Health Promotion Trial Research Articles

SELF-EFFICACY PARTIALLY MEDIATES PHYSICAL FUNCTIONING AND QUALITY OF LIFE IN MIDDLE-AGED ADULTS WITH DISABILITY

Abstract Middle-age is understudied. Adults living with long-term physical disability (LTPD) face added health conditions during middle-age, heightening psychosocial stress. The role of self-efficacy in managing these conditions and their impact on quality of life (QoL) remains unclear. Regression analyses were conducted using control participants from a health promotion trial, examining whether mid-intervention self-efficacy mediated the predictive relationship between baseline physical functioning (IV) and post-intervention QoL (DV). The sample (n = 159) was predominantly female (68.6%) and aged 45-64 (M = 55.99). Regression coefficients showed statistical significance for the models examining direct effects of physical functioning on QoL, Beta =.292, t(152) = 3.759, p <.001, physical functioning on self-efficacy, Beta =.208, t(152) = 2.638, p =.009, and self-efficacy on QoL, Beta =.579, t(151) = 8.731, p <.001. A regression model was conducted examining the indirect effect of self-efficacy as a mediator between physical functioning and QoL. Physical functioning significantly predicted QoL when the mediator was accounted for in the model, Beta =.187, t(150) = 2.819, p =.005. Self-efficacy as a mediator had a stronger predictive relationship on QoL than physical functioning, Beta =.542, t(150) = 8.190, p <.001. The statistically significant indirect effects show self-efficacy partially mediated physical functioning and QoL, demonstrating physical functioning’s influence on QoL is through self-efficacy. However, its effect may lack clinical significance due to minimal Beta change. Since LTPD often limits physical improvement, interventions should prioritize self-efficacy to enhance QoL for those aging with LTPD.

Compounding effects of stress on diet, physical activity, and wellbeing among African American parents: a qualitative study to inform the LEADS health promotion trial.

The purpose of the study was to conduct in-depth qualitative interviews to understand the lived experiences of African American parents of overweight adolescents who had previously participated in a family-based weight loss program and to utilize these insights to inform the essential elements of the LEADS trial, an integrated resilience stress management and health promotion intervention. Participants (N = 30) were African American parents and/or caregivers (96.7% female; Mage = 49.73, SD = 10.88; MBMI = 37.63, SD = 8.21) of adolescents with overweight and/or obesity. Interviews were transcribed and coded using inductive and deductive approaches for themes by two independent coders. Inter-rater reliability was acceptable (r = 0.70-0.80) and discrepancies were resolved to 100% agreement. Prominent stress themes included caregiver responsibilities, work, interpersonal family conflict, and physical and emotional consequences of chronic stress. Participants also noted decreases in physical activity and poor food choices due to stress. Coping mechanisms included prayer/meditation, church social support, and talking with family/partner. Results highlight the importance of mitigating stress among African American parents through stress management and cultural/familial resilience approaches to increase the likelihood of engagement in behavioral strategies in health promotion programs. Future studies should assess the utility of incorporating stress management components and health promotion techniques to improve health outcomes among African American families.

Congregation leader and member discussions in a church-based family strengthening, mental health promotion and HIV prevention trial: Intervention.

Collaboration with African religious congregations can promote psychosocial well-being with greater accessibility. Effective collaboration requires studying congregations as unique intervention contexts. This study explored how an intervention in western Kenya fit within and altered congregational discussion patterns. We conducted a cluster-randomized trial of a church-based intervention to improve family relationships, mental health and sexual health. For each intervention topic covered, we describe baseline and post-intervention changes in church leaders' beliefs and communication as well as discussion frequency between leaders and members and among members. Mixed-effects logistic regression assessed pre-post change in member-reported discussion frequency. At baseline, members and leaders reported already discussing family, parenting, and emotions frequently and sexuality and finances less frequently. Leaders generally felt they should discuss all topics but were less comfortable and knowledgeable about sexuality and finances than other topics. After the intervention, leader comfort and knowledge increased and discussion frequency increased for nearly all topics, especially those discussed less initially. Good fit between the desires and activities of church members and leaders suggests the potential for further collaboration, especially on mental health and family well-being. Increased discussion of sensitive topics underscores the potential of community-level interventions to affect social norms.

Association between neighborhood disadvantage and children's oral health outcomes in urban families in the Chicago area.

The prevalence of childhood caries in urban Chicago, compared with national and state data, indicates that neighborhood context influences oral health. Our objective was to delineate the influence of a child's neighborhood on oral health outcomes that are predictive of caries (toothbrushing frequency and plaque levels). Our study population represents urban, Medicaid-enrolled families in the metropolitan Chicago area. Data were obtained from a cohort of participants (child-parent dyads) who participated in the Coordinated Oral Health Promotion (CO-OP) trial at 12 months of study participation (N = 362). Oral health outcomes included toothbrushing frequency and plaque levels. Participants' neighborhood resource levels were measured by the Area Deprivation Index (ADI). Linear and logistic regression models were used to measure the influence of ADI on plaque scores and toothbrushing frequency, respectively. Data from 362 child-parent dyads were analyzed. The mean child age was 33.6 months (SD 6.8). The majority of children were reported to brush at least twice daily (n = 228, 63%), but the mean plaque score was 1.9 (SD 0.7), classified as "poor." In covariate-adjusted analyses, ADI was not associated with brushing frequency (0.94, 95% CI 0.84-1.06). ADI was associated with plaque scores (0.05, 95% CI 0.01-0.09, p value = 0.007). Findings support the hypothesis that neighborhood-level factors influence children's plaque levels. Because excessive plaque places a child at high risk for cavities, we recommend the inclusion of neighborhood context in interventions and policies to reduce children's oral health disparities. Existing programs and clinics that serve disadvantaged communities are well-positioned to support caregivers of young children in maintaining recommended oral health behaviors.

Experiences of adult survivors of childhood cancer in a randomized cardiovascular health promotion trial: a qualitative report from the Childhood Cancer Survivor Study.

To better understand preferences and attitudes that adult-aged survivors of childhood cancer have toward survivorship care plans (SCP) and related SCP-based counseling. Semi-structured qualitative interviews were conducted with 20 survivors participating in the Childhood Cancer Survivor Study who were at increased risk for cardiovascular disease secondary to their original cancer treatment. All participants were part of a larger randomized clinical trial (NCT03104543) testing the efficacy of an SCP-based counseling intervention with goal-setting designed to improve control of cardiovascular risk factors (i.e., hypertension, dyslipidemia, diabetes). A primarily deductive thematic analysis methodology guided interpretation; coded interview segments were grouped into primary themes of facilitators, barriers, suggestions, and positive sentiments. Participants described benefits of the intervention including facilitation of accountability, goal-setting, and increased knowledge of their health. Many participants also noted improved knowledge of their cancer treatment and subsequent risks, and they were interested in sharing this information with their primary care provider. However, several participants were disappointed when they did not achieve their goals or felt that they had low motivation. Participants generally wanted increased flexibility in the intervention, whether in the duration, frequency, or method of delivery. The SCP-based intervention was generally well-received by those interviewed and appears promising for promoting goal-setting and accountability as part of an SCP-based intervention to improve control of cardiovascular risk factors. Many survivors are at risk for cardiovascular disease or other potentially modifiable effects of their treatment. SCP-based interventions may facilitate improved control of these late effects.

Registration and primary outcome reporting in behavioral health trials

BackgroundRegistration of research studies is designed to lock investigators into a data collection and analysis plan before a study starts and thereby limit their ability to engage in flexible data analysis and selective outcome reporting. Studies of registered clinical trials show that one- to two-thirds are registered after the study has started and that non-adherence to important design and analytic features, such as reporting data pertaining to all primary outcomes, remains high. Less is known about the effects of registration on research transparency and integrity outside of clinical trials. To address this gap in knowledge, the current study examined the effects of registration on the reporting of research findings in a sample of behavioral health trials published in BMC Public Health.MethodsRegistered trials published in the BMC Public Health section “Health Behavior, Health Promotion and Society” between 2011 and 2015 were included in the study. For each trial, we reviewed associated online submissions from 13 different registration sites. For those determined to have been prospectively registered, we used the trial registry, MEDLINE (Pubmed), PsychINFO, Web of Science and e-mails to investigators to identify subsequent publications from the study that reported results pertaining to primary outcomes. The two investigators then independently reviewed the outcome publication(s) and compared the primary outcomes reported in these to the registered primary outcomes.ResultsThe final analytic sample comprised 136 locatable, registered trials with an identifiable start date. Sixty-eight of the 136 were prospectively registered. Among these prospectively registered trials, only 16 published manuscripts reported outcomes and methods that were concordant with their registrations.ConclusionsRetrospective submission of protocols for publication and retrospective registration remain common in public health research, and adherence to prespecified outcomes is rare. In its current form, registration of behavioral and health promotion trials is likely to have minimal effect on preventing selective outcome reporting in publications, and the pervasiveness of vague and incomplete registry entries means that registries will have limited utility in terms of facilitating replication studies.

A Qualitative Study of Stress and Coping to Inform the LEADS Health Promotion Trial for African American Adolescents with Overweight and Obesity.

The purpose of this study was to conduct in-depth individual interviews with 30 African American adolescents with overweight and obesity and their families (caregiver/adolescent dyads) to gain a better understanding of how to integrate stress and coping essential elements into an existing family-based health promotion program for weight loss. Interview data from 30 African American adolescents with overweight and obesity (Mage = 15.30 ± 2.18; MBMI%-ile = 96.7 ± 3.90) were transcribed and coded for themes using inductive and deductive approaches by two independent coders. Inter-rater reliability was acceptable (r = 0.70–0.80) and discrepancies were resolved to 100% agreement. The themes were guided by the Relapse Prevention Model, which focuses on assessing barriers of overall coping capacity in high stress situations that may undermine health behavior change (physical activity, diet, weight loss). Prominent themes included feeling stressed primarily in response to relationship conflicts within the family and among peers, school responsibilities, and negative emotions (anxiety, depression, anger). A mix of themes emerged related to coping strategies ranging from cognitive reframing and distraction to avoidant coping. Recommendations for future programs include addressing sources of stress and providing supportive resources, as well as embracing broader systems such as neighborhoods and communities. Implications for future intervention studies are discussed.

Process evaluation of a workplace-based health promotion and exercise cluster-randomised trial to increase productivity and reduce neck pain in office workers: a RE-AIM approach

BackgroundThis study uses the RE-AIM framework to provide a process evaluation of a workplace-based cluster randomised trial comparing an ergonomic plus exercise intervention to an ergonomic plus health promotion intervention; and to highlight variations across organisations; and consider the implications of the findings for intervention translation.MethodThis study applied the RE-AIM (reach, effectiveness, adoption, implementation, maintenance) methodology to examine the interventions’ implementation and to explore the extent to which differences between participating organisations contributed to the variations in findings. Qualitative and quantitative data collected from individual participants, research team observations and organisations were interrogated to report on the five RE-AIM domains.ResultsOverall reach was 22.7% but varied across organisations (range 9 to 83%). Participants were generally representative of the recruitment pool though more females (n = 452 or 59%) were recruited than were in the pool (49%). Effectiveness measures (health-related productivity loss and neck pain) varied across all organisations, with no clear pattern emerging to indicate the source of the variation. Organisation-level adoption (66%) and staffing level adoption (91%) were high. The interventions were implemented with minimal protocol variations and high staffing consistency, but organisations varied in their provision of resources (e.g. training space, seniority of liaisons). Mean adherence of participants to the EET intervention was 56% during the intervention period, but varied from 41 to 71% across organisations. At 12 months, 15% of participants reported regular EET adherence. Overall mean (SD) adherence to EHP was 56% (29%) across organisations during the intervention period (range 28 to 77%), with 62% of participants reporting regular adherence at 12 months. No organisations continued the interventions after the follow-up period.ConclusionAlthough the study protocol was implemented with high consistency and fidelity, variations in four domains (reach, effectiveness, adoption and implementation) arose between the 14 participating organisations. These variations may be the source of mixed effectiveness across organisations. Factors known to increase the success of workplace interventions, such as strong management support, a visible commitment to employee wellbeing and participant engagement in intervention design should be considered and adequately measured for future interventions.Trial registrationACTRN12612001154897; 29 October 2012.

Communicating health information and improving coordination with primary care (CHIIP): Rationale and design of a randomized cardiovascular health promotion trial for adult survivors of childhood cancer

Long-term survival for children diagnosed with cancer exceeds 80%. Notably, premature cardiovascular disease has become the leading non-cancer cause of late mortality among these survivors. This randomized controlled trial (RCT; NCT03104543) focuses on adult participants in the Childhood Cancer Survivor Study identified as high risk for ischemic heart disease or heart failure due to their cancer treatment. Participants undergo a home-based evaluation of blood pressure and laboratory tests to determine the prevalence of undiagnosed and/or undertreated hypertension, dyslipidemia, and diabetes. Those with abnormal values are then enrolled in an RCT to test the efficacy of a 12-month personalized, remotely delivered survivorship care plan (SCP) intervention designed to reduce undertreatment of these three target conditions. The intervention approximates a clinical encounter and is based on chronic disease self-management strategies. With a goal of 750, currently 342 out of 742 eligible participants approached have enrolled (46.1%). Initially, we randomized participants to different recruitment strategies, including shorter approach packets and a tiered consent, but did not find significant differences in participation rates (40.7% to 42.9%; p = .95). Subsequently, slightly greater participation was seen with larger upfront unconditional incentive checks ($50 vs. $25: 50.7% vs. 44.1%; p = .10). Overall, the financial impact of the $50 upfront incentive was cost neutral, and possibly cost-saving, vs. a $25 upfront incentive. The overall study will determine if a National Academy of Medicine-recommended SCP intervention can improve cardiovascular outcomes among long-term survivors of childhood cancer. Modifications to the recruitment strategy may improve participation rates over time.

Social Cognitive Theories and Electronic Health Design: Scoping Review.

BackgroundThere are several social cognitive theories (SCTs) and models that support platform design in electronic health (eHealth) promotion trials. The rationale for this scoping review was to determine how social design features (informational aid, expressive support, gaming, and tailored content) are used to promote self-efficacy, engagement, knowledge, and behavior change.ObjectiveThis study aimed to review a broad spectrum of digital health interventions in the literature seeking trials that use SCTs for the design of eHealth applications.MethodsThe author conducted a systematic scoping review of 161 Web-based health interventions from published randomized clinical trials using 1 or more tools to address the social cognitive determinants in their website design from January 2006 to April 2016. An iterative approach was used in the selection of studies and data extraction. The studies were analyzed for quality and coded for type of social design features employed.ResultsExpressive interaction tools were found in 48.6% (54/111) of studies categorized as a strong recommendation by the Joanna Briggs Institute criteria. Overall, less than half of the studies addressed participant social support and motivational needs (43.8%). The vast majority of studies (100%) relied on the use of the Web for delivery of informational aid and tailored content for the individual participant (75.9%).ConclusionsThis review fills a research gap by linking social theory to Web strategy to improve the impact and sustainability of eHealth interventions. A Digital Health Intervention Model was developed to provide a framework to enhance future Web-based health intervention design and execution.

Friends and Family: How African-American Adolescents’ Perceptions of Dietary Beliefs and Behaviors of Others Relate to Diet Quality

Adolescents' dietary intake often fails to meet national dietary guidelines, especially among low-income African-American youth. The dietary habits established in adolescence are likely to continue into adulthood, and a poor-quality diet increases the risk of developing obesity and chronic disease. Based on principles from ecological and social-cognitive behavior change health theories, perceptions of parental beliefs about healthy eating, perceptions of peer eating behaviors, and parental monitoring of what adolescents eat may positively influence adolescent diet quality. The purposes of this study were to determine whether perceived parental beliefs about nutrition, perceived peer eating behaviors, and reported parental monitoring of the adolescent diet were related to African-American adolescent diet quality and whether these relationships were moderated by adolescent age or sex. This secondary cross-sectional study used baseline data (2002 to 2004) from an urban community sample of low-income adolescents participating in a health promotion trial. Participants were 216 African-American adolescent-caregiver dyads in Baltimore, MD. The 2010 Healthy Eating Index was used to estimate adolescent diet quality. Analyses included correlations, t tests, age- and sex-by-perception regression interactions, and multivariate regressions adjusted for body mass index-for-age percentile, caregiver weight status, and caregiver depressive symptoms. Higher diet quality scores were related to higher levels of perceived parental and peer support for healthy eating behaviors among adolescents (β=.21; P<0.05; β=.15; P<0.05, respectively) and to caregiver reports of parental monitoring of adolescent dietary behavior (β=1.38, P<0.01). Findings were not moderated by age or sex. Consistent with ecological and social-cognitive theories, adolescents look to their friends and family in making healthy food choices. The relationships uncovered by this study describe some of the contextual, interpersonal influences associated with diet quality among low-income, urban African-American adolescents and warrant further exploration in future intervention studies.

Implementation trial of school staff health promotion: Polish experiences.

The paper presents the results of the trial implementation of staff health promotion in the Health Promoting Schools (HPS) programme in Poland. The design and key results of the summative evaluation of the 3-year project and activities of schools after completion of the project are described. Over 900 teachers and non-teaching employees from 21 schools participated in the project. Its purpose was to verify the schools' ability to take action related to the promotion of staff health in the HPSs in Poland. The results of the summative evaluation of the project were considered positive and promising. The percentage of persons who declared that they take greater care of their health, and teachers who described their health as very good, increased. Most employees introduced beneficial changes in their health behaviours. In all schools, changes in working conditions and personnel relations were introduced. Eighty-two per cent of teachers and seventy-five per cent of other employees had a positive attitude to the project and ninety per cent declared that the activities ought to be continued. Nearly all the schools' project leaders considered it a valuable initiative, had personal benefits and satisfaction from its implementation. After completing the project, 16/20 schools continued activities promoting the health of employees. Since the trial implementation of health promotion among school staff was considered a success, in 2016 some indicators relating to school staff health were included in the self-evaluation of HPS, and work began to prepare coordinators of regional and district HPS networks to work with the schools.

Readiness to Change Over Time: Change Commitment and Change Efficacy in a Workplace Health-Promotion Trial.

Organizational readiness to change may be a key determinant of implementation success and a mediator of the effectiveness of implementation interventions. If organizational readiness can be reliably and validly assessed at the outset of a change initiative, it could be used to assess the effectiveness of implementation-support activities by measuring changes in readiness factors over time. We analyzed two waves of readiness-to-change survey data collected as part of a three-arm, randomized controlled trial to implement evidence-based health promotion practices in small worksites in low-wage industries. We measured five readiness factors: context (favorable broader conditions); change valence (valuing health promotion); information assessment (demands and resources to implement health promotion); change commitment (an intention to implement health promotion); and change efficacy (a belief in shared ability to implement health promotion). We expected commitment and efficacy to increase at intervention sites along with their self-reported effort to implement health promotion practices, termed wellness-program effort. We compared means between baseline and 15 months, and between intervention and control sites. We used linear regression to test whether intervention and control sites differed in their change-readiness scores over time. Only context and change commitment met reliability thresholds. Change commitment declined significantly for both control (-0.39) and interventions sites (-0.29) from baseline to 15 months, while context did not change for either. Only wellness program effort at 15 months, but not at baseline, differed significantly between control and intervention sites (1.20 controls, 2.02 intervention). Regression analyses resulted in two significant differences between intervention and control sites in changes from baseline to 15 months: (1) intervention sites exhibited significantly smaller change in context scores relative to control sites over time and (2) intervention sites exhibited significantly higher changes in wellness program effort relative to control sites. Contrary to our hypothesis, change commitment declined significantly at both Healthlinks and control sites, even as wellness-program effort increased significantly at HealthLinks sites. Regression to the mean may explain the decline in change commitment. Future research needs to assess whether baseline commitment is an independent predictor of wellness-program effort or an effect modifier of the HealthLinks intervention.

Cluster randomised trial of a school-community child health promotion and obesity prevention intervention: findings from the evaluation of fun \u2018n healthy in Moreland!

BackgroundMulti-level, longer-term obesity prevention interventions that focus on inequalities are scarce. Fun ‘n healthy in Moreland! aimed to improve child adiposity, school policies and environments, parent engagement, health behaviours and child wellbeing.MethodsAll children from primary schools in an inner urban, culturally diverse and economically disadvantaged area in Victoria, Australia were eligible for participation. The intervention, fun ‘n healthy in Moreland!, used a Health Promoting Schools Framework and provided schools with evidence, school research data and part time support from a Community Development Worker to develop health promoting strategies. Comparison schools continued as normal. Participants were not blinded to intervention status. The primary outcome was change in adiposity. Repeated cross-sectional design with nested longitudinal subsample.ResultsStudents from twenty-four primary schools (clusters) were randomised (aged 5–12 years at baseline). 1426 students from 12 intervention schools and 1539 students from 10 comparison schools consented to follow up measurements. Despite increased prevalence of healthy weight across all schools, after 3.5 years of intervention there was no statistically significant difference between trial arms in BMI z score post-intervention (Mean (sd): Intervention 0.68(1.16); Comparison: 0.72(1.12); Adjusted mean difference (AMD): -0.05, CI: -0.19 to 0.08, p = 0.44). Children from intervention schools consumed more daily fruit serves (AMD: 0.19, CI:0.00 to 0.37, p = 0.10), were more likely to have water (AOR: 1.71, CI:1.05 to 2.78, p = 0.03) and vegetables (AOR: 1.23, CI: 0.99 to 1.55, p = 0.07), and less likely to have fruit juice/cordial (AOR: 0.58, CI:0.36 to 0.93, p = 0.02) in school lunch compared to children in comparison schools. More intervention schools (8/11) had healthy eating and physical activity policies compared with comparison schools (2/9). Principals and schools highly valued the approach as a catalyst for broader positive school changes. The cost of the intervention per child was $65 per year.ConclusionThe fun n healthy in Moreland! intervention did not result in statistically significant differences in BMI z score across trial arms but did result in greater policy implementation, increased parent engagement and resources, improved child self-rated health, increased fruit, vegetable and water consumption, and reduction in sweet drinks. A longer-term follow up evaluation may be needed to demonstrate whether these changes are sustainable and impact on childhood overweight and obesity.Clinical trial registrationACTRN12607000385448 (Date submitted 31/05/2007; Date registered 23/07/2007; Date last updated 15/12/2009).

Challenges and opportunities in evaluating a digital sexual health intervention in a clinic setting: Staff and patient views.

ObjectivesThe aim of the study was to gather the views of sexual health clinic staff and male clinic users regarding digital sexual health promotion and online trial procedures.MethodsThe Men’s Safer Sex website was offered on tablet computers to men in the waiting rooms of three sexual health clinics, in a feasibility online randomised controlled trial (RCT). Interviews were conducted with 11 men who had participated in the trial and with nine clinic staff, to explore their views of the website and views of the online trial. Interviews were audio-recorded and transcribed, and we conducted a thematic analysis of interviews and of 281 free text comments from the online RCT outcome questionnaires.ResultsClinic users and staff felt that digital interventions such as the Men’s Safer Sex website are useful, especially if NHS endorsed. Pre-appointment waiting time presents a good opportunity for intervention but clinic users and staff felt that a website should supplement rather than replace face-to-face healthcare. The RCT procedures fitted well around clinical activities, but men did not self-direct to the tablet computers. Staff were more concerned about consent and confidentiality than clinic users, and staff and patients were frustrated by multiple technical problems. The trial outcome questionnaire was thought-provoking and could constitute an intervention in itself. Participants felt that clinics would need to promote a digital intervention and/or offer the site routinely to promote engagement.ConclusionDigital interventions could usefully supplement in-person sexual health care, but there are important obstacles in terms of IT access in NHS settings, and in promoting engagement.

Promoting Sleep Health Among Families of Young Children in Head Start: Protocol for a Social-Ecological Approach.

Inadequate or poor quality sleep in early childhood impairs social–emotional and cognitive function via effects on the developing brain and increases obesity risk via hormonal and endocrine effects. The prevalence of short sleep duration, behavioral sleep problems, and sleep-disordered breathing among children aged 3 to 5 years is 20% to 50%. Healthy sleep habits increase sleep duration and prevent behavioral sleep problems. Awareness of sleep-disordered breathing symptoms leads to its timely treatment. We designed a study that aims to empower families whose children are in early childhood programs with the knowledge and skills needed to obtain healthy sleep and to recognize a sleep problem. We used the social–ecological framework to guide individual, interpersonal, organizational, community, and policy interventions. This study builds on the Sweet Dreamzzz, Inc, Early Childhood Sleep Education Program (ECSEP) in Head Start. A stepped-wedge–cluster randomized trial will test effects on child, parent, and classroom outcomes; a policy evaluation will assess the impact of knowledge-translation strategies. The study has 3 aims. The first is to adapt educational materials into multimedia formats and build the capacity of Head Start agencies to implement the study. The second aim is to enroll 540 parent–child dyads in a primary prevention trial of sleep health promotion in Head Start and to analyze effects on children’s sleep duration (primary outcome); parents’ knowledge, attitudes, self-efficacy, and behavior; and children’s sleep difficulties. The third aim is to conduct a secondary prevention feasibility study of screening and guidance for sleep problems. Secondary outcomes are changes in classroom behaviors and policies. Integrating sleep health literacy into early childhood programs could affect the life-course development of millions of children.

A Cluster-Randomized, Community-Based, Tribally Delivered Oral Health Promotion Trial in Navajo Head Start Children

The authors tested the effectiveness of a community-based, tribally delivered oral health promotion (OHP) intervention (INT) at reducing caries increment in Navajo children attending Head Start. In a 3-y cluster-randomized trial, we developed an OHP INT with Navajo input that was delivered by trained Navajo lay health workers to children attending 52 Navajo Head Start classrooms (26 INT, 26 usual care [UC]). The INT was designed as a highly personalized set of oral health–focused interactions (5 for children and 4 for parents), along with 4 fluoride varnish applications delivered in Head Start during academic years of 2011 to 2012 and 2012 to 2013. The authors evaluated INT impact on decayed, missing, and filled tooth surfaces (dmfs) increment compared with UC. Other outcomes included caries prevalence and caregiver oral health–related knowledge and behaviors. Modified intention-to-treat and per-protocol analyses were conducted. The authors enrolled 1,016 caregiver-child dyads. Baseline mean dmfs/caries prevalence equaled 19.9/86.5% for the INT group and 22.8/90.1% for the UC group, respectively. INT adherence was 53% (i.e., ≥3 child OHP events, ≥1 caregiver OHP events, and ≥3 fluoride varnish). After 3 y, dmfs increased in both groups (+12.9 INT vs. +10.8 UC; P = 0.216), as did caries prevalence (86.5% to 96.6% INT vs. 90.1% to 98.2% UC; P = 0.808) in a modified intention-to-treat analysis of 897 caregiver-child dyads receiving 1 y of INT. Caregiver oral health knowledge scores improved in both groups (75.1% to 81.2% INT vs. 73.6% to 79.5% UC; P = 0.369). Caregiver oral health behavior scores improved more rapidly in the INT group versus the UC group (P = 0.006). The dmfs increment was smaller among adherent INT children (+8.9) than among UC children (+10.8; P = 0.028) in a per-protocol analysis. In conclusion, the severity of dental disease in Navajo Head Start children is extreme and difficult to improve. The authors argue that successful approaches to prevention may require even more highly personalized approaches shaped by cultural perspectives and attentive to the social determinants of oral health (ClinicalTrials.gov NCT01116739).

Process Evaluation of the Project SHINE Intervention for African American Families: An Integrated Positive Parenting and Peer Monitoring Approach to Health Promotion.

This study describes the process evaluation of Project SHINE, a randomized family-based health promotion intervention that integrated parenting and peer monitoring for improving sedentary behavior, physical activity, and diet in African American families. Adolescent-parent dyads (n = 89) were randomized to a 6-week behavioral, positive parenting, and peer monitoring skills intervention or a general health education comparison condition. Process evaluation included observational ratings of fidelity, attendance records, psychosocial measures, and qualitative interviews. Results indicated that the intervention was delivered with high fidelity based on facilitator adherence (>98% of content delivered) and competent use of theoretically based behavior change and positive parenting skills (100% of ratings >3 on a 1-4 scale). Although only 43% of peers attended the "bring a friend" session, overall attendance was high (4.39 ± 1.51 sessions) as was the retention rate (88%). Parents in the intervention condition reported significant improvements in communication related to adolescents' engagement in health behaviors both on their own and with peers. These findings were supported by qualitative themes related to improvements in family communication and connectedness. This study provides an innovative example of how future family-based health promotion trials can expand their process evaluation approaches by assessing theoretically relevant positive parenting variables as part of ongoing monitoring.

Health promotion coaching for obese individuals with serious mental illnesses produces clinically significant reductions in cardiovascular risks up to 18 months

ABSTRACT FROM: Bartels SJ, Pratt SI, Aschbrenner KA, et al . Pragmatic replication trial of health promotion coaching for obesity in serious mental illness and maintenance of outcomes. Am J...

Teeth Tales: a community-based child oral health promotion trial with migrant families in Australia

ObjectivesThe Teeth Tales trial aimed to establish a model for child oral health promotion for culturally diverse communities in Australia.DesignAn exploratory trial implementing a community-based child oral health promotion intervention...