Bosaeus 2015.
| Methods | RCT: PONCH (Pregnancy Obesity Nutrition and Child Health Study) | |
| Participants | 101 women randomised Inclusion criteria: pregnant women of normal weight (BMI 18.5 to 24.9), aged 20‐45 years Exclusion criteria: non‐European descent, self‐reported diabetes, use of neuroleptic drugs, and vegetarianism or veganism. Exclusion after study entry: women having a miscarriage, abortion, intrauterine fetal death, sudden infant death, twin pregnancy or giving birth before 34 weeks' gestation (n = 1 but not reported which group) Setting: Sahlgrenska University Hospital, Gothenburg, Sweden |
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| Interventions |
DIETARY ADVICE: 3 fish meals a week versus control Group 1: dietary counselling (from registered dieticians): 3 sessions, 5 phone calls during pregnancy (from 8‐12 weeks GA). Participants were advised to eat 3 meals of fish a week, with advice on types of fish to consume to avoid pollutants, to generally lower sugar intake to reach < 10% energy; to eat 500 g of vegetables and fruits a day; to increase daily energy intake by 350 kcal in the second trimester and by 500 kcal in the third trimester: n = 49 Group 2: control group: study visit each trimester (not further described): n = 52 Timing of counselling: from 8‐12 weeks GA DHA + EPA dose/day: other: unable to determine |
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| Outcomes |
Women/birth: fish intake; body composition; GWG; serum phospholipid fatty acids (in all 3 trimesters); fat mass (air‐displacement plethysmography); size, number and lipolytic activity of adipocytes; and adipokine release and density of immune cells and blood vessels in adipose tissue Babies/infants/children: birthweight (numerical results not reported) |
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| Notes |
Funding: "Supported by grants from Novo Nordisk Foundation, the Swedish Research Council (No. 12206), the Swedish Research Council (Project No. 2013‐28632‐103061‐41), the Swedish Diabetes Association Research Foundation, the Swedish Federal Government under the LUA/ALF agreement, IngaBritt and Arne Lundbergs Foundation, Freemasonry Barnhus Board in Gothenburg, Olle Engkvist Building contractor Foundation (210/56) and Queen Silvia’s Jubilee Fund". Declarations of interest: none declared Women in the intervention group did not use supplements containing fish oil or omega‐3 fatty acids during pregnancy but in the control group, 1 woman in the first trimester, 2 in the second trimester and 4 women in the third trimester used these supplements. No outcomes could be used in this review. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: “Randomization was done by a computerized program…matched for age, BMI and parity” |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Not feasible to blind |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
| Incomplete outcome data (attrition bias) All outcomes | High risk | 66/101 (65%) attrition (complete measurements from all trimesters): 31/49 (63%) in the intervention group and 35/52 (67%) in the control group lost to follow‐up |
| Selective reporting (reporting bias) | Unclear risk | ‘Exclusions’ not always reported by intervention or control group; preterm < 37 weeks not reported; birthweight not fully reported |
| Other bias | Unclear risk | Baseline characteristics comparable except for women in the intervention reporting lower fish consumption and being shorter than women in the control group |