Which factors play a role in the decision of mothers to participate in child follow-up examinations after participation in an RCT?: a semi-quantitative study.

OBJECTIVES: To determine which factors contribute to the decision of mothers to participate with their child in follow-up (FU) examinations after participation in a randomised controlled trial (RCT) prior to conception. DESIGN: A cross-sectional survey, including Likert-scale items. Comparisons will be made between respondents who participated in all FU rounds of data collection and those who did not participate in any FU round with their child. PARTICIPANTS: Women who participated in an RCT investigating the effect of a preconception lifestyle intervention (LIFEstyle study: Netherlands Trial Register: NTR1530) were invited to participate with their child in three FU data collections when the child had a mean age of 4.2 years, 4.6 years and 6.5 years, respectively. FU rounds included a health questionnaire, physical examination and cardiac assessment, successively. RESULTS: Sixty-seven respondents were included, of whom 7 (10%) did not participate in any FU round and 24 (36%) participated in all FU rounds. Women who participated with their child in all 3 FU data collection rounds felt more involved in the FU research (95.8%) and agreed more often that the FU was introduced well (91.7%) as compared with women that did not participate in any FU data collection round with their child (14.3% and 28.6%, respectively). Participants of FU rounds more often agreed that participation felt like a health check for their child as compared with non-participants. In addition, participants of the physical examination and cardiac assessment more often let their decision to participate depend fully on their child, as compared with non-participants (39.4% vs 17.7% and 52.5% vs 24%, respectively). CONCLUSIONS: To increase participation rates in future FU studies of children after maternal participation in an RCT, we suggest to involve women in the design of the FU study, to emphasise possible perceived benefits of participation and to encourage women to actively involve their child in the decision of participation.

Development of a core outcome set for school-based intervention studies on preventing childhood overweight and obesity: study protocol.

INTRODUCTION: Prevention of childhood overweight is an important health priority. Evidence synthesis from studies evaluating school-based overweight preventive interventions is hampered by the wealth of different outcomes across studies. Therefore, consensus on a core set of outcomes for school-based overweight prevention studies is needed. This paper presents the protocol for the development of a core outcome set (COS) for school-based intervention studies aimed at childhood overweight prevention. METHODS AND ANALYSIS: First, a scoping review will be performed to identify outcomes included in studies evaluating school-based overweight prevention interventions in 6-12 year-old children. Additionally, child focus groups will be organised in three countries to list the outcomes children consider important in school-based interventions. Next, an expert panel will identify all unique outcomes (eg, body composition) from the results of the scoping review and focus groups, ruling out how outcomes were defined and measured (eg, body mass index, body fat). In the next phase, a group of international stakeholders will participate in a Delphi study in which they will rate all unique outcomes on a 9-point Likert scale over three rounds to reach consensus on a COS. Participants will include healthcare professionals, policymakers, teachers, school leaders and parents of 6-12 year-olds. All rated outcomes will be presented to stakeholders in two online consensus meetings. ETHICS AND DISSEMINATION: The Medical Ethics Committee of the VU Medical Center approved the child focus group study in the Netherlands (nr. 2020.071) and the Delphi study-including the consensus meeting (nr. 2022.0295). Other sites will obtain ethics approval for focus groups in their country. The University of Strathclyde School of Psychological Sciences ethics committee approved the Delphi study-including consensus meeting (nr. 72.27.04.2022 .A). The final COS will be disseminated through the diverse networks of all authors and participants. TRIAL REGISTRATION NUMBER: This COS initiative is registered with the Core Outcome Measures in Effectiveness initiative (registration nr. 971).