N/A
N=118
Weight Management for Improved Pregnancy Outcomes
Obesity · Pregnancy
Bottom Line
View on ClinicalTrials.gov: NCT00950235 ↗Enrolled (actual)
118
Serious AEs
1.7%
Results posted
Jul 2015
Primary outcome: Primary: Maternal Weight Change — 1.2; -2.6 kg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Weight Management (Behavioral); Usual Care (Other)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Kaiser Permanente
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maternal Weight Change |
1.2; -2.6 | — |
| SECONDARY Pregnancy Weight Change |
8.4; 5.0 | — |
| SECONDARY Large for Gestational Age (LGA) |
15; 5 | — |
Summary
This study will examine the safety and effectiveness of a dietary intervention in pregnant women. Women who are obese will be invited to participate. The control arm will receive routine prenatal care and one in-person nutritional and dietary counseling session to promote healthy eating during their pregnancy. The intervention arm will receive a more intensive dietary program that will include in-person counseling and group support sessions. The goal of the intervention will be weight maintenance (weight at 2 weeks after delivery should be within 3% of baseline weight) and avoidance of postpartum weight retention
Eligibility Criteria
Inclusion Criteria
- BMI 30 or more
- Less than 20 weeks gestation
- member of Kaiser Permanente Northwest (NW)
- receive pre-natal care at Kaiser Permanente NW
- speaks English
Exclusion Criteria
- no current treatment for cancer
- no bariatric surgery
- no current renal disease
- no multiple birth anticipated
- no hyperemesis requiring hospitalization
- no diabetes (type 1 or 2)
Data sourced from ClinicalTrials.gov (NCT00950235). 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.