Trial Outcomes & Findings for Optimizing Health From Pregnancy Through One Year Postpartum (NCT NCT03069690)

NCT ID: NCT03069690

Last Updated: 2025-04-16

Results Overview

Maternal weight in lbs

Recruitment status

COMPLETED

Study phase

Target enrollment

320 participants

Primary outcome timeframe

Baseline and 1 year postpartum

Results posted on

2025-04-16

Participant Flow

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.

Prior to pregnancy randomization: 3 participants had pregnancy loss. 5 participants never completed their baseline assessment and were not eligible to be randomized.

Participant milestones

Participant milestones
Measure	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.	TAUpreg Participants will receive treatment as usual during pregnancy	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.	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.	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.	TAUpreg; TAUpost Participates will receive treatment as usual during pregnancy and treatment as usual during the postpartum period.
Pregnancy Intervention STARTED	25	18	64	67	70	68
Pregnancy Intervention COMPLETED	0	0	64	67	70	68
Pregnancy Intervention NOT COMPLETED	25	18	0	0	0	0
Postpartum Intervention STARTED	0	0	64	67	70	68
Postpartum Intervention COMPLETED	0	0	59	62	68	64
Postpartum Intervention NOT COMPLETED	0	0	5	5	2	4

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	TAUpreg Participants will receive treatment as usual during pregnancy	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.	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.	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.	TAUpreg; TAUpost Participates will receive treatment as usual during pregnancy and treatment as usual during the postpartum period.
Pregnancy Intervention Pregnancy loss	9	4	0	0	0	0
Pregnancy Intervention Lost to Follow-up	16	14	0	0	0	0
Postpartum Intervention Lost to Follow-up	0	0	5	5	2	4

Baseline Characteristics

Optimizing Health From Pregnancy Through One Year Postpartum

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HABITpreg n=25 Participants 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.	TAUpreg n=18 Participants Participants will receive treatment as usual during pregnancy	HABITpreg; TAUpost n=64 Participants 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.	HABITpreg, HABITpost n=67 Participants 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	TAUpreg; HABITpost n=70 Participants 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.	TAUpreg; TAUpost n=68 Participants Participates will receive treatment as usual during pregnancy and treatment as usual during the postpartum period.	Total n=312 Participants Total of all reporting groups
Race (NIH/OMB) Black or African American	9 Participants n=113 Participants	9 Participants n=163 Participants	11 Participants n=160 Participants	17 Participants n=483 Participants	14 Participants n=36 Participants	17 Participants n=10 Participants	77 Participants n=115 Participants
Race (NIH/OMB) White	13 Participants n=113 Participants	5 Participants n=163 Participants	48 Participants n=160 Participants	47 Participants n=483 Participants	55 Participants n=36 Participants	46 Participants n=10 Participants	214 Participants n=115 Participants
Age, Continuous	31.55 years STANDARD_DEVIATION 6.21 • n=113 Participants	28.86 years STANDARD_DEVIATION 4.16 • n=163 Participants	31.01 years STANDARD_DEVIATION 5.09 • n=160 Participants	30.83 years STANDARD_DEVIATION 4.17 • n=483 Participants	31.31 years STANDARD_DEVIATION 4.86 • n=36 Participants	31.26 years STANDARD_DEVIATION 5.13 • n=10 Participants	31.11 years STANDARD_DEVIATION 4.80 • n=115 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Sex: Female, Male Female	25 Participants n=113 Participants	18 Participants n=163 Participants	64 Participants n=160 Participants	67 Participants n=483 Participants	70 Participants n=36 Participants	68 Participants n=10 Participants	312 Participants n=115 Participants
Sex: Female, Male Male	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=113 Participants	3 Participants n=163 Participants	2 Participants n=160 Participants	4 Participants n=483 Participants	3 Participants n=36 Participants	2 Participants n=10 Participants	15 Participants n=115 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=113 Participants	15 Participants n=163 Participants	62 Participants n=160 Participants	63 Participants n=483 Participants	66 Participants n=36 Participants	66 Participants n=10 Participants	296 Participants n=115 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants	0 Participants n=483 Participants	1 Participants n=36 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants
Race (NIH/OMB) Asian	1 Participants n=113 Participants	1 Participants n=163 Participants	2 Participants n=160 Participants	0 Participants n=483 Participants	1 Participants n=36 Participants	0 Participants n=10 Participants	5 Participants n=115 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants	1 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants
Race (NIH/OMB) More than one race	2 Participants n=113 Participants	3 Participants n=163 Participants	3 Participants n=160 Participants	2 Participants n=483 Participants	0 Participants n=36 Participants	5 Participants n=10 Participants	15 Participants n=115 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants

PRIMARY outcome

Timeframe: 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.

Maternal weight in lbs

Outcome measures

Outcome measures
Measure	HABITpreg n=25 Participants 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	TAUpreg n=18 Participants Participants will receive treatment as usual during pregnancy	HABITpreg; TAUpost n=64 Participants 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.	HABITpreg, HABITpost n=67 Participants 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	TAUpreg; HABITpost n=70 Participants 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.	TAUpreg; TAUpost n=68 Participants Participates will receive treatment as usual during pregnancy and treatment as usual during the postpartum period.
Maternal Weight 12 month follow-up	—	—	196.59 pounds Standard Deviation 44.81	201.03 pounds Standard Deviation 43.64	193.70 pounds Standard Deviation 37.51	201.66 pounds Standard Deviation 45.54
Maternal Weight Baseline	202.16 pounds Standard Deviation 42.10	217.09 pounds Standard Deviation 54.92	194.16 pounds Standard Deviation 40.33	196.73 pounds Standard Deviation 39.44	190.13 pounds Standard Deviation 32.84	195.62 pounds Standard Deviation 41.32

SECONDARY outcome

Timeframe: 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.

Blood Analysis of Maternal Lipids (High-Density Lipoprotein (HDL), Low-Density Lipoprotein calculated (LDL), Cholesterol, Triglyceride).

Outcome measures

Outcome measures
Measure	HABITpreg n=25 Participants 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	TAUpreg n=18 Participants Participants will receive treatment as usual during pregnancy	HABITpreg; TAUpost n=64 Participants 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.	HABITpreg, HABITpost n=67 Participants 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	TAUpreg; HABITpost n=70 Participants 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.	TAUpreg; TAUpost n=68 Participants Participates will receive treatment as usual during pregnancy and treatment as usual during the postpartum period.
Maternal Lipids High-Density Lipoprotein- T12 follow-up	—	—	55.16 mg/dL Standard Deviation 11.69	53.77 mg/dL Standard Deviation 13.64	55.57 mg/dL Standard Deviation 10.92	54.29 mg/dL Standard Deviation 11.38
Maternal Lipids Low-Density Lipoprotein calculated- T12 follow-up	—	—	97.67 mg/dL Standard Deviation 27.15	103.63 mg/dL Standard Deviation 32.52	106.10 mg/dL Standard Deviation 33.40	104.00 mg/dL Standard Deviation 33.80
Maternal Lipids Triglyceride- T12 follow-up	—	—	113.87 mg/dL Standard Deviation 71.66	106.79 mg/dL Standard Deviation 69.02	94.51 mg/dL Standard Deviation 48.36	96.97 mg/dL Standard Deviation 49.11
Maternal Lipids High-Density Lipoprotein- Baseline	66.84 mg/dL Standard Deviation 12.25	60.28 mg/dL Standard Deviation 15.11	64.94 mg/dL Standard Deviation 11.44	62.21 mg/dL Standard Deviation 13.43	65.53 mg/dL Standard Deviation 12.93	66.27 mg/dL Standard Deviation 11.70
Maternal Lipids Low-Density Lipoprotein calculated- Baseline	99.16 mg/dL Standard Deviation 22.50	84.50 mg/dL Standard Deviation 21.89	96.77 mg/dL Standard Deviation 26.16	100.61 mg/dL Standard Deviation 33.46	102.57 mg/dL Standard Deviation 27.99	99.99 mg/dL Standard Deviation 27.20
Maternal Lipids Cholesterol- Baseline	188.08 mg/dL Standard Deviation 27.75	165.33 mg/dL Standard Deviation 28.75	187.47 mg/dL Standard Deviation 32.96	187.52 mg/dL Standard Deviation 43.20	191.74 mg/dL Standard Deviation 36.14	189.33 mg/dL Standard Deviation 34.65
Maternal Lipids Triglyceride- Baseline	110.80 mg/dL Standard Deviation 39.54	102.78 mg/dL Standard Deviation 43.60	128.79 mg/dL Standard Deviation 54.53	123.24 mg/dL Standard Deviation 54.70	118.06 mg/dL Standard Deviation 54.37	115.72 mg/dL Standard Deviation 41.55
Maternal Lipids Cholesterol- T12 follow-up	—	—	175.62 mg/dL Standard Deviation 35.95	178.75 mg/dL Standard Deviation 42.79	180.59 mg/dL Standard Deviation 32.84	177.75 mg/dL Standard Deviation 41.31

SECONDARY outcome

Timeframe: 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.

Maternal inflammatory markers from blood analysis

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	HABITpreg n=25 Participants 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	TAUpreg n=18 Participants Participants will receive treatment as usual during pregnancy	HABITpreg; TAUpost n=64 Participants 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.	HABITpreg, HABITpost n=67 Participants 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	TAUpreg; HABITpost n=70 Participants 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.	TAUpreg; TAUpost n=68 Participants Participates will receive treatment as usual during pregnancy and treatment as usual during the postpartum period.
Depressive Symptoms (EPDS) T12 follow-up	—	—	5.28 score on a scale Standard Deviation 5	4.70 score on a scale Standard Deviation 5.23	5.83 score on a scale Standard Deviation 6.19	7.03 score on a scale Standard Deviation 6.79
Depressive Symptoms (EPDS) Baseline	6.08 score on a scale Standard Deviation 5.56	8.61 score on a scale Standard Deviation 6.12	6.13 score on a scale Standard Deviation 4.77	4.93 score on a scale Standard Deviation 4.68	5.61 score on a scale Standard Deviation 5.33	6.47 score on a scale Standard Deviation 4.89

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	HABITpreg n=25 Participants 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	TAUpreg n=18 Participants Participants will receive treatment as usual during pregnancy	HABITpreg; TAUpost n=64 Participants 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.	HABITpreg, HABITpost n=67 Participants 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	TAUpreg; HABITpost n=70 Participants 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.	TAUpreg; TAUpost n=68 Participants Participates will receive treatment as usual during pregnancy and treatment as usual during the postpartum period.
Depressive Symptoms (CESD) T12 follow-up	—	—	11.68 score on a scale Standard Deviation 10.70	10.29 score on a scale Standard Deviation 9.52	12.78 score on a scale Standard Deviation 11.70	13.25 score on a scale Standard Deviation 11.49
Depressive Symptoms (CESD) Baseline	13.88 score on a scale Standard Deviation 10.63	18.22 score on a scale Standard Deviation 11.24	13.19 score on a scale Standard Deviation 9.14	11.06 score on a scale Standard Deviation 8.31	12.04 score on a scale Standard Deviation 8.90	13.18 score on a scale Standard Deviation 8.61

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Gestational weight gain in lbs