Clinical trial NCT03069690: Optimizing Health From Pregnancy Through One Year Postpartum
Official title: Optimizing Health From Pregnancy Through One Year Postpartum: A Sequential Multiple Assignment Randomized Trial (SMART) of Perinatal Lifestyle Interventions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Pregnancy Related
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2017-03-03
Enrollment: 320
Sex: FEMALE
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Maternal Weight
timeFrame: Baseline and 1 year postpartum
Secondary outcomes:
measure: Maternal Lipids
timeFrame: Baseline and 1 year postpartum (T12)
measure: Maternal Inflammatory Markers
timeFrame: Baseline and 1 year postpartum (T12)
measure: Depressive Symptoms (EPDS)
timeFrame: Baseline and 1 year postpartum (T12)
measure: Depressive Symptoms (CESD)
timeFrame: Baseline and 1 year postpartum (T12)
Other outcomes:
measure: Gestational Weight Gain
timeFrame: Time of delivery
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Michele Levine, PhD
role: PRINCIPAL_INVESTIGATOR
References: