Preventing Excessive Gestational Weight Gain in Obese Women
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 Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Preventing Excessive Gestational Weight Gain in Obese Women|
- Weight gain per week of observation [ Time Frame: 13 weeks gestation, 35 weeks gestation ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
- Proportion of women exceeding IOM guidelines [ Time Frame: 13 weeks, 40 weeks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||June 2017|
|Estimated Primary Completion Date:||March 2016 (Final data collection date for primary outcome measure)|
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01545934
|Contact: Suzanne Phelan, PhDfirstname.lastname@example.org|
|Contact: Anna C Brannen, B.S.||email@example.com|
|United States, California|
|California Polytechnic State University||Recruiting|
|San Luis Obispo, California, United States, 93401|
|Contact: Suzanne Phelan, PhD. 805-756-2087 firstname.lastname@example.org|
|Contact: Anna C Brannen, B.S. 805-756-5365 email@example.com|
|Principal Investigator: Suzanne Phelan, PhD|
|United States, Rhode Island|
|Providence, Rhode Island, United States, 02906|
|Contact: Rena R Wing, Phd 401-793-8959 firstname.lastname@example.org|
|Principal Investigator: Rena R Wing, PhD|
|Principal Investigator:||Suzanne Phelan, PhD||Cal Poly|