Trial name | UPBEAT [58] | ROLO [59] | Belgian Flanders [64] | NELLI [65] | The TOP study [66] | ||
---|---|---|---|---|---|---|---|
Investigators | Dodd, Grivell, Owens | Poston | McAuliffe | Vinter, Tanvig, Jensen | Bogaerts, Devlieger | Luoto | Renault |
Funding | NHMRC (ID 519240 and 1043178) | NIHR | HRB Ireland | Trygfonden, Denmark | Â | Finnish Diabetes Research Fund | Sygekassernes Helsefond; Broedrene Hartmann Fondon |
Inclusion criteria | Overweight or obese | Obese | Women with prior birth of infant >4Â kg | Obese | Obese | Women of all BMI categories | Obese |
Setting | Adelaide, South Australia | Multiple centres, United Kingdom | Dublin, Ireland | Odense, Denmark | Multiple centres, Belgium | Pirkananaa region, Southwest Finland | Copenhagen, Denmark |
Intervention intensity | 3 face-to-face sessions (2 with dietitian, 1 with RA); 3 telephone contacts | 8 weekly sessions with health trainer | Initial group dietary education session, 2 follow-up sessions with dietitian | 4 sessions with dietitian; weekly physiotherapy sessions | 4 sessions with midwife | 5 counselling sessions with midwife | Up to 13 sessions (alternate face-to-face and telephone with dietitian) |
Intervention content | Healthy eating in pregnancy; food substitutions; promote increased physical activity; identify barriers/enablers | Healthy eating; food substitutions; promote increased physical activity; SMART goals | Healthy eating in pregnancy; low glycaemic index foods | Dietary advice consistent with national guidelines; individual energy requirements calculated; moderate physical activity | Dietary advice consistent with national guidelines | Promote increased physical activity; dietary advice consistent with national guidelines | Mediterranean style diet consistent with national recommendations; increased physical activity measured by pedometer |
Baseline data | 10–20 weeks gestation | 15–19 weeks gestation | Prior to 18 weeks gestation | 10–14 weeks gestation | Prior to 15 weeks gestation | 8–12 weeks gestation | Prior to 16 weeks gestation |
Primary trial findings | Reduction infant birth weight >4 kg Improved diet and physical activity | Reduction GWG 0.5 kg Improved diet and physical activity | Reduction GWG 1.3 kg Improved diet, physical activity and insulin resistance | Reduction GWG 1.6 kg Improved insulin resistance | Reduction GWG 1.1 kg | Reduction infant birth weight >4 kg Improved diet and physical activity | Reduction GWG 1.38 kg |
Sample size | 2212 women randomised | 1556 women randomised | 429 women randomised | 360 women randomised | 205 women randomised | 238 women randomised | 425 women randomised |
Follow-up | 6, 18, and 36Â months | 6 and 36Â months | 6 and 60Â months | 6 and 36Â months | 36Â months | 36Â months | 6, 9, 18, and 36Â months |
Retention | 72% (~1592) | 60% (~930) | 68% (~290) | 54% (~194) | 65% (~134) | 65% (~154) | 65% (~250) |