ObesityNCT01345149
Effect of Intervention With Diet and Physical Activity in Obese Pregnant Women
A study testing Diet + Exercise in people with Obesity, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
Purpose: To evaluate if lifestyle intervention (diet and exercise) can reduce maternal weight gain, the incidence of pregnancy complications and minimize the number of macrosomic infants. 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
- Obesity
- What is being tested?
- Diet + Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2009to Jun 2012
- 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
- Age >18 years
- BMI > 30
- Singleton pregnancy
- Must speak and understand Danish
Who cannot join
- Alcohol or drug abuse
- Diabetes type I or other critical medical disease.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Obstetrics and Gynecology, Hvidovre University Hospital
Copenhagen, DK-2650
About this study
Official title: Effect of Lifestyleintervention With Diet and Physical Activity in Obese Pregnant Women
Purpose: To evaluate if lifestyle intervention (diet and exercise) can reduce maternal weight gain, the incidence of pregnancy complications and minimize the number of macrosomic infants.
Read the detailed description
Obese pregnant women with a BMI>30 are randomized to Diet + Exercise, Exercise or control (1:1:1) in order to reduce maternal weight gain to less than 5 kg during pregnancy.
The effect on the children of mothers in this study is evaluated in the study: Is it possible to reduce the Number of Macrosomic Infants With Abundant Fat Tissue by Lifestyle Intervention during Pregnancy (NCT01235676)
- Conditions
- Obesity
- Being tested
- Diet + Exercise
- Keywords
- Obesity, Pregnancy, Intervention, Diet, Physical activity
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet + ExerciseBehavioural
Also called Lifestyle intervention.
Diet: Intensive counselling about calorie restriction to reduce weight gain by dietician.
Exercise: Individual counselling
| Study group | Role | What they receive |
|---|---|---|
| Diet + Exercise | Experimental | Diet: Intensive counselling about calorie restriction to reduce weight gain by dietician.
Exercise: Individual counselling Receives: Behavioral: Diet + Exercise |
| Exercise | Experimental | Exercise: Individual counselling Receives: Behavioral: Diet + Exercise |
| Control | No intervention | Standard treatment without intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal weight gain
Measured: At delivery, avarage 27 weeks after inclusion. For the last participant this will be aproximately April 2012
Secondary outcomes (3)
Pregnancy complications
Measured: At delivery, avarage 27 weeks after inclusion. For the last participant this will be aproximately April 2012
Glucose tolerance in pregnancy
Measured: At delivery, avarage 27 weeks after inclusion. For the last participant this will be aproximately April 2012
Birth weight
Measured: At delivery, avarage 27 weeks after inclusion. For the last participant this will be aproximately April 2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2011 (estimated)
- Study startApr 2009
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristina Renault, Hvidovre University Hospital
- Investigators
- Niels Jørgen Secher, Professor, Study chair, Department of Obstetrics and Gynecology, Hvidovre University HospitalLisbeth Nilas, Prof. DMSc, Study chair, Department of Obstetrics and Gynecology, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01345149
- Sponsor's protocol ID
- H-D-2008-119
- Status last verified
- Sep 2012
- First submitted
- 27 Apr 2011
- Last updated
- 6 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ammundsen AA, Krak E, Schmidt P, Halldorsson TI, Molgaard C, Vaag AA, Norgaard K, Carlsen EM, Brons C, Renault KM. Early-Pregnancy Calcium and Protein Intake Are Associated with Newborn Bone Mineral Density in Women with Obesity. J Nutr. 2026 Oct 10:101879. doi: 10.1016/j.tjnut.2026.101879. Online ahead of print.
PubMed 42858896Renault KM, Carlsen EM, Norgaard K, Nilas L, Pryds O, Secher NJ, Cortes D, Jensen JE, Olsen SF, Halldorsson TI. Intake of carbohydrates during pregnancy in obese women is associated with fat mass in the newborn offspring. Am J Clin Nutr. 2015 Dec;102(6):1475-81. doi: 10.3945/ajcn.115.110551. Epub 2015 Nov 11.
PubMed 26561621Renault KM, Carlsen EM, Norgaard K, Nilas L, Pryds O, Secher NJ, Olsen SF, Halldorsson TI. Intake of Sweets, Snacks and Soft Drinks Predicts Weight Gain in Obese Pregnant Women: Detailed Analysis of the Results of a Randomised Controlled Trial. PLoS One. 2015 Jul 20;10(7):e0133041. doi: 10.1371/journal.pone.0133041. eCollection 2015.
PubMed 26192183
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lifestyleintervention With Diet and Physical Activity in Obese Pregnant Women
- ClinicalTrials.gov ID
- NCT01345149
- Acronym / sponsor ID
- H-D-2008-119
- Conditions
- Obesity
- Keywords
- Obesity, Pregnancy, Intervention, Diet, Physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 29 Apr 2011 (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.
Purpose: To evaluate if lifestyle intervention (diet and exercise) can reduce maternal weight gain, the incidence of pregnancy complications and minimize the number of macrosomic infants.
Detailed description
Obese pregnant women with a BMI>30 are randomized to Diet + Exercise, Exercise or control (1:1:1) in order to reduce maternal weight gain to less than 5 kg during pregnancy.
The effect on the children of mothers in this study is evaluated in the study: Is it possible to reduce the Number of Macrosomic Infants With Abundant Fat Tissue by Lifestyle Intervention during Pregnancy (NCT01235676)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diet + Exercise | Experimental | Behavioral: Diet + ExerciseDiet: Intensive counselling about calorie restriction to reduce weight gain by dietician. Exercise: Individual counselling |
| Exercise | Experimental | Behavioral: Diet + ExerciseExercise: Individual counselling |
| Control | No intervention | –Standard treatment without intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >18 years
- BMI > 30
- Singleton pregnancy
- Must speak and understand Danish
Key exclusion criteria (2 listed)
- Alcohol or drug abuse
- Diabetes type I or other critical medical disease.
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 |
|---|---|---|
| Diet + ExerciseAlso: Lifestyle intervention.Diet: Intensive counselling about calorie restriction to reduce weight gain by dietician. Exercise: Individual counselling | Behavioural | Diet + Exercise, Exercise |
Primary outcome
Maternal weight gain
Time frame: At delivery, avarage 27 weeks after inclusion. For the last participant this will be aproximately April 2012
3 secondary outcomes
Pregnancy complications
Time frame: At delivery, avarage 27 weeks after inclusion. For the last participant this will be aproximately April 2012
Glucose tolerance in pregnancy
Time frame: At delivery, avarage 27 weeks after inclusion. For the last participant this will be aproximately April 2012
Birth weight
Time frame: At delivery, avarage 27 weeks after inclusion. For the last participant this will be aproximately April 2012
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2012.
- Derived from this study: PubMed 42858896Ammundsen AA, Krak E, Schmidt P, Halldorsson TI, Molgaard C, Vaag AA, Norgaard K, Carlsen EM, Brons C, Renault KM. Early-Pregnancy Calcium and Protein Intake Are Associated with Newborn Bone Mineral Density in Women with Obesity. J Nutr. 2026 Oct 10:101879. doi: 10.1016/j.tjnut.2026.101879. Online ahead of print.
- Derived from this study: PubMed 26561621Renault KM, Carlsen EM, Norgaard K, Nilas L, Pryds O, Secher NJ, Cortes D, Jensen JE, Olsen SF, Halldorsson TI. Intake of carbohydrates during pregnancy in obese women is associated with fat mass in the newborn offspring. Am J Clin Nutr. 2015 Dec;102(6):1475-81. doi: 10.3945/ajcn.115.110551. Epub 2015 Nov 11.
- Derived from this study: PubMed 26192183Renault KM, Carlsen EM, Norgaard K, Nilas L, Pryds O, Secher NJ, Olsen SF, Halldorsson TI. Intake of Sweets, Snacks and Soft Drinks Predicts Weight Gain in Obese Pregnant Women: Detailed Analysis of the Results of a Randomised Controlled Trial. PLoS One. 2015 Jul 20;10(7):e0133041. doi: 10.1371/journal.pone.0133041. eCollection 2015.
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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.
Niels Jørgen Secher, Professor study chair
Department of Obstetrics and Gynecology, Hvidovre University Hospital
Lisbeth Nilas, Prof. DMSc study chair
Department of Obstetrics and Gynecology, Hvidovre University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet + Exercise in people with Obesity, run by Hvidovre University Hospital at 1 site in Denmark.
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 4 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: finished, as of the sponsor's last update on 6 Sep 2012. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal weight gain (time frame: At delivery, avarage 27 weeks after inclusion. For the last participant this will be aproximately April 2012). 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 NCT01345149, which also lists 3 linked publications.
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 6 Sep 2012.