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Comparison · NCT02432209-afb8e59d

Intensive Lifestyle Mod. Intervention vs Standard Lifestyle Intervention: Mode of Delivery-Cesarean Section

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. Intensive Lifestyle Mod. Intervention vs Standard Lifestyle Intervention: Mode of Delivery-Cesarean Section. Trial comparisons, record NCT02432209-afb8e59d. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02432209-afb8e59d

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.5280.370.68wilson
Risk in group 20.5750.4220.715wilson
Risk difference, group 1 minus group 2-0.0472-0.2580.169newcombe hybrid score
Risk ratio, group 1 over group 20.9180.611.38log
Odds ratio, group 1 over group 20.8260.3342.04log
Number needed to treat, for one fewer participant with the outcome on Intensive Lifestyle Mod. Intervention than on Standard Lifestyle Intervention21.2from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Intensive Lifestyle Mod. Intervention
The intensive lifestyle modification intervention will consist of caloric restriction (consumption of approximately 1200-1500 kcal/d), use of an over-the-counter weight loss medication (Alli, which is brand name Orlistat, a gastric lipase inhibitor that limits gut fat absorption), and moderate physical activity (goal of reaching 10,000 steps a day). The pretreatment intervention will last 16 weeks and is designed to promote a weight loss of approximately 7% of total body weight.~Caloric Restriction: Subjects on Active comparator will have Caloric Restriction to a 1200-1500 kcal/day diet through use of Nutrisystem Meal Plan.~Orlistat: Subjects on Active comparator will use an over-the-counter weight loss medication, Orlistat, a gastric lipase inhibitor that limits gut fat absorption.~Moderate physical activity: All subjects in both arms will be encouraged to engage in moderate physical activity with target of 10,000 steps a day.
1936OG000
Group 2Standard Lifestyle Intervention
Women in the standard lifestyle intervention (standard) will receive publicly available written materials that promote engagement in moderate physical activity with target of 10,000 steps a day. Detailed instruction of physical activity will not be provided.~Moderate physical activity: All subjects in both arms will be encouraged to engage in moderate physical activity with target of 10,000 steps a day.
2340OG001

Outcome

Type
SECONDARY
Title
Mode of Delivery-Cesarean Section
Description
Babies by Cesarean Section/Number of participants who delivered baby
Time frame
At time of birth, approximately 17 months into the study
Population
For those who delivered baby(babies)

Source ClinicalTrials.gov

Trial

Title
Improving Reproductive Fitness Through Pretreatment With Lifestyle Modification in Obese Women With Unexplained Infertility
NCT number
NCT02432209
Phases
PHASE3
Conditions
Infertility, Female
Interventions
Caloric Restriction, Orlistat, Moderate physical activity
Lead sponsor
Yale University
Results first posted
2021-03-15

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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