Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03069690 |
| Other study ID # |
PRO16020497 |
| Secondary ID |
R01HL132578-01 |
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2017 |
| Est. completion date |
June 30, 2024 |
Study information
| Verified date |
June 2023 |
| Source |
University of Pittsburgh |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
