N/A
N=312
Optimizing Health From Pregnancy Through One Year Postpartum
Obesity · Pregnancy Related
Bottom Line
View on ClinicalTrials.gov: NCT03069690 ↗Enrolled (actual)
312
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Maternal Weight — 196.59; 201.03; 193.70; 201.66 pounds — p=.80
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- HABITpreg (Behavioral); HABITpost (Behavioral)
- Age
- Pediatric, Adult, Older Adult · 14+ yrs
- Sex
- Female
- Sponsor
- University of Pittsburgh
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maternal Weight |
196.59; 201.03; 193.70; 201.66; 202.16; 217.09 | .80 |
| SECONDARY Maternal Lipids |
55.16; 53.77; 55.57; 54.29; 97.67; 103.63 | — |
| SECONDARY Maternal Inflammatory Markers |
— | — |
| SECONDARY Depressive Symptoms (EPDS) |
5.28; 4.70; 5.83; 7.03; 6.08; 8.61 | — |
| SECONDARY Depressive Symptoms (CESD) |
11.68; 10.29; 12.78; 13.25; 13.88; 18.22 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT03069690). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.