such as agenda setting. The primary outcome is patient activation. Secondary outcomes include communication self-efficacy, pain intensity and interference, and psychological functioning. DiscussionHaving the knowledge and confidence to participate in one's pain care, coupled with the skills needed to effectively communicate with providers, is essential to optimize chronic pain care. This is particularly important for Black patients who often experience lower quality pain care. Interventions such as COOPERATE hold promise for helping patients to acquire the requisite tools to take greater control of their chronic pain care.Trial Registration: clinicaltrials.gov, # NCT03562793.

Resourcefulness Intervention Efficacy for Parent Caregivers of Technology-Dependent Children: A Randomized Trial.

Parent caregivers of children who require lifesaving technology (e.g., mechanical ventilation, feeding tubes) must maintain a high level of vigilance 24/7. A two-arm randomized controlled trial tested the efficacy of a resourcefulness intervention on parents' mental/physical health and family functioning at four time points over six months. Participants (n = 93) cared for their technology-dependent children <18 years at home. The intervention arm received teaching on social (help-seeking), personal (self-help) resourcefulness skills; access to the intervention video and skill application video-vignettes; four weeks of skills reinforcement using daily logs; four weekly phone contacts; and booster sessions at two- and four-month postenrollment. The attention control arm received phone contact at identical time points plus the current standard of care. Statistically significant improvement was noted; fewer depressive cognitions and improved physical health for the intervention participants than attention control participants over time after controlling for covariates. The findings support the resourcefulness intervention efficacy.

Goals for Reaching Optimal Wellness (GROWell): A clinical trial protocol of a digital dietary intervention for pregnant and postpartum people with prenatal overweight or obesity

BackgroundExcess gestational weight gain (EGWG) is associated with multiple pregnancy complications and health risks for birthing people and their infants. Likewise, postpartum weight retention (PPWR), or not losing all pregnancy weight, has long-term health consequences. EGWG among people who enter pregnancy with overweight or obesity have worse obstetric outcomes and increased PPWR compared to women who gain within Institute of Medicine guidelines. MethodsThis study protocol describes the details of a blinded, randomized clinical trial of GROWell: Goals for Reaching Optimal Wellness, a mHealth tool designed to improve diet quality among people who enter pregnancy with overweight or obese BMIs to help them achieve appropriate GWG and safe postpartum pregnancy weight loss. Individuals with overweight and obesity will be randomly assigned to an attention control or intervention arm. The intervention group will receive personalized, goal-oriented text messages regarding dietary choices, while the attention control group will receive text messages about healthy pregnancy, labor, delivery, and early infancy. Both groups will complete online surveys at baseline, follow up, 3 and 6 months postpartum. Results and discussionCurrently, 162 subjects have been enrolled. Outcomes associated with GWG and pregnancy are expected in late 2023, while outcomes on postpartum weight retention GROWell adherence are expected in late 2024. The results of this trial will support the use of an evidence-based mHealth tool to be integrated into clinical practice to reduce EGWG and PPWR among pregnant people with overweight and obese BMIs, a resource that is currently lacking. Trial registrationClinicalTrials.gov identifier: NCT04449432. Registered on June 26, 2020.

The Nourish Protocol: A digital health randomized controlled trial to promote the DASH eating pattern among adults with hypertension

IntroductionOver 100 million adults in the United States have hypertension. The DASH (Dietary Approaches to Stop Hypertension) eating pattern is an evidence-based first-line treatment option for hypertension; however, adherence to the DASH eating pattern at a population level remains low. To address this gap, we will implement Nourish, a randomized controlled efficacy trial that will leverage a commercially-available smartphone application and evidence-based behavior change principles to improve adherence to the DASH eating pattern among adults with hypertension. MethodsThe Nourish trial is a two-arm, 12-month randomized control trial that will enroll adults (N = 300) with hypertension, defined as a systolic blood pressure of 120–159 mmHg; a diastolic blood pressure of 80–99 mmHg; and/or adults on blood pressure-lowering medication. Nourish will test the efficacy of a digital health intervention, as compared to the attention control arm, on DASH eating pattern adherence and blood pressure. Intervention components will include skills training, self-monitoring, personalized feedback, and responsive coaching. The primary outcome of the trial is 6-month changes in adherence to the DASH eating pattern, as measured by 24-h dietary recalls. DiscussionMillions of Americans remain in need of effective behavioral interventions to manage and improve their hypertension and its adverse consequences. The ubiquity of smartphones offers a promising approach to disseminate the DASH eating pattern. By leveraging these widely used smartphone applications, combined with evidence-based behavior change principles and the DASH eating plan, Nourish will demonstrate the effectiveness of a digital health intervention to improve DASH adherence, and ultimately, to reduce blood pressure.Trial Number: NCT03875

Interrupting Sitting Time in Postmenopausal Women: Protocol for the Rise for Health Randomized Controlled Trial.

BackgroundMany older adults spend the majority of their waking hours sitting, which increases their risk of chronic diseases. Given the challenges that many older adults face when engaging in moderate-to-vigorous physical activity, understanding the health benefits of decreasing sitting time and increasing the number of sit-to-stand transitions is needed to address this growing public health concern.ObjectiveThe aim of this 3-arm randomized controlled trial is to investigate how changes in sitting time and brief sit-to-stand transitions impact biomarkers of healthy aging and physical, emotional, and cognitive functioning compared with a healthy attention control arm.MethodsSedentary and postmenopausal women (N=405) will be recruited and randomly assigned to 1 of the 3 study conditions for 3 months: healthy living attention control (Healthy Living), reduce sitting time (Reduce Sitting), and increase sit-to-stand transitions (Increase Transitions). Assessments conducted at baseline and 3 months included fasting blood draw, blood pressure, anthropometric measurements, physical functioning, cognitive testing, and 7 days of a thigh-worn accelerometer (activPAL) and a hip-worn accelerometer (ActiGraph). Blood-based biomarkers of healthy aging included those associated with glycemic control (glycated hemoglobin, fasting plasma insulin and glucose, and homeostatic model assessment of insulin resistance).ResultsRecruitment began in May 2018. The intervention is ongoing, with data collection expected to continue through the end of 2022.ConclusionsThe Rise for Health study is designed to test whether 2 different approaches to interrupting sitting time can improve healthy aging in postmenopausal women. Results from this study may inform the development of sedentary behavior guidelines and interventions to reduce sitting time in older adults.Trial RegistrationClinicalTrials.gov NCT03473145; https://clinicaltrials.gov/ct2/show/NCT03473145International Registered Report Identifier (IRRID)DERR1-10.2196/28684

A Health-Literacy Intervention for Early Childhood Obesity Prevention: A Cluster-Randomized Controlled Trial.

Children who become overweight by age 2 have greater risk of long-term obesity and health problems. The study aim was to assess the effectiveness of a primary care-based intervention on the prevalence of overweight at age 24 months. In a cluster-randomized trial, sites were randomly assigned to the Greenlight intervention or an attention-control arm. Across 4 pediatric residency clinics, we enrolled infant-caregiver dyads at the 2-month well-child visit. Inclusion criteria included parent English- or Spanish-speaking and birth weight ≥1500 g. Designed with health-literacy principles, the intervention included a parent toolkit at each well-child visit, augmented by provider training in clear-health communication. The primary outcome was proportion of children overweight (BMI ≥85th percentile) at age 24 months. Secondary outcomes included weight status (BMI z score). A total of 459 intervention and 406 control dyads were enrolled. In total, 49% of all children were overweight at 24 months. Adjusted odds for overweight at 24 months (treatment versus control) was 1.02 (95% confidence interval [CI]: 0.63 to 1.64). Adjusted mean BMI z score differences (treatment minus control) were -0.04 (95% CI: -0.07 to -0.01), -0.09 (95% CI: -0.14 to -0.03), -0.19 (-0.33 to -0.05), -0.20 (-0.36 to -0.03), -0.16 (95% CI: -0.34 to 0.01), and 0.00 (95% CI -0.21 to 0.21) at 4, 6, 12, 15, 18, and 24 months, respectively. The intervention resulted in less weight gain through age 18 months, which was not sustained through 24 months. Clinic-based interventions may be beneficial for early weight gain, but greater intervention intensity may be needed to maintain positive effects.

SWOG S1820: Altering Intake, Managing Symptoms for bowel dysfunction in survivors of Rectal Cancer (The AIMS-RC intervention trial)

ObjectiveTo describe the study protocol of SWOG S1820, a trial of the Altering Intake, Managing Symptoms intervention for bowel dysfunction in survivors of Rectal Cancer (AIMS-RC). DesignSWOG S1820 is a multi-site, randomized trial of 94 post-treatment survivors of rectal cancer, comparing the intervention and attention control arms. SettingAffiliated institutions of the National Cancer Institute (NCI)-supported National Community Oncology Research Program (NCORP) and the National Clinical Trial Network (NCTN). ParticipantsSurvivors of rectal cancer who are between 6 and 24 months after treatment completion. InterventionAIMS-RC is a 17-week, 10 session telephone coaching program to help survivors of rectal cancer track their symptoms and improve their diets for better health and bowel function. It includes telephone-based coaching, resource manual, and personalized text/email messaging for motivation in between the telephone sessions. Main outcome measuresBowel function, low anterior resection syndrome score, quality of life (QOL), dietary quality, motivation, self-efficacy, positive/negative affect, feasibility, adherence, retention, acceptability. AnalysisThirty-seven participants per arm (74 total) provide 80% power to detect this 0.5 standard deviation effect size, based on a two-sample t-test with a 1-sided alpha = 0.1. A total of 94 randomized participants will be accrued to account for 7% ineligibility and 15% attrition at 6 months.

Randomized trial of exercise on depressive symptomatology and brain derived neurotrophic factor (BDNF) in ovarian cancer survivors: The Women's Activity and Lifestyle Study in Connecticut (WALC)

ObjectivesDepression is one of the most prevalent mental disorders, and rates are higher among cancer survivors than the general population, and higher in ovarian cancer patients compared to cohorts of other cancer survivors. Physical activity has been associated with lower depressive symptoms in cancer survivors, yet no trial has examined this association in women with ovarian cancer. We examined the effect of exercise on depression symptomatology and serum brain derived neurotrophin factor (BDNF) which has been associated with depression, in women with ovarian cancer. MethodsWe conducted a 6-month home-based randomized trial of exercise vs. attention-control (AC) in 144 ovarian cancer survivors. Depressive symptomatology was measured via the Center for Epidemiologic Studies Depression Scale (CES-D). Serum total and free BDNF was measured at baseline and 6-months. Student's t-statistic and mixed-model repeated measures analysis was used to evaluate six-month change between arms in CES-D scores and BDNF. ResultsWomen were 57.3 ± 8.6 (mean ± SD) years old, 1.7 ± 1.0 years post-diagnosis with a baseline CES-D score of 11.79 ± 10.21. The majority (55%) were diagnosed with stage III/IV ovarian cancer. CES-D scores decreased in the exercise arm by 2.7 points (95% CI: −4.4, −0.9) or a 21% decrease compared to a 0.3 point decrease (−2.2, 1.5) (3% decrease) in the AC arm (P = 0.05). There was no difference in change in total or free BDNF between the exercise and AC arms. ConclusionsOvarian cancer survivors are able to exercise at recommended levels, and exercise was associated with a significant reduction in depressive symptomatology.

Results of a Randomized Trial Testing the Efficacy of Tele-Savvy, an Online Synchronous/Asynchronous Psychoeducation Program for Family Caregivers of Persons Living with Dementia.

Background and ObjectivesFamily caregivers will grow in number as dementia prevalence increases, underscoring the continued importance of equipping these individuals for their new roles and ameliorating the adverse effects of caregiving.Research Design and MethodsA three-armed, waitlist, randomized trial design tested Tele-Savvy, an online adaptation of a successful in-person psychoeducation program, the Savvy Caregiver. Tele-Savvy is delivered over 43 days to groups of 6–8 caregivers in 7 weekly synchronous sessions accompanied by 36 brief asynchronous video lessons. We enrolled 23 cohorts of 15 eligible caregivers (N = 261), randomized 2:2:1 to active, attention control, and usual care arms. We assessed caregiver psychological well-being and caregiving mastery at baseline and 3, 6, 9, and 12 months. Multilevel linear models assessed outcomes over the 3 time points examined. The trial was slightly truncated, with Data and Safety Monitoring Board approval, because of the apparent confounding psychological effects of coronavirus disease 2019 restrictions.ResultsStudy findings indicate statistically and clinically significant benefits to Tele-Savvy arm caregivers (with moderate to large effect sizes) in the areas of depression, perceived stress, reaction to care recipients’ behaviors, and enhancement of caregiver mastery. Expected benefits for caregiver burden and anxiety were not found.Discussion and ImplicationsFindings attest to program efficacy and the viability of employing distance means to improve family caregivers’ emotional well-being and sense of mastery in the caregiving role over a 6-month period. Next steps entail finding alternate ways to deliver the program to those with connectivity and/or time constraint problems.

Pilot randomized controlled trial (RCT) in women with non-small cell lung cancer (NSCLC) to assess the feasibility of delivering group-based psychosocial care via videoconference.

257 Background: Women with lung cancer are vulnerable to psychological distress and social isolation, which may be related to the smoking-related stigma of the disease. We developed a group-based psychosocial intervention seeking to address the specific needs of this understudied patient population. The goal of this pilot RCT was to examine the feasibility and acceptability of delivering group-based psychosocial care via videoconference (i.e., Zoom). Methods: Women with NSCLC within 3 months of diagnosis completed baseline measures of their computer literacy and were then randomized to a group-based psychosocial intervention receiving coping skill training or a group-based attention control (AC) arm receiving psychoeducation. Both arms involved five, 60 min. videoconference sessions (groups of 3-5 patients) that were led by a master-level counselor. Participants completed one Zoom “practice run” prior to starting the group sessions. After the last session, they rated the overall experience of the intervention delivery and the specific software. Results: Seventy patients (mean age = 66 yrs with 54% over age 65; 71% non-Hispanic White; 50% college educated; 75% advanced stage) consented (63% consent rate) and 65 were randomized (intervention: N = 33; AC: N = 32). At baseline, 47% indicated that they use a computer daily while 50% said they rarely or never use a computer. Attendance was high in both arms (means: intervention = 3.18; AC = 3.56 with 63% attended all sessions). Across arms, 89% preferred a group-delivery and 92% preferred online delivery. The majority used a smartphone or tablet to participate (72%). Regarding the Zoom software, 71% said it was easy to use, 65% of women would recommend it to others, and 41% felt comfortable with it after one use (but 26% said they felt never comfortable with it). Only 44% thought that the sessions via Zoom were the same as they would have been in-person. Conclusions: It seems to be feasible and acceptable to deliver group-based psychosocial interventions via videoconference in women with NSCLC undergoing treatment. Challenges regarding scheduling the group sessions and familiarizing infrequent computer users with the technology were encountered but were resolved over the course of the trial. Clinical trial information: NCT03731585 .

Testing the effectiveness of physical activity advice delivered via text messaging vs. human phone advisors in a Latino population: The On The Move randomized controlled trial design and methods

Physical inactivity is a key risk factor for a range of chronic diseases and conditions, yet, approximately 50% of U.S. adults fall below recommended levels of regular aerobic physical activity (PA). This is particularly true for ethnic minority populations such as Latino adults for whom few culturally adapted programs have been developed and tested. Text messaging (SMS) represents a convenient and accessible communication channel for delivering targeted PA information and support, but has not been rigorously evaluated against standard telehealth advising programs. The objective of the On The Move randomized controlled trial is to test the effectiveness of a linguistically and culturally targeted SMS PA intervention (SMS PA Advisor) versus two comparison conditions: a) a standard, staff-delivered phone PA intervention (Telephone PA Advisor) and b) an attention-control arm consisting of a culturally targeted SMS intervention to promote a healthy diet (SMS Nutrition Advisor). The study sample (N = 350) consists of generally healthy, insufficiently active Latino adults ages 35 years and older living in five northern California counties. Study assessments occur at baseline, 6, and 12 months, with a subset of participants completing 18-month assessments. The primary outcome is 12-month change in walking, and secondary outcomes include other forms of PA, assessed via validated self-report measures and supported by accelerometry, and physical function and well-being variables. Potential mediators and moderators of intervention success will be explored to better determine which subgroups do best with which type of intervention. Here we present the study design and methods, including recruitment strategies and yields.Trial Registration: clinicaltrial.gov Identifier = NCT02385591