Graham 1992.

Methods	This randomised controlled trial aimed to measure the effectiveness of home‐based visiting from trained lay‐persons to reduce LBW.  The study was conducted in the prenatal clinic of a university hospital in Cleveland, USA, from March 1987 to September 1989.
Participants	Inclusion criteria: Living within 5‐mile radius of clinic, 17‐28 weeks' gestation, ‘low’ family function rating, at least 1 stressful life event during pregnancy, and additional risk factors such as smoking, low maternal weight‐height ratio, aged over 27 years, or history of a previous premature baby. Exclusion criteria: White patients, difficulty reading English. Recruitment: Every person registering at clinic was eligible to be screened. The first 105 screened participants were dropped from the study when it was found that they had difficulty reading the questions. 1326 women screened. 1022 ‘low risk, 190 ‘high risk’ women – of which 145 were randomised (I = 87, C = 58). 8.5% of low risk and 15% high risk women were smokers. Baseline characteristics: Smoking characteristics not reported. Predominantly black, poor, inner city population. No progress plus coding as outcomes not able to be included in this review.
Interventions	Control: Routine care from obstetrical staff in the clinic. Intervention: 2 non‐professional black women who demonstrated rapport with women served as home‐visitors and were trained in childbirth education, community resources, and nutrition during pregnancy.  4 x 1 hour home visits occurred at 4‐6 week intervals. The home visitors followed a protocol which included psychosocial support, efforts at stress reduction, information on health risks (especially smoking and drinking), nutrition education, and a small gift. Main intervention strategy: Not coded as outcomes not included in this review. Provided by study staff: efficacy study.
Outcomes	Smoking outcomes were not able to be included in this review as it is unclear how many smokers were included in each study arm. LBW was the primary outcome for this study, but was not included in this review, as aspects other than the smoking component of the intervention may have had an effect on birthweight. See Table 4 for summary of outcomes not able to be included in this meta‐analysis.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Table of random numbers.
Allocation concealment (selection bias)	Unclear risk	Not stated.
Incomplete outcome data (attrition bias) All outcomes	High risk	24/87 dropped out and unclear if included in analysis. 7 refused intervention, 11 could not be contacted, 5 transferred care, 1 miscarried prior to visit. Numbers reported as randomised different in abstract (154) and flow chart (145).
Selective reporting (reporting bias)	Unclear risk	Unclear if selective reporting as smoking cessation was not the primary aim of the intervention.
Other bias	Low risk	No other bias detected.
Biochemical validation of smoking abstinence (detection bias)	Unclear risk	Not applicable. Smoking outcomes not reported.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Women and home visitors not blinded, as would be expected in an educational intervention.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not reported.
Incomplete implementation	High risk	Process evaluation showed only 63/87 women received home visits
Equal baseline characteristics in study arms	Unclear risk	Not reported.
Contamination of control group	Low risk	Home visiting intervention so risk contamination of control group is low.