Weight GainVIGANCT00451425
Weight Gain During Pregnancy - a Randomized Controlled Trial of Intervention to Prevent Excessive Gestational Weight Gain
A study testing motivational intervention in pregnancy in people with Weight Gain, run by Region Örebro County at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Weight Gain
- What is being tested?
- motivational intervention in pregnancy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 430 participants
- Where
- 1 siteSweden
- Study dates
- May 2007to Oct 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- >18 years,
- Adequate language skills (swedish),
- BMI>19.9,
- Pregnancy estimated <16 weeks (LMP),
- Planned for basic pregnancy surveillance (healthy mother).
Who cannot join
- History of eating disorder,
- History of having a growth restricted child.
Trial locations and contacts
1 site in 1 country.
Kerstin Nilsson, MD contact
About this study
Official title: Weight Gain During Pregnancy - a Randomized Controlled Trial of Intervention to Prevent Excessive Gestational Weight Gain.
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.
- Conditions
- Weight Gain
- Being tested
- motivational intervention in pregnancy
- Keywords
- pregnancy, weight gain, obesity, macrosomia
- Medical subject headings
- Weight Gain, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
motivational intervention in pregnancyBehavioural
Motivational program including individualized counseling on diet and physical activity
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | standard maternity care Receives: Behavioral: motivational intervention in pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of women with a weight gain during pregnancy within IOM´s recommendation is compared between study groups.
Measured: 9 months
Secondary outcomes (4)
Weight retention(kg) up until one year after delivery is compared between study groups.
Measured: one year after delivery
Number of fetal and maternal complications in pregnancy is compared between study groups
Measured: 9 months
Number of fetal and maternal complications during delivery is compared between study groups
Measured: during delivery
Child birth weight and weight development of the child up to one year of age is compared between study groups.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2007 (estimated)
- Study startMay 2007
- Primary completionDec 2009 (estimated)
- Study completionOct 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Weight GainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 430 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Investigators
- Kerstin Nilsson, MD. MD, Study chair, Region Örebro County
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00451425
- Sponsor's protocol ID
- Dnr 2007/031
- Acronym
- VIGA
- Status last verified
- May 2009
- First submitted
- 21 Mar 2007
- Last updated
- 29 May 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25367823
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Gain During Pregnancy - a Randomized Controlled Trial of Intervention to Prevent Excessive Gestational Weight Gain.
- ClinicalTrials.gov ID
- NCT00451425
- Acronym / sponsor ID
- VIGA / Dnr 2007/031
- Conditions
- Weight Gain
- Keywords
- pregnancy, weight gain, obesity, macrosomia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 430 participants (estimated)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Oct 2010 (estimated)
- First posted
- 23 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | Behavioral: motivational intervention in pregnancystandard maternity care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- >18 years,
- Adequate language skills (swedish),
- BMI>19.9,
- Pregnancy estimated <16 weeks (LMP),
- Planned for basic pregnancy surveillance (healthy mother).
Key exclusion criteria (2 listed)
- History of eating disorder,
- History of having a growth restricted child.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| motivational intervention in pregnancyMotivational program including individualized counseling on diet and physical activity | Behavioural | control |
Primary outcome
The number of women with a weight gain during pregnancy within IOM´s recommendation is compared between study groups.
Time frame: 9 months
4 secondary outcomes
Weight retention(kg) up until one year after delivery is compared between study groups.
Time frame: one year after delivery
Number of fetal and maternal complications in pregnancy is compared between study groups
Time frame: 9 months
Number of fetal and maternal complications during delivery is compared between study groups
Time frame: during delivery
Child birth weight and weight development of the child up to one year of age is compared between study groups.
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2009.
- Derived from this study: PubMed 25367823Ronnberg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kerstin Nilsson, MD contact
Kerstin Nilsson, MD. MD study chair
Region Örebro County
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing motivational intervention in pregnancy in people with Weight Gain, run by Region Örebro County at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact AnnKristin M Ronnberg, MD (+46-19-602 6912, annkristin.roennberg@orebroll.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of women with a weight gain during pregnancy within IOM´s recommendation is compared between study groups. (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00451425, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2009.