Preventing Excessive Gestational Weight Gain in Obese Women
|ClinicalTrials.gov Identifier: NCT01545934|
Recruitment Status : Active, not recruiting
First Posted : March 7, 2012
Last Update Posted : July 26, 2016
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Behavioral: Lifestyle intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||350 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Preventing Excessive Gestational Weight Gain in Obese Women|
|Study Start Date :||November 2012|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||June 2021|
|No Intervention: Standard Care|
|Experimental: Lifestyle intervention||
Behavioral: Lifestyle intervention
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.
- 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.
- Offspring weight gain [ Time Frame: 1 week, 6 months, 12 months ]Offspring weight for age z scores from birth (1 week), to 6 months, and 12 months of age.
- Changes in maternal dietary intake [ Time Frame: 13 weeks gestation, 34 weeks gestatation, 6 months postpartum, 12 months postpartum ]Changes in maternal calorie intake (Kcal/day) and fat intake (% kcal from fat).
- Changes in offspring dietary intake [ Time Frame: 1 week, 6 months, 12 months ]Changes in offspring intake of breast milk (#feeds per day) and/or formula (#feeds per day).
- Changes in maternal glucose, insulin, and lipids [ Time Frame: 13 weeks gestation, 34 weeks gestation, 6 months postpartum. 12 months postpartum ]
- Proportion of women exceeding IOM guidelines [ Time Frame: 13 weeks, 40 weeks ]Women will be categorized as exceeding or not exceeding IOM guidelines for gestational weight gain. Self-reported pre-pregnancy weight will be subtracted from weight measured at last clinic visit prior to delivery. Women will be categorized as exceeding or not exceeding 2009 IOM guidelines.
- Proportion of women at or below prepregnancy weight [ Time Frame: 22-30 weeks post delivery, 48-56 weeks post delivery ]Weight measured at 22-30 and 48-56 weeks postpartum and subtracted from self-reported prepregnancy weight and then categorized as at or below vs. above self-reported prepregnancy weight.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01545934
|United States, California|
|California Polytechnic State University|
|San Luis Obispo, California, United States, 93401|
|United States, Rhode Island|
|Providence, Rhode Island, United States, 02906|
|Principal Investigator:||Suzanne Phelan, PhD||Cal Poly|