Dataset Information

Feasibility and Efficacy of the "FUNPALs Playgroup" Intervention to Improve Toddler Dietary and Activity Behaviors: A Pilot Randomized Controlled Trial.

ABSTRACT: This study evaluated the feasibility and effects of the Families Understanding Nutrition and Physically Active Lifestyles (FUNPALs) Playgroup on toddler (12-36-month-old) diet and activity behaviors. Parent-toddler dyads were recruited from disadvantaged communities and randomly assigned to receive 10-weekly sessions of the FUNPALs Playgroup (n = 24) or dose-matched health education control group (n = 26). FUNPALs Playgroups involved physical and snack activities, delivery of health information, and positive parenting coaching. The control group involved group health education for parents only. Process outcomes (e.g., retention rate, fidelity) and focus groups determined feasibility and perceived effects. To evaluate preliminary effects, validated measures of toddler diet (food frequency questionnaire and a carotenoid biomarker), physical activity (PA; accelerometers), general and feeding parenting (self-report surveys), and home environment (phone interview) were collected pre and post. The sample comprised parents (84% female) who self-identified as Hispanic/Latino (38%) and/or African American (32%). Retention was high (78%). Parents from both groups enjoyed the program and perceived improvements in their children's health behaviors. Objective measures demonstrated improvement with large effects (η2 = 0.29) in toddler diet (p < 0.001) but not PA (p = 0.099). In conclusion, the FUNPALs Playgroup is feasible and may improve toddler eating behaviors.

SUBMITTER: Cepni AB

PROVIDER: S-EPMC8345510 | biostudies-literature | 2021 Jul

REPOSITORIES: biostudies-literature

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Feasibility and Efficacy of the "FUNPALs Playgroup" Intervention to Improve Toddler Dietary and Activity Behaviors: A Pilot Randomized Controlled Trial.

Cepni Aliye B AB Taylor Ashley A Crumbley Christine C Thompson Debbe D Moran Nancy E NE Olvera Norma N O'Connor Daniel P DP Arlinghaus Katherine R KR Johnston Craig A CA Ledoux Tracey A TA

International journal of environmental research and public health 20210723 15

This study evaluated the feasibility and effects of the Families Understanding Nutrition and Physically Active Lifestyles (FUNPALs) Playgroup on toddler (12-36-month-old) diet and activity behaviors. Parent-toddler dyads were recruited from disadvantaged communities and randomly assigned to receive 10-weekly sessions of the FUNPALs Playgroup (<i>n</i> = 24) or dose-matched health education control group (<i>n</i> = 26). FUNPALs Playgroups involved physical and snack activities, delivery of healt ...[more]

PMID: 34360118

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Project description:BackgroundInternationally, the implementation of evidence-based healthy eating policies and practices within early childhood education and care (ECEC) settings that encourage children's healthy diet is recommended. Despite the existence of evidence-based healthy eating practices, research indicates that current implementation rates are inadequate. Web-based approaches provide a potentially effective and less costly approach to support ECEC staff with implementing nutrition policies and practices.ObjectiveThe broad aim of this pilot randomized controlled trial is to assess the feasibility of assessing the impact of a web-based program together with health promotion officer (HPO) support on ECEC center implementation of healthy eating policies and practices. Specifically, we seek to describe the completion rate of study evaluation processes (participant consent and data collection rates); examine ECEC center uptake, acceptability, and appropriateness of the intervention and implementation strategies; understand the potential cost of delivering and receiving implementation support strategies; and describe the potential impact of the web-based intervention on the implementation of targeted healthy eating practices among centers in the intervention group.MethodsA 6-month pilot implementation trial using a cluster-randomized controlled trial design was conducted in 22 ECEC centers within the Hunter New England region of New South Wales, Australia. Potentially eligible centers were distributed a recruitment package and telephoned by the research team to assess eligibility and obtain consent. Centers randomly allocated to the intervention group received access to a web-based program, together with HPO support (eg, educational outreach visit and local technical assistance) to implement 5 healthy eating practices. The web-based program incorporated audit with feedback, development of formal implementation blueprints, and educational materials to facilitate improvement in implementation. The centers allocated to the control group received the usual care.ResultsOf the 57 centers approached for the study, 22 (47%) provided consent to participate. Data collection components were completed by 100% (22/22) of the centers. High uptake for implementation strategies provided by HPOs (10/11, 91% to 11/11, 100%) and the web-based program (11/11, 100%) was observed. At follow-up, intervention centers had logged on to the program at an average of 5.18 (SD 2.52) times. The web-based program and implementation support strategies were highly acceptable (10/11, 91% to 11/11, 100%). Implementation of 4 healthy eating practices improved in the intervention group, ranging from 19% (2/11) to 64% (7/11).ConclusionsThis study provides promising pilot data to warrant the conduct of a fully powered implementation trial to assess the impact of the program on ECEC healthy eating practice implementation.Trial registrationAustralian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12619001158156; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378099.International registered report identifier (irrid)RR2-10.1186/s40814-020-00707-w.

Project description:BackgroundPredictive theoretical models suggest that health knowledge works in conjunction with motivation and behavioral skills to influence adolescents' obesogenic behavior. However, most of the existing adolescent interventions target these variables in isolation. Furthermore, health literacy (HL), a precursor to health knowledge, is necessary for translating health knowledge into behavior and is negatively related to adolescents' obesity status. However, HL has not been included in obesity interventions targeting adolescents.ObjectiveThis study aims to pilot the feasibility of a 2-armed web-based obesity prevention intervention in school settings and assess the preliminary effectiveness of adding an HL module to an obesity prevention intervention for adolescents.MethodsThis web-based pilot feasibility study will take place in the Northeastern United States. Participants will be adolescents (aged 13-16 years) attending school, and recruitment will be conducted through flyers to parents and adolescents in participating classes or advisory groups at the school. The intervention includes 2 arms: an experimental arm that will receive an HL module and 3 obesity prevention modules and a comparison arm that will receive a vaping module and 3 obesity prevention modules. A blinded randomized procedure will be used to allocate classrooms and advisory groups to the experimental and comparison arms. The intervention will be fully web-based. Participants will complete measures of their HL and obesogenic behavior-related health knowledge, motivation, and behaviors at 3 time points (baseline, 1 month after the intervention, and 3 months after the intervention) via web-based surveys. The primary outcomes will be the measures of study feasibility (recruitment, retention, completion, and treatment fidelity rates). Secondary outcomes will be preliminary efficacy, as measured by logistic and linear regressions and calculation of effect sizes. Descriptive statistics will be calculated for all measures at each time point.ResultsThis study was approved by the City University of New York Institutional Review Board in August 2020. As of June 2022, the web-based intervention design is complete and ready for use. Recruitment, data collection, and intervention implementation are scheduled to begin in September 2022. These results are expected to be published in 2023.ConclusionsThis study's feasibility findings will inform changes to the intervention content and randomized controlled trial design. The study's efficacy findings will inform the sample size for the full-scale randomized controlled trial and the preliminary utility of the intervention.Trial registrationClinicalTrials.gov NCT04252677; https://clinicaltrials.gov/ct2/show/NCT04252677.International registered report identifier (irrid)PRR1-10.2196/40191.

Project description:Few randomized controlled trials (RCTs) report interventions targeting improvement of frailty status as an outcome.This RCT enrolled 117 older adults (65-79?years of age) in Toufen, Taiwan who scored 3-6 on The Chinese Canadian Study of Health and Aging Clinical Frailty Scale Telephone Version and then score ?1 on the Cardiovascular Health Study Phenotypic Classification of Frailty (CHS_PCF). With a two by two factorial design, subjects were randomly assigned to interventions (Exercise and nutrition, EN, n?=?55 or problem solving therapy, PST, n?=?57) or controls (non-EN, n?=?62 or non-PST, n?=?60). Educational booklets were provided to all. EN group subjects received nutrition consultation and a thrice-weekly exercise-training program while PST group subjects received 6 sessions in 3?month. Subjects were followed at 3, 6, and 12?months. Primary outcome was improvement of the CHS_PCF by at least one category (from pre-frail to robust, or from frail to pre-frail or robust) from baseline assessments. One hundred and one completed final assessments. Intention-to-treat analysis with the generalized estimating equation model was applied with adjustment for time and treatment-by-time interactions.Mean age was 71.4?±?3.7?years, with 59% females. Baseline characteristic were generally comparable between groups. EN group subjects had a higher improvement rate on the primary outcome than non-EN group subjects (45% vs 27%, adjusted p?=?0.008) at 3?months, but not 6 or 12?months. They also had more increase of serum 25(OH) vitamin D level (4.9?±?7.7 vs 1.2?±?5.4, p?=?0.006) and lower percentage of osteopenia (74% vs 89% p?=?0.042) at 12?months. PST group subjects had better improvement (2.7?±?6.1 vs 0.2?±?6.7, p?=?0.035, 6-month) and less deterioration (-3.5?±?9.7 vs -7.1?±?8.7, p?=?0.036, 12-month) of dominant leg extension power than non-PST subjects. Some secondary outcomes were also improved in control groups (non-EN or non-PST). No adverse effects were reported.The three-month EN intervention resulted in short-term (3-month) frailty status improvement and long-term effect on bone mineral density and serum vitamin D (12-month) among Taiwanese community-dwelling elders. The effect of PST was less pronounced.ClinicalTrials.gov: EC0970301

Project description:BackgroundDespite numerous benefits for both mom and baby, few infants are exclusively breastfed for the recommended first six months. Additionally, infants are given solids too early. Prenatal education increases rates of breastfeeding initiation and we hypothesize it can also improve exclusive breastfeeding rates and prevent the early introduction of solids. We conducted a randomized controlled pilot and feasibility trial to understand the feasibility and maternal acceptance of a prenatal behavioral lifestyle intervention (PBLI) delivered via group based phone counseling (GBPC) and its effectiveness on rates of exclusive breastfeeding up to six months postpartum. Secondary aims included rates of any breastfeeding up to six months, rates of early introduction of solids, and infant feeding progression.MethodsForty-one pregnant women were recruited from a Kansas City Metropolitan Obstetrics and Gynecology office and randomly assigned to a usual care group or a PBLI. Women in the PBLI participated in six GBPC sessions where they learned about breastfeeding and introducing solids. Feeding questionnaires to assess breastfeeding and introduction of solids were sent at two weeks, two months, four months, and six months postpartum. Structured interviews were also conducted after the intervention and at six months postpartum to assess maternal acceptance and intervention feasibility.ResultsParticipants overwhelmingly found the intervention acceptable and beneficial. Rates of exclusive breastfeeding and any breastfeeding did not differ between groups at any time point. No between group differences were found for early introduction of solids or infant feeding progression.ConclusionsMothers discontinue breastfeeding earlier than recommended despite high rates of initiation. A PBLI delivered via GBP is feasible, acceptable to participants, and showed positive impacts such as maternal empowerment for both breastfeeding and introducing solids. Future interventions should incorporate both prenatal and postpartum components.Trial registrationStudy protocols were approved by the University of Kansas Medical Center's Human Subjects Committee (STUDY00140506) and registered at ClinicalTrials.gov on 02/22/2018 ( NCT03442517 , retrospectively registered). All participants gave written informed consent prior to data collection.

Project description:BackgroundPersistent pain in adolescence adversely affects everyday life and is an important public health problem. The primary aim was to determine the feasibility of an 8-week app-based self-management intervention to reduce pain and improve health-related quality of life in a community-based population of adolescents with persistent pain. A secondary aim was to explore differences in health outcomes between the intervention and control groups.MethodsA sample of 73 adolescents aged 16-19 years with persistent pain from a community-based population were randomized into 2 groups. The intervention group received the Norwegian culturally adapted version of the iCanCope with PainTM app, which includes symptom tracking, goal setting, self-management strategies, and social support. The attention control group received a symptom tracking app. Feasibility was assessed as attrition rates and level of engagement (interactions with the app). The secondary outcomes included pain intensity, health-related quality of life, self-efficacy, pain self-efficacy, perceived social support from friends, anxiety and depression, and patient global impression. Statistical analyses were conducted using SPSS.ResultsDemographic and baseline outcome variables did not differ between the 2 groups. No differences were found between the participants completing the study and those who withdrew. Twenty-eight adolescents completed the intervention as planned (62% attrition). Both groups had a low level of app engagement. Intention-to-treat analysis (n = 19 + 14) showed no significant differences in outcomes between groups. However, the large effect size (Cohen's d = .9) for depression suggested a lower depression score in the intervention group.ConclusionsHigh treatment attrition and low engagement indicate the need for changes in trial design in a full-scale randomized controlled trial to improve participant retention.Trial registrationThe iCanCope with Pain Norway trial was retrospectively registered in Clinical Trials.gov (ID: NCT03551977 ). Registered 6 June 2018.

Dataset Information

Feasibility and Efficacy of the "FUNPALs Playgroup" Intervention to Improve Toddler Dietary and Activity Behaviors: A Pilot Randomized Controlled Trial.

Publications

Feasibility and Efficacy of the "FUNPALs Playgroup" Intervention to Improve Toddler Dietary and Activity Behaviors: A Pilot Randomized Controlled Trial.

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