Optimizing Health From Pregnancy Through One Year Postpartum

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Optimizing Health From Pregnancy Through One Year Postpartum: A Sequential Multiple Assignment Randomized Trial (SMART) of Perinatal Lifestyle Interventions

Conditions
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Obesity, Pregnancy Related

Intervention / Treatment
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* Behavioral: HABITpreg
* Behavioral: HABITpost


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 14 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HABITpreg; TAUpost<br>Participants will receive study intervention during pregnant and treatment as usual postpartum. | Behavioral: HABITpreg<br>* 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.<br>|
| Experimental: HABITpreg, HABITpost<br>Participants will receive study intervention during pregnancy and study intervention during the postpartum period. | Behavioral: HABITpreg<br>* 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.<br>Behavioral: HABITpost<br>* 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.<br>|
| Experimental: TAUpreg; HABITpost<br>Participants will receive treatment as usual during pregnancy and study intervention during the postpartum period. | Behavioral: HABITpost<br>* 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.<br>|
| No Intervention: TAUpreg; TAUpost<br>Participates will receive treatment as usual during pregnancy and treatment as usual during the postpartum period. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal weight | weight in lbs | 1 year postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal lipids | blood analysis | 1 year postpartum | 
| Maternal inflammatory markers | blood analysis | 1 year postpartum | 
| Depressive symptoms | Scores from the Edinburgh Postnatal Depression Scale | 1 year postpartum | 
| Depressive symptoms | Scores from the Center for Epidemiological Studies-Depression | 1 year postpartum |