Promoting Healthy Weight Gain During Pregnancy

NCT ID: NCT01117961

Last Updated: 2013-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

401 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2012-05-31

Brief Summary

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Study goal is to determine whether behavioral lifestyle intervention during pregnancy can reduce the number of women who exceed the Institute of Medicine recommendations for weight gain during pregnancy.

It is hypothesized that the intervention will reduce the number of women who exceed weight gain guidelines relative to standard care. The investigators also expect the intervention to reduce the proportion of women exceeding weight gain guidelines in both normal weight and overweight groups.

Detailed Description

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Conditions

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Weight Gain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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control

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

Lifestyle intervention delivered during pregnancy

Group Type EXPERIMENTAL

Lifestyle

Intervention Type BEHAVIORAL

Behavioral lifestyle intervention targeting diet and physical activity to reduce excessive gestational weight gain

Interventions

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Lifestyle

Behavioral lifestyle intervention targeting diet and physical activity to reduce excessive gestational weight gain

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* non-smoking, adults,
* \< 16 weeks gestation

Exclusion Criteria

* medical comorbidities
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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California Polytechnic State University-San Luis Obispo

OTHER

Sponsor Role collaborator

Women and Infants Hospital of Rhode Island

OTHER

Sponsor Role collaborator

University of California, Berkeley

OTHER

Sponsor Role collaborator

The Miriam Hospital

OTHER

Sponsor Role lead

Responsible Party

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Rena R. Wing

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Mercado A, Marquez B, Abrams B, Phipps MG, Wing RR, Phelan S. Where Do Women Get Advice About Weight, Eating, and Physical Activity During Pregnancy? J Womens Health (Larchmt). 2017 Sep;26(9):951-956. doi: 10.1089/jwh.2016.6078. Epub 2017 May 19.

Reference Type DERIVED
PMID: 28525293 (View on PubMed)

Phelan S, Phipps MG, Abrams B, Darroch F, Grantham K, Schaffner A, Wing RR. Does behavioral intervention in pregnancy reduce postpartum weight retention? Twelve-month outcomes of the Fit for Delivery randomized trial. Am J Clin Nutr. 2014 Feb;99(2):302-11. doi: 10.3945/ajcn.113.070151. Epub 2013 Nov 27.

Reference Type DERIVED
PMID: 24284438 (View on PubMed)

Phelan S, Phipps MG, Abrams B, Darroch F, Schaffner A, Wing RR. Randomized trial of a behavioral intervention to prevent excessive gestational weight gain: the Fit for Delivery Study. Am J Clin Nutr. 2011 Apr;93(4):772-9. doi: 10.3945/ajcn.110.005306. Epub 2011 Feb 10.

Reference Type DERIVED
PMID: 21310836 (View on PubMed)

Other Identifiers

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CMTT# 2035-06

Identifier Type: -

Identifier Source: org_study_id

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