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Quality assurance of data collection in the multi-site community randomized trial and prevalence survey of the children's healthy living program.

ABSTRACT: BACKGROUND:Quality assurance plays an important role in research by assuring data integrity, and thus, valid study results. We aim to describe and share the results of the quality assurance process used to guide the data collection process in a multi-site childhood obesity prevalence study and intervention trial across the US Affiliated Pacific Region. METHODS:Quality assurance assessments following a standardized protocol were conducted by one assessor in every participating site. Results were summarized to examine and align the implementation of protocol procedures across diverse settings. RESULTS:Data collection protocols focused on food and physical activity were adhered to closely; however, protocols for handling completed forms and ensuring data security showed more variability. CONCLUSIONS:Quality assurance protocols are common in the clinical literature but are limited in multi-site community-based studies, especially in underserved populations. The reduction in the number of QA problems found in the second as compared to the first data collection periods for the intervention study attest to the value of this assessment. This paper can serve as a reference for similar studies wishing to implement quality assurance protocols of the data collection process to preserve data integrity and enhance the validity of study findings. TRIAL REGISTRATION:NIH clinical trial #NCT01881373.

SUBMITTER: Yamanaka A

PROVIDER: S-EPMC5009559 | biostudies-literature | 2016 Sep

REPOSITORIES: biostudies-literature

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Quality assurance of data collection in the multi-site community randomized trial and prevalence survey of the children's healthy living program.

Yamanaka Ashley A Fialkowski Marie Kainoa MK Wilkens Lynne L Li Fenfang F Ettienne Reynolette R Fleming Travis T Power Julianne J Deenik Jonathan J Coleman Patricia P Leon Guerrero Rachael R Novotny Rachel R

BMC research notes 20160902 1

<h4>Background</h4>Quality assurance plays an important role in research by assuring data integrity, and thus, valid study results. We aim to describe and share the results of the quality assurance process used to guide the data collection process in a multi-site childhood obesity prevalence study and intervention trial across the US Affiliated Pacific Region.<h4>Methods</h4>Quality assurance assessments following a standardized protocol were conducted by one assessor in every participating site ...[more]

PMID: 27590179

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Project description:BackgroundElectronic data collection is increasingly used for household surveys, but factors influencing design and implementation have not been widely studied. The Every Newborn-INDEPTH (EN-INDEPTH) study was a multi-site survey using electronic data collection in five INDEPTH health and demographic surveillance system sites.MethodsWe described experiences and learning involved in the design and implementation of the EN-INDEPTH survey, and undertook six focus group discussions with field and research team to explore their experiences. Thematic analyses were conducted in NVivo12 using an iterative process guided by a priori themes.ResultsFive steps of the process of selecting, adapting and implementing electronic data collection in the EN-INDEPTH study are described. Firstly, we reviewed possible electronic data collection platforms, and selected the World Bank's Survey Solutions® as the most suited for the EN-INDEPTH study. Secondly, the survey questionnaire was coded and translated into local languages, and further context-specific adaptations were made. Thirdly, data collectors were selected and trained using standardised manual. Training varied between 4.5 and 10 days. Fourthly, instruments were piloted in the field and the questionnaires finalised. During data collection, data collectors appreciated the built-in skip patterns and error messages. Internet connection unreliability was a challenge, especially for data synchronisation. For the fifth and final step, data management and analyses, it was considered that data quality was higher and less time was spent on data cleaning. The possibility to use paradata to analyse survey timing and corrections was valued. Synchronisation and data transfer should be given special consideration.ConclusionWe synthesised experiences using electronic data collection in a multi-site household survey, including perceived advantages and challenges. Our recommendations for others considering electronic data collection include ensuring adaptations of tools to local context, piloting/refining the questionnaire in one site first, buying power banks to mitigate against power interruption and paying attention to issues such as GPS tracking and synchronisation, particularly in settings with poor internet connectivity.

Project description:BackgroundFew data are available on dual burden of under and over nutrition of children in the Pacific region. The objective was to examine prevalence of stunting at birth and current stunting and their relationship to obesity in US Affiliated Pacific (USAP) jurisdictions.MethodsCross sectional survey with cluster sampling by community. 5558, 2-8 years olds were measured in 51 communities in 11 USAP jurisdictions. The main outcome measures were stunting at birth, current stunting and obesity by body mass index. Prevalences of stunting at birth, current stunting and obesity were determined, adjusting for age distribution and community clustering. Differences by among age, sex, race and jurisdiction income levels were evaluated by chi-square analysis. Relationships of stunting at birth and current stunting with obesity were examined using a hierarchical model accounting for the study design.ResultsPrevalences were stunting at birth 6.8% (Standard Error, SE = 0.9%), current stunting 1.4% (SE = 0.2%) and obesity 14.03.8% (SE = 0.9%). Obesity was highest in upper middle income jurisdictions (UMIJ) at 17.5%. Stunting at birth differed by race (p = 0.0001) with highest prevalence among Native Hawaiian/Pacific Islanders (10.7%). Prevalence of stunting at birth was different by jurisdiction income level with 27.5% in lower middle income jurisdictions (LMIJ), and 22.2% in UMIJ, and 5.5% in higher than high income jurisdictions (HIJ) at 5.5% (p < 0.0001). Prevalence of current stunting was higher in LMIJ than HIJ (p = 0.001), although children with current stunting were less likely to have been stunted at birth. The association between stunting at birth and current stunting was negative (OR = 0.19, 95% CI: 0.05-0.69).ConclusionsCurrently stunted children were marginally less likely to be obese than not stunted children in the USAP, where the prevalence of current stunting is low. Stunting (at birth and current) was highest in LMIJ, while UMIJ jurisdictions had the highest dual burden of malnutrition (that is the highest combination of both stunting at birth and obesity).Trial registrationNational Institutes for Health clinical trial # NCT01881373 (clinicaltrials.gov).

Project description:BackgroundWorkplace Health Promotion Programs (WHPP) have been shown to be an efficient way of improving workers' health. These programs can be incorporated in the worker's daily schedule and improve their productivity at work. Improving employees' health also benefits the employers by increasing their return on investment and lowering healthcare costs. The Activate Your Health program, created by Capsana in 2015, is a WHPP targeting multiple lifestyle habits for a three-year period. This WHPP includes tailored web-based interventions and the support of different health professionals throughout the years. We hypothesize that this approach will yield long-term lifestyle changes. The objective of the current paper is to describe the Activate Your Health program's design.Methods/designEleven companies are taking part in this WHPP and had to choose among five different options of this program and all their employees were encouraged to participate. Each option differs by the number and type of interventions included. The limited option, which is considered the control group, only consists in completing a questionnaire regarding their health status, lifestyle habits and behaviors. On the other end, the extensive option receives a combination of multiple interventions: online menus, health challenges, support in creating a healthy work environment, coaching by health professionals (nurse, nutritionist, and kinesiologist), health screening and flexibility assessment, online resources, social health platform, and activity tracking. The remaining options are in between these options and vary by the amount of intervention. Baseline data are already gathered; two other data collection periods will take place after one and 2 years into the program. The primary outcomes of the current program are physical activity and fitness measures, nutritional data, smoking habits, stress and intention to change.DiscussionThe Activate Your Health program will allow us to compare which combinations of interventions are the most effective. It is expected that the extensive option will be the most advantageous to improve lifestyle habits. The results will indicate the strength and weakness of each intervention and how it could be improved.Trial registrationClinicaltrails.gov, registration number: NCT02933385 (updated on the 26th of March 2019, initially registered on the 5th of October 2016).

Project description:BACKGROUND:Healthy Together (HT) is family-centered program to support healthy eating and physical activity designed for implementation in community organizations serving families who may be experiencing vulnerabilities (e.g., related to low income, isolation, ethnicity, immigrant/refugee status, and/or Indigenous background). The purpose of this study was to conduct an evaluation of HT in a real-world, scale-up phase using the RE-AIM framework. METHODS:Using a cross-sectional, non-comparative design, a community-based program evaluation was conducted in 29 organizations implementing HT as part of their core service programs. Data were collected using questionnaires with program participants and facilitators, and interviews with directors of participating organizations. Quantitative data were analyzed using descriptive statistics and qualitative data were content analyzed. RESULTS:With regards to Reach, over 3400 caregivers, children and youth attended community programming that offered HT. Among those attending on the scheduled day for the evaluation, 663 completed the questionnaires. The majority of caregiver respondents (n?=?431) were female (92%) and attended with children 0-6?years. Respondents also included children 4-6?years (n?=?142) and 7-12?years (n?=?65), and youth 13-18?years (n?=?25). Effectiveness was demonstrated in reported improvements in physical activity, healthy eating, and strengthened social connections. HT was also widely supported by participants and facilitators. Adoption was influenced by the desire to enrich core service programs for families, HT's fit within existing programs, organizational commitment, and funding support. Implementation experiences indicated that fidelity to the HT program was generally maintained, with some setting specific adaptations. Maintenance of HT was influenced by financial and non-financial resources within community organizations. Most organizations also introduced new initiatives to extend support for healthy eating and physical activity. CONCLUSION:Our findings indicate improvements in healthy eating and physical activity, and social connections among program participants, as well as efforts by community organizations to create environments to support healthy weights. HT was successfully delivered in "real-world" community settings across multiple contexts and with families with diverse backgrounds. This along with strategies to support program implementation and sustainability indicate that HT provides a model for other public health interventions to promote family health and wellbeing. TRIAL REGISTRATION:ClincialTrials.gov NCT03550248. Registered May 25, 2018.

Project description:Importance:Pacific Islanders have among the highest rates of obesity and type 2 diabetes in the world. Targeting children is critical for primary prevention. Objectives:To prevent young child overweight and obesity and to improve health in the US-Affiliated Pacific region via the Children's Healthy Living Program. Design, Setting, and Participants:In this multijurisdictional, multilevel, multicomponent community randomized clinical trial, where all evaluable children were analyzed according to the random assignment of their community, hierarchical difference-in-difference models accounted for the community randomization, community clustering with jurisdictions, and these models were adjusted for the age and sex distribution of the community. The setting was 27 communities in 5 jurisdictions (Alaska, American Samoa, Commonwealth of the Northern Mariana Islands, Guam, and Hawaii). Participants were 4329 children (time 1) and 4042 children (time 2) aged 2 to 8 years in 27 selected communities from October 7, 2012, to October 25, 2015. Data analysis was completed in June 2018. Interventions:Nineteen activities addressed policy, environment, messaging, training, and 6 target behaviors (sleep time, screen time, physical activity, fruits and vegetables, water, and sugar-sweetened beverages). Main Outcomes and Measures:Primary outcomes were body size measurements. Secondary outcomes were acanthosis nigricans, sleep quality and duration, dietary intake, physical activity, and other questionnaire reponses. Results:The study included 27 communities and 8371 evaluable children (mean [SD] age, 5.4 [1.8] years; 50.9% male [n?=?4264]). Data analysis included 952 children in the intervention group and 930 children in the control group aged 2 to 5 years at time 1; 825 children in the intervention group and 735 children in the control group aged 2 to 5 years at time 2; 565 children in the intervention group and 561 children in the control group aged 6 to 8 years at time 1; and 517 children in the intervention group and 560 children in the control group aged 6 to 8 years at time 2. The intervention communities showed significant improvement compared with control communities in overweight and obesity prevalence (effect size [d]?=?-3.95%; 95% CI, -7.47% to -0.43%), waist circumference (d?=?-0.71 cm; 95% CI, -1.37 to -0.05 cm), and acanthosis nigricans prevalence (d?=?-2.28%; 95% CI, -2.77% to -1.57%). Age and sex subgroup analysis revealed greater difference among the intervention communities in acanthosis nigricans prevalence in the group aged 2 to 5 years (-3.99%) vs the group aged 6 to 8 years (-3.40%), and the interaction was significant (d?=?0.59%, P?<?.001), as well as the smaller difference in the group aged 2 to 5 years (-0.10%) vs the group aged 6 to 8 years (-1.07%) in screen time (d?=?-0.97 hour per day, P?=?.01). Conclusions and Relevance:The intervention reduced the prevalence of young child overweight and obesity and acanthosis nigricans. Comprehensive, effective, and sustainable interventions are needed to improve child health in the US-Affiliated Pacific region. Trial Registration:ClinicalTrials.gov Identifier: NCT01881373.

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Quality assurance of data collection in the multi-site community randomized trial and prevalence survey of the children's healthy living program.

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Quality assurance of data collection in the multi-site community randomized trial and prevalence survey of the children's healthy living program.

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