Preventing Excessive Gestational Weight Gain in Obese Women

Obesity Clinical Trial

Official title:

Preventing Excessive Gestational Weight Gain in Obese Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01545934
• Other study ID #: U01 HL114377A
• Status: Completed
• Phase: N/A
• Start date: November 2012
• Est. completion date: June 2020

Study information

• Verified date: July 2021
• Source: California Polytechnic State University-San Luis Obispo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 264
• Est. completion date: June 2020
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Over 18 years old

• < 16 weeks gestation

• BMI >= 25

• Willing to consent

Exclusion Criteria:

• Pregnant with Twins

• Untreated medical or psychological problem

• Inability to be physically active

Related Conditions & MeSH terms

• Gestational Weight Gain
• Obesity
• Weight Gain

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.

Locations

Country	Name	City	State
United States	Miriam Hospital	Providence	Rhode Island
United States	California Polytechnic State University	San Luis Obispo	California

Sponsors (2)

Lead Sponsor	Collaborator
California Polytechnic State University-San Luis Obispo	Brown University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	13 weeks gestation, 35 weeks gestation
Secondary	Offspring Weight Gain	Offspring weight for age z scores from birth (1 week), to 6 months, and 12 months of age.	1 week, 6 months, 12 months
Secondary	Kcals/Day	Changes in maternal calorie intake (Kcal/day)	13 weeks gestation, 34 weeks gestation
Secondary	Changes in Offspring Dietary Intake	Changes in offspring intake of breast milk (#feeds per day) and/or formula (#feeds per day).	1 week, 6 months, 12 months
Secondary	Changes in Maternal Glucose	Fasting glucose	13 weeks gestation, 34 weeks gestation
Secondary	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.	13 weeks, 40 weeks
Secondary	Number of Women at or Below Prepregnancy Weight as a Proportion of the Total Number of Participants in Each Group	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.	48-56 weeks post delivery