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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
264
The intervention is a multicomponent program designed to prevent excessive gestational weight gain in obese women through modifications of diet, exercise, and behavioral strategies during pregnancy.
California Polytechnic State University
San Luis Obispo, California, United States
Miriam Hospital
Providence, Rhode Island, United States
Weight Gain Per Week of Observation
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.
Time frame: 13 weeks gestation, 35 weeks gestation
Offspring Weight Gain
Offspring weight for age z scores from birth (1 week), to 6 months, and 12 months of age.
Time frame: 1 week, 6 months, 12 months
Kcals/Day
Changes in maternal calorie intake (Kcal/day)
Time frame: 13 weeks gestation, 34 weeks gestation
Changes in Offspring Dietary Intake
Changes in offspring intake of breast milk (#feeds per day) and/or formula (#feeds per day).
Time frame: 1 week, 6 months, 12 months
Changes in Maternal Glucose
Fasting glucose
Time frame: 13 weeks gestation, 34 weeks gestation
Number of Women Exceeding IOM Guidelines as a Proportion of Total Number of Women in Each Group.
Self-reported pre-pregnancy weight will be subtracted from weight measured at last clinic visit prior to delivery. Women will be categorized as exceeding 2009 IOM guidelines if the difference is \> 11.5 kg gain for women with prepregnancy overweight or \>9 kg for women with prepregnancy obesity.
Time frame: 13 weeks, 40 weeks
Number of Women at or Below Prepregnancy Weight as a Proportion of the Total Number of Participants in Each Group
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Weight measured at 48-56 weeks postpartum and subtracted from self-reported prepregnancy weight and then categorized as at or below vs. above self-reported prepregnancy weight.
Time frame: 48-56 weeks post delivery