OverweightNCT02703753
TOP-mums, for a Healthy Start
A study testing Lifestyle intervention in people with Overweight and Obesity, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
This study evaluates the effect of a lifestyle intervention for women with a pregnancy wish who have a high risk on perinatal morbidity because of overweight or obesity. Half of the patients will receive the lifestyle intervention while the other half will receive usual care. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity, Pregnancy Complications
- What is being tested?
- Lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteNetherlands
- Study dates
- 27 Jul 2016to 22 Apr 2024
- 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 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women with a pregnancy wish within 1 year;
- Aged 18-40 years;
- Overweight/obesity (BMI ≥ 25 kg/m2).
Who cannot join
- Haemodynamically significant heart disease;
- Restrictive lung disease;
- Congenital metabolic disease;
- Mentally retarded;
- Bariatric surgery;
- Diabetes type II, dependent on medicine.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center
Maastricht, Limburg, 6229HX
About this study
Official title: TOwards Prepared Mums (TOP-mums), for a Healthy Start: A Lifestyle Intervention to Reduce Overweight and Smoking in Women With a Pregnancy Wish to Prevent Perinatal Morbidity
This study evaluates the effect of a lifestyle intervention for women with a pregnancy wish who have a high risk on perinatal morbidity because of overweight or obesity. Half of the patients will receive the lifestyle intervention while the other half will receive usual care. It is hypothesized that an effective lifestyle intervention directed towards healthy living, including reduction of overweight or obesity and, if applicable, smoking reduction, health problems in mothers and their offspring can be prevented.
- Conditions
- Overweight, Obesity, Pregnancy Complications
- Being tested
- Lifestyle intervention
- Medical subject headings
- Overweight, Obesity, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle interventionBehavioural
The investigational treatment consists of a lifestyle intervention targeting on a healthy diet, physical activity and, if applicable, smoking cessation.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention is an integral and multidisciplinary lifestyle intervention consisting of a healthy diet, appropriate physical activity and, if applicable, smoking cessation, customised to the needs of the women. Receives: Behavioral: Lifestyle intervention |
| Control group | No intervention | The control group will receive usual care, including standard lifestyle advices during consultation with the GP, midwife, obstetrician or at the child well being centre. Furthermore, the control group will receive 1 recipe for a healthy meal per week. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in body weight
Measured: From baseline to 6 weeks postpartum
Secondary outcomes (42)
Gestational weight gain
Measured: 6 weeks of gestational age to 36 weeks of gestational age
Postpartum weight retention
Measured: 6 weeks of gestational age to 6 months postpartum
Smoking cessation
Measured: Baseline. Prepregnancy: after 1, 2, 3, 6, 9 and 12 months. During pregnancy: at 6,12,20,32,36 and 40 weeks of gestational age. Postpartum: at 6 weeks and at 3, 6, 9 and 12 months.
Biochemical verification of tobacco use
The amount of carbon monoxice (CO) in exhaled breath will be measured using a CO monitor (piCO Baby Smokerlyzer®, Bedfont, Kent, United Kingdom). Biochemical verification will also be done by measurement of urine cotinine.
Measured: Baseline. Prepregnancy: after 1, 2, 3, 6, 9 and 12 months. During pregnancy: at 6,12,20,32,36 and 40 weeks of gestational age. Postpartum: at 6 weeks and at 3, 6, 9 and 12 months.
Dietary habits
By a food diary and the three factor eating questionnaire.
Measured: Baseline. Prepregnancy: after 3 and 12 months. During pregnancy: at 6 and 32 weeks of gestational age. Postpartum: 3 and 12 months.
Physical activity habits
By an accelerometer and the Baecke questionnaire.
Measured: Baseline. Prepregnancy: after 3 and 12 months. During pregnancy: at 6 and 32 weeks of gestational age. Postpartum: 3 and 12 months.
Miscarriage
Measured: During pregnancy: at 6, 12 and 20 weeks of gestational age.
Time to pregnancy
Measured: From pregnancy wish to first day of last menstruation
Pregnancy complications
Gestational diabetes mellitus, pregnancy-induced hypertension, preeclampsia.
Measured: At birth
Delivery complications
Caesarean section, induction of labour, vacuum extraction, postpartum haemorrhage, maternal hospital stay, shoulder dystocia.
Measured: At birth
Vitamin D status
Measured: Will be measured at baseline and at 32 weeks of gestational age.
Dysmaturity and macrosomia
Measured: At birth
Prematurity
Birth before 37 weeks of gestational age
Measured: At birth
Fasting glucose level
Measured: Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.
Fasting insulin level
Measured: Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.
Insuline resistance (HOMA-IR)
Measured: Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.
Total cholesterol
Measured: Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.
LDL cholesterol
Measured: Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.
HDL cholesterol
Measured: Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.
Triglycerides
Measured: Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.
Free fatty acids
Measured: Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.
Alkaline phosphatase
Measured: Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.
Gamma-GT
Measured: Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.
ASAT
Measured: Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.
ALAT
Measured: Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.
Blood pressure
Measured: Will be measured at baseline; Prepregnancy: after 1, 2, 3, 6, 9 and 12 months; During pregnancy: at 6, 12, 20, 32, 36 and 40 weeks of gestational age; Postpartum: at 6 weeks and at 3, 6, 9 and 12 months.
Pulse wave velocity
Measured: Will be measured at baseline; Prepregnancy: after 3, 6 and 12 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: at 6 and 12 months.
Fat mass and fatt free mass
Body composition will be measured using the deuterium dilution method
Measured: Will be measured at baseline, at 32 weeks of gestational age during pregnancy and 6 months postpartum
Fasting glucose level of the child
Measured: At birth and 12 months postpartum
Fasting insulin level of the child
Measured: At birth and 12 months postpartum
Insulin resistance (HOMA-IR) of the child
Measured: At birth and 12 months postpartum
Total cholesterol of the child
Measured: At birth and 12 months postpartum
LDL cholesterol of the child
Measured: At birth and 12 months postpartum
HDL cholesterol of the child
Measured: At birth and 12 months postpartum
Triglycerides of the child
Measured: At birth and 12 months postpartum
Free fatty acids of the child
Measured: At birth and 12 months postpartum
Tidal volume of the child
Measured: Will be measured at 6 weeks and 12 months postpartum
Respiratory rate of the child
Measured: Will be measured at 6 weeks and 12 months postpartum
Respiratory system resistance of the child
Measured: Will be measured at 6 weeks and 12 months postpartum
Respiratory system reactance of the child
Measured: Will be measured at 6 weeks and 12 months postpartum
Endothelial vasodilatation of the child: Percentage change between baseline and maximum perfusion acetylcholine
Measured: Will be measured at 6 weeks and 3 and 12 months postpartum
Endothelial vasodilatation of the child: Percentage change between baseline and maximum perfusion nitroprusside
Measured: Will be measured at 6 weeks and 3 and 12 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2016 (estimated)
- Study start27 Jul 2016
- Primary completionDec 2023
- Study completion22 Apr 2024
Why it stopped: Inclusion was too slow, a lot of data loss during COVID pandemic
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 OverweightStudies 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
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anita Vreugdenhil, MD, PhD, Principal investigator, Maastricht UMCLuc Zimmermann, Prof, MD, Study chair, Maastricht UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02703753
- Sponsor's protocol ID
- METC152026
- Status last verified
- May 2024
- First submitted
- 25 Feb 2016
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Timmermans YEG, van de Kant KDG, Reijnders D, Kleijkers LMP, Dompeling E, Kramer BW, Zimmermann LJI, Steegers-Theunissen RPM, Spaanderman MEA, Vreugdenhil ACE. Towards Prepared mums (TOP-mums) for a healthy start, a lifestyle intervention for women with overweight and a child wish: study protocol for a randomised controlled trial in the Netherlands. BMJ Open. 2019 Nov 19;9(11):e030236. doi: 10.1136/bmjopen-2019-030236.
PubMed 31748290
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TOwards Prepared Mums (TOP-mums), for a Healthy Start: A Lifestyle Intervention to Reduce Overweight and Smoking in Women With a Pregnancy Wish to Prevent Perinatal Morbidity
- ClinicalTrials.gov ID
- NCT02703753
- Acronym / sponsor ID
- METC152026
- Conditions
- Overweight, Obesity, Pregnancy Complications
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inclusion was too slow, a lot of data loss during COVID pandemic
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 27 Jul 2016 (actual)
- Primary completion
- Dec 2023 (actual)
- Study completion
- 22 Apr 2024 (actual)
- First posted
- 9 Mar 2016 (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.
This study evaluates the effect of a lifestyle intervention for women with a pregnancy wish who have a high risk on perinatal morbidity because of overweight or obesity. Half of the patients will receive the lifestyle intervention while the other half will receive usual care. It is hypothesized that an effective lifestyle intervention directed towards healthy living, including reduction of overweight or obesity and, if applicable, smoking reduction, health problems in mothers and their offspring can be prevented.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Lifestyle interventionThe intervention is an integral and multidisciplinary lifestyle intervention consisting of a healthy diet, appropriate physical activity and, if applicable, smoking cessation, customised to the needs of the women. |
| Control group | No intervention | –The control group will receive usual care, including standard lifestyle advices during consultation with the GP, midwife, obstetrician or at the child well being centre. Furthermore, the control group will receive 1 recipe for a healthy meal per week. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women with a pregnancy wish within 1 year;
- Aged 18-40 years;
- Overweight/obesity (BMI ≥ 25 kg/m2).
Key exclusion criteria (6 listed)
- Haemodynamically significant heart disease;
- Restrictive lung disease;
- Congenital metabolic disease;
- Mentally retarded;
- Bariatric surgery;
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 |
|---|---|---|
| Lifestyle interventionThe investigational treatment consists of a lifestyle intervention targeting on a healthy diet, physical activity and, if applicable, smoking cessation. | Behavioural | Intervention group |
Primary outcome
Reduction in body weight
Time frame: From baseline to 6 weeks postpartum
42 secondary outcomes
Gestational weight gain
Time frame: 6 weeks of gestational age to 36 weeks of gestational age
Postpartum weight retention
Time frame: 6 weeks of gestational age to 6 months postpartum
Smoking cessation
Time frame: Baseline. Prepregnancy: after 1, 2, 3, 6, 9 and 12 months. During pregnancy: at 6,12,20,32,36 and 40 weeks of gestational age. Postpartum: at 6 weeks and at 3, 6, 9 and 12 months.
Biochemical verification of tobacco use
Time frame: Baseline. Prepregnancy: after 1, 2, 3, 6, 9 and 12 months. During pregnancy: at 6,12,20,32,36 and 40 weeks of gestational age. Postpartum: at 6 weeks and at 3, 6, 9 and 12 months.
Dietary habits
Time frame: Baseline. Prepregnancy: after 3 and 12 months. During pregnancy: at 6 and 32 weeks of gestational age. Postpartum: 3 and 12 months.
Physical activity habits
Time frame: Baseline. Prepregnancy: after 3 and 12 months. During pregnancy: at 6 and 32 weeks of gestational age. Postpartum: 3 and 12 months.
Miscarriage
Time frame: During pregnancy: at 6, 12 and 20 weeks of gestational age.
Time to pregnancy
Time frame: From pregnancy wish to first day of last menstruation
Pregnancy complications
Time frame: At birth
Delivery complications
Time frame: At birth
Vitamin D status
Time frame: Will be measured at baseline and at 32 weeks of gestational age.
Dysmaturity and macrosomia
Time frame: At birth
Prematurity
Time frame: At birth
Fasting glucose level
Time frame: Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.
Fasting insulin level
Time frame: Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.
Insuline resistance (HOMA-IR)
Time frame: Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.
Total cholesterol
Time frame: Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.
LDL cholesterol
Time frame: Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.
HDL cholesterol
Time frame: Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.
Triglycerides
Time frame: Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.
Free fatty acids
Time frame: Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.
Alkaline phosphatase
Time frame: Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.
Gamma-GT
Time frame: Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.
ASAT
Time frame: Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.
ALAT
Time frame: Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.
Blood pressure
Time frame: Will be measured at baseline; Prepregnancy: after 1, 2, 3, 6, 9 and 12 months; During pregnancy: at 6, 12, 20, 32, 36 and 40 weeks of gestational age; Postpartum: at 6 weeks and at 3, 6, 9 and 12 months.
Pulse wave velocity
Time frame: Will be measured at baseline; Prepregnancy: after 3, 6 and 12 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: at 6 and 12 months.
Fat mass and fatt free mass
Time frame: Will be measured at baseline, at 32 weeks of gestational age during pregnancy and 6 months postpartum
Fasting glucose level of the child
Time frame: At birth and 12 months postpartum
Fasting insulin level of the child
Time frame: At birth and 12 months postpartum
Insulin resistance (HOMA-IR) of the child
Time frame: At birth and 12 months postpartum
Total cholesterol of the child
Time frame: At birth and 12 months postpartum
LDL cholesterol of the child
Time frame: At birth and 12 months postpartum
HDL cholesterol of the child
Time frame: At birth and 12 months postpartum
Triglycerides of the child
Time frame: At birth and 12 months postpartum
Free fatty acids of the child
Time frame: At birth and 12 months postpartum
Tidal volume of the child
Time frame: Will be measured at 6 weeks and 12 months postpartum
Respiratory rate of the child
Time frame: Will be measured at 6 weeks and 12 months postpartum
Respiratory system resistance of the child
Time frame: Will be measured at 6 weeks and 12 months postpartum
Respiratory system reactance of the child
Time frame: Will be measured at 6 weeks and 12 months postpartum
Results and safety
The study was stopped early (reason given: Inclusion was too slow, a lot of data loss during COVID pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Derived from this study: PubMed 31748290Timmermans YEG, van de Kant KDG, Reijnders D, Kleijkers LMP, Dompeling E, Kramer BW, Zimmermann LJI, Steegers-Theunissen RPM, Spaanderman MEA, Vreugdenhil ACE. Towards Prepared mums (TOP-mums) for a healthy start, a lifestyle intervention for women with overweight and a child wish: study protocol for a randomised controlled trial in the Netherlands. BMJ Open. 2019 Nov 19;9(11):e030236. doi: 10.1136/bmjopen-2019-030236.
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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.
Anita Vreugdenhil, MD, PhD principal investigator
Maastricht UMC
Luc Zimmermann, Prof, MD study chair
Maastricht UMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle intervention in people with Overweight and Obesity, run by Maastricht University Medical Center at 1 site in Netherlands.
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 3 inclusion and 6 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: stopped early, as of the sponsor's last update on 10 May 2024. 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 Netherlands. 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 was stopped early (reason given: Inclusion was too slow, a lot of data loss during COVID pandemic). Results are not available in the source record.
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?
Reduction in body weight (time frame: From baseline to 6 weeks postpartum). 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 NCT02703753, 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 10 May 2024.