Comparison · NCT02432209-43c26907
Intensive Lifestyle Mod. Intervention vs Standard Lifestyle Intervention: Rate of Good Birth Outcomes
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: Rate of Good Birth Outcomes. Trial comparisons, record NCT02432209-43c26907. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02432209-43c26907
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.122 | 0.0829 | 0.177 | wilson | |
| Risk in group 2 | 0.152 | 0.108 | 0.21 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0295 | -0.0994 | 0.0406 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.806 | 0.484 | 1.34 | log | |
| Odds ratio, group 1 over group 2 | 0.779 | 0.432 | 1.4 | log | |
| Number needed to treat, for one fewer participant with the outcome on Intensive Lifestyle Mod. Intervention than on Standard Lifestyle Intervention | 33.9 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Intensive 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. | 23 | 188 | OG000 |
| Group 2 | Standard 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. | 29 | 191 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Rate of Good Birth Outcomes
- Description
- Defined as a live birth of an infant born at ≥ 37 weeks, with a birth weight between 2500 and 4000g and without a major congenital anomaly
- Time frame
- At time of birth, approximately 17 months into the study
- Population
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
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02432209?tab=results
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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