Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Moms Are Worth It is a lifestyle behavior intervention study aims to prevent excessive gestational weight gain in overweight or obese pregnant women through promotion of the stress management, healthy eating, and physical activity. Eligible women will be randomly assigned to a usual care or an intervention plus usual care group. The intervention will last 20 weeks and will be delivered via weekly web and individual health coaching session (10 of them)
Current effective lifestyle behavior intervention studies aimed to prevent excessive gestational weight gain (EGWG) in overweight or obese pregnant women have limited practicality, scalability, and sustainability because of high participant burden and excessive cost for clinical practice. Also, prior studies paid little or no attention to motivation, emotion and cognition, all of which are critical to motivate and enable individuals to engage in healthy lifestyle behaviors and achieve positive health outcomes. A promising approach to prevent EGWG in overweight or obese pregnant women is through goal-oriented episodic future thinking (GOEFT). This pilot randomized controlled trial, aims to prevent EGWG in overweight or obese pregnant women. The proposed self-directed, web-based GOEFT intervention will focus on increasing motivation (autonomous motivation and self-efficacy) and improving emotion (emotion control and stress) and cognition (executive function, ExF), thus promoting healthy lifestyle behaviors. This will lead to prevention of EGWG and a reduced rate of gestational diabetes, gestational hypertension, cesarean delivery and fetal macrosomia. Our intervention will last 20 weeks (starting at 17 week-gestation). Participants (N = 90; 50% White, 50% minority) will be recruited and enrolled from prenatal care clinics at The Ohio State University Wexner Medical Center and be randomly assigned to our GOEFT intervention (n = 45) or usual care (n = 45). All participants will be assessed at baseline (<17 week-gestation, T1), 24-27 week-gestation (T2) and 35-37 week-gestation (T3). Specific aims are (1) to determine feasibility of the GOEFT intervention: recruitment, randomization, retention and intervention implementation, (2) to investigate the potential efficacy of the intervention on gestational weight gain and maternal and birth outcomes, (3) to investigate the potential impact of the intervention on lifestyle behaviors and (4) to investigate the potential impact of the intervention on motivation, emotion and cognition.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Goal-Oriented Episodic Future Thinking (GOEFT) Intervention | Experimental | In addition to usual prenatal care, intervention participants will receive a 20-week intervention via web and individual health counseling. The intervention topics focus on stress management, healthy eating, and physical activity. |
|
| Usual Prenatal Care | No Intervention | The usual prenatal care group will receive usual care from their providers |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Goal-Oriented Episodic Future Thinking | Behavioral | Individuals in the intervention group will receive a 20-week web-based intervention and individual health coaching focused on stress management, healthy eating and physical activity. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Body Weight | Data extracted from electronic medical record | Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2) |
| Percent Change in Body Weight | Data extracted from electronic medical record | 24-27 week-gestation (T2) to 35-37 week-gestation (T3) |
| Percent Change in Body Weight | Data extracted from electronic medical record | Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Diagnosed With Gestational Diabetes | Data extracted from electronic medical record. Percentage of participants who were diagnosed with Gestational Diabetes during the study timeframe. | 24-27 week-gestation (T2) to 35-37 week-gestation (T3) |
| Percentage of Participants Diagnosed With Gestational Hypertension |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Participants need to be pregnant women.
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mei-Wei Chang, PhD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University | Columbus | Ohio | 43210 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Eligible participants completed baseline measures; had body mass index (BMI) of 25.0-45.0 kg/m2 (calculated using self reported height and pre-pregnancy weight) and be between 18 and 45 years old. We excluded potential participants with self-reported history of ≥ 3 miscarriages, eating disorder, and diagnosed hypertension and type 1 or 2 diabetes, or contraindications to walking.
Between February, 2021 and March, 2022, Clinicians at collaborating sites referred pregnant patients to our study. The study research assistants screened the potential participants for eligibility over the phone.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Goal-Oriented Episodic Future Thinking (GOEFT) Intervention | In addition to usual prenatal care, intervention participants will receive a 20-week intervention via web and individual health counseling. The intervention topics focus on stress management, healthy eating, and physical activity. Goal-Oriented Episodic Future Thinking: Individuals in the intervention group will receive a 20-week web-based intervention and individual health coaching focused on stress management, healthy eating and physical activity. |
| FG001 | Usual Prenatal Care | The usual prenatal care group will receive usual care from their providers |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline to T2 |
|
| ||||||||||||||||||
| Baseline to T3 |
| |||||||||||||||||||
| T2 toT3 |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Goal-Oriented Episodic Future Thinking (GOEFT) Intervention | In addition to usual prenatal care, intervention participants will receive a 20-week intervention via web and individual health counseling. The intervention topics focus on stress management, healthy eating, and physical activity. Goal-Oriented Episodic Future Thinking: Individuals in the intervention group will receive a 20-week web-based intervention and individual health coaching focused on stress management, healthy eating and physical activity. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change in Body Weight | Data extracted from electronic medical record | Posted | Mean | Standard Deviation | percentage change | Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2) |
|
20 Week period of study
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Additional criteria for Serious Adverse event was loss of pregnancy
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Goal-Oriented Episodic Future Thinking (GOEFT) Intervention | In addition to usual prenatal care, intervention participants will receive a 20-week intervention via web and individual health counseling. The intervention topics focus on stress management, healthy eating, and physical activity. Goal-Oriented Episodic Future Thinking: Individuals in the intervention group will receive a 20-week web-based intervention and individual health coaching focused on stress management, healthy eating and physical activity. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Loss of Pregancy | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mei-Wei Chang, PhD | Ohio State University College of Nursing | 614-247-7211 | chang.1572@osu.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 6, 2020 | Oct 16, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 21, 2020 | Oct 16, 2020 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| D000078064 | Gestational Weight Gain |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Data extracted from electronic medical record. Percentage of participants diagnosed with Gestational Hypertension in the study timeframe. |
| 24-27 week-gestation (T2) to 35-37 week-gestation (T3) |
| Percentage of Participants With Cesarean Delivery | Data extracted from electronic medical record. Percentage of participants who experienced Cesarean Delivery. | 35-37 week-gestation (T3) |
| Newborn Body Weight | Data extracted from electronic medical record. Newborn Body Weight taken at birth. | 35-37 week-gestation (T3) |
| Percentage of Participants With Premature (<37 Weeks Gestation) Births | Gestational age for each participant was extracted from electronic medical record and births before 37 weeks gestation were considered to be premature. The number of premature births was averaged within the study groups. | 35-37 week-gestation (T3) |
| Percentage of Change in Dietary Intake Behaviors - Caloric Intake (Kcal) | Assessed using the National Cancer Institute Automated Self-Administered 24-hour Recall (ASA24). Participants completed 24-hour Dietary Recalls on two random days over a week. The variable of interest - calories (Kcal) - values for the 2 24-hour periods were added to ascertain the total amount consumed at the specific data collection time periods. Data from Baseline (T1) was compared to that collected at T2 for each participant and averaged for an aggregate score. Positive numbers represent an increase in calories consumed, negative numbers represent a decrease in calories consumed. Only participants who completed 2 days worth of dietary data were included in this analysis. | Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2) |
| Percentage of Change in Dietary Intake Behaviors - Fat (gm) | Assessed using the National Cancer Institute Automated Self-Administered 24-hour Recall (ASA24). Participants completed 24-hour Dietary Recalls on two random days over a week. The variable of interest - fat (gm) - values for the 2 24-hour periods were added to ascertain the total amount consumed at the specific data collection time periods. Data from Baseline (T1) was compared to that collected at T2 for each participant and averaged for an aggregate score. Positive numbers represent an increase in fat consumed, negative numbers represent a decrease in fat consumed. Only participants who completed 2 days worth of dietary data were included in this analysis. | Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2) |
| Percentage of Change in Dietary Intake Behaviors - Fruit (Cup) | Assessed using the National Cancer Institute Automated Self-Administered 24-hour Recall (ASA24). Participants completed 24-hour Dietary Recalls on two random days over a week. The variable of interest - fruit (cup) - values for the 2 24-hour periods were added to ascertain the total amount consumed at the specific data collection time periods. Data from Baseline (T1) was compared to that collected at T2 for each participant and averaged for an aggregate score. Positive numbers represent an increase in fruit consumed, negative numbers represent a decrease in fruit consumed. Only participants who completed 2 days worth of dietary data were included in this analysis. | Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2) |
| Percentage of Change in Dietary Intake Behaviors - Vegetable (Cup) | Assessed using the National Cancer Institute Automated Self-Administered 24-hour Recall (ASA24). Participants completed 24-hour Dietary Recalls on two random days over a week. The variable of interest - vegetables (cup) - values for the 2 24-hour periods were added to ascertain the total amount consumed at the specific data collection time periods. Data from Baseline (T1) was compared to that collected at T2 for each participant and averaged for an aggregate score. Positive numbers represent an increase in vegetables consumed, negative numbers represent a decrease in vegetables consumed. Only participants who completed 2 days worth of dietary data were included in this analysis. | Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2) |
| Percentage of Change in Dietary Intake Behaviors - Added Sugars (Teaspoon or 4gm) | Assessed using the National Cancer Institute Automated Self-Administered 24-hour Recall (ASA24). Participants completed 24-hour Dietary Recalls on two random days over a week. The variable of interest - added sugars teaspoon or 4 gm) - values for the 2 24-hour periods were added to ascertain the total amount consumed at the specific data collection time periods. Data from Baseline (T1) was compared to that collected at T2 for each participant and averaged for an aggregate score. Positive numbers represent an increase in added sugars consumed, negative numbers represent a decrease in added sugars consumed. Only participants who completed 2 days worth of dietary data were included in this analysis. | Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2) |
| Percentage of Change in Dietary Intake Behaviors - Caloric Intake (Kcal) | Assessed using the National Cancer Institute Automated Self-Administered 24-hour Recall (ASA24). Participants completed 24-hour Dietary Recalls on two random days over a week. The variable of interest - calories (Kcal) - values for the 2 24-hour periods were added to ascertain the total amount consumed at the specific data collection time periods. Data from Baseline (T1) was compared to that collected at T3 for each participant and averaged for an aggregate score. Positive numbers represent an increase in calories consumed, negative numbers represent a decrease in calories consumed. Only participants who completed 2 days worth of dietary data were included in this analysis. | Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3) |
| Percentage of Change in Dietary Intake Behaviors - Fat Intake (gm) | Assessed using the National Cancer Institute Automated Self-Administered 24-hour Recall (ASA24). Participants completed 24-hour Dietary Recalls on two random days over a week. The variable of interest - fat (gm) - values for the 2 24-hour periods were added to ascertain the total amount consumed at the specific data collection time periods. Data from Baseline (T1) was compared to that collected at T3 for each participant and averaged for an aggregate score. Positive numbers represent an increase in fat consumed, negative numbers represent a decrease in fat consumed. Only participants who completed 2 days worth of dietary data were included in this analysis. | Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3) |
| Percentage of Change in Dietary Intake Behaviors - Fruit Intake (Cups) | Assessed using the National Cancer Institute Automated Self-Administered 24-hour Recall (ASA24). Participants completed 24-hour Dietary Recalls on two random days over a week. The variable of interest - fruit (cup) - values for the 2 24-hour periods were added to ascertain the total amount consumed at the specific data collection time periods. Data from Baseline (T1) was compared to that collected at T3 for each participant and averaged for an aggregate score. Positive numbers represent an increase in fruit consumed, negative numbers represent a decrease in fruit consumed. Only participants who completed 2 days worth of dietary data were included in this analysis. | Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3) |
| Percentage of Change in Dietary Intake Behaviors - Vegetable Intake (Cups) | Assessed using the National Cancer Institute Automated Self-Administered 24-hour Recall (ASA24). Participants completed 24-hour Dietary Recalls on two random days over a week. The variable of interest - vegetable (cup) - values for the 2 24-hour periods were added to ascertain the total amount consumed at the specific data collection time periods. Data from Baseline (T1) was compared to that collected at T3 for each participant and averaged for an aggregate score. Positive numbers represent an increase in vegetables consumed, negative numbers represent a decrease in vegetables consumed. Only participants who completed 2 days worth of dietary data were included in this analysis. | Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3) |
| Percentage of Change in Dietary Intake Behaviors - Added Sugars Intake (gm) | Assessed using the National Cancer Institute Automated Self-Administered 24-hour Recall (ASA24). Participants completed 24-hour Dietary Recalls on two random days over a week. The variable of interest - added sugars (teaspoon or 4 gm) - values for the 2 24-hour periods were added to ascertain the total amount consumed at the specific data collection time periods. Data from Baseline (T1) was compared to that collected at T3 for each participant and averaged for an aggregate score. Positive numbers represent an increase in added sugars consumed, negative numbers represent a decrease in added sugars consumed. Only participants who completed 2 days worth of dietary data were included in this analysis. | Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3) |
| Percentage of Change in Physical Activity - 7-Day Metabolic Equivalent of Task (MET) | Assessed using Actigraph (GT3x), an objective measurement of physical activity. Investigators distributed the Actigraph in person participants' home (T2 and T3) to wear at the wrist at least seven consecutive days (≥ 10 hours/per day). The variable of interest - 7-day MET - values for the period was added to ascertain the total amount at the specific data collection time periods. Data from Baseline (T1) was compared to that collected at T2 for each participant and averaged for an aggregate score. Positive numbers represent an increase in physical activity negative numbers represent a decrease in physical. Only participants who completed the minimum requirement for reporting [wear at the wrist at least seven consecutive days (≥ 10 hours/per day)] were included in the analysis. | Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2) |
| Percentage of Change in Physical Activity - 7-Day Metabolic Equivalent of Task (MET) | Assessed using Actigraph (GT3x), an objective measurement of physical activity. Investigators distributed the Actigraph in person participants' home (T2 and T3) to wear at the wrist at least seven consecutive days (≥ 10 hours/per day). The variable of interest - 7-day MET - values for the period was added to ascertain the total amount at the specific data collection time periods. Data from Baseline (T1) was compared to that collected at T3 for each participant and averaged for an aggregate score. Positive numbers represent an increase in physical activity negative numbers represent a decrease in physical. Only participants who completed the minimum requirement for reporting [wear at the wr](streamdown:incomplete-link) | Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3) |
| Change in Autonomous Motivation for Physical Activity | Will be measured using Treatment Self-Regulation Questionnaire (6 items) to measure autonomous motivation for Physical Activity (6 items) Values are: 1 - Not At All True, 2, 3, 4 - Somewhat True, 5, 6, 7 - Very True The investigators will sum 6 items to create a composite score, ranging from 6 to 42. Higher scores indicate higher autonomous motivation for Physical Activity. | Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2) |
| Change in Autonomous Motivation for Physical Activity | Will be measured using Treatment Self-Regulation Questionnaire (6 items) to measure autonomous motivation for Physical Activity (6 items) Values are: 1 - Not At All True, 2, 3, 4 - Somewhat True, 5, 6, 7 - Very True The investigators will sum 6 items to create a composite score, ranging from 6 to 42. Higher scores indicate higher autonomous motivation for Physical Activity. | Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3) |
| Change in Autonomous Motivation for Stress Management | Will be measured using Treatment Self-Regulation Questionnaire (6 items) to measure autonomous motivation for stress management (6 items) Values are: 1 - Not At All True, 2, 3, 4 - Somewhat True, 5, 6, 7 - Very True The investigators will sum 6 items to create a composite score, ranging from 6 to 42. Higher scores indicate higher autonomous motivation for stress management. | Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2) |
| Change in Autonomous Motivation for Stress Management | Will be measured using Treatment Self-Regulation Questionnaire (6 items) to measure autonomous motivation for stress management (6 items) Values are: 1 - Not At AllTrue, 2, 3, 4 - Somewhat True, 5, 6, 7 - Very True The investigators will sum 6 items to create a composite score, ranging from 6 to 42. Higher scores indicate higher autonomous motivation for stress managment. | Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3) |
| Change in Autonomous Motivation for Healthy Eating | Will be measured using Treatment Self-Regulation Questionnaire (6 items) to measure autonomous motivation for Healthy Eating (6 items) Values are: 1 - Not At All True, 2, 3, 4 - Somewhat True, 5, 6, 7 - Very True The investigators will sum 6 items to create a composite score, ranging from 6 to 42. Higher scores indicate higher autonomous motivation for Healthy Eating. | Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2) |
| Change in Autonomous Motivation for Healthy Eating | Will be measured using Treatment Self-Regulation Questionnaire (6 items) to measure autonomous motivation for Healthy Eating (6 items) Values are: 1 - Not At All True, 2, 3, 4 - Somewhat True, 5, 6, 7 - Very True The investigators will sum 6 items to create a composite score, ranging from 6 to 42. Higher scores indicate higher autonomous motivation for Healthy Eating | Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3) |
| Change in Healthy Eating Self-efficacy | Will be measured using a "Survey for Healthy Eating Self-efficacy" (8 items) Values are: 1 - Not At All Confident, 2 - Not Too Confident, 3 - Somewhat Confident, 4 - Very Confident. The investigators will sum all 8 items to create a composite score, ranging from 8 to 32. The higher score, the higher healthy eating self-efficacy. | Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2) |
| Change in Healthy Eating Self-efficacy | Will be measured using a "Survey for Healthy Eating Self-efficacy" (8 items) Values are: 1 - Not At All Confident, 2 - Not Too Confident, 3 - Somewhat Confident, 4 - Very Confident The investigators will sum all 8 items to create a composite score, ranging from 8 to 32. The higher score, the higher healthy eating self-efficacy. | Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3) |
| Change in Coping Self-efficacy | Will be measured using a "Survey for Coping Self-efficacy" (10 items) Values are: 1 - Not At All Confident, 2 - Not Too Confident, 3 - Somewhat Confident, 4 - Very Confident The investigators will sum 10 items to create a composite score, ranging from 10 to 40. Higher scores indicate higher coping self-efficacy. | Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2) |
| Change in Coping Self-efficacy | Will be measured using a "Survey for Coping Self-efficacy" (10 items) Values are: 1 - Not At All Confident, 2 - Not Too Confident, 3 - Somewhat Confident, 4 - Very Confident The investigators will sum 10 items to create a composite score, ranging from 10 to 40. Higher scores indicate higher coping self-efficacy. | Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3) |
| Change in Physical Activity Self-efficacy | Will be measured using a "Survey for Physical Activity Self-efficacy" (10 items) that ask participants' confidence in performing the specific activity. Values are: 1 - Not At All Confident, 2 - Not Too Confident, 3 - Somewhat Confident, 4 - Very Confident The investigators will sum all 10 items to create a composite score, ranging from 10 to 40. The higher score, the higher physical activity self-efficacy. | Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2) |
| Change in Physical Activity Self-efficacy | Will be measured using a "Survey for Physical Activity Self-efficacy" (10 items) that ask participants' confidence in performing the specific activity. Values are: 1 - Not At All Confident, 2 - Not Too Confident, 3 - Somewhat Confident, 4 - Very Confident The investigators will sum all 10 items to create a composite score, ranging from 10 to 40. The higher score, the higher physical activity self-efficacy. | Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3) |
| Change in Emotion Regulation | The Emotion Regulation Questionnaire (10 items) was used to measure emotional control. The questionnaire asked participants to report the use of emotional regulatory process using a 7-point scale ranging from 1 (strongly disagree) to 7 (strongly agree). After revise coding 4 items, we summed responses of 10 items to create an emotional control score (ranged from 10 to 70). Higher scores indicated better emotional control. | Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2) |
| Change in Emotion Regulation | The Emotion Regulation Questionnaire (10 items) was used to measure emotional control. The questionnaire asked participants to report the use of emotional regulatory process using a 7-point scale ranging from 1 (strongly disagree) to 7 (strongly agree). After revise coding 4 items, we summed responses of 10 items to create an emotional control score (ranged from 10 to 70). Higher scores indicated better emotional control. | Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3) |
| Change in Perceived Stress | Will be measured using The Perceived Stress Scale (10 items) that measures the degree to which situations in one's life are appraised as stressful. Values are: 0 - Never, 1 - Almost Never, 2 - Sometimes, 3 - Fairly Often, 4 - Very Often The investigators will sum 10 items to create a composite score, ranging from 0 to 40. The higher score, the higher levels of perceived stress. | Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2) |
| Change in Perceived Stress | Will be measured using The Perceived Stress Scale (10 items) that measures the degree to which situations in one's life are appraised as stressful. Values are: 0 - Never, 1 - Almost Never, 2 - Sometimes, 3 - Fairly Often, 4 - Very Often The investigators will sum 10 items to create a composite score, ranging from 0 to 40. The higher score, the higher levels of perceived stress. | Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3) |
| Change in Executive Function - Behavior Regulation | The Behavior Rating Inventory of Executive Function-Adults (75 items) was used to measure executive function. This survey asked participants to rate self-regulation behaviors in the everyday environment using a 3-point Likert scale ranging from 0 (never) to 2 (often). This survey covers 2 main domains: behavior regulation (30 items) and metacognition (45 items). We summed responses to the 30 behavior regulation items to create a behavior regulation score. Behavior regulation scores range from 0-60. We used the same approach to create a composite score for metacognition. Higher scores indicated worse behavior regulation or metacognition. The scores from T1 were compared to scores for T2 to evaluate the effect of the intervention. | Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2) |
| Change in Executive Function - Behavioral Regulation | The Behavior Rating Inventory of Executive Function-Adults (75 items) was used to measure executive function. This survey asked participants to rate self-regulation behaviors in the everyday environment using a 3-point Likert scale ranging from 0 (never) to 2 (often). This survey covers 2 main domains: behavior regulation (30 items) and metacognition (45 items). We summed responses to the 30 behavior regulation items to create a behavior regulation score. Behavior regulation scores range from 0-60. We used the same approach to create a composite score for metacognition. Higher scores indicated worse behavior regulation or metacognition. The scores from T1 were compared to scores for T3 to evaluate the effect of the intervention. | Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3) |
| Change in Executive Function - Metacognition | The Behavior Rating Inventory of Executive Function-Adults (75 items) was used to measure executive function [31]. This survey asked participants to rate self-regulation behaviors in the everyday environment using a 3-point scale ranging from 0 (never) to 2 (often). This survey covers 2 main domains: behavior regulation (30 items) and metacognition (45 items). We summed responses to the 30 behavior regulation items to create a behavior regulation score. We used the same approach to create a composite score for metacognition. Metacognition scores range from 0-90. Higher scores indicated worse metacognition. The scores from T1 were compared to scores from T2 to evaluate the effect of the intervention. | Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2) |
| Change in Executive Function - Metacognition | The Behavior Rating Inventory of Executive Function-Adults (75 items) was used to measure executive function [31]. This survey asked participants to rate self-regulation behaviors in the everyday environment using a 3-point scale ranging from 0 (never) to 2 (often). This survey covers 2 main domains: behavior regulation (30 items) and metacognition (45 items). We summed responses to the 30 behavior regulation items to create a behavior regulation score. We used the same approach to create a composite score for metacognition. Metacognition scores range from 0-90. Higher scores indicated worse metacognition. The scores from T1 were compared to scores from T3 to evaluate the effect of the intervention. | Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3) |
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
| BG001 | Usual Prenatal Care | The usual prenatal care group will receive usual care from their providers |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Marital Status | Count of Participants | Participants | No |
|
The usual prenatal care group will receive usual care from their providers |
|
|
| Primary | Percent Change in Body Weight | Data extracted from electronic medical record | Posted | Mean | Standard Deviation | percent change | 24-27 week-gestation (T2) to 35-37 week-gestation (T3) |
|
|
|
| Primary | Percent Change in Body Weight | Data extracted from electronic medical record | Posted | Mean | Standard Deviation | percent change | Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3) |
|
|
|
| Secondary | Percentage of Participants Diagnosed With Gestational Diabetes | Data extracted from electronic medical record. Percentage of participants who were diagnosed with Gestational Diabetes during the study timeframe. | Posted | Mean | Standard Deviation | percentage of participants | 24-27 week-gestation (T2) to 35-37 week-gestation (T3) |
|
|
|
| Secondary | Percentage of Participants Diagnosed With Gestational Hypertension | Data extracted from electronic medical record. Percentage of participants diagnosed with Gestational Hypertension in the study timeframe. | Posted | Mean | Standard Deviation | percent of participants | 24-27 week-gestation (T2) to 35-37 week-gestation (T3) |
|
|
|
| Secondary | Percentage of Participants With Cesarean Delivery | Data extracted from electronic medical record. Percentage of participants who experienced Cesarean Delivery. | Posted | Mean | Standard Deviation | percentage of participants | 35-37 week-gestation (T3) |
|
|
|
| Secondary | Newborn Body Weight | Data extracted from electronic medical record. Newborn Body Weight taken at birth. | Posted | Mean | Standard Deviation | grams | 35-37 week-gestation (T3) |
|
|
|
| Secondary | Percentage of Participants With Premature (<37 Weeks Gestation) Births | Gestational age for each participant was extracted from electronic medical record and births before 37 weeks gestation were considered to be premature. The number of premature births was averaged within the study groups. | Posted | Count of Participants | Participants | 35-37 week-gestation (T3) |
|
|
|
| Secondary | Percentage of Change in Dietary Intake Behaviors - Caloric Intake (Kcal) | Assessed using the National Cancer Institute Automated Self-Administered 24-hour Recall (ASA24). Participants completed 24-hour Dietary Recalls on two random days over a week. The variable of interest - calories (Kcal) - values for the 2 24-hour periods were added to ascertain the total amount consumed at the specific data collection time periods. Data from Baseline (T1) was compared to that collected at T2 for each participant and averaged for an aggregate score. Positive numbers represent an increase in calories consumed, negative numbers represent a decrease in calories consumed. Only participants who completed 2 days worth of dietary data were included in this analysis. | Posted | Mean | Standard Deviation | percentage of change | Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2) |
|
|
|
| Secondary | Percentage of Change in Dietary Intake Behaviors - Fat (gm) | Assessed using the National Cancer Institute Automated Self-Administered 24-hour Recall (ASA24). Participants completed 24-hour Dietary Recalls on two random days over a week. The variable of interest - fat (gm) - values for the 2 24-hour periods were added to ascertain the total amount consumed at the specific data collection time periods. Data from Baseline (T1) was compared to that collected at T2 for each participant and averaged for an aggregate score. Positive numbers represent an increase in fat consumed, negative numbers represent a decrease in fat consumed. Only participants who completed 2 days worth of dietary data were included in this analysis. | Posted | Mean | Standard Deviation | percentage of change | Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2) |
|
|
|
| Secondary | Percentage of Change in Dietary Intake Behaviors - Fruit (Cup) | Assessed using the National Cancer Institute Automated Self-Administered 24-hour Recall (ASA24). Participants completed 24-hour Dietary Recalls on two random days over a week. The variable of interest - fruit (cup) - values for the 2 24-hour periods were added to ascertain the total amount consumed at the specific data collection time periods. Data from Baseline (T1) was compared to that collected at T2 for each participant and averaged for an aggregate score. Positive numbers represent an increase in fruit consumed, negative numbers represent a decrease in fruit consumed. Only participants who completed 2 days worth of dietary data were included in this analysis. | Posted | Mean | Standard Deviation | percentage of change | Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2) |
|
|
|
| Secondary | Percentage of Change in Dietary Intake Behaviors - Vegetable (Cup) | Assessed using the National Cancer Institute Automated Self-Administered 24-hour Recall (ASA24). Participants completed 24-hour Dietary Recalls on two random days over a week. The variable of interest - vegetables (cup) - values for the 2 24-hour periods were added to ascertain the total amount consumed at the specific data collection time periods. Data from Baseline (T1) was compared to that collected at T2 for each participant and averaged for an aggregate score. Positive numbers represent an increase in vegetables consumed, negative numbers represent a decrease in vegetables consumed. Only participants who completed 2 days worth of dietary data were included in this analysis. | Posted | Mean | Standard Deviation | percentage of change | Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2) |
|
|
|
| Secondary | Percentage of Change in Dietary Intake Behaviors - Added Sugars (Teaspoon or 4gm) | Assessed using the National Cancer Institute Automated Self-Administered 24-hour Recall (ASA24). Participants completed 24-hour Dietary Recalls on two random days over a week. The variable of interest - added sugars teaspoon or 4 gm) - values for the 2 24-hour periods were added to ascertain the total amount consumed at the specific data collection time periods. Data from Baseline (T1) was compared to that collected at T2 for each participant and averaged for an aggregate score. Positive numbers represent an increase in added sugars consumed, negative numbers represent a decrease in added sugars consumed. Only participants who completed 2 days worth of dietary data were included in this analysis. | Posted | Mean | Standard Deviation | percentage of change | Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2) |
|
|
|
| Secondary | Percentage of Change in Dietary Intake Behaviors - Caloric Intake (Kcal) | Assessed using the National Cancer Institute Automated Self-Administered 24-hour Recall (ASA24). Participants completed 24-hour Dietary Recalls on two random days over a week. The variable of interest - calories (Kcal) - values for the 2 24-hour periods were added to ascertain the total amount consumed at the specific data collection time periods. Data from Baseline (T1) was compared to that collected at T3 for each participant and averaged for an aggregate score. Positive numbers represent an increase in calories consumed, negative numbers represent a decrease in calories consumed. Only participants who completed 2 days worth of dietary data were included in this analysis. | Posted | Mean | Standard Deviation | percentage of change | Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3) |
|
|
|
| Secondary | Percentage of Change in Dietary Intake Behaviors - Fat Intake (gm) | Assessed using the National Cancer Institute Automated Self-Administered 24-hour Recall (ASA24). Participants completed 24-hour Dietary Recalls on two random days over a week. The variable of interest - fat (gm) - values for the 2 24-hour periods were added to ascertain the total amount consumed at the specific data collection time periods. Data from Baseline (T1) was compared to that collected at T3 for each participant and averaged for an aggregate score. Positive numbers represent an increase in fat consumed, negative numbers represent a decrease in fat consumed. Only participants who completed 2 days worth of dietary data were included in this analysis. | Posted | Mean | Standard Deviation | percentage of change | Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3) |
|
|
|
| Secondary | Percentage of Change in Dietary Intake Behaviors - Fruit Intake (Cups) | Assessed using the National Cancer Institute Automated Self-Administered 24-hour Recall (ASA24). Participants completed 24-hour Dietary Recalls on two random days over a week. The variable of interest - fruit (cup) - values for the 2 24-hour periods were added to ascertain the total amount consumed at the specific data collection time periods. Data from Baseline (T1) was compared to that collected at T3 for each participant and averaged for an aggregate score. Positive numbers represent an increase in fruit consumed, negative numbers represent a decrease in fruit consumed. Only participants who completed 2 days worth of dietary data were included in this analysis. | Posted | Mean | Standard Deviation | percentage of change | Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3) |
|
|
|
| Secondary | Percentage of Change in Dietary Intake Behaviors - Vegetable Intake (Cups) | Assessed using the National Cancer Institute Automated Self-Administered 24-hour Recall (ASA24). Participants completed 24-hour Dietary Recalls on two random days over a week. The variable of interest - vegetable (cup) - values for the 2 24-hour periods were added to ascertain the total amount consumed at the specific data collection time periods. Data from Baseline (T1) was compared to that collected at T3 for each participant and averaged for an aggregate score. Positive numbers represent an increase in vegetables consumed, negative numbers represent a decrease in vegetables consumed. Only participants who completed 2 days worth of dietary data were included in this analysis. | Posted | Mean | Standard Deviation | percentage of change | Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3) |
|
|
|
| Secondary | Percentage of Change in Dietary Intake Behaviors - Added Sugars Intake (gm) | Assessed using the National Cancer Institute Automated Self-Administered 24-hour Recall (ASA24). Participants completed 24-hour Dietary Recalls on two random days over a week. The variable of interest - added sugars (teaspoon or 4 gm) - values for the 2 24-hour periods were added to ascertain the total amount consumed at the specific data collection time periods. Data from Baseline (T1) was compared to that collected at T3 for each participant and averaged for an aggregate score. Positive numbers represent an increase in added sugars consumed, negative numbers represent a decrease in added sugars consumed. Only participants who completed 2 days worth of dietary data were included in this analysis. | Posted | Mean | Standard Deviation | percentage of change | Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3) |
|
|
|
| Secondary | Percentage of Change in Physical Activity - 7-Day Metabolic Equivalent of Task (MET) | Assessed using Actigraph (GT3x), an objective measurement of physical activity. Investigators distributed the Actigraph in person participants' home (T2 and T3) to wear at the wrist at least seven consecutive days (≥ 10 hours/per day). The variable of interest - 7-day MET - values for the period was added to ascertain the total amount at the specific data collection time periods. Data from Baseline (T1) was compared to that collected at T2 for each participant and averaged for an aggregate score. Positive numbers represent an increase in physical activity negative numbers represent a decrease in physical. Only participants who completed the minimum requirement for reporting [wear at the wrist at least seven consecutive days (≥ 10 hours/per day)] were included in the analysis. | Posted | Mean | Standard Deviation | percentage of change | Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2) |
|
|
|
| Secondary | Percentage of Change in Physical Activity - 7-Day Metabolic Equivalent of Task (MET) | Assessed using Actigraph (GT3x), an objective measurement of physical activity. Investigators distributed the Actigraph in person participants' home (T2 and T3) to wear at the wrist at least seven consecutive days (≥ 10 hours/per day). The variable of interest - 7-day MET - values for the period was added to ascertain the total amount at the specific data collection time periods. Data from Baseline (T1) was compared to that collected at T3 for each participant and averaged for an aggregate score. Positive numbers represent an increase in physical activity negative numbers represent a decrease in physical. Only participants who completed the minimum requirement for reporting [wear at the wr](streamdown:incomplete-link) | Posted | Mean | Standard Deviation | percentage of change | Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3) |
|
|
|
| Secondary | Change in Autonomous Motivation for Physical Activity | Will be measured using Treatment Self-Regulation Questionnaire (6 items) to measure autonomous motivation for Physical Activity (6 items) Values are: 1 - Not At All True, 2, 3, 4 - Somewhat True, 5, 6, 7 - Very True The investigators will sum 6 items to create a composite score, ranging from 6 to 42. Higher scores indicate higher autonomous motivation for Physical Activity. | Posted | Mean | Standard Deviation | score on a scale | Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2) |
|
|
|
| Secondary | Change in Autonomous Motivation for Physical Activity | Will be measured using Treatment Self-Regulation Questionnaire (6 items) to measure autonomous motivation for Physical Activity (6 items) Values are: 1 - Not At All True, 2, 3, 4 - Somewhat True, 5, 6, 7 - Very True The investigators will sum 6 items to create a composite score, ranging from 6 to 42. Higher scores indicate higher autonomous motivation for Physical Activity. | Posted | Mean | Standard Deviation | score on a scale | Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3) |
|
|
|
| Secondary | Change in Autonomous Motivation for Stress Management | Will be measured using Treatment Self-Regulation Questionnaire (6 items) to measure autonomous motivation for stress management (6 items) Values are: 1 - Not At All True, 2, 3, 4 - Somewhat True, 5, 6, 7 - Very True The investigators will sum 6 items to create a composite score, ranging from 6 to 42. Higher scores indicate higher autonomous motivation for stress management. | Posted | Mean | Standard Deviation | score on a scale | Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2) |
|
|
|
| Secondary | Change in Autonomous Motivation for Stress Management | Will be measured using Treatment Self-Regulation Questionnaire (6 items) to measure autonomous motivation for stress management (6 items) Values are: 1 - Not At AllTrue, 2, 3, 4 - Somewhat True, 5, 6, 7 - Very True The investigators will sum 6 items to create a composite score, ranging from 6 to 42. Higher scores indicate higher autonomous motivation for stress managment. | Posted | Mean | Standard Deviation | score on a scale | Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3) |
|
|
|
| Secondary | Change in Autonomous Motivation for Healthy Eating | Will be measured using Treatment Self-Regulation Questionnaire (6 items) to measure autonomous motivation for Healthy Eating (6 items) Values are: 1 - Not At All True, 2, 3, 4 - Somewhat True, 5, 6, 7 - Very True The investigators will sum 6 items to create a composite score, ranging from 6 to 42. Higher scores indicate higher autonomous motivation for Healthy Eating. | Posted | Mean | Standard Deviation | score on a scale | Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2) |
|
|
|
| Secondary | Change in Autonomous Motivation for Healthy Eating | Will be measured using Treatment Self-Regulation Questionnaire (6 items) to measure autonomous motivation for Healthy Eating (6 items) Values are: 1 - Not At All True, 2, 3, 4 - Somewhat True, 5, 6, 7 - Very True The investigators will sum 6 items to create a composite score, ranging from 6 to 42. Higher scores indicate higher autonomous motivation for Healthy Eating | Posted | Mean | Standard Deviation | score on a scale | Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3) |
|
|
|
| Secondary | Change in Healthy Eating Self-efficacy | Will be measured using a "Survey for Healthy Eating Self-efficacy" (8 items) Values are: 1 - Not At All Confident, 2 - Not Too Confident, 3 - Somewhat Confident, 4 - Very Confident. The investigators will sum all 8 items to create a composite score, ranging from 8 to 32. The higher score, the higher healthy eating self-efficacy. | Posted | Mean | Standard Deviation | score on a scale | Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2) |
|
|
|
| Secondary | Change in Healthy Eating Self-efficacy | Will be measured using a "Survey for Healthy Eating Self-efficacy" (8 items) Values are: 1 - Not At All Confident, 2 - Not Too Confident, 3 - Somewhat Confident, 4 - Very Confident The investigators will sum all 8 items to create a composite score, ranging from 8 to 32. The higher score, the higher healthy eating self-efficacy. | Posted | Mean | Standard Deviation | score on a scale | Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3) |
|
|
|
| Secondary | Change in Coping Self-efficacy | Will be measured using a "Survey for Coping Self-efficacy" (10 items) Values are: 1 - Not At All Confident, 2 - Not Too Confident, 3 - Somewhat Confident, 4 - Very Confident The investigators will sum 10 items to create a composite score, ranging from 10 to 40. Higher scores indicate higher coping self-efficacy. | Posted | Mean | Standard Deviation | score on a scale | Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2) |
|
|
|
| Secondary | Change in Coping Self-efficacy | Will be measured using a "Survey for Coping Self-efficacy" (10 items) Values are: 1 - Not At All Confident, 2 - Not Too Confident, 3 - Somewhat Confident, 4 - Very Confident The investigators will sum 10 items to create a composite score, ranging from 10 to 40. Higher scores indicate higher coping self-efficacy. | Posted | Mean | Standard Deviation | score on a scale | Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3) |
|
|
|
| Secondary | Change in Physical Activity Self-efficacy | Will be measured using a "Survey for Physical Activity Self-efficacy" (10 items) that ask participants' confidence in performing the specific activity. Values are: 1 - Not At All Confident, 2 - Not Too Confident, 3 - Somewhat Confident, 4 - Very Confident The investigators will sum all 10 items to create a composite score, ranging from 10 to 40. The higher score, the higher physical activity self-efficacy. | Posted | Mean | Standard Deviation | score on a scale | Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2) |
|
|
|
| Secondary | Change in Physical Activity Self-efficacy | Will be measured using a "Survey for Physical Activity Self-efficacy" (10 items) that ask participants' confidence in performing the specific activity. Values are: 1 - Not At All Confident, 2 - Not Too Confident, 3 - Somewhat Confident, 4 - Very Confident The investigators will sum all 10 items to create a composite score, ranging from 10 to 40. The higher score, the higher physical activity self-efficacy. | Posted | Mean | Standard Deviation | score on a scale | Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3) |
|
|
|
| Secondary | Change in Emotion Regulation | The Emotion Regulation Questionnaire (10 items) was used to measure emotional control. The questionnaire asked participants to report the use of emotional regulatory process using a 7-point scale ranging from 1 (strongly disagree) to 7 (strongly agree). After revise coding 4 items, we summed responses of 10 items to create an emotional control score (ranged from 10 to 70). Higher scores indicated better emotional control. | Posted | Mean | Standard Deviation | score on a scale | Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2) |
|
|
|
| Secondary | Change in Emotion Regulation | The Emotion Regulation Questionnaire (10 items) was used to measure emotional control. The questionnaire asked participants to report the use of emotional regulatory process using a 7-point scale ranging from 1 (strongly disagree) to 7 (strongly agree). After revise coding 4 items, we summed responses of 10 items to create an emotional control score (ranged from 10 to 70). Higher scores indicated better emotional control. | Posted | Mean | Standard Deviation | score on a scale | Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3) |
|
|
|
| Secondary | Change in Perceived Stress | Will be measured using The Perceived Stress Scale (10 items) that measures the degree to which situations in one's life are appraised as stressful. Values are: 0 - Never, 1 - Almost Never, 2 - Sometimes, 3 - Fairly Often, 4 - Very Often The investigators will sum 10 items to create a composite score, ranging from 0 to 40. The higher score, the higher levels of perceived stress. | Posted | Mean | Standard Deviation | score on a scale | Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2) |
|
|
|
| Secondary | Change in Perceived Stress | Will be measured using The Perceived Stress Scale (10 items) that measures the degree to which situations in one's life are appraised as stressful. Values are: 0 - Never, 1 - Almost Never, 2 - Sometimes, 3 - Fairly Often, 4 - Very Often The investigators will sum 10 items to create a composite score, ranging from 0 to 40. The higher score, the higher levels of perceived stress. | Posted | Mean | Standard Deviation | score on a scale | Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3) |
|
|
|
| Secondary | Change in Executive Function - Behavior Regulation | The Behavior Rating Inventory of Executive Function-Adults (75 items) was used to measure executive function. This survey asked participants to rate self-regulation behaviors in the everyday environment using a 3-point Likert scale ranging from 0 (never) to 2 (often). This survey covers 2 main domains: behavior regulation (30 items) and metacognition (45 items). We summed responses to the 30 behavior regulation items to create a behavior regulation score. Behavior regulation scores range from 0-60. We used the same approach to create a composite score for metacognition. Higher scores indicated worse behavior regulation or metacognition. The scores from T1 were compared to scores for T2 to evaluate the effect of the intervention. | Posted | Mean | Standard Deviation | score on a scale | Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2) |
|
|
|
| Secondary | Change in Executive Function - Behavioral Regulation | The Behavior Rating Inventory of Executive Function-Adults (75 items) was used to measure executive function. This survey asked participants to rate self-regulation behaviors in the everyday environment using a 3-point Likert scale ranging from 0 (never) to 2 (often). This survey covers 2 main domains: behavior regulation (30 items) and metacognition (45 items). We summed responses to the 30 behavior regulation items to create a behavior regulation score. Behavior regulation scores range from 0-60. We used the same approach to create a composite score for metacognition. Higher scores indicated worse behavior regulation or metacognition. The scores from T1 were compared to scores for T3 to evaluate the effect of the intervention. | Posted | Mean | Standard Deviation | score on a scale | Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3) |
|
|
|
| Secondary | Change in Executive Function - Metacognition | The Behavior Rating Inventory of Executive Function-Adults (75 items) was used to measure executive function [31]. This survey asked participants to rate self-regulation behaviors in the everyday environment using a 3-point scale ranging from 0 (never) to 2 (often). This survey covers 2 main domains: behavior regulation (30 items) and metacognition (45 items). We summed responses to the 30 behavior regulation items to create a behavior regulation score. We used the same approach to create a composite score for metacognition. Metacognition scores range from 0-90. Higher scores indicated worse metacognition. The scores from T1 were compared to scores from T2 to evaluate the effect of the intervention. | Posted | Mean | Standard Deviation | score on a scale | Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2) |
|
|
|
| Secondary | Change in Executive Function - Metacognition | The Behavior Rating Inventory of Executive Function-Adults (75 items) was used to measure executive function [31]. This survey asked participants to rate self-regulation behaviors in the everyday environment using a 3-point scale ranging from 0 (never) to 2 (often). This survey covers 2 main domains: behavior regulation (30 items) and metacognition (45 items). We summed responses to the 30 behavior regulation items to create a behavior regulation score. We used the same approach to create a composite score for metacognition. Metacognition scores range from 0-90. Higher scores indicated worse metacognition. The scores from T1 were compared to scores from T3 to evaluate the effect of the intervention. | Posted | Mean | Standard Deviation | score on a scale | Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3) |
|
|
|
| 0 |
| 35 |
| 1 |
| 35 |
| 0 |
| 35 |
| EG001 | Usual Prenatal Care | The usual prenatal care group will receive usual care from their providers | 0 | 35 | 2 | 35 | 0 | 35 |
Not provided
Not provided
Not provided
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015430 | Weight Gain |
| D001836 | Body Weight Changes |