Comparison · NCT02432209-deaths
Intensive Lifestyle Mod. Intervention vs Standard Lifestyle Intervention: deaths from any cause
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Intensive Lifestyle Mod. Intervention vs Standard Lifestyle Intervention: deaths from any cause. Trial comparisons, record NCT02432209-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02432209-deaths
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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 | 0 | 0.02 | wilson | |
| Risk in group 2 | 0 | 0 | 0.0197 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.0197 | 0.02 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to harm | from the risk difference interval | the two groups' risks are equal |
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. | 0 | 188 | EG000 |
| 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. | 0 | 191 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, all-cause mortality
- Time frame
- From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
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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