| Primary | Unprotected Sexual Occasions (USOs) | USOs were instances of sexual intercourse where neither partner utilized any form of contraception. Participants were assessed using Timeline Follow-Back (TLFB), a calendar assisted structured interview that provided a way to cue memory so that accurate recall was enhanced for event-level data. TLFB has been used to assess sexual risk-taking. Participants were asked to provide the number of USOs experienced 90 days prior to baseline assessment, between baseline assessment and 2-month follow up, and from 2-month follow up to 6-month follow up. | Some participants did not attend the 2-month or 6-month assessments. | Posted | | Mean | Standard Deviation | USOs per participant | | Up to 6 months | | | | ID | Title | Description |
|---|
| OG000 | Health Check-up for Expectant Moms | Theory-driven and derived from empirical support Health Check-up for Expectant Moms: A brief intervention (one session plus two booster sessions) | | OG001 | Time, Attention, and Information-matched Control | Well-validated Time, attention, and information-matched control: We will include facts about alcohol/drug use and risky sex during pregnancy, along with informational brochures that provide face validity. |
| | | Title | Denominators | Categories |
|---|
| Baseline (past 90 days) | - ParticipantsOG00088
- ParticipantsOG00188
| |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| Baseline to 2-month assessment | Generalized linear mixed model analysis | generalized linear mixed model analysis under a negative binomial framework | 0.2964 | | | | | | | | | | | | | | Superiority | | | | 2-month assessment to 6-month assessment |
|
| Primary | Alcohol Use Measured by Timeline Follow-Back (TLFB) | Alcohol use was measured by the TLFB. Participants were asked if they had consumed any standard alcoholic drinks 90 days prior to baseline assessment, between baseline assessment and 2-month follow up, and from 2-month follow up to 6-month follow up. Participants' responses could only be Yes or No. Results reflect the participants who responded Yes. | Some participants did not attend the 2-month or 6-month assessments. | Posted | | Count of Participants | | Participants | | Up to 6 months | | | | ID | Title | Description |
|---|
| OG000 | Health Check-up for Expectant Moms | Theory-driven and derived from empirical support Health Check-up for Expectant Moms: A brief intervention (one session plus two booster sessions) | | OG001 | Time, Attention, and Information-matched Control | Well-validated Time, attention, and information-matched control: We will include facts about alcohol/drug use and risky sex during pregnancy, along with informational brochures that provide face validity. |
| |
| Primary | Cannabis Use Measured by Timeline Follow-Back (TLFB) | Cannabis use was measured by the TLFB. Participants were asked if they had used or consumed any cannabis 90 days prior to baseline assessment, between baseline assessment and 2-month follow up, and from 2-month follow up to 6-month follow up. Participants' responses could only be Yes or No. Results reflect the participants who responded Yes. | Some participants did not attend the 2-month or 6-month assessments. | Posted | | Count of Participants | | Participants | | Up to 6 months | | | | ID | Title | Description |
|---|
| OG000 | Health Check-up for Expectant Moms | Theory-driven and derived from empirical support Health Check-up for Expectant Moms: A brief intervention (one session plus two booster sessions) | | OG001 | Time, Attention, and Information-matched Control | Well-validated Time, attention, and information-matched control: We will include facts about alcohol/drug use and risky sex during pregnancy, along with informational brochures that provide face validity. |
| |
| Secondary | Sexually Transmitted Infections (STIs) | STIs were measured using urine samples or home vaginal swabs testing kits, which were collected at the baseline assessment and 6 weeks postpartum. Results reflect participants whose results came back with positive results for any STI. | Not all participants provided a urine sample or home vaginal swab for testing due to a national shortage on STI tests during the COVID-19 pandemic. | Posted | | Count of Participants | | Participants | | Baseline to 6 weeks postpartum (up to 11 months) | | | | ID | Title | Description |
|---|
| OG000 | Health Check-up for Expectant Moms | Theory-driven and derived from empirical support Health Check-up for Expectant Moms: A brief intervention (one session plus two booster sessions) | | OG001 | Time, Attention, and Information-matched Control | Well-validated Time, attention, and information-matched control: We will include facts about alcohol/drug use and risky sex during pregnancy, along with informational brochures that provide face validity. |
| |
| Secondary | Unprotected Sexual Occasions (USOs) Postpartum | USOs were instances of sexual intercourse where neither partner utilized any form of contraception. Participants were assessed using Timeline Follow-Back (TLFB), a calendar assisted structured interview that provided a way to cue memory so that accurate recall was enhanced for event-level data. TLFB has been used to assess sexual risk-taking. Participants were asked to provide the number of USOs experienced from the period of birth up to 6 weeks postpartum. | Not all participants participated in the postpartum follow-up assessment. | Posted | | Mean | Standard Deviation | USOs per participant | | 6 weeks postpartum (up to 11 months) | | | | ID | Title | Description |
|---|
| OG000 | Health Check-up for Expectant Moms | Theory-driven and derived from empirical support Health Check-up for Expectant Moms: A brief intervention (one session plus two booster sessions) | | OG001 | Time, Attention, and Information-matched Control | Well-validated Time, attention, and information-matched control: We will include facts about alcohol/drug use and risky sex during pregnancy, along with informational brochures that provide face validity. |
| |
| Secondary | Birth Weight of Baby | Birth weight of participants' babies was measured in grams. | Birth weight data was collected from EMRs at the participating sites, regardless of whether the participant completed the 6 Weeks Post Partum visit or not, which is why the Overall Number of Participants Analyzed is different than the Participant Flow. Data from some participants could not be collected because it was missing from the EMR or the participant did not consent to the release of the information. Additionally, data from twins was not included to avoid confounding the results. | Posted | | Mean | Standard Deviation | grams | | 6 weeks postpartum (up to 11 months) | | | | ID | Title | Description |
|---|
| OG000 | Health Check-up for Expectant Moms | Theory-driven and derived from empirical support Health Check-up for Expectant Moms: A brief intervention (one session plus two booster sessions) | | OG001 | Time, Attention, and Information-matched Control | Well-validated Time, attention, and information-matched control: We will include facts about alcohol/drug use and risky sex during pregnancy, along with informational brochures that provide face validity. |
| |
| Secondary | Baby Head Circumference | Head circumference of participants' babies was measured in centimeters. | Birth head circumference data was collected from EMRs and paper records, regardless of whether the participant completed the 6 Weeks Post Partum visit or not, which is why the Overall Number of Participants Analyzed is different than the Participant Flow. Data from some participants could not be collected because it was missing from the EMR or the participant did not consent to the release of the information. Additionally, data from twins was not included to avoid confounding the results. | Posted | | Mean | Standard Deviation | Centimeters | | 6 weeks postpartum (up to 11 months) | | | | ID | Title | Description |
|---|
| OG000 | Health Check-up for Expectant Moms | Theory-driven and derived from empirical support Health Check-up for Expectant Moms: A brief intervention (one session plus two booster sessions) | | OG001 | Time, Attention, and Information-matched Control | Well-validated Time, attention, and information-matched control: We will include facts about alcohol/drug use and risky sex during pregnancy, along with informational brochures that provide face validity. |
| |
| Secondary | Baby Birth Length | Birth length of participants' babies was measured in centimeters. | Birth length data was collected from EMRs and paper records, regardless of whether the participant completed the 6 Weeks Post Partum visit or not, which is why the Overall Number of Participants Analyzed is different than the Participant Flow. Data from some participants could not be collected because it was missing from the EMR or the participant did not consent to the release of the information. Additionally, data from twins was not included to avoid confounding the results. | Posted | | Mean | Standard Deviation | Centimeters | | 6 weeks postpartum (up to 11 months) | | | | ID | Title | Description |
|---|
| OG000 | Health Check-up for Expectant Moms | Theory-driven and derived from empirical support Health Check-up for Expectant Moms: A brief intervention (one session plus two booster sessions) | | OG001 | Time, Attention, and Information-matched Control | Well-validated Time, attention, and information-matched control: We will include facts about alcohol/drug use and risky sex during pregnancy, along with informational brochures that provide face validity. |
| |
| Secondary | Heavy Episodic Drinking | Heavy episodic drinking was defined as consumption of 4 or more standard alcoholic drinks during a single day. Participants were asked if they had engaged in any heavy episodic drinking 90 days prior to baseline assessment and from the period from birth to 6 weeks postpartum. Participants' responses could only be Yes or No. Results reflect the participants who responded Yes. | Not all participants participated in the postpartum follow-up assessment. | Posted | | Count of Participants | | Participants | | 6 weeks postpartum (up to 11 months) | | | | ID | Title | Description |
|---|
| OG000 | Health Check-up for Expectant Moms | Theory-driven and derived from empirical support Health Check-up for Expectant Moms: A brief intervention (one session plus two booster sessions) | | OG001 | Time, Attention, and Information-matched Control | Well-validated Time, attention, and information-matched control: We will include facts about alcohol/drug use and risky sex during pregnancy, along with informational brochures that provide face validity. |
| |
| Secondary | Estimated Cost-effectiveness of Health Check-up for Expectant Moms (HCEM) | Cost-effectiveness was measured in US dollars (USD) and was evaluated as the incremental cost-effectiveness ratio (ICER) that considers the difference in the mean total costs and the difference in health outcomes and events between the two arms. Results reflect the cost-effectiveness evaluation based on estimated costs per case of unprotected sexual occasion averted, alcohol or illicit drug use averted, and sexually transmitted infection (STI) event averted. To develop a plausible full range, a 25% variation of the estimated mean in each arm was used. All participants who were randomized were included in the analysis for this outcome measure. | | Posted | | Mean | Full Range | dollars per averted event | | 6 weeks post-partum (up to 11 months) | | | | ID | Title | Description |
|---|
| OG000 | Health Check-up for Expectant Moms | Theory-driven and derived from empirical support Health Check-up for Expectant Moms: A brief intervention (one session plus two booster sessions) | | OG001 | Time, Attention, and Information-matched Control | Well-validated Time, attention, and information-matched control: We will include facts about alcohol/drug use and risky sex during pregnancy, along with informational brochures that provide face validity. |
| |