Methods | Randomised controlled trial; 3 groups intervention design; 2 experimental groups (from pregnancy to 6 months postpartum (EP) and from birth to 6 months postpartum (EPP). The group receiving the intervention in the postnatal period only is not included in our analysis) and 1 comparison group |
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Participants | From January to June 2006, pregnant women were recruited from the obstetric clinics of a hospital in Taiwan. (160 women randomised.) Inclusion criteria: 16 gestational weeks, age 18 years or older, no cognitive impairment or psychiatric illness, ability to speak and read Chinese, not participating in another study, and intention to give birth at the study site |
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Interventions | Intervention group: (80 participants).The educational intervention began at 16 gestational weeks (baseline) and to 6 months postpartum. The intervention was delivered at regularly scheduled clinic visits by nurses with training in nutrition and physical fitness. The nurse discussed with each participant how to design an individualised diet and physical activity plan. The intervention consisted of 6 1-to-1 counselling sessions: 1 primary session (about 30-40 minutes) at the 16-week gestation visit, and 5 1-to-1 booster sessions (at 28 gestational weeks, 36-38 gestational weeks, before hospital discharge after a 3-7-day stay, 6 weeks’ postpartum and 3 months postpartum). After each clinic visit, women in the experimental groups were sent a personalised graph of their weight changes. At the 1st session, the experimental groups also received a researcher-prepared brochure that provided detailed information on weight management goals during pregnancy and postpartum Control group: (80 participants) routine care, provided once each trimester which health education on nutrition and exercise during pregnancy |
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Outcomes | Gestational weight gain, weight retention at 6 months postpartum, health-promoting behaviour; physical activity For analysis 1.9.1 physical activity measurement was a part of the health-promoting lifestyle profile composed of 50-item scale uses a 4-point response format (range = 50200) to measure the frequency of engaging in activities related to self-actualisation, nutrition, physical activity,interpersonal support, health responsibility and stress management |
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Notes | ||
Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Using a table of random numbers. |
Allocation concealment (selection bias) | Unclear risk | Not stated. |
Blinding (performance bias and detection bias) All outcomes |
Unclear risk | The research assistant collecting outcome data was reported to be blind to the group assignments |
Incomplete outcome data (attrition bias) All outcomes |
Unclear risk | 80 women in each group were randomised, 61 and 64 of intervention and control group were analysed (78% followed up) |
Selective reporting (reporting bias) | Unclear risk | Assessment from published study report. |
Other bias | Low risk | No notable baseline differences were found between groups. |