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Patient and public involvement in randomized trials of lifestyle intervention among pregnant women with obesity: An umbrella review

Int J Gynaecol Obstet. 2026 Mar 20. doi: 10.1002/ijgo.70978. Online ahead of print.

ABSTRACT

BACKGROUND: Obesity increases the risk of obstetric and neonatal complications, and adherence to lifestyle interventions during pregnancy presents a challenge. Patient and public involvement (PPI) in trials may foster a more patient-centered approach, potentially improving compliance with intervention and follow up.

OBJECTIVE: To assess the extent of PPI in systematic reviews (SRs) and meta-analyses (MAs) focused on lifestyle interventions for pregnant women with obesity and its impact on compliance and follow-up rates of included randomized controlled trials (RCTs).

SEARCH STRATEGY: Searches were conducted in PubMed, Scopus, Web of Science, and Embase using terms related to “lifestyle”, “obesity”, and “pregnancy”, along with filters for SRs and MAs.

SELECTION CRITERIA: SRs of RCTs, with or without MAs, published from 2013 to 2024, focusing on lifestyle interventions for pregnant women with obesity (BMI ≥30 [calculated as weight in kilograms divided by the square of height in meters]).

DATA COLLECTION AND ANALYSIS: SR quality was assessed using AMSTAR 2. PPI reporting was evaluated using the GRIPP2 checklist and the ACTIVE framework. Compliance and follow-up rates were compared between RCTs with and without PPI.

MAIN RESULTS: Eleven SRs, 10 with MAs (including 94 RCTs) were included. They were of low quality in 3/11 (27%) and critically low in 8/11 (73%). No SRs reported implementing PPI. Only 6/94 (10%) RCTs reported PPI, 2/29 (7%) directly after the introduction of GRIPP2 (2018) and 4/65 (6%) indirectly before its introduction (P = 0.79). PPI occurred during RCT methodology planning in 2/6 (33%), knowledge translation in 2/6 (33%), or both in 2/6 (33%). Compared with RCTs not reporting PPI (n = 94), the median intervention compliance rate in RCTs reporting PPI (n = 6) was higher (74% versus 68%, P = 0.637), and the follow-up rate was lower (78% versus 89%, P = 0.138), but the difference was not statistically significant. These findings warrant cautious interpretation given the limited number of RCTs reporting PPI.

CONCLUSIONS: PPI remains scarce in both SRs and RCTs evaluating lifestyle interventions in pregnant women with obesity. Future research should integrate and clearly report PPI to strengthen the evaluation of lifestyle interventions in this population.

PMID:41859876 | DOI:10.1002/ijgo.70978

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