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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL132578-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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This study will evaluate the impact of different combinations of intervention as a function of gestational weight gain in pregnant woman. Participants will be randomized at two points during the study. Participants will first be randomized at enrollment to receive study intervention during pregnancy or treatment as usual. Participants will also be randomized just before delivery to receive intervention postpartum or treatment as usual.
The perinatal period, from pregnancy through the first postpartum year, has important implications for women's health. Excessive gestational weight gain is linked to deleterious health outcomes; yet most women exceed guidelines established for gestational weight gain , particularly women who begin pregnancy overweight or obese. These women are likely to remain overweight or obese at one year postpartum even if gestational weight gain is within guidelines and pregnancy-related weight gain is lost postpartum. Efforts to mitigate the health risks related to perinatal overweight can have substantial benefits for women's longer-term obesity and cardiometabolic health. To date, interventions to minimize excessive gestational weight gain alone have had limited impact. Some women may require continued intervention in the postpartum period to achieve optimal weight management. Alternatively, intervention delivered only postpartum may be sufficient to achieve a healthier weight at one year postpartum. It also is important to adapt intervention as women's needs vary over the course of pregnancy and postpartum. Accordingly, this application proposes a sequential multiple assignment randomized trial (SMART) to determine the efficacy of different intervention sequences during pregnancy, postpartum, or both. This non-restricted SMART also will allow investigators to investigate the impact of different combinations of intervention as a function of gestational weight gain. The proposed SMART is innovative as the first effort to evaluate different sequences of intervention across the perinatal period to mitigate maternal health risk by one year postpartum.
Pregnant women (N=300), stratified by prenatal weight status (body mass index=25-29.9 vs. ≥30) will be enrolled at entry into prenatal care and randomized initially to intervention that addresses the challenges of weight and self-regulation during pregnancy, Health and Behaviors in Transition (HABITpreg), or an educationally-enhanced treatment as usual (TAUpreg). At delivery, women will be re-randomized to a postpartum self-regulation intervention (HABITpost) or educationally-enhanced treatment as usual (TAUpost). Women will complete assessments at a prenatal baseline, the end of pregnancy, and 6- and 12-months postpartum.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HABITpreg; TAUpost | Experimental | Participants will receive study intervention during pregnant and treatment as usual postpartum. |
|
| HABITpreg, HABITpost | Experimental | Participants will receive study intervention during pregnancy and study intervention during the postpartum period. |
|
| TAUpreg; HABITpost | Experimental | Participants will receive treatment as usual during pregnancy and study intervention during the postpartum period. |
|
| TAUpreg; TAUpost | No Intervention | Participates will receive treatment as usual during pregnancy and treatment as usual during the postpartum period. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HABITpreg | Behavioral | Treatment during pregnancy will consist of up to 10 in person sessions taking place at regularly scheduled obstetric appointments, at the investigator's research building, or a nearby location. Participants in the HABITpregnancy group will also receive texts and phone calls between sessions. HABIT will focus on weight, physical activity, eating and psychosocial issues. Women will receive consultation about nutritional balance, dietary guidelines for pregnant women and advice to maintain an optimal rate of weight gain according to prepregnancy BMI. Women will use self-monitoring forms to identify and modify cues for unhealthy behaviors. Beliefs about body weight and eating during pregnancy will be addressed and effects of physical activity on body weight, health, and mood will be included. Due to COVID-19(coronavirus disease) restrictions and safety guidelines, HABIT pregnant treatment sessions have been taking place virtually, using video chat or phone calls starting in March 2020. |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal Weight | Maternal weight in lbs | Baseline and 1 year postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal Lipids | Blood Analysis of Maternal Lipids (High-Density Lipoprotein (HDL), Low-Density Lipoprotein calculated (LDL), Cholesterol, Triglyceride). | Baseline and 1 year postpartum (T12) |
| Maternal Inflammatory Markers |
| Measure | Description | Time Frame |
|---|---|---|
| Gestational Weight Gain | Gestational weight gain in lbs | Time of delivery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michele Levine, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41861918 | Derived | Donofry SD, Damon ST, Jouppi RJ, Davis JA, Kolko Conlon RP, Call CC, Levine MD. Depressive symptoms mediate the relationship between dispositional mindfulness and dietary quality on weekends but not weekdays among pregnant individuals with pre-pregnancy BMI>/=25. Appetite. 2026 Jul 1;222:108545. doi: 10.1016/j.appet.2026.108545. Epub 2026 Mar 18. | |
| 41390087 | Derived | Jouppi RJ, Vize CE, Call CC, Emery Tavernier RL, Brown LB, Kolko Conlon RP, Grace JL, Sweeney GM, Levine MD. Pregnancy Eating Attitudes-Questionnaire (PEA-Q): Longitudinal measurement invariance from early to late pregnancy in a community sample. Appetite. 2026 Apr 1;219:108421. doi: 10.1016/j.appet.2025.108421. Epub 2025 Dec 11. |
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Prior to pregnancy randomization:
3 participants had pregnancy loss. 5 participants never completed their baseline assessment and were not eligible to be randomized.
Recruitment for the project began in January, 2017 and the first participant was enrolled on February 1, 2017. Enrollment of pregnant individuals into this clinical trial concluded in September 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | HABITpreg | HABITpreg: Treatment during pregnancy will consist of up to 10 in person sessions taking place at regularly scheduled obstetric appointments, at the investigator's research building, or a nearby location. Participants in the HABITpregnancy group will also receive texts and phone calls between sessions. HABIT will focus on weight, physical activity, eating and psychosocial issues. Women will receive consultation about nutritional balance, dietary guidelines for pregnant women and advice to maintain an optimal rate of weight gain according to prepregnancy BMI. Women will use self-monitoring forms to identify and modify cues for unhealthy behaviors. Beliefs about body weight and eating during pregnancy will be addressed and effects of physical activity on body weight, health, and mood will be included. Due to COVID-19(coronavirus disease) restrictions and safety guidelines, HABIT pregnant treatment sessions have been taking place virtually, using video chat or phone calls starting in March 2020. |
| FG001 | TAUpreg | Participants will receive treatment as usual during pregnancy |
| FG002 | HABITpreg; TAUpost | Participants will receive study intervention during pregnant and treatment as usual postpartum. HABITpreg: Treatment during pregnancy will consist of up to 10 in person sessions taking place at regularly scheduled obstetric appointments, at the investigator's research building, or a nearby location. Participants in the HABITpregnancy group will also receive texts and phone calls between sessions. HABIT will focus on weight, physical activity, eating and psychosocial issues. Women will receive consultation about nutritional balance, dietary guidelines for pregnant women and advice to maintain an optimal rate of weight gain according to prepregnancy BMI. Women will use self-monitoring forms to identify and modify cues for unhealthy behaviors. Beliefs about body weight and eating during pregnancy will be addressed and effects of physical activity on body weight, health, and mood will be included. Due to COVID-19(coronavirus disease) restrictions and safety guidelines, HABIT pregnant treatment sessions have been taking place virtually, using video chat or phone calls starting in March 2020. |
| FG003 | HABITpreg, HABITpost | Participants will receive study intervention during pregnancy and the postpartum period. HABITpreg: Treatment during pregnancy will consist of up to 10 in person sessions taking place at regularly scheduled obstetric appointments, at the investigator's research building, or a nearby location. Participants will also receive texts and phone calls between sessions. HABIT will focus on weight, physical activity, eating and psychosocial issues. Women will receive consultation about nutritional balance, dietary guidelines for pregnant women and advice to maintain an optimal rate of weight gain according to prepregnancy BMI. Women will use self-monitoring forms to identify and modify cues for unhealthy behaviors. Beliefs about body weight and eating during pregnancy will be addressed and effects of physical activity on body weight, health, and mood will be included. HABITpost: Treatment during the postpartum period will consist of an intervention over the 24 weeks immediately following delivery. Treatment will include 12 biweekly sessions completed over the phone or in person. In person sessions will be done at the participant's home or another convenient location. Participants will receive calls and texts between sessions. Sessions will focus on weight, physical activity, eating and psychosocial issues. Due to COVID-19 restrictions and safety guidelines, treatment sessions have been taking place virtually, using video chat or phone calls starting in March 2020. |
| FG004 | TAUpreg; HABITpost | Participants will receive treatment as usual during pregnancy and study intervention during the postpartum period. HABITpost: Treatment during the postpartum period (HABITpost) will consist of an intervention over the 24 weeks immediately following delivery. Treatment will include 12 biweekly sessions completed over the phone or in person. In person sessions will be done at the participant's home or another convenient location. Additionally, participants will receive calls and texts between sessions. Sessions will focus on weight, physical activity, eating and psychosocial issues. Due to COVID-19 restrictions and safety guidelines, HABIT post treatment sessions have been taking place virtually, using video chat or phone calls starting in March 2020. |
| FG005 | TAUpreg; TAUpost | Participates will receive treatment as usual during pregnancy and treatment as usual during the postpartum period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pregnancy Intervention |
|
| ||||||||||||||||||
| Postpartum Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | HABITpreg | Treatment during pregnancy will consist of up to 10 in person sessions taking place at regularly scheduled obstetric appointments, at the investigator's research building, or a nearby location. Participants in the HABITpregnancy group will also receive texts and phone calls between sessions. HABIT will focus on weight, physical activity, eating and psychosocial issues. Women will receive consultation about nutritional balance, dietary guidelines for pregnant women and advice to maintain an optimal rate of weight gain according to prepregnancy BMI. Women will use self-monitoring forms to identify and modify cues for unhealthy behaviors. Beliefs about body weight and eating during pregnancy will be addressed and effects of physical activity on body weight, health, and mood will be included. Due to COVID-19(coronavirus disease) restrictions and safety guidelines, HABIT pregnant treatment sessions have been taking place virtually, using video chat or phone calls starting in March 2020. |
| 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 | Maternal Weight | Maternal weight in lbs | Missing T12 weight data from 17 participants. (HABITpreg; TAUpost- missing 5, HABITpreg; HABITpost- missing 5, TAUpreg; HABITpost- missing 2, TAUpreg; TAUpost- missing 5) As discussed in the flow, participants in the HABITpreg (25) and TAUpreg (18) did not complete the second randomization therefore we only have baseline data for these individuals. | Posted | Mean | Standard Deviation | pounds | Baseline and 1 year postpartum |
|
Adverse event data was collected over the course of the study. Throughout pregnancy and through 1 year postpartum.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HABITpreg | Participants will receive study intervention during pregnancy. | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pregnancy loss | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michele Levine | University of Pittsburgh Medical Center | (412) 647-0703 | levinem@upmc.edu |
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| 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 | Nov 20, 2024 | Jan 24, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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The intervention model is a nonrestricted sequential multiple assignment randomized trial (SMART). Participants are randomized to intervention or control during pregnant and again postpartum.
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|
| HABITpost | Behavioral | Treatment during the postpartum period (HABITpost) will consist of an intervention over the 24 weeks immediately following delivery. Treatment will include 12 biweekly sessions completed over the phone or in person. In person sessions will be done at the participant's home or another convenient location. Additionally, participants will receive calls and texts between sessions. Sessions will focus on weight, physical activity, eating and psychosocial issues. Due to COVID-19 restrictions and safety guidelines, HABIT post treatment sessions have been taking place virtually, using video chat or phone calls starting in March 2020. |
|
Maternal inflammatory markers from blood analysis
| Baseline and 1 year postpartum (T12) |
| Depressive Symptoms (EPDS) | Scores from the Edinburgh Postnatal Depression Scale (EPDS) This scale is developed to assist health professionals in detecting mothers suffering from postpartum depression (PPD), consists of 10 short statements indicating how a mother felt during the previous week. Each response is scored 0, 1, 2 and 3 based on the seriousness of the symptom. The total score is found by adding together the scores for each of the 10 items. Scores range from 0-30. Scoring above 12 or 13 are likely to be suffering from depression and should seek medical attention. A careful clinical evaluation by a health care professional is needed to confirm a diagnosis and establish a treatment plan. | Baseline and 1 year postpartum (T12) |
| Depressive Symptoms (CESD) | Scores from the Center for Epidemiological Studies-Depression (CESD) This scale is a self-report measure of depression. Questions measure 8 different subscales, including: Sadness (Dysphoria): (Q. 2, 4, 6), Loss of Interest (Anhedonia): (Q. 8, 10), Appetite: (Q. 1, 18), Sleep: (Q. 5, 11, 19), Thinking / concentration: (Q. 3, 20), Guilt (Worthlessness): (Q. 9, 17), Tired (Fatigue): (Q. 7, 16), Movement (Agitation): (Q. 12, 13), Suicidal Ideation: (Q. 14, 15) Each response is scored 0, 1, 2 and 3 based on the frequency of the symptom. The total score is calculated by finding the sum of 20 items. Scores range from 0-60. A score equal to or above 16 indicates a person at risk for clinical depression. | Baseline and 1 year postpartum (T12) |
| Lost to Follow-up |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG001 | TAUpreg | Participants will receive treatment as usual during pregnancy |
| BG002 | HABITpreg; TAUpost | Participants will receive study intervention during pregnant and treatment as usual postpartum. HABITpreg: Treatment during pregnancy will consist of up to 10 in person sessions taking place at regularly scheduled obstetric appointments, at the investigator's research building, or a nearby location. Participants in the HABITpregnancy group will also receive texts and phone calls between sessions. HABIT will focus on weight, physical activity, eating and psychosocial issues. Women will receive consultation about nutritional balance, dietary guidelines for pregnant women and advice to maintain an optimal rate of weight gain according to prepregnancy BMI. Women will use self-monitoring forms to identify and modify cues for unhealthy behaviors. Beliefs about body weight and eating during pregnancy will be addressed and effects of physical activity on body weight, health, and mood will be included. Due to COVID-19(coronavirus disease) restrictions and safety guidelines, HABIT pregnant treatment sessions have been taking place virtually, using video chat or phone calls starting in March 2020. |
| BG003 | HABITpreg, HABITpost | Participants will receive study intervention during pregnancy and the postpartum period. HABITpreg: Treatment during pregnancy will consist of up to 10 in person sessions taking place at regularly scheduled obstetric appointments, at the investigator's research building, or a nearby location. Participants will also receive texts and phone calls between sessions. HABIT will focus on weight, physical activity, eating and psychosocial issues. Women will receive consultation about nutritional balance, dietary guidelines for pregnant women and advice to maintain an optimal rate of weight gain according to prepregnancy BMI. Women will use self-monitoring forms to identify and modify cues for unhealthy behaviors. Beliefs about body weight and eating during pregnancy will be addressed and effects of physical activity on body weight, health, and mood will be included. HABITpost: Treatment during the postpartum period will consist of an intervention over the 24 weeks immediately following delivery. Treatment will include 12 biweekly sessions completed over the phone or in person. In person sessions will be done at the participant's home or another convenient location. Participants will receive calls and texts between sessions. Sessions will focus on weight, physical activity, eating and psychosocial issues. Due to COVID-19 restrictions and safety guidelines, treatment sessions have been taking place virtually, using video chat or phone calls starting in March 2020 |
| BG004 | TAUpreg; HABITpost | Participants will receive treatment as usual during pregnancy and study intervention during the postpartum period. HABITpost: Treatment during the postpartum period (HABITpost) will consist of an intervention over the 24 weeks immediately following delivery. Treatment will include 12 biweekly sessions completed over the phone or in person. In person sessions will be done at the participant's home or another convenient location. Additionally, participants will receive calls and texts between sessions. Sessions will focus on weight, physical activity, eating and psychosocial issues. Due to COVID-19 restrictions and safety guidelines, HABIT post treatment sessions have been taking place virtually, using video chat or phone calls starting in March 2020. |
| BG005 | TAUpreg; TAUpost | Participates will receive treatment as usual during pregnancy and treatment as usual during the postpartum period. |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | TAUpreg | Participants will receive treatment as usual during pregnancy |
| OG002 | HABITpreg; TAUpost | Participants will receive study intervention during pregnant and treatment as usual postpartum. HABITpreg: Treatment during pregnancy will consist of up to 10 in person sessions taking place at regularly scheduled obstetric appointments, at the investigator's research building, or a nearby location. Participants in the HABITpregnancy group will also receive texts and phone calls between sessions. HABIT will focus on weight, physical activity, eating and psychosocial issues. Women will receive consultation about nutritional balance, dietary guidelines for pregnant women and advice to maintain an optimal rate of weight gain according to prepregnancy BMI. Women will use self-monitoring forms to identify and modify cues for unhealthy behaviors. Beliefs about body weight and eating during pregnancy will be addressed and effects of physical activity on body weight, health, and mood will be included. Due to COVID-19(coronavirus disease) restrictions and safety guidelines, HABIT pregnant treatment sessions have been taking place virtually, using video chat or phone calls starting in March 2020. |
| OG003 | HABITpreg, HABITpost | Participants will receive study intervention during pregnancy and the postpartum period. HABITpreg: Treatment during pregnancy will consist of up to 10 in person sessions taking place at regularly scheduled obstetric appointments, at the investigator's research building, or a nearby location. Participants will also receive texts and phone calls between sessions. HABIT will focus on weight, physical activity, eating and psychosocial issues. Women will receive consultation about nutritional balance, dietary guidelines for pregnant women and advice to maintain an optimal rate of weight gain according to prepregnancy BMI. Women will use self-monitoring forms to identify and modify cues for unhealthy behaviors. Beliefs about body weight and eating during pregnancy will be addressed and effects of physical activity on body weight, health, and mood will be included. HABITpost: Treatment during the postpartum period will consist of an intervention over the 24 weeks immediately following delivery. Treatment will include 12 biweekly sessions completed over the phone or in person. In person sessions will be done at the participant's home or another convenient location. Participants will receive calls and texts between sessions. Sessions will focus on weight, physical activity, eating and psychosocial issues. Due to COVID-19 restrictions and safety guidelines, treatment sessions have been taking place virtually, using video chat or phone calls starting in March 2020 |
| OG004 | TAUpreg; HABITpost | Participants will receive treatment as usual during pregnancy and study intervention during the postpartum period. HABITpost: Treatment during the postpartum period (HABITpost) will consist of an intervention over the 24 weeks immediately following delivery. Treatment will include 12 biweekly sessions completed over the phone or in person. In person sessions will be done at the participant's home or another convenient location. Additionally, participants will receive calls and texts between sessions. Sessions will focus on weight, physical activity, eating and psychosocial issues. Due to COVID-19 restrictions and safety guidelines, HABIT post treatment sessions have been taking place virtually, using video chat or phone calls starting in March 2020. |
| OG005 | TAUpreg; TAUpost | Participates will receive treatment as usual during pregnancy and treatment as usual during the postpartum period. |
|
|
|
| Secondary | Maternal Lipids | Blood Analysis of Maternal Lipids (High-Density Lipoprotein (HDL), Low-Density Lipoprotein calculated (LDL), Cholesterol, Triglyceride). | Missing blood samples from 36 participants at T12 follow-up (HABITpreg; TAUpost- missing 9, HABITpreg; HABITpost- missing 11; TAUpreg; HABITpost- missing 7, TAUpreg; TAUpost- missing 9) Missing 1 sample at baseline in the TAUpreg; TAUpost group. As discussed in the flow, participants in the HABITpreg (25) and TAUpreg (18) did not complete the second randomization therefore we only have baseline data for these individuals. | Posted | Mean | Standard Deviation | mg/dL | Baseline and 1 year postpartum (T12) |
|
|
|
| Secondary | Maternal Inflammatory Markers | Maternal inflammatory markers from blood analysis | Blood analysis for maternal inflammatory markers have not been completed, and will not be run in the future, due to prohibitive costs associated with the assays. | Posted | Baseline and 1 year postpartum (T12) |
|
|
| Secondary | Depressive Symptoms (EPDS) | Scores from the Edinburgh Postnatal Depression Scale (EPDS) This scale is developed to assist health professionals in detecting mothers suffering from postpartum depression (PPD), consists of 10 short statements indicating how a mother felt during the previous week. Each response is scored 0, 1, 2 and 3 based on the seriousness of the symptom. The total score is found by adding together the scores for each of the 10 items. Scores range from 0-30. Scoring above 12 or 13 are likely to be suffering from depression and should seek medical attention. A careful clinical evaluation by a health care professional is needed to confirm a diagnosis and establish a treatment plan. | At T12 follow-up- Scores from 24 participants are missing due to incomplete data on them at T12. (HABITpreg; TAUpost- 7 missing, HABITpreg; HABITpost- 6 missing, TAUpreg; HABITpost- 4 missing, TAUpreg; TAUpost- 7 missing) As discussed in the flow, participants in the HABITpreg (25) and TAUpreg (18) did not complete the second randomization therefore we only have baseline data for these individuals. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 1 year postpartum (T12) |
|
|
|
| Secondary | Depressive Symptoms (CESD) | Scores from the Center for Epidemiological Studies-Depression (CESD) This scale is a self-report measure of depression. Questions measure 8 different subscales, including: Sadness (Dysphoria): (Q. 2, 4, 6), Loss of Interest (Anhedonia): (Q. 8, 10), Appetite: (Q. 1, 18), Sleep: (Q. 5, 11, 19), Thinking / concentration: (Q. 3, 20), Guilt (Worthlessness): (Q. 9, 17), Tired (Fatigue): (Q. 7, 16), Movement (Agitation): (Q. 12, 13), Suicidal Ideation: (Q. 14, 15) Each response is scored 0, 1, 2 and 3 based on the frequency of the symptom. The total score is calculated by finding the sum of 20 items. Scores range from 0-60. A score equal to or above 16 indicates a person at risk for clinical depression. | At T12 follow-up- Scores from 21 participants are missing due to incomplete data on them at T12. (HABITpreg; TAUpost- 7 missing, HABITpreg; HABITpost- 5 missing, TAUpreg; HABITpost- 5 missing, TAUpreg; TAUpost- 4 missing) As discussed in the flow, participants in the HABITpreg (25) and TAUpreg (18) did not complete the second randomization therefore we only have baseline data for these individuals. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 1 year postpartum (T12) |
|
|
|
| Other Pre-specified | Gestational Weight Gain | Gestational weight gain in lbs | Missing weight data from 17 participants. (HABITpreg; TAUpost- missing 5, HABITpreg; HABITpost- missing 5, TAUpreg; HABITpost- missing 2, TAUpreg; TAUpost- missing 5) As discussed in the flow, participants in the HABITpreg (25) and TAUpreg (18) did not complete the second randomization therefore we only have baseline data for these individuals. | Posted | Mean | Standard Deviation | pounds | Time of delivery |
|
|
|
| 156 |
| 0 |
| 156 |
| 9 |
| 156 |
| EG001 | TAUpreg | Participants will receive treatment as usual during pregnancy. | 0 | 156 | 0 | 156 | 4 | 156 |
| EG002 | HABITpreg; TAUpost | Participants will receive study intervention during pregnancy and treatment as usual postpartum. HABITpreg: Treatment during pregnancy will consist of up to 10 in person sessions taking place at regularly scheduled obstetric appointments, at the investigator's research building, or a nearby location. Participants in the HABITpregnancy group will also receive texts and phone calls between sessions. HABIT will focus on weight, physical activity, eating and psychosocial issues. Women will receive consultation about nutritional balance, dietary guidelines for pregnant women and advice to maintain an optimal rate of weight gain according to prepregnancy BMI. Women will use self-monitoring forms to identify and modify cues for unhealthy behaviors. Beliefs about body weight and eating during pregnancy will be addressed and effects of physical activity on body weight, health, and mood will be included. Due to COVID-19(coronavirus disease) restrictions and safety guidelines, HABIT pregnant treatment sessions have been taking place virtually, using video chat or phone calls starting in March 2020. | 0 | 64 | 0 | 64 | 0 | 64 |
| EG003 | HABITpreg, HABITpost | Participants will receive study intervention during pregnancy and the postpartum period. HABITpreg: Treatment during pregnancy will consist of up to 10 in person sessions taking place at regularly scheduled obstetric appointments, at the investigator's research building, or a nearby location. Participants will also receive texts and phone calls between sessions. HABIT will focus on weight, physical activity, eating and psychosocial issues. Women will receive consultation about nutritional balance, dietary guidelines for pregnant women and advice to maintain an optimal rate of weight gain according to prepregnancy BMI. Women will use self-monitoring forms to identify and modify cues for unhealthy behaviors. Beliefs about body weight and eating during pregnancy will be addressed and effects of physical activity on body weight, health, and mood will be included. HABITpost: Treatment during the postpartum period will consist of an intervention over the 24 weeks immediately following delivery. Treatment will include 12 biweekly sessions completed over the phone or in person. In person sessions will be done at the participant's home or another convenient location. Participants will receive calls and texts between sessions. Sessions will focus on weight, physical activity, eating and psychosocial issues. Due to COVID-19 restrictions and safety guidelines, treatment sessions have been taking place virtually, using video chat or phone calls starting in March 2020 | 0 | 67 | 0 | 67 | 0 | 67 |
| EG004 | TAUpreg; HABITpost | Participants will receive treatment as usual during pregnancy and study intervention during the postpartum period. HABITpost: Treatment during the postpartum period (HABITpost) will consist of an intervention over the 24 weeks immediately following delivery. Treatment will include 12 biweekly sessions completed over the phone or in person. In person sessions will be done at the participant's home or another convenient location. Additionally, participants will receive calls and texts between sessions. Sessions will focus on weight, physical activity, eating and psychosocial issues. Due to COVID-19 restrictions and safety guidelines, HABIT post treatment sessions have been taking place virtually, using video chat or phone calls starting in March 2020. | 0 | 70 | 0 | 70 | 0 | 70 |
| EG005 | TAUpreg; TAUpost | Participates will receive treatment as usual during pregnancy and treatment as usual during the postpartum period. | 0 | 68 | 0 | 68 | 0 | 68 |
Not provided
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
|
|
| Low-Density Lipoprotein calculated- T12 follow-up |
|
|
| Cholesterol- T12 follow-up |
|
|
| Triglyceride- T12 follow-up |
|
|
| High-Density Lipoprotein- Baseline |
|
|
| Low-Density Lipoprotein calculated- Baseline |
|
|
| Cholesterol- Baseline |
|
|
| Triglyceride- Baseline |
|
|
|
| Baseline |
|
|
|
| Baseline |
|
|