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Factors assessed in the first year of a longitudinal study predict subsequent study visit compliance: the TEDDY study
Jessica Melin1, Kristian F Lynch2, Markus Lundgren3,4
1Department of Clinical Science, Lund University, CRC Hus 60 Pl 11, Box 50332, 202 13, Malmö, Sweden. Jessica.melin@med.lu.se.
Insights
Maternal satisfaction and father participation improved study visit compliance in the TEDDY study for children at risk of type 1 diabetes. Factors like maternal smoking and postpartum depression were linked to lower compliance.
Area of Science:
- Pediatric research
- Longitudinal studies
- Type 1 Diabetes (T1D) research
Background:
- Study protocol compliance is crucial for research validity, especially in longitudinal studies where missed visits can introduce bias and reduce statistical power.
- The Environmental Determinants of Diabetes in the Young (TEDDY) study is a multinational effort investigating environmental triggers for islet autoimmunity and T1D in at-risk children.
Purpose of the Study:
- To identify sociodemographic variables and maternal characteristics from the first year of the TEDDY study associated with study visit compliance over the subsequent three years.
- To understand factors influencing participant adherence in a long-term pediatric cohort study focused on type 1 diabetes.
Main Methods:
- Collected data on sociodemographic variables, maternal lifestyle, postpartum depression, maternal reactions to child's T1D risk, and study-related factors at child ages 6 and 15 months.
- Employed multiple linear regression to analyze the association between these early-life variables and study visit compliance during the subsequent three years of the TEDDY study.
Main Results:
- Higher study visit compliance was observed in Sweden, for first-born children, mothers who were older, and mothers reporting greater satisfaction with the TEDDY study.
- Father participation and father's study satisfaction were also linked to better compliance, though father's satisfaction was not significant when maternal satisfaction was included.
- Conversely, maternal smoking, postpartum depression, and increased anxiety about the child's T1D risk were associated with lower study visit compliance.
Conclusions:
- Sociodemographic factors, maternal characteristics (notably study satisfaction), and paternal involvement in the initial year predict subsequent study visit compliance in children at genetic risk for T1D.
- Findings offer valuable insights for developing targeted strategies to enhance participant retention and improve compliance in future longitudinal pediatric research.
Background:
Compliance with a study protocol is central to meeting its research goals. In longitudinal research studies, data loss due to missed visits limit statistical power and introduce bias. The Environmental Determinants of Diabetes in the Young (TEDDY) study is a longitudinal multinational (US, Finland, Germany, and Sweden) investigation of children at risk for type 1 diabetes (T1D) that seeks to identify the environmental triggers of islet autoimmunity and T1D. The purpose of the current study was to identify sociodemographic variables and maternal characteristics assessed in the first year of TEDDY that were associated with study visit compliance in the subsequent 3 years.
Methods:
Sociodemographic variables, maternal life-style behaviors, post-partum depression, maternal reactions to the child's T1D risk, and study-related variables were collected at child-age 6 months and 15 months. Multiple linear regression was used to examine the association of these variables to study visit compliance in the subsequent 3 years.
Results:
Study visit compliance was highest in Sweden (p > 0.001), in children who were their mother's first child (p > 0.001), and whose mothers were older (p > 0.001) and more satisfied with the TEDDY study (p > 0.001). Father participation was also associated with better study visit compliance (p > 0.001). In contrast, children whose mothers smoked (p > 0.001), suffered from post-partum depression (p = 0.034), and were more anxious about their child's T1D risk (p = 0.002), completed fewer visits. Father's study satisfaction was also associated with study visit compliance (p = 0.029); however, it was not significant in models that included maternal study satisfaction.
Conclusions:
Sociodemographic variables, maternal characteristics-including study satisfaction-and fathers' participation in the first year of a longitudinal study were associated with subsequent study visit compliance in a sample of children genetically at-risk for T1D followed for 4 years. This information can inform future strategies designed to improve study visit compliance in longitudinal pediatric studies.
Trial Registration:
NCT00279318, 06/09/2004.
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