Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

Acceptability, Adherence and Retention of a Feasibility Randomised Trial on Periodontal Treatment and Vitamin D/ Calcium Milk Fortification among Pregnant Women: A Mixed-Methods Evaluation

Version 1 : Received: 8 September 2020 / Approved: 10 September 2020 / Online: 10 September 2020 (04:44:05 CEST)

How to cite: Adegboye, A.R.A.; Dias Santana, D.; Guedes Cocate, P.; Benaim, C.; Teixeira dos Santos, P.P.; Heitmann, B.L.; da Veiga Soares de Carvalho, M.C.; Maia Schlussel, M.; Trindade de Castro, M.B.; Kac, G. Acceptability, Adherence and Retention of a Feasibility Randomised Trial on Periodontal Treatment and Vitamin D/ Calcium Milk Fortification among Pregnant Women: A Mixed-Methods Evaluation. Preprints 2020, 2020090220 (doi: 10.20944/preprints202009.0220.v1). Adegboye, A.R.A.; Dias Santana, D.; Guedes Cocate, P.; Benaim, C.; Teixeira dos Santos, P.P.; Heitmann, B.L.; da Veiga Soares de Carvalho, M.C.; Maia Schlussel, M.; Trindade de Castro, M.B.; Kac, G. Acceptability, Adherence and Retention of a Feasibility Randomised Trial on Periodontal Treatment and Vitamin D/ Calcium Milk Fortification among Pregnant Women: A Mixed-Methods Evaluation. Preprints 2020, 2020090220 (doi: 10.20944/preprints202009.0220.v1).

Abstract

This study aims to assess the acceptability, adherence, and retention of a feasibility trial on milk fortification with calcium and vitamin D (Ca+VitD) and periodontal therapy (PT) among low income Brazilian pregnant women with periodontitis (IMPROVE trial). This 2x2 factorial feasibility trial used a mixed-methods evaluation. 69 pregnant women were randomly allocated to four groups: 1.fortified sachet with Ca+VitD and milk plus early PT (throughout gestation); 2.placebo and milk plus early PT; 3.fortified sachet with Ca+VitD and milk plus late PT after childbirth; 4.placebo and milk plus late PT. Data were collected via questionnaires, field notes, participant flow logs, treatment diary, and focal group discussions. Quantitative and qualitative data were analysed using appropriate descriptive statistics and content analysis, respectively. Eligibility rate (12%) was below the target of 15%, but participation (76.1%) and recruitment rate (2 women/week) exceeded the targets. Retention rate (78.6%) was slightly below the target (80%). Adherence to the PT was significantly higher in the early treatment groups (98.8%) compared to the late treatment groups (29%). All women accepted the random allocation and baseline groups were balanced. There was no report of adverse events. This multi-component intervention is acceptable, well-tolerated, and feasible among low-risk pregnant women in Brazil.

Subject Areas

feasibility; acceptability; adherence; attrition rate; periodontal therapy; milk fortification; pregnancy

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