Preventing Excessive Gestational Weight Gain in Obese Women

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Behavioral: Lifestyle intervention

• Registration Number: NCT01545934
• Lead Sponsor: California Polytechnic State University-San Luis Obispo

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-28
• Study First Submitted QC: 2012-03-02
• Study First Posted: 2012-03-07
• Study Start: 2012-11
• Primary Completion: 2016-05
• Study Completion: 2020-06
• Results First Submitted: 2020-08-27
• Results First Submitted QC: 2021-01-26
• Results First Posted: 2021-01-28
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-29
• Last Update Posted: 2021-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 264

Inclusion Criteria

Not provided

Exclusion Criteria

• Pregnant with Twins
• Untreated medical or psychological problem
• Inability to be physically active

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lifestyle intervention	Lifestyle intervention	-

Primary Outcome Measures

Name	Time	Method
Weight Gain Per Week of Observation	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.

Secondary Outcome Measures

Name	Time	Method
Number of Women Exceeding IOM Guidelines as a Proportion of Total Number of Women in Each Group.	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.
Offspring Weight Gain	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 Glucose	13 weeks gestation, 34 weeks gestation	Fasting glucose
Kcals/Day	13 weeks gestation, 34 weeks gestation	Changes in maternal calorie intake (Kcal/day)
Changes in Offspring Dietary Intake	1 week, 6 months, 12 months	Changes in offspring intake of breast milk (#feeds per day) and/or formula (#feeds per day).
Number of Women at or Below Prepregnancy Weight as a Proportion of the Total Number of Participants in Each Group	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.

Trial Locations

Locations (2)

California Polytechnic State University; 🇺🇸 San Luis Obispo, California, United States

Miriam Hospital; 🇺🇸 Providence, Rhode Island, United States