Preventing Excessive Gestational Weight Gain in Obese Women

This study is currently recruiting participants.

Verified November 2012 by California Polytechnic State University-San Luis Obispo

Sponsor:

Collaborator:

Brown University

Information provided by (Responsible Party):

Suzanne Phelan, California Polytechnic State University-San Luis Obispo

ClinicalTrials.gov Identifier:

NCT01545934

First received: February 28, 2012

Last updated: November 28, 2012

Last verified: November 2012

History of Changes

Purpose

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.

Condition	Intervention
Obesity	Behavioral: Lifestyle intervention

Study Type:	Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Medicines Obesity

U.S. FDA Resources

Further study details as provided by California Polytechnic State University-San Luis Obispo:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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.

Estimated Enrollment:	350
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)

Arms	Assigned Interventions
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.

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion criteria:

18-40 years old
< 16 weeks gestation
BMI >= 25
Non-Smoking
Non-Drinking
Willing to consent

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01545934

Contacts

Contact: Suzanne Phelan, PhD	805-756-2087	sphelan@calpoly.edu
Contact: Anna C Brannen, B.S.	805-756-5365	acbranne@calpoly.edu

Locations

United States, California
California Polytechnic State University	Recruiting
San Luis Obispo, California, United States, 93401
Contact: Suzanne Phelan, PhD. 805-756-2087 sphelan@calpoly.edu
Contact: Anna C Brannen, B.S. 805-756-5365 acbranne@calpoly.edu
Principal Investigator: Suzanne Phelan, PhD
United States, Rhode Island
Miriam Hospital	Not yet recruiting
Providence, Rhode Island, United States, 02906
Contact: Rena R Wing, Phd 401-793-8959 rwing@calpoly.edu
Principal Investigator: Rena R Wing, PhD

Sponsors and Collaborators

California Polytechnic State University-San Luis Obispo

Brown University

Investigators

Principal Investigator:

Suzanne Phelan, PhD

Cal Poly

More Information

No publications provided

Responsible Party:	Suzanne Phelan, Principle Investigator, California Polytechnic State University-San Luis Obispo
ClinicalTrials.gov Identifier:	NCT01545934 History of Changes
Other Study ID Numbers:	U01 HL114377A
Study First Received:	February 28, 2012
Last Updated:	November 28, 2012
Health Authority:	United States: NIH

Keywords provided by California Polytechnic State University-San Luis Obispo:

Overweight
Obese
Pregnancy
Weight Gain

Additional relevant MeSH terms:

Obesity
Weight Gain
Overnutrition
Nutrition Disorders

Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on May 23, 2013

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