N/A
N=264
Preventing Excessive Gestational Weight Gain in Obese Women
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT01545934 ↗Enrolled (actual)
264
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Weight Gain Per Week of Observation — 0.39; 0.33 kg/wk
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lifestyle intervention (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- California Polytechnic State University-San Luis Obispo
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Weight Gain Per Week of Observation |
0.39; 0.33 | — |
| SECONDARY Offspring Weight Gain |
— | — |
| SECONDARY Kcals/Day |
1777; 1743; 1785; 1673 | — |
| SECONDARY Changes in Offspring Dietary Intake |
— | — |
| SECONDARY Changes in Maternal Glucose |
84; 87; 85; 83 | — |
| SECONDARY Number of Women Exceeding IOM Guidelines as a Proportion of Total Number of Women in Each Group. |
69; 53 | — |
| SECONDARY Number of Women at or Below Prepregnancy Weight as a Proportion of the Total Number of Participants in Each Group |
38; 41 | — |
Summary
The purpose of this study is to study the effects of a multicomponent lifestyle intervention that includes partial meal replacements as a means to prevent excessive gestational weight gain in obese women. The primary hypothesis is that the intervention will reduce the rate of gestational weight gain compared with standard care.
Eligibility Criteria
Inclusion criteria
- Over 18 years old
- = 25
- Willing to consent
Exclusion Criteria
- Pregnant with Twins
- Untreated medical or psychological problem
- Inability to be physically active
Data sourced from ClinicalTrials.gov (NCT01545934). 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.