Feasibility and acceptability of a brief routine weight management intervention for postnatal women embedded within the national child immunisation programme in primary care: randomised controlled cluster feasibility trial

Abstract

Background: The prevalence of obesity in women continues to rise and pregnancy is a high-risk time for excessive weight gain. The period after childbirth represents an opportunity to offer women support to manage their weight. The primary aim here was to investigate the acceptability and feasibility of delivering a self-management intervention to postnatal women to support weight loss, embedded within the national child immunisation programme. Methods: The research involved a randomised controlled cluster feasibility trial. Data were collected at baseline and 3 months later. Twenty-eight postnatal women living with overweight or obesity were recruited via Birmingham Women Hospital or general practices. Babies are routinely immunised at 2, 3 and 4 months of age; the intervention was embedded within these appointments. The intervention involved brief motivation/support by practice nurses to encourage participants to make healthier lifestyle choices through self-monitoring of weight and signposting to an online weight management programme, when they attended their practice to have their child immunised. The role of the nurse was to provide external accountability for weight loss. Participants were asked to weigh themselves weekly and record this on a record card or using the online programme. The weight goal was for participants to lose 0.5 to 1 kg per week. Usual care received a healthy lifestyle leaflet. The primary outcome was the feasibility of a phase III trial to test the subsequent effectiveness of the intervention, as assessed against three stop-go traffic light criteria (recruitment, adherence to regular self-weighing and registration with an online weight management programme).

Adverse event recording failed to reflect potential harms: a review of trial protocols of behavioral, lifestyle and psychological therapy interventions

“…Justification for not recording non-serious AEs was given in 6/15 protocols, typically that the intervention was behavioral and not expected to cause harm ( Figs. 3 and 4 ) [15][16][17][18][19][20] .…”

“…Twenty-five protocols made exemptions to AE recording. Eight of 15 protocols which stated non-serious AEs were not to be recorded did record serious AEs [18][19][20][21][22][23][24][25] . Other: data and relationship violence [2] , social stories [2] gambling [1] , back pain self-management [1] , debt counselling [1] , arts therapy [1] , oral health behavior [1] , returning to work [1] , hand hygiene [1] , motivational interviewing [1] , anger management [1] , standing up for myself (learning disability population) [1] , loneliness and social networks [1] , good behavior school [1] (10.6%) [37] Depression in people who had a stroke Further stroke related events were not classified as serious AEs, because these events were expected within this population.…”

Examining demographic and psychosocial factors related to self-weighing behavior during pregnancy and postpartum periods

“…Studies examining self-weighing behavior in pregnant and postpartum cohorts report moderate to high completion rates ( Daley et al, 2021 , Krukowski et al, 2021 , Daley et al, 2020 , Shieh et al, 2017 , Daley et al, 2015 ) and associations between self-weighing and weight loss ( Lohr et al, 2023 , Huseinovic et al, 2018 ) or eating behaviors. ( Yu et al, 2022 ) Most of these studies defined regular self-weighing as at least once per week.…”