Prelinguistic communication complexity predicts expressive language in initial minimally verbal autistic children.

BACKGROUND: Prelinguistic communication complexity refers to the use of different communication forms such as eye gaze, gestures and vocalisations and the degree to which these forms are coordinated and how directed to a communication partner. To date, little is known about the relationship between prelinguistic communication complexity and expressive language in minimally verbal autistic children. AIMS: To test the hypothesis that prelinguistic communication complexity predicts expressive language 12 months later in autistic children and explore whether there are any differences in specific prelinguistic intentional communicative behaviours that are related to later expressive language levels. METHODS & PROCEDURES: This longitudinal study examined 37 minimally verbal autistic children (29-71 months old). The Communication Complexity Scale (CCS) was used to measure participants' prelinguistic communication behaviours, which were extracted from a semi-structured play interaction at Time 1. The Chinese Communicative Development Inventory (CCDI) was used to examine participants' expressive language at Time 1 and Time 2 (12 months later). According to Time 2 vocabulary size, participants were divided into two groups: Low CCDI, between 0 and 62 words, and High CCDI, more than 100 words. Linear regression was used to examine the relationship between early prelinguistic communication complexity and later expressive language. Binary logistic regression was used to determine which of the early communication behaviours were uniquely significantly related to later expressive language levels. OUTCOMES & RESULTS: There was a significant positive relationship between prelinguistic communication complexity and expressive language 12 months later, even after controlling for age and concurrent language. Findings revealed a group difference in the frequency of gesture and vocalisation combinations between the Low and High CCDI groups at Time 1. Gesture-vocalisation combinations also predicted better expressive language levels at Time 2. CONCLUSIONS & IMPLICATIONS: Our findings suggest that it may be beneficial to incorporate different complex communication behaviours into prelinguistic intervention targets for minimally verbal autistic children. The CCS hierarchies can be used as a reference for the intervention goals of minimally verbal autistic children. These findings highlight the importance of targeting gesture and vocalisation combinations when autistic children transition from single prelinguistic communication behaviours to multimodal behaviours. WHAT THIS PAPER ADDS: What is already known on this subject Children use eye gaze, gestures and vocalisations to communicate with others before they learn spoken language. There is strong evidence suggest that the frequency of prelinguistic communication predicts later linguistic achievements in autistic children. However, less is known about whether prelinguistic communication complexity also predicts later language and which specific behaviours are most predictive of language outcomes. What this study adds Minimally verbal autistic children who exhibit more complex prelinguistic communication behaviours have better expressive language 12 months later. Gestures combined with vocalisations predict better expressive language in minimally verbal autistic children. What are the clinical implications of this work? When identifying intervention targets for minimally verbal autistic children, the clinicians may reference the prelinguistic communication behaviours from the CCS. The gesture and vocalisation combinations are the key behaviours when targets transit from single form to two-form behaviours.

Pediatric Tube Weaning: A Meta-Analysis of Factors Contributing to Success.

Approximately 3-10% of children have severe feeding issues, and some require enteral/tube nutrition to grow and thrive. For many children, tube feeding is temporary, making efficacious interventions for tube weaning essential. We conducted a systematic review and meta-analysis of tube weaning treatments. Outcomes included percentage of participants completely weaned from the tube, and mean percentage of kilocalories consumed orally following treatment. Data were extracted from 42 studies, including cohort studies and single-subject research design studies. We evaluated moderators of treatment success, including treatment setting, use of behavioral approaches, use of hunger provocation, and use of a multidisciplinary approach. Results indicated that, after treatment, children received significantly more calories orally, and 67-69% of children were fully weaned. These analyses suggest that current interventions are generally effective; however, variability within treatments exist. Prospective randomized clinical trials are needed to understand effective components of weaning interventions.

Evaluation of an adapted version of the Diabetes Prevention Program for low- and middle-income countries: A cluster randomized trial to evaluate "Lifestyle Africa" in South Africa.

BACKGROUND: Low- and middle-income countries (LMICs) are experiencing major increases in diabetes and cardiovascular conditions linked to overweight and obesity. Lifestyle interventions such as the United States National Diabetes Prevention Program (DPP) developed in high-income countries require adaptation and cultural tailoring for LMICs. The objective of this study was to evaluate the efficacy of "Lifestyle Africa," an adapted version of the DPP tailored for an underresourced community in South Africa compared to usual care. METHODS AND FINDINGS: Participants were residents of a predominantly Xhosa-speaking urban township of Cape Town, South Africa characterized by high rates of poverty. Participants with body mass index (BMI) ≥ 25 kg/m2 who were members of existing social support groups or "clubs" receiving health services from local nongovernmental organizations (NGOs) were enrolled in a cluster randomized controlled trial that compared Lifestyle Africa (the intervention condition) to usual care (the control condition). The Lifestyle Africa intervention consisted of 17 video-based group sessions delivered by trained community health workers (CHWs). Clusters were randomized using a numbered list of the CHWs and their assigned clubs based on a computer-based random allocation scheme. CHWs, participants, and research team members could not be blinded to condition. Percentage weight loss (primary outcome), hemoglobin A1c (HbA1c), blood pressure, triglycerides, and low-density lipoprotein (LDL) cholesterol were assessed 7 to 9 months after enrollment. An individual-level intention-to-treat analysis was conducted adjusting for clustering within clubs and baseline values. Trial registration is at ClinicalTrials.gov (NCT03342274). Between February 2018 and May 2019, 782 individuals were screened, and 494 were enrolled. Participants were predominantly retired (57% were receiving a pension) and female (89%) with a mean age of 68 years. Participants from 28 clusters were allocated to Lifestyle Africa (15, n = 240) or usual care (13, n = 254). Fidelity assessments indicated that the intervention was generally delivered as intended. The modal number of sessions held across all clubs was 17, and the mean attendance of participants across all sessions was 61%. Outcome assessment was completed by 215 (90%) intervention and 223 (88%) control participants. Intent-to-treat analyses utilizing multilevel modeling included all randomized participants. Mean weight change (primary outcome) was -0.61% (95% confidence interval (CI) = -1.22, -0.01) in Lifestyle Africa and -0.44% (95% CI = -1.06, 0.18) in control with no significant difference (group difference = -0.17%; 95% CI = -1.04, 0.71; p = 0.71). However, HbA1c was significantly lower at follow-up in Lifestyle Africa compared to the usual care group (mean difference = -0.24, 95% CI = -0.39, -0.09, p = 0.001). None of the other secondary outcomes differed at follow-up: systolic blood pressure (group difference = -1.36; 95% CI = -6.92, 4.21; p = 0.63), diastolic blood pressure (group difference = -0.39; 95% CI = -3.25, 2.30; p = 0.78), LDL (group difference = -0.07; 95% CI = -0.19, 0.05; p = 0.26), triglycerides (group difference = -0.02; 95% CI = -0.20, 0.16; p = 0.80). There were no unanticipated problems and serious adverse events were rare, unrelated to the intervention, and similar across groups (11 in Lifestyle Africa versus 13 in usual care). Limitations of the study include the lack of a rigorous dietary intake measure and the high representation of older women. CONCLUSIONS: In this study, we found that Lifestyle Africa was feasible for CHWs to deliver and, although it had no effect on the primary outcome of weight loss or secondary outcomes of blood pressure or triglycerides, it had an apparent small significant effect on HbA1c. The study demonstrates the potential feasibility of CHWs to deliver a program without expert involvement by utilizing video-based sessions. The intervention may hold promise for addressing cardiovascular disease (CVD) and diabetes at scale in LMICs. TRIAL REGISTRATION: ClinicalTrials.gov NCT03342274.

Validation of remote height and weight assessment in a rural randomized clinical trial.

BACKGROUND: The purpose of this study is to describe and assess a remote height and weight protocol that was developed for an ongoing trial conducted during the SARS COV-2 pandemic. METHODS: Thirty-eight rural families (children 8.3 ± 0.7 years; 68% female; and caregivers 38.2 ± 6.1 years) were provided detailed instructions on how to measure height and weight. Families obtained measures via remote data collection (caregiver weight, child height and weight) and also by trained staff. Differences between data collection methods were examined. RESULTS: Per absolute mean difference analyses, slightly larger differences were found for child weight (0.21 ± 0.21 kg), child height (1.53 ± 1.29 cm), and caregiver weight (0.48 ± 0.42 kg) between school and home measurements. Both analyses indicate differences had only minor impact on child BMI percentile (- 0.12, 0.68) and parent BMI (0.05, 0.13). Intraclass coefficients ranged from 0.98 to 1.00 indicating that almost all of the variance was due to between person differences and not measurement differences within a person. CONCLUSION: Results suggest that remote height and weight collection is feasible for caregivers and children and that there are minimal differences in the various measurement methods studied here when assessing group differences. These differences did not have clinically meaningful impacts on BMI. This is promising for the use of remote height and weight measurement in clinical trials, especially for hard-to reach-populations. TRIAL REGISTRATION: Clinical. Registered in clinicaltrials.gov ( NCT03304249 ) on 06/10/2017.

Daily adherence variability and psychosocial differences in adolescents with asthma: a pilot study.

Adolescents with asthma endorse psychosocial difficulties as barriers to inhaled corticosteroid adherence. This study examined patterns of variability in adherence and within-person associations of psychosocial variables with adherence across days. Participants included twenty-five adolescents (Mage = 14.7, SD = 1.68; 48% male) with persistent asthma. We measured adherence via electronic monitoring. Adolescents completed daily surveys measuring asthma symptoms, stress, mood, and affect. We examined within-person differences in the effect of symptoms and psychosocial variables on adherence. Adherence decreased over time. The addition of a random slope improved model fit (- 2ΔLL(1) = 9.36, p < .01). Greater asthma symptoms were significantly associated with higher adherence at the within-person level and with lower adherence between persons. We observed evidence of individual differences in the associations of stress and affect with adherence. Within-person, day-level fluctuations in adherence occur. Symptoms and psychosocial variables may influence adherence. Individually tailored interventions may effectively address nonadherence.

Word retrieval difficulty in adult females with the FMR1 premutation: Changes over time and across contexts.

Individuals with a premutation of the fragile X mental retardation (FMR1) gene are at risk for a variety of psychological, physical, and cognitive issues, including difficulty with word retrieval. The present study examined three indicators of word retrieval difficulty; reduced productivity, reduced lexical diversity, and increased errors in word retrieval in a group of 38 female premutation carriers during standard-length speech samples collected over a period of eight years. Our results revealed that as women aged, they produced fewer words, produced fewer different words, and had greater word retrieval errors. In addition, the rate of word retrieval errors was highly correlated between two speaking contexts, indicating that this difficulty was pervasive and not solely the result of speaking in monologue. Our results suggest that subtle areas of cognitive decline emerge at a much earlier age among female premutation carriers than would be expected during healthy aging.

Evaluating associations between fitspiration and thinspiration content on Instagram and disordered-eating behaviors using ecological momentary assessment: A registered report.

INTRODUCTION: Greater use of appearance-focused social media, such as Instagram, is associated with increased body dissatisfaction and eating disorder (ED) symptoms; however, questions remain about the mechanism connecting social media use to disordered-eating behaviors (DEBs). The proposed study evaluates how and for whom exposure to fitspiration or thinspiration on Instagram is associated with DEBs. METHODS: We will evaluate a hypothesized pathway from Instagram use to disordered-eating mediated by negative affect. We will test how individual differences in internalized weight stigma, trait self-esteem, and trait self-comparison moderate the pathway from social media use to negative affect. We will recruit 175 undergraduate women who report engaging in DEBs on average at least once per week over the past 3 months. Participants will complete a 7-day ecological momentary assessment protocol, during which they will report their Instagram use, affect, and engagement in DEBs. RESULTS: Multi-level modeling will be used to assess moderated mediation. Results from this study will provide increased specificity about how Instagram usage is linked to eating pathology and who may be most vulnerable to experiencing distress. DISCUSSION: Information about negative affect from Instagram and engagement in DEBs could contribute to the development of Just-In-Time Interventions for problematic social media use.

Association of Multisetting Community Programs and Policies With Child Body Mass Index: The Healthy Communities Study.

INTRODUCTION: Expert opinion suggests that efforts to address childhood obesity should seek to transform the environments in which children operate. The objective of this study was to describe the extent to which multisetting programs and policies interact with community and child predictors and are associated with child body mass index (BMI) in the 130 US communities participating in the Healthy Communities Study. METHODS: For 2 years beginning in fall 2013, we collected data through key informant interviews on community programs and policies related to healthy weight among children that occurred in the 10 years before the interview. We characterized community programs and policies by intensity of efforts and the number of settings in which a program or policy was implemented. Child height and weight were measured during household data collection. We used multilevel modeling to examine associations of community programs and policies in multiple settings and child and community predictors with BMI z scores of children. RESULTS: The mean number of settings in which community policies and programs were implemented was 7.3 per community. Of 130 communities, 31 (23.8%) implemented community programs and policies in multiple settings. Higher-intensity community programs and policies were associated with lower BMI in communities that used multiple settings but not in communities that implemented programs and policies in few settings. CONCLUSION: Efforts to prevent childhood obesity may be more effective when community programs and policies are both intensive and are implemented in multiple settings in which children live, learn, and play.

Improving Educators' Knowledge, Confidence, and Usefulness of a Comprehensive, Integrated, Three-tiered (Ci3T) Model of Prevention: Outcomes of Professional Learning.

We examined shifts in educators' perceived knowledge, confidence, and usefulness and actual knowledge of concepts in the Comprehensive, Integrated, Three-tiered (Ci3T) model of prevention before and after participation in a practice-based professional learning series to design, implement, and evaluate a Ci3T model for their school. Participants completed the Knowledge, Confidence, and Use (KCU) survey prior to and at the conclusion of the year-long, six-part Ci3T Professional Learning Series. Results indicated participants demonstrated statistically significant increases in perceived and actual knowledge, perceived confidence, and perceived usefulness of concepts measured, with effect sizes suggesting large effects. Implications for supporting educators in designing a Ci3T model of prevention to meet students' educational needs using a practice-based professional learning series are discussed along with limitations and considerations for future research.

Mothers' perspectives on challenging behaviours in their children with fragile X syndrome.

BACKGROUND: Individuals with intellectual and developmental disabilities are more likely to engage in problem behaviours than peers with typical development. The purpose of this study was to provide descriptive and qualitative information about problem behaviours in children with fragile X syndrome (FXS) and how families respond to these behaviours. METHOD: We examined interview responses from 53 mothers of 9-year-old children with FXS. RESULTS: Defiance, tantrums, inattention, stereotypy, and aggression were the most frequently reported problem behaviours of children with FXS. Stereotypy, physical aggression, self-injury, and elopement were reported more often by mothers of children with dual diagnoses of FXS and autism than by mothers of children with a single diagnosis of FXS. CONCLUSIONS: Results indicated that for many families, by 9 years of age, problem behaviours led to frustration and altered family activities.

Implicit Attitudes and Smoking Behavior in a Smoking Cessation Induction Trial.

INTRODUCTION: Although studies have suggested that implicit attitudes may predict smoking-related decisions, evidence that changes in implicit attitudes toward smoking are related to changes in smoking behavior is lacking. Using data from a trial comparing interventions to induce quit attempts among unmotivated smokers, this study examined whether changes in implicit attitudes were associated with quit attempts and cessation after controlling for explicit motivation. METHODS: Daily smokers recruited from the community completed measures of implicit attitudes (Implicit Association Test) and explicit measure of motivation to smoke at baseline, mid-intervention (week 12 [W12]) and follow-up (week 26 [W26]). Quit attempts and cessation were assessed at follow-up, and cessation was biochemically verified. RESULTS: As hypothesized, Implicit Association Test scores became more negative from baseline to W12, a change that was sustained at follow-up. Logistic regression analyses in which implicit attitudes were used to predict smoking outcomes revealed that negative changes in implicit attitudes from baseline to W12 and from baseline to W26 were significantly related to quit attempts (OR = 0.71, 95% CI [0.52, 0.97], p < .05 for both) independent of explicit motivation. Negative changes in implicit attitudes from baseline to W26 were significantly related to cessation (OR = 0.50, 95% CI [0.25, 1.00], p < .05). CONCLUSIONS: Negative changes in implicit attitudes were associated with positive changes in smoking behavior independent of explicit motivation. This result indicates that smoking cessation interventions may be enhanced by incorporating strategies to change implicit attitudes, and that changes in implicit attitudes are also potentially important intervention outcomes. IMPLICATIONS: Smoking cessation interventions may be improved by going beyond the current focus on explicit psychological constructs and targeting automatic cognitive processes such as implicit attitudes. The results are encouragement to examine how best to manipulate smokers' implicit attitudes as well as to determine the effect on their smoking behavior.

Child Maltreatment, Trauma, and Physical Health Outcomes: The Role of Abuse Type and Placement Moves on Health Conditions and Service Use for Youth in Foster Care.

OBJECTIVE: The purpose of the study was to investigate the relations between abuse types, non-maltreatment-related trauma, and health service utilization in a sample of youth in foster care with and without chronic medical conditions. METHOD: A total of 213 youth, aged 8-21 years, provided self-report of general trauma and abuse exposure. Medicaid claims for each child were collected from official state databases. RESULTS: Exposure to sexual abuse, neglect, or general trauma but not exposure to physical abuse or psychological abuse increased the rates of medical visits, while only general trauma increased medical hospitalizations. CONCLUSIONS: Trauma types are not equally predictive of health care utilization for youth with chronic health conditions.

Language Skills Influence Transition Planning in Adolescents With Fragile X Syndrome.

Individuals with fragile X syndrome (FXS) and their parents have a range of experiences navigating the crucial transition period between adolescence and adulthood. Semistructured interviews of 47 mothers of adolescents with FXS (mean child age = 15.89 years) were analyzed to identify mothers' changing expectations during the adolescent period and parent goals related to work and postsecondary education. Mothers' work and education goals were explored in relation to child factors such as language skills and autism characteristics. Lower language skills were associated with lower likelihood of reporting vocational goals. Results suggest that adolescents with FXS with lower language ability are less likely to have vocational plans for adulthood during this critical period and may need greater transition planning assistance.

Effectiveness of a paediatric weight management intervention for rural youth (iAmHealthy): Primary outcomes of a cluster randomised control trial.

BACKGROUND: Youth in rural areas are disproportionally affected by obesity. Given the unique barriers rural populations face, tailoring and increasing access to obesity interventions is necessary. OBJECTIVE: This paper evaluates the effectiveness of iAmHealthy, a family-based paediatric obesity intervention delivered to rural children, compared to a Newsletter Control. METHODS: Participating schools (n = 18) were randomly assigned to iAmHealthy or Newsletter Control. iAmHealthy consists of individual health coaching and group sessions delivered via televideo to a participant's home. The child and parent's body mass index (BMI), child physical activity and child dietary intake were assessed at baseline, post-treatment (8 months) and follow-up (20 months). Multilevel modeling estimated the effect of treatment at both time points. RESULTS: Parent and child dyads were recruited (n = 148) and randomised to iAmHealthy (n = 64) or the Control group (n = 84). The Control group had significant increases in child BMIz from baseline to follow-up. iAmHealthy youth had no significant changes in BMIz from baseline to post or follow-up. Child dietary intake, physical activity and parent BMI results are also discussed. CONCLUSIONS: This trial extends previous paediatric obesity work by simultaneously increasing convenience and dose of treatment. Results suggest iAmHealthy resulted in a change in BMIz trajectories and long-term health behaviour for youth.

Evaluating interactive videoconferencing for assessing symptoms of autism.

BACKGROUND: Autism affects as many as 1 in 88 children. Best practices recommend early identification and intervention for optimal outcomes. Currently, a gap exists between time of first concern and diagnosis, particularly for families living in rural areas. Telemedicine as a tool for assessment and diagnosis of autism is one way to address this disparity. Emerging evidence suggests telemedicine as a viable option for assessing children with a variety of special needs. MATERIALS AND METHODS: This study expands upon the current literature by investigating clinicians' ability to assess autism via telemedicine. Using interactive videoconferencing, we simulated autism assessment procedures with families with an existing diagnosis (autism or developmental disability) using current gold-standard assessment tools. We compared diagnostic accuracy, item-by-item reliability on the Autism Diagnostic Observation Schedule (ADOS)-Module 1, and the Autism Diagnostic Interview-Revised (ADI-R) as well as parent satisfaction in an in-person and interactive videoconferencing condition. Ten children (3-5 years old) with developmental delays and 11 children matched on chronological age with a diagnosis of autism were assigned to be assessed and interviewed either in-person or over videoconferencing. Clinicians observed both in-person and through videoconferencing regardless of patient assignment. RESULTS: Results indicated no significant difference in reliability of diagnostic accuracy, ADOS observations, ratings for ADI-R parent report of symptoms, and parent satisfaction between conditions. Results indicate adequate clinician agreement and parent satisfaction regardless of observational condition. CONCLUSIONS: Future research should include a larger sample size and assess children without an existing diagnosis.

Story Comprehension Monitoring Across Visual, Listening, and Written Modalities in Children with and Without Autism Spectrum Disorder.

Visual, as compared to verbal, tasks are often assumed to be easier for individuals with autism spectrum disorder (ASD), but is this true for story comprehension? This study evaluated story comprehension monitoring across visual, listening, and written modalities and assessed predictors in two closely matched groups (age, socioeconomic status, language, nonverbal cognition, and word reading) of children and adolescents (8-14 years) with ASD (n = 20) and typical development (typically developing [TD]; n = 20). The results of mixed-effects models indicated that story comprehension monitoring was low overall, and performance was comparable across visual, listening, and written modalities for participants with ASD. Age, vocabulary, nonverbal working memory, response and distractor inhibition, and social communication significantly predicted comprehension monitoring.

The Feasibility and Data Quality for a Listening Comprehension Task in an Unmoderated Remote Study With Children.

PURPOSE: The purpose of this research note was to examine the sample representation, feasibility and completion, and data quality when using an unmoderated remote study (i.e., conducted without direct contact with a researcher) for a listening comprehension task with 4- to 11-year-old children. METHOD: Thirty-five participants met inclusionary criteria for this study. Sample representation was examined descriptively. Feasibility and completion (i.e., submission of parent questionnaires and more than 50% of task with no missing data) were examined descriptively and compared with differences of proportions tests. Data quality (i.e., missing data for items with interference or not codable) was examined descriptively with multilevel logistic regression models, as well as one-sample proportions tests by listening comprehension task and participant characteristics. RESULTS: Our sample skewed toward predominantly White and toward families with highly educated parents. Overall, most participants completed the task and had quality data (i.e., audibly clear responses that could be coded, few missing responses, and task completion) in this unmoderated format. There were not any statistically significant effects across participant characteristics in terms of rates of completion. Data quality only significantly differed by response type with mouse selection having the least amount of missing data followed by prompted audio-recorded questions and then open-ended audio-recorded questions. CONCLUSIONS: The unmoderated remote study approach seems feasible for a listening comprehension task for most children ages 4-11 years old. Future work is needed to determine if these results apply to samples with broader representation. Overall, we found good data quality despite the less controlled environment in remote studies. SUPPLEMENTAL MATERIAL: https://doi.org/10.23641/asha.23114924.

Adapting Curricula for Children With Language Comprehension Deficits.

PURPOSE: We will describe how a multisite research team adapted a language-focused curriculum to be used in a scale-up project. Specifically, we identified underlying principles to modify a Tier 1 whole-classroom language comprehension-focused curriculum to be used as a Tier 2 small-group curriculum with children identified as at risk for low language comprehension, including children with developmental language disorder (DLD). METHOD: We discuss how researchers used the following five guiding principles to adapt a curriculum for children at risk for low language comprehension, including children with DLD: (a) increased and ongoing professional development, (b) simplification of language input, (c) increased scaffolding, (d) attention to distributed practice, and (e) materials to support diversity and inclusion. RESULTS: We used these guiding principles to modify a popular language-based curriculum used in schools across the country. CONCLUSION: This clinical focus article showcases how guiding principles and frameworks for adaptation, within implementation science, can serve as a guidepost for speech-language pathologists and other educators who are adapting or scaling up a curriculum or intervention that was not designed for their target population.

Cost-effectiveness of Lifestyle Africa: an adaptation of the diabetes prevention programme for delivery by community health workers in urban South Africa.

BACKGROUND: Lifestyle Africa is an adapted version of the Diabetes Prevention Program designed for delivery by community health workers to socioeconomically disadvantaged populations in low- and middle-income countries (LMICs). Results from the Lifestyle Africa trial conducted in an under-resourced community in South Africa indicated that the programme had a significant effect on reducing haemoglobin A1c (HbA1c). OBJECTIVE: To estimate the cost of implementation and the cost-effectiveness (in cost per point reduction in HbA1c) of the Lifestyle Africa programme to inform decision-makers of the resources required and the value of this intervention. METHODS: Interviews were held with project administrators to identify the activities and resources required to implement the intervention. A direct-measure micro-costing approach was used to determine the number of units and unit cost for each resource. The incremental cost per one point improvement in HbA1c was calculated. RESULTS: The intervention equated to 71 United States dollars (USD) in implementation costs per participant and a 0.26 improvement in HbA1c per participant. CONCLUSIONS: Lifestyle Africa reduced HbA1c for relatively little cost and holds promise for addressing chronic disease in LMIC. Decision-makers should consider the comparative clinical effectiveness and cost-effectiveness of this intervention when making resource allocation decisions. TRIAL REGISTRATION: Trial registration is at ClinicalTrials.gov (NCT03342274).

Rationale and design of integrating a parents first obesity intervention with a pediatric weight management intervention for rural families - Evaluating the ripple effect.

Rural families are disproportionately affected by obesity. Obesity often runs in families and is impacted by hereditary components, the shared home environment, and parent modeling/child observational learning. Moreover, parent changes in weight predict child changes in weight. Thus, targeting the family unit has the potential to enhance outcomes for adults and children simultaneously. Additionally, engaging rural nurses in medical clinics and schools may be important in determining whether rural telehealth programs are successfully implemented and sustained. This paper describes the rationale and design of a randomized control trial (RCT) evaluating the effectiveness of an integrated adult- and child-focused obesity treatment tailored for rural participants. Outcomes of this study include participant weight loss from baseline to 9-months, device-measured physical activity, and dietary intake. This project will additionally compare reach between clinic and school settings and evaluate the impact of nurse engagement. This study will include 240 participants from eight rural communities who will be randomized to either a Parent +Family-based group or a Newsletter +Family-based group. Parents in the Parent +Family-based group will receive a 3-month adult obesity treatment designed for adult behavior change as a first step. Then, parents and children together will enter the family-based program (iAmHealthy), allowing for potential enhancement of a theorized ripple effect. Parents in the Newsletter +Family-based group will receive 3 monthly newsletters and then participate in the 6-month family-based intervention designed for child behavior change. This study is the first RCT to examine the effectiveness of an integrated adult- and child-focused obesity treatment program. Registered with ClinicalTrials.gov NCT ID NCT05612971.