Obesity, Pregnancy Related
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALHABITpreg
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.
BEHAVIORALHABITpost
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.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The intervention model is a nonrestricted sequential multiple assignment randomized trial (SMART). Participants are randomized to intervention or control during pregnant and again postpartum.
Eligibility
Sex/Gender
FEMALE
Age
14 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have a prenatal BMI ≥ 25 * Are at or before 18 weeks and 4 days of gestation * Are English speaking * Have a singleton pregnancy
Exclusion criteria
* Multiple gestations * Preexisting diabetes * Previous bariatric surgery in the previous 3 years * Use of medications known to affect weight (e.g., second generation antipsychotic medications, regular steroid use). * Women who endorse acute psychiatric symptoms (e.g., suicidality) that warrant immediate treatment will be excluded and referred for care.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maternal Weight | Baseline and 1 year postpartum | Maternal weight in lbs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maternal Lipids | Baseline and 1 year postpartum (T12) | Blood Analysis of Maternal Lipids (High-Density Lipoprotein (HDL), Low-Density Lipoprotein calculated (LDL), Cholesterol, Triglyceride). |
| Maternal Inflammatory Markers | Baseline and 1 year postpartum (T12) | Maternal inflammatory markers from blood analysis |
| Depressive Symptoms (EPDS) | Baseline and 1 year postpartum (T12) | 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. |
| Depressive Symptoms (CESD) | Baseline and 1 year postpartum (T12) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Gestational Weight Gain | Time of delivery | Gestational weight gain in lbs |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
Prior to pregnancy randomization: 3 participants had pregnancy loss. 5 participants never completed their baseline assessment and were not eligible to be randomized.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 25 |
| TAUpreg Participants will receive treatment as usual during pregnancy | 18 |
| 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. | 64 |
| 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 | 67 |
| 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. | 70 |
| TAUpreg; TAUpost Participates will receive treatment as usual during pregnancy and treatment as usual during the postpartum period. | 68 |
| Total | 312 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Postpartum Intervention | Lost to Follow-up | 0 | 0 | 5 | 5 | 2 | 4 |
| Pregnancy Intervention | Lost to Follow-up | 16 | 14 | 0 | 0 | 0 | 0 |
| Pregnancy Intervention | Pregnancy loss | 9 | 4 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | HABITpreg | TAUpreg | HABITpreg; TAUpost | HABITpreg, HABITpost | TAUpreg; HABITpost | TAUpreg; TAUpost | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 31.55 years STANDARD_DEVIATION 6.21 | 28.86 years STANDARD_DEVIATION 4.16 | 31.01 years STANDARD_DEVIATION 5.09 | 30.83 years STANDARD_DEVIATION 4.17 | 31.31 years STANDARD_DEVIATION 4.86 | 31.26 years STANDARD_DEVIATION 5.13 | 31.11 years STANDARD_DEVIATION 4.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 3 Participants | 2 Participants | 4 Participants | 3 Participants | 2 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 15 Participants | 62 Participants | 63 Participants | 66 Participants | 66 Participants | 296 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 9 Participants | 11 Participants | 17 Participants | 14 Participants | 17 Participants | 77 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 3 Participants | 3 Participants | 2 Participants | 0 Participants | 5 Participants | 15 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 13 Participants | 5 Participants | 48 Participants | 47 Participants | 55 Participants | 46 Participants | 214 Participants |
| Sex: Female, Male Female | 25 Participants | 18 Participants | 64 Participants | 67 Participants | 70 Participants | 68 Participants | 312 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 156 | 0 / 156 | 0 / 64 | 0 / 67 | 0 / 70 | 0 / 68 |
| other Total, other adverse events | 9 / 156 | 4 / 156 | 0 / 64 | 0 / 67 | 0 / 70 | 0 / 68 |
| serious Total, serious adverse events | 0 / 156 | 0 / 156 | 0 / 64 | 0 / 67 | 0 / 70 | 0 / 68 |
Outcome results
Primary
Maternal Weight
Maternal weight in lbs
Time frame: Baseline and 1 year postpartum
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HABITpreg | Maternal Weight | Baseline | 202.16 pounds | Standard Deviation 42.1 |
| TAUpreg | Maternal Weight | Baseline | 217.09 pounds | Standard Deviation 54.92 |
| HABITpreg; TAUpost | Maternal Weight | 12 month follow-up | 196.59 pounds | Standard Deviation 44.81 |
| HABITpreg; TAUpost | Maternal Weight | Baseline | 194.16 pounds | Standard Deviation 40.33 |
| HABITpreg, HABITpost | Maternal Weight | 12 month follow-up | 201.03 pounds | Standard Deviation 43.64 |
| HABITpreg, HABITpost | Maternal Weight | Baseline | 196.73 pounds | Standard Deviation 39.44 |
| TAUpreg; HABITpost | Maternal Weight | 12 month follow-up | 193.70 pounds | Standard Deviation 37.51 |
| TAUpreg; HABITpost | Maternal Weight | Baseline | 190.13 pounds | Standard Deviation 32.84 |
| TAUpreg; TAUpost | Maternal Weight | Baseline | 195.62 pounds | Standard Deviation 41.32 |
| TAUpreg; TAUpost | Maternal Weight | 12 month follow-up | 201.66 pounds | Standard Deviation 45.54 |
p-value: 0.895% CI: [-5.649, 4.85]ANCOVA
p-value: 0.895% CI: [-8.813, 2.039]ANCOVA
p-value: 0.895% CI: [-6.53, 4.184]ANCOVA
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.
Time frame: Baseline and 1 year postpartum (T12)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HABITpreg | Depressive Symptoms (CESD) | Baseline | 13.88 score on a scale | Standard Deviation 10.63 |
| TAUpreg | Depressive Symptoms (CESD) | Baseline | 18.22 score on a scale | Standard Deviation 11.24 |
| HABITpreg; TAUpost | Depressive Symptoms (CESD) | T12 follow-up | 11.68 score on a scale | Standard Deviation 10.7 |
| HABITpreg; TAUpost | Depressive Symptoms (CESD) | Baseline | 13.19 score on a scale | Standard Deviation 9.14 |
| HABITpreg, HABITpost | Depressive Symptoms (CESD) | T12 follow-up | 10.29 score on a scale | Standard Deviation 9.52 |
| HABITpreg, HABITpost | Depressive Symptoms (CESD) | Baseline | 11.06 score on a scale | Standard Deviation 8.31 |
| TAUpreg; HABITpost | Depressive Symptoms (CESD) | T12 follow-up | 12.78 score on a scale | Standard Deviation 11.7 |
| TAUpreg; HABITpost | Depressive Symptoms (CESD) | Baseline | 12.04 score on a scale | Standard Deviation 8.9 |
| TAUpreg; TAUpost | Depressive Symptoms (CESD) | Baseline | 13.18 score on a scale | Standard Deviation 8.61 |
| TAUpreg; TAUpost | Depressive Symptoms (CESD) | T12 follow-up | 13.25 score on a scale | Standard Deviation 11.49 |
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.
Time frame: Baseline and 1 year postpartum (T12)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HABITpreg | Depressive Symptoms (EPDS) | Baseline | 6.08 score on a scale | Standard Deviation 5.56 |
| TAUpreg | Depressive Symptoms (EPDS) | Baseline | 8.61 score on a scale | Standard Deviation 6.12 |
| HABITpreg; TAUpost | Depressive Symptoms (EPDS) | Baseline | 6.13 score on a scale | Standard Deviation 4.77 |
| HABITpreg; TAUpost | Depressive Symptoms (EPDS) | T12 follow-up | 5.28 score on a scale | Standard Deviation 5 |
| HABITpreg, HABITpost | Depressive Symptoms (EPDS) | T12 follow-up | 4.70 score on a scale | Standard Deviation 5.23 |
| HABITpreg, HABITpost | Depressive Symptoms (EPDS) | Baseline | 4.93 score on a scale | Standard Deviation 4.68 |
| TAUpreg; HABITpost | Depressive Symptoms (EPDS) | T12 follow-up | 5.83 score on a scale | Standard Deviation 6.19 |
| TAUpreg; HABITpost | Depressive Symptoms (EPDS) | Baseline | 5.61 score on a scale | Standard Deviation 5.33 |
| TAUpreg; TAUpost | Depressive Symptoms (EPDS) | Baseline | 6.47 score on a scale | Standard Deviation 4.89 |
| TAUpreg; TAUpost | Depressive Symptoms (EPDS) | T12 follow-up | 7.03 score on a scale | Standard Deviation 6.79 |
Secondary
Maternal Inflammatory Markers
Maternal inflammatory markers from blood analysis
Time frame: Baseline and 1 year postpartum (T12)
Population: 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.
Secondary
Maternal Lipids
Blood Analysis of Maternal Lipids (High-Density Lipoprotein (HDL), Low-Density Lipoprotein calculated (LDL), Cholesterol, Triglyceride).
Time frame: Baseline and 1 year postpartum (T12)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HABITpreg | Maternal Lipids | Cholesterol- Baseline | 188.08 mg/dL | Standard Deviation 27.75 |
| HABITpreg | Maternal Lipids | Low-Density Lipoprotein calculated- Baseline | 99.16 mg/dL | Standard Deviation 22.5 |
| HABITpreg | Maternal Lipids | Triglyceride- Baseline | 110.80 mg/dL | Standard Deviation 39.54 |
| HABITpreg | Maternal Lipids | High-Density Lipoprotein- Baseline | 66.84 mg/dL | Standard Deviation 12.25 |
| TAUpreg | Maternal Lipids | Cholesterol- Baseline | 165.33 mg/dL | Standard Deviation 28.75 |
| TAUpreg | Maternal Lipids | Triglyceride- Baseline | 102.78 mg/dL | Standard Deviation 43.6 |
| TAUpreg | Maternal Lipids | Low-Density Lipoprotein calculated- Baseline | 84.50 mg/dL | Standard Deviation 21.89 |
| TAUpreg | Maternal Lipids | High-Density Lipoprotein- Baseline | 60.28 mg/dL | Standard Deviation 15.11 |
| HABITpreg; TAUpost | Maternal Lipids | Triglyceride- T12 follow-up | 113.87 mg/dL | Standard Deviation 71.66 |
| HABITpreg; TAUpost | Maternal Lipids | Low-Density Lipoprotein calculated- T12 follow-up | 97.67 mg/dL | Standard Deviation 27.15 |
| HABITpreg; TAUpost | Maternal Lipids | Cholesterol- T12 follow-up | 175.62 mg/dL | Standard Deviation 35.95 |
| HABITpreg; TAUpost | Maternal Lipids | Triglyceride- Baseline | 128.79 mg/dL | Standard Deviation 54.53 |
| HABITpreg; TAUpost | Maternal Lipids | Cholesterol- Baseline | 187.47 mg/dL | Standard Deviation 32.96 |
| HABITpreg; TAUpost | Maternal Lipids | High-Density Lipoprotein- T12 follow-up | 55.16 mg/dL | Standard Deviation 11.69 |
| HABITpreg; TAUpost | Maternal Lipids | High-Density Lipoprotein- Baseline | 64.94 mg/dL | Standard Deviation 11.44 |
| HABITpreg; TAUpost | Maternal Lipids | Low-Density Lipoprotein calculated- Baseline | 96.77 mg/dL | Standard Deviation 26.16 |
| HABITpreg, HABITpost | Maternal Lipids | Triglyceride- T12 follow-up | 106.79 mg/dL | Standard Deviation 69.02 |
| HABITpreg, HABITpost | Maternal Lipids | High-Density Lipoprotein- T12 follow-up | 53.77 mg/dL | Standard Deviation 13.64 |
| HABITpreg, HABITpost | Maternal Lipids | Triglyceride- Baseline | 123.24 mg/dL | Standard Deviation 54.7 |
| HABITpreg, HABITpost | Maternal Lipids | Low-Density Lipoprotein calculated- T12 follow-up | 103.63 mg/dL | Standard Deviation 32.52 |
| HABITpreg, HABITpost | Maternal Lipids | Low-Density Lipoprotein calculated- Baseline | 100.61 mg/dL | Standard Deviation 33.46 |
| HABITpreg, HABITpost | Maternal Lipids | Cholesterol- T12 follow-up | 178.75 mg/dL | Standard Deviation 42.79 |
| HABITpreg, HABITpost | Maternal Lipids | High-Density Lipoprotein- Baseline | 62.21 mg/dL | Standard Deviation 13.43 |
| HABITpreg, HABITpost | Maternal Lipids | Cholesterol- Baseline | 187.52 mg/dL | Standard Deviation 43.2 |
| TAUpreg; HABITpost | Maternal Lipids | Cholesterol- Baseline | 191.74 mg/dL | Standard Deviation 36.14 |
| TAUpreg; HABITpost | Maternal Lipids | Triglyceride- T12 follow-up | 94.51 mg/dL | Standard Deviation 48.36 |
| TAUpreg; HABITpost | Maternal Lipids | Triglyceride- Baseline | 118.06 mg/dL | Standard Deviation 54.37 |
| TAUpreg; HABITpost | Maternal Lipids | Low-Density Lipoprotein calculated- Baseline | 102.57 mg/dL | Standard Deviation 27.99 |
| TAUpreg; HABITpost | Maternal Lipids | High-Density Lipoprotein- Baseline | 65.53 mg/dL | Standard Deviation 12.93 |
| TAUpreg; HABITpost | Maternal Lipids | Low-Density Lipoprotein calculated- T12 follow-up | 106.10 mg/dL | Standard Deviation 33.4 |
| TAUpreg; HABITpost | Maternal Lipids | High-Density Lipoprotein- T12 follow-up | 55.57 mg/dL | Standard Deviation 10.92 |
| TAUpreg; HABITpost | Maternal Lipids | Cholesterol- T12 follow-up | 180.59 mg/dL | Standard Deviation 32.84 |
| TAUpreg; TAUpost | Maternal Lipids | Triglyceride- Baseline | 115.72 mg/dL | Standard Deviation 41.55 |
| TAUpreg; TAUpost | Maternal Lipids | High-Density Lipoprotein- T12 follow-up | 54.29 mg/dL | Standard Deviation 11.38 |
| TAUpreg; TAUpost | Maternal Lipids | Low-Density Lipoprotein calculated- T12 follow-up | 104.00 mg/dL | Standard Deviation 33.8 |
| TAUpreg; TAUpost | Maternal Lipids | Cholesterol- T12 follow-up | 177.75 mg/dL | Standard Deviation 41.31 |
| TAUpreg; TAUpost | Maternal Lipids | Triglyceride- T12 follow-up | 96.97 mg/dL | Standard Deviation 49.11 |
| TAUpreg; TAUpost | Maternal Lipids | High-Density Lipoprotein- Baseline | 66.27 mg/dL | Standard Deviation 11.7 |
| TAUpreg; TAUpost | Maternal Lipids | Cholesterol- Baseline | 189.33 mg/dL | Standard Deviation 34.65 |
| TAUpreg; TAUpost | Maternal Lipids | Low-Density Lipoprotein calculated- Baseline | 99.99 mg/dL | Standard Deviation 27.2 |
Other Pre-specified
Gestational Weight Gain
Gestational weight gain in lbs
Time frame: Time of delivery
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HABITpreg; TAUpost | Gestational Weight Gain | 6.32 pounds | Standard Deviation 19.41 |
| HABITpreg, HABITpost | Gestational Weight Gain | 7.14 pounds | Standard Deviation 16.02 |
| TAUpreg; HABITpost | Gestational Weight Gain | 7.63 pounds | Standard Deviation 16.52 |
| TAUpreg; TAUpost | Gestational Weight Gain | 10.76 pounds | Standard Deviation 16.91 |