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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01545934
Other study ID # U01 HL114377A
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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