Preventing Excessive Gestational Weight Gain in Obese Women
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01545934|
Recruitment Status : Active, not recruiting
First Posted : March 7, 2012
Results First Posted : January 28, 2021
Last Update Posted : January 28, 2021
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Behavioral: Lifestyle intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||264 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Preventing Excessive Gestational Weight Gain in Obese Women|
|Actual Study Start Date :||November 2012|
|Actual Primary Completion Date :||May 2016|
|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.
- Kcals/Day [ Time Frame: 13 weeks gestation, 34 weeks gestation ]Changes in maternal calorie intake (Kcal/day)
- 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 [ Time Frame: 13 weeks gestation, 34 weeks gestation ]Fasting glucose
- Number of Women Exceeding IOM Guidelines as a Proportion of Total Number of Women in Each Group. [ Time Frame: 13 weeks, 40 weeks ]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.
- Number of Women at or Below Prepregnancy Weight as a Proportion of the Total Number of Participants in Each Group [ Time Frame: 48-56 weeks post delivery ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|