Browsing by Subject "randomized controlled trial"
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Item Latino Father-Focused, Healthy Lifestyle Intervention to Improve Adolescent Energy Balance-Related Behaviors(2022-01) Baltaci, AysegulBackground: Poor dietary habits, lack of physical activity, and sedentary behaviors including frequent screen time have been identified as critical behavioral determinants of childhood obesity. Hispanic youth have disproportionately high rates of overweight and obesity in the U.S. The majority of Latino/Hispanic adolescents have lower healthy food and higher unhealthy food intakes and lower physical activity and higher screen time behaviors than recommended. Parenting practices were associated with child and adolescent food- and activity-related behaviors. Intervention studies focusing on positive parenting practices (setting expectations/limits, role modeling, home availability) to prevent overweight/obesity among Latino children and adolescents are limited with an underrepresentation by Latino fathers. Thus, the Padres Preparados, Jóvenes Saludables (Padres) program was developed based on principles of community-based participatory research and social cognitive theory to prevent overweight and obesity among Latino adolescents (10–14 years) by improving adolescents’ energy balance-related behaviors (EBRBs) and the frequency of positive paternal parenting practices. A two-arm (intervention versus delayed-treatment control group) randomized controlled trial was conducted to assess the effectiveness of 8 weekly 2.5-hour experiential learning sessions delivered to 103 fathers and 110 adolescents (mothers were encouraged to attend) in four trusted community locations in the Minneapolis/St. Paul urban area. Families completed surveys and anthropometric measurements for the assessment of changes in paternal parenting practices, and father and adolescent EBRBs and weight status at baseline and post-intervention. Adolescents also completed 24-hour dietary recall interviews at baseline and post-intervention. The intervention group participated in the learning sessions immediately after baseline data collection while the delayed-treatment control group participated in the learning sessions three months after the post data collection. Overall objective: The first objective was to assess associations between paternal food parenting practices and family meals and paternal food/meal involvement and adolescent dietary intake separately and in combination in a cross-sectional study design using Padres baseline data. The second objective was to evaluate the impact of the Padres program and intervention dose on father and adolescent EBRBs based on a randomized controlled trial. The third objective was to determine the Padres program impact and modifier effect on father- and adolescent-reported paternal food and activity parenting practices based on a randomized controlled trial. Methodology: The data analysis methods of the first study included multiple linear regression models to assess associations of paternal food parenting practices, family meals and paternal food/meal involvement with adolescent intake separately. In addition, adjusted GLM (generalized linear mixed model) procedures and slice statements and PLM (post GLM processing) procedures with Bonferroni corrections were used to evaluate the combination of paternal food parenting practices and family meals and paternal food/meal involvement on adolescent intake. The second study used baseline and post data to assess intervention impact (intervention vs. delayed-treatment control group) and dose effects on father and adolescent EBRBs. Analyses included paired and two sample t-tests and adjusted linear regression models (within groups), and mixed models (between groups) for continuous outcomes and McNemar’s tests (within groups) and Generalized Linear Mixed Models (GLMM) (between groups) for binary outcomes. The methods of the third study using baseline and post Padres data consisted of McNemar’s tests (within groups) and GLMM models (between groups) to assess intervention impact (intervention vs. delayed-treatment control group) and modifier effects on father- and adolescent-reported paternal food- and activity-related parenting practices. Results: The first study demonstrated that Latino adolescents consumed more healthy foods and less unhealthy foods when their fathers had more frequent positive food parenting practices. The first study also indicated significant combined associations of paternal food parenting practices and family meals on adolescent intakes of fruit, sweets/salty snacks, and sugar-sweetened beverages (SSBs). The second study showed lower intakes of SSBs, sweet/salty snacks, and fast food by intervention group fathers after attending the Padres program but did not show any intervention effect on adolescent EBRBs and father and adolescent weight status. In further analysis, the second study demonstrated that father SSB, sweet/salty snack, and fast food intakes and adolescent sweets/salty snack intake were lower after the Padres program for those who had a high intervention dose compared to low intervention dose. Also, a low adolescent BMI percentile was related to high intervention dose and mother attendance. In the third study, father-reported frequency of paternal fruit role modeling and fast food availability and adolescent-reported paternal allowance of adolescent screen time and frequency of fruit role modeling were improved after the intervention in the intervention compared to the delayed-treatment control group. Discrepancies in the frequencies of improved paternal parenting practices were shown except for the frequency of fruit role modeling. Paternal food responsibilities (father-reported) and family meals (adolescent-reported) were identified as modifiers of paternal food parenting practices. Conclusion: This dissertation research demonstrated improvements in only a small number of paternal parenting practices and father and adolescent EBRBs and weight status after the intervention. Possible explanations for the lack of significant findings include the small sample size, low family socioeconomic status and time constraints due to busy work schedules based on social determinants of health, and inadequate time for behavioral change to occur by measuring change immediately after the last learning session. Further family-focused intervention studies with a larger sample size are needed to further examine associations between parenting practices and Latino adolescent food and activity related behaviors to prevent childhood obesity. In family-focused interventions, increasing Latino fathers’ representation and recognizing the roles of social determinants of health and Latino family strengths are essential.Item A Randomized-Controlled Trial of Mindfulness and Executive Function Trainings to Promote Self-Regulation in Internationally Adopted Children(2015-08) Lawler, JamieWhile children adopted internationally show remarkable recovery once placed in families, as a group these children continue to show delays in certain aspects of development years after adoption. In particular, the area that seems to show the most lasting, and sometimes profound deficits is children’s self-regulation. The current study uses a randomized, controlled trial to evaluate the effects of mindfulness-based and executive function trainings on internationally adopted (IA) children’s self-regulation, including inhibitory control, attention, and emotion regulation. Seventy-two IA children ages 6-10 were randomized into Mindfulness training (MT), Executive Function training (EF), or no intervention (NI) groups. The MT and EF groups attended 12 one-hour group sessions. Children in both intervention groups showed fewer hyperactivity and attention problems and showed better emotion regulation in the classroom, as rated by teachers blind to group status. The EF training was more successful in improving inhibitory control, while the MT group may have improved in delay of gratification. Both interventions improved selective attention in children with poor baseline regulatory functioning. Parent-reported behavior did not significantly change in any domain. Contrary to expectations, the mindfulness intervention did not improve perspective taking skills or prosocial behavior. Implications and future directions are discussed.Item Training Health Professionals in Tanzania: Effects of an Afrocentric Sexual Health Education Curriculum for Medical, Nursing and Midwifery Students (Randomized Controlled Trial Data)(2023-08-31) Rosser, B. R. Simon; Mkoka, Dickson A.; Leshabari, Sebalda; Kohli, Nidhi; Lukumay, Gift G.; Rohloff, Corissa T.; Trent, Maria; Mgopa, Lucy R.; Mkonyi, Ever; Ross, Michael W.; Mushy, Stella E.; Mohammed, Inari; Massae, Agnes F.; Zhang, Ziwei; Mwakawanga, Dorkasi L.; rosser@umn.edu; Rosser, B. R. Simon; Sexual Health Research at the University of Minnesota (SHRUM) Program"Training for Health Professionals” was a randomized, controlled, single-blind, trial conducted at Muhimbili University of Health and Allied Sciences (MUHAS) in Dar es Salaam, Tanzania. As part of the study, 412 medical, nursing and midwifery students were stratified by discipline, completed baseline assessments, then randomized to attend a 4-day sexual health workshop (intervention, n=206) or to a waitlist control (n=206). The workshop curriculum covered sexual health across the lifespan, male and female sexual dysfunctions, key populations (LGBT), sexual violence, clinical skills building, ethics, policy writing, and cultural considerations. Primary outcomes were sexual health knowledge, attitudes, and clinical skills. The primary outcomes of sexual health knowledge and attitudes were assessed at baseline, post-intervention (intervention group only), and 3-month follow-up via a quantitative survey. This survey also included demographic information, education background, and evaluation of the sexual health workshop. The primary outcome of clinical skills was assessed at baseline and 3-month follow-up via videotaped standardized patient (SP) interviews. Each of the videos (2 at baseline, 2 at follow-up) was independently rated by an expert (a faculty member) and the patient (the SP actor). After each interview participants completed a survey reflecting on their performance as a student clinician. At the end of the follow-up videos, participants completed a survey evaluating the standardized patient experience (SPE). In sum, this record includes an Excel file with the data codebook (also provided as six separate CSV files for accessibility) and five CSV data files covering the above outcomes. The responses were de-identified as described below in the README file.Item Which Treatment do Parents Prefer?: A Randomized Preference Trial to Inform Personalization of a Parent Training Program(2016-07) He, YaliuStudies on personalized interventions suggest that the ‘one size fits all’ approach of most psychotherapeutic interventions fails to meet the needs of many healthcare consumers. Because parents ultimately decide upon treatment for their children, there is a growing recognition that parents should be involved in the selection of their children’s mental health treatments. The goal of this pilot study is to investigate the relationships among parent preference, treatment attendance, treatment modality, and parenting treatment outcomes using a doubly randomized preference trial. At baseline, 129 families with children ages 4 to 12 years presenting at community mental health clinics participated in a conduct problems intervention study. Families consenting to participate in the study were randomly assigned to preference (n = 64) or non-preference groups (n = 64). Those in the choice group were able to choose between four intervention options while families in the no-choice group were randomly assigned to one of those four options. The results of Study 1 showed that individual family home-based Parent Management Training Oregon Model (PMTO) was the most preferred treatment and parents who were randomized to the choice group were more likely to attend the interventions than parents in the no-choice group. Using data from baseline, post-intervention and 6-month follow-up, in Study 2, the results of mixed-effects models showed that parents in the choice group who selected PMTO interventions had better parental treatment outcomes over time compared to parents in the choice group who selected child therapy. Implications were discussed.