Garmendia 2015.

Trial name or title	Diet and physical activity counselling and n3‐long chain (PUFA) supplementation in obese pregnant women (MIGHT)
Methods	RCT (cluster, with 4 arms): NCT02574767
Participants	Recruitment target: 1000 women. Inclusion criteria: ≤ 14 weeks' gestational age at first prenatal visit; BMI > 30 kg/m2 at first prenatal visit; singleton pregnancy; plan to deliver at Sotero del Rio Hospital. Exclusion criteria: pre‐existing diabetes (known or diagnosed at first control (fasting plasma glucose > 126 mg/dl or 2 h plasma glucose > 200 mg/dl during an OGTT; insulin or metformin use; known medical or obstetric complications which restrict physical activity; history of eating disorders; high risk of haemorrhagic bleeding; high‐risk pregnancy according to national guidelines. Setting: 12 primary healthcare centres (PHCC) and Sotero del Rio Hospital, Chile.
Interventions	Intervention groups 1) 'Lifestyle counselling + PUFA supplement group': home‐based diet & physical activity counselling (2 home visits of 1 hour duration consisting of individually tailored dietary educational and behaviour education plus PUFA supplementation (n3LC‐PUFAs oral supplementation based on Schizochytrium oil (S‐oil) containing 800 mg DHA acid/day, administered as capsular preparations containing 200 mg DHA/capsule (4 capsules/day). 2) 'PUFA supplementation" group': routine dietary and physical activity counselling plus n3LC‐PUFAs oral supplementation based on Schizochytrium oil (S‐oil) containing 800 mg DHA acid/day, administered as capsular preparations containing 200 mg DHA/capsule (4 capsules/day). Control groups 3) 'Llifestyle counselling + PUFA placebo group': home‐based diet & physical activity counselling (2 home visits of 1 hour duration consisting of individually tailored dietary educational and behaviour education plus capsular preparations containing 50 mg DHA capsule (4 capsules/day), delivered in the same way as the n3LC‐PUFA supplementation. 4) 'Routine diet & PA + PUFA placebo group': routine dietary and physical activity counselling plus capsulare preparations containing 50 mg DHA/capsule (4 capsules/day), delivered in the same way as the n3LC‐PUFA supplementation.
Outcomes	Primary outcomes: GDM (at 24‐28 weeks of gestation according to ADA 2011 guidelines); macrosomia (birthweight > 4000 g); prevalence of insulin resistance at birth. Other outcomes: low birthweight (below 2500 g); excess weight gain during pregnancy; pre‐eclampsia (at 24‐28 weeks of gestation); preterm birth (< 37 weeks); caesarean.
Starting date	August 2015
Contact information	Dr Maria Luisa Garmendia. E‐mail: mgarmendia@inta.uchile.ch
Notes	Funding and collaborators: University of Chile; Fondo Nacional de Desarrolo Cientificao y Technológico, Chile; DSM Nutritional Products, Inc; Corporación de Apoyo de la Investigatión Científica en Nutrición.