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. 2013 Jul 23;2013(7):CD005627. doi: 10.1002/14651858.CD005627.pub3

O'Toole 2003.

Methods Interventions were randomly assigned, but method not reported. Allocation using blinded drawing of labels containing group assignment.
Participants 23 postpartum women, who were overweight prior to pregnancy, had gained more than 15 kg during pregnancy and were more than 5 kg heavier than prepregnancy at the time of enrolment. Participants were randomised between 6 weeks and 6 months postpartum.
Interventions Intervention I: structured diet and physical activity group, which included individualised diet prescriptions derived from baseline measurements, daily food and activity diaries and healthy cooking demonstration.
 A specific, individualised activity plan consisting of moderate intensity activity guided by heart rate was developed for each participant. The intervention also included educational group sessions held once a week for 12 weeks, biweekly for the following 2 months, and monthly up to 1 year postpartum.
Intervention II: self‐directed group based on general advice about diet and exercise. This group participated in a single 1‐hour educational session about healthy diet and exercise practices. Participants were given some brochures about nutrition and a food guide pyramid.
 Trial duration: long‐term.
Outcomes Postpartum weight loss, percentage of women who achieved a BMI below 25, body fat, fat‐free mass (values not available) and VO2 max.
Other outcomes not considered in this review: energy intake and energy expenditure in physical activity (kcal/week)
Notes 40 women enrolled in the study, but 29 remained at 12 weeks postpartum (73% of retention) and 23 remained up to 1 year postpartum (58% of retention). There were no differences between those who finished the study and those who dropped out. Data on fat‐free mass were not available.
Risk of bias
Bias Authors' judgement Support for judgement
Adequate sequence generation Unclear risk Randomisation stated, but method not reported.
Allocation concealment Low risk Allocation using blinded drawing of labels containing group assignment.
Blinding 
 All outcomes Unclear risk No detail provided.
Incomplete outcome data addressed 
 All outcomes High risk 42% of lost to follow‐up (up to 1 year postpartum).
Free of selective reporting Low risk Outcomes of relevance described.
Free of other bias Low risk Study supported by the American Heart Association Heartland Affiliate, award 0051330Z. No mention of any research protocol published a priori. The characteristics of participants were not significantly different between groups at baseline.