Preventing Excessive Gestational Weight Gain in Obese Women
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- California Polytechnic State University-San Luis Obispo
- Enrollment
- 264
- Locations
- 2
- Primary Endpoint
- Weight Gain Per Week of Observation
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief 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.
Investigators
Suzanne Phelan
Principle Investigator
California Polytechnic State University-San Luis Obispo
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Pregnant with Twins
- •Untreated medical or psychological problem
- •Inability to be physically active
Outcomes
Primary Outcomes
Weight Gain Per Week of Observation
Time Frame: 13 weeks gestation, 35 weeks gestation
Rate of gestational weight gain will be computed as difference between weights measured at study entry and gestational week 35; this difference will be divided by the number of weeks of observation during pregnancy (i.e., weeks between study entry and final pregnancy assessment). If gestational week 35 is unavailable, most proximal clinic visit weight will be used.
Secondary Outcomes
- Number of Women Exceeding IOM Guidelines as a Proportion of Total Number of Women in Each Group.(13 weeks, 40 weeks)
- Offspring Weight Gain(1 week, 6 months, 12 months)
- Changes in Maternal Glucose(13 weeks gestation, 34 weeks gestation)
- Kcals/Day(13 weeks gestation, 34 weeks gestation)
- Changes in Offspring Dietary Intake(1 week, 6 months, 12 months)
- Number of Women at or Below Prepregnancy Weight as a Proportion of the Total Number of Participants in Each Group(48-56 weeks post delivery)