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Weight Gain During Pregnancy - a Randomized Controlled Trial of Intervention to Prevent Excessive Gestational Weight Gain

NCT ID: NCT00451425

Last Updated: 2009-05-29

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

430 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2010-10-31

Brief Summary

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Excessive weight gain during pregnancy is associated with complications during delivery primarily due to macrosomia (large babies) but also with high levels of weight retention post pregnancy and thereby increased risk of future weight related health problems. The primary aim of this study is to evaluate the efficacy of an intervention consisting of; recurrent Motivational Interviewing (MI), prescription of physical activity and extended information on recommended weight gain during pregnancy in regards to preventing excessive gestational weight gain.

Detailed Description

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Conditions

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Weight Gain

Keywords

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pregnancy weight gain obesity macrosomia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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control

standard maternity care

Group Type NO_INTERVENTION

motivational intervention in pregnancy

Intervention Type BEHAVIORAL

Motivational program including individualized counseling on diet and physical activity

Interventions

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motivational intervention in pregnancy

Motivational program including individualized counseling on diet and physical activity

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* \>18 years,
* Adequate language skills (swedish),
* BMI\>19.9,
* Pregnancy estimated \<16 weeks (LMP),
* Planned for basic pregnancy surveillance (healthy mother).

Exclusion Criteria

* History of eating disorder,
* History of having a growth restricted child.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Region Örebro County

OTHER

Sponsor Role lead

Responsible Party

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Orebro lans landsting

Principal Investigators

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Kerstin Nilsson, MD. MD

Role: STUDY_CHAIR

Region Örebro County

Locations

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Modrahalsovarden Orebro lan

Örebro, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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AnnKristin M Ronnberg, MD

Role: CONTACT

Phone: +46-19-602 6912

Email: [email protected]

Kerstin Nilsson, MD

Role: CONTACT

Email: [email protected]

References

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Ronnberg AK, Ostlund I, Fadl H, Gottvall T, Nilsson K. Intervention during pregnancy to reduce excessive gestational weight gain-a randomised controlled trial. BJOG. 2015 Mar;122(4):537-44. doi: 10.1111/1471-0528.13131. Epub 2014 Nov 4.

Reference Type DERIVED
PMID: 25367823 (View on PubMed)

Other Identifiers

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Dnr 2007/031

Identifier Type: -

Identifier Source: org_study_id