Dataset Information

Randomised controlled trial of support from volunteer counsellors for mothers considering breast feeding.

ABSTRACT:

Objective

To investigate whether offering volunteer support from counsellors in breast feeding would result in more women breast feeding.

Design

Randomised controlled trial.

Setting

32 general practices in London and south Essex.

Participants

720 women considering breast feeding.

Main outcome measures

Primary outcome was prevalence of any breast feeding at six weeks. Secondary outcomes were the proportion of women giving any breast feeds, or bottle feeds at four months, duration of any breast feeding, time to introduction of bottle feeds, and satisfaction with breast feeding.

Results

Offering support in breast feeding did not significantly increase the prevalence of any breast feeding to six weeks (65% (218/336) in the intervention group and 63% (213/336) in the control group; relative risk 1.02, 95% confidence interval 0.84 to 1.24). Survival analysis up to four months confirmed that neither duration of breast feeding nor time to introduction of formula feeds differed significantly between control and intervention groups. Not all women in the intervention group contacted counsellors postnatally, but 73% (123/179) of those who did rated them as very helpful. More women in the intervention group than in the control group said that their most helpful advice came from counsellors rather than from other sources.

Conclusions

Women valued the support of a counsellor in breast feeding, but the intervention did not significantly increase breastfeeding rates, perhaps because some women did not ask for help.

SUBMITTER: Graffy J

PROVIDER: S-EPMC313903 | biostudies-literature | 2004 Jan

REPOSITORIES: biostudies-literature

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Publications

Randomised controlled trial of support from volunteer counsellors for mothers considering breast feeding.

Graffy Jonathan J Taylor Jane J Williams Anthony A Eldridge Sandra S

BMJ (Clinical research ed.) 20040101 7430

<h4>Objective</h4>To investigate whether offering volunteer support from counsellors in breast feeding would result in more women breast feeding.<h4>Design</h4>Randomised controlled trial.<h4>Setting</h4>32 general practices in London and south Essex.<h4>Participants</h4>720 women considering breast feeding.<h4>Main outcome measures</h4>Primary outcome was prevalence of any breast feeding at six weeks. Secondary outcomes were the proportion of women giving any breast feeds, or bottle feeds at fo ...[more]

PMID: 14703543

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Project description:BackgroundExclusive breastfeeding for the first 6 months of life is the optimal way to feed infants. However, recent studies suggest that exclusive breastfeeding rates in China remain low and are well below the recommended target. There has been evidence that a lack of awareness of, or exposure to, breastfeeding information is associated with poor breastfeeding practices. WeChat, the most widely used social networking platform in China, has shown some potential to promote health behaviours. We thus hypothesised that a breastfeeding intervention program delivered via WeChat would achieve at least a 10% increase in exclusive breastfeeding prevalence at 6 months compared to the control group.MethodsA two-arm, parallel, multicentre randomised controlled trial of 1000 pregnant women will be conducted at four maternity hospitals of Chengdu, China. Eligible women who consent to participate in the trial will be recruited at 28-30 weeks of gestation, and randomly allocated to either the intervention group (participants receive breastfeeding-related information from WeChat) or the control group (participants receive non-breastfeeding information from WeChat) using a central randomisation system on a 1:1 ratio at each participating site. The primary outcomes are exclusive breastfeeding rate and full breastfeeding rate at 6 months postpartum. All randomised participants will be included in the outcome analyses with missing data being imputed based on the best-case and worst-case scenarios. Multilevel mixed regression models will be used in the primary analyses to assess the effectiveness of intervention program on the breastfeeding rates.DiscussionThis trial uses the most widely used social media program as a means of delivering messages to mothers to increase exclusive breastfeeding in China. Increasing exclusive breastfeeding will contribute to meeting the health and environmental goals of the Sustainable Development Guidelines. Trial registration ClinicalTrials.gov, NCT04499404. Registered 5 August 2020-Retrospectively registered, https://clinicaltrials.gov/show/NCT04499404.

Project description:We sought evidence of effectiveness of lay support to improve maternal and child outcomes in disadvantaged families.Prospective, pragmatic, individually randomised controlled trial.3 Maternity Trusts in West Midlands, UK.Following routine midwife systematic assessment of social risk factors, 1324 nulliparous women were assigned, using telephone randomisation, to standard maternity care, or addition of referral to a Pregnancy Outreach Worker (POW) service. Those under 16 years and teenagers recruited to the Family Nurse Partnership trial were excluded.POWs were trained to provide individual support and case management for the women including home visiting from randomisation to 6 weeks after birth. Standard maternity care (control) included provision for referring women with social risk factors to specialist midwifery services, available to both arms.Primary outcomes were antenatal visits attended and Edinburgh Postnatal Depression Scale (EPDS) 8-12 weeks postpartum. Prespecified, powered, subgroup comparison was among women with 2 or more social risks. Secondary outcomes included maternal and neonatal birth outcomes; maternal self-efficacy, and mother-to-infant bonding at 8-12 weeks; child development assessment at 6 weeks, breastfeeding at 6 weeks, and immunisation uptake at 4 months, all collected from routine child health systems.Antenatal attendances were high in the standard care control and did not increase further with addition of the POW intervention (10.1 vs 10.1 (mean difference; MD) -0.00, 95% CI (95% CI -0.37 to 0.37)). In the powered subgroup of women with 2 or more social risk factors, mean EPDS (MD -0.79 (95% CI -1.56 to -0.02) was significantly better, although for all women recruited, no significant differences were seen (MD -0.59 (95% CI -1.24 to 0.06). Mother-to-infant bonding was significantly better in the intervention group for all women (MD -0.30 (95% CI -0.61 to -0.00) p=0.05), and there were no differences in other secondary outcomes.This trial demonstrates differences in depressive symptomatology with addition of the POW service in the powered subgroup of women with 2 or more social risk factors. Addition to existing evidence indicates benefit from lay interventions in preventing postnatal depression. This finding is important for women and their families given the known effect of maternal depression on longer term childhood outcomes.ISRCTN35027323; Results.

Project description:ObjectiveTo assess the feasibility of implementing a dedicated feeding support team on a postnatal ward and pilot the potential effectiveness and cost-effectiveness of team (proactive) and woman-initiated (reactive) telephone support after discharge.DesignRandomised controlled trial embedded within a before-and-after study. Participatory approach and mixed-method process evaluation.SettingA postnatal ward in Scotland.SampleWomen living in disadvantaged areas initiating breast feeding.MethodsEligible women were recruited to a before-and-after intervention study, a proportion of whom were independently randomised after hospital discharge to intervention: daily proactive and reactive telephone calls for ≤14 days or control: reactive telephone calls ≤ day 14. Intention-to-treat analysis compared the randomised groups on cases with complete outcomes at follow-up.Main outcome measuresPrimary outcomeany breast feeding at 6-8 weeks assessed by a telephone call from a researcher blind to group allocation.Secondary outcomesexclusive breast feeding, satisfaction with care, NHS costs and cost per additional woman breast feeding.ResultsThere was no difference in feeding outcomes for women initiating breast feeding before the intervention (n=413) and after (n=388). 69 women were randomised to telephone support: 35 intervention (32 complete cases) and 34 control (26 complete cases). 22 intervention women compared with 12 control women were giving their baby some breast milk (RR 1.49, 95% CI 0.92 to 2.40) and 17 intervention women compared with eight control women were exclusively breast feeding (RR 1.73, 95% CI 0.88 to 3.37) at 6-8 weeks after birth. The incremental cost of providing proactive calls was £87 per additional woman breast feeding and £91 per additional woman exclusively breast feeding at 6-8 weeks; costs were sensitive to service organisation.ConclusionsProactive telephone care delivered by a dedicated feeding team shows promise as a cost-effective intervention for improving breastfeeding outcomes. Integrating the FEeding Support Team (FEST) intervention into routine postnatal care was feasible.Trial registration numberISRCTN27207603. The study protocol and final report are available on request.

Project description:BackgroundVarious kinds of breast reconstruction (BR) options, including implants and autologous, and surgery techniques, including traditional and endoscope assisted, can be used to perform surgery. All options have their own advantages and disadvantages. Women decide on an option depending on the values and preferences they emphasize. Lacking knowledge about BR or having decision difficulties during the treatment decision process makes women experience more decision regret, psychological distress, and poor body image. Delivering decision support with a values clarification exercise using eHealth approaches would be beneficial for patient outcomes.ObjectiveThis study aims to examine the effects of a decision support app on decision-making quality and psychological morbidity for women considering BR surgery.MethodsThis randomized controlled trial included women who were over 20 years of age and were newly diagnosed with breast cancer and candidates for mastectomy. Women having an option for breast conservation were excluded. After being referred from the outpatient physician, the women provided consent and completed the baseline assessment. Women allocated to the control group (CG) received usual care and were provided with a pamphlet with information about types of surgery and the advantages and disadvantages of different surgery types. Women allocated to the intervention group (IG) were given the same pamphlet and guided to use the Pink Journey app to support their decision. Then they were also prompted to discuss the opinions with their significant others. Finally, the decision-making process of using the app was printed out for women that they could take home. Decision conflict, anxiety, and depression were measured at baseline. At 1 week after the intervention (T1) and at 1 month (T2), 8 months (T3), and 12 months (T4) after surgery, the women completed decision conflict, decision regret, anxiety, depression, and body image scales. An intention-to-treat analysis was performed.ResultsFrom February 2018 to July 2019, 96 women were randomly assigned to the CG (n=48) or the IG (n=48). Results revealed that body image distress declined significantly for the IG but increased for the CG. The interaction of time and group also reached significance, indicating a significant decrease in body image distress from baseline in the IG compared with the CG after the 12th month (T4) follow-up (β=-2.25, standard error=1.01, P=.027). However, there was no significant difference in decision conflict (P=.21-.87), decision regret (P=.44-.55), anxiety (P=.26-.33), and depression (P=.20-.75), indicating that the decrease in these outcomes in the IG was not greater than those in the CG.ConclusionsAlthough we found no effect on decision conflict, decision regret, anxiety, and depression, a decision aid that combines surgery information and values clarification can help women reduce their body image distress.Trial registrationClinicalTrials.gov NCT04190992; https://clinicaltrials.gov/ct2/show/NCT04190992.

Dataset Information

Randomised controlled trial of support from volunteer counsellors for mothers considering breast feeding.

Objective

Design

Setting

Participants

Main outcome measures

Results

Conclusions

Publications

Randomised controlled trial of support from volunteer counsellors for mothers considering breast feeding.

Similar Datasets

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