Dietary HabitsNCT03191331
Dietary Intervention, Gestational Weight Gain and Gestational Diabetes.
A study testing Dietary intervention in people with Dietary Habits and Gestational Diabetes, run by University of Eastern Finland at 2 sites in Finland.
Trial summary
The aim of this pilot study is to conduct a dietary intervention for overweight (body maas index BMI≥25) and obese (BMI≥30) pregnant women in two maternity care clinics and explore the effect of the intervention on gestational weight gain and the prevalence of gestational diabetes between the intervention and control… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dietary Habits, Gestational Diabetes, Weight Gain
- What is being tested?
- Dietary intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 2 sitesFinland
- Study dates
- 6 Jun 2017to 1 Jun 2019
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age less than 35 years
- BMI 25 or over
- healthy, no chronic medical conditions
- singleton pregnancy
- first trimester of pregnancy at the time of recruitment
Who cannot join
- Age 35 and older
- BMI less than 25
- chronic medical conditions
- multiple pregnancy
- pregnancy at second or third trimester at the time of recruitment
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
Neulamäki antenatal care clinic
Kuopio
Pyörö antenatal care clinic
Kuopio
About this study
Official title: Intervention Study on Dietary Changes in Relation to Weight Gain and Prevalence of Gestational Diabetes During Pregnancy
The aim of this pilot study is to conduct a dietary intervention for overweight (body maas index BMI≥25) and obese (BMI≥30) pregnant women in two maternity care clinics and explore the effect of the intervention on gestational weight gain and the prevalence of gestational diabetes between the intervention and control groups.
Read the detailed description
Half of the women are allocated to the intervention group and another half for the control group. The intervention group will get written material of healthy diet during pregnancy as well as emphasized nutritional guidance given by public health nurses at each visit in the maternity care clinic. There will also be two group meetings with a dietitian. The control group will get the same written material, but otherwise basic care and guidance at each visit in the maternity care clinics. The collected data of both groups include the information on weight gain, the result of an oral glucose tolerance test and 4 day food records, Three factor eating questionnaire (TFEQ R-18) and Binge Eating Scale (BES).
- Being tested
- Dietary intervention
- Keywords
- dietary intervention, gestational weight gain, gestational diabetes, overweight, obesity
- Medical subject headings
- Feeding Behavior, Diabetes, Gestational, Weight Gain, Overweight, Obesity, Gestational Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary interventionBehavioural
Written material on healthy diet during pregnancy, dietary counseling at each maternity clinic visit given by public health nurse, group meeting with a dietician x2.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Dietary intervention. Intervention group will receive written material on healthy diet during pregnancy, nutritional guidance given by public health nurses at each maternity care clinic visit and group meeting with dietician x2. Receives: Behavioral: Dietary intervention |
| Control group | No intervention | The control group will receive written material on healthy diet during pregnancy, otherwise basic care and guidance at maternity care clinics. |
What is being measured
The primary outcome is the main question the study is designed to answer.
gestational weight gain (GWG)
gestational weight gain from 1st trimester of pregnancy until childbirth, measured at each maternity clinic visit
Measured: from first to third trimester of pregnancy, gestational weeks
Secondary outcomes (4)
gestational diabetes mellitus (GDM),
GDM is measured by the result of an oral glucose tolerance test (OGTT)
Measured: gestational weeks 12-16
eating habits
eating habits are measured by 4 day food records
Measured: 1st, 2nd and 3rd trimester of pregnancy, gestational weeks
eating habits
Eating habits are measured by TFEQ R-18 questionnaire
Measured: 1st, 2nd and 3rd trimester, gestational weeks
Eating habits
Eating habits are measured by Binge Eating Scale (BES)
Measured: 1st, 2nd and 3rd trimester, gestational weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study start6 Jun 2017
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary HabitsStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- intervention group and control group.
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Eastern Finland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reeta Lamminpää, University of Eastern Finland
- Investigators
- Reeta Lamminpää, PhD, Principal investigator, University of Eastern Finland, Department of Nursing Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03191331
- Sponsor's protocol ID
- Dietary intervention1619
- Status last verified
- Mar 2020
- First submitted
- 29 May 2017
- Last updated
- 27 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention Study on Dietary Changes in Relation to Weight Gain and Prevalence of Gestational Diabetes During Pregnancy
- ClinicalTrials.gov ID
- NCT03191331
- Acronym / sponsor ID
- Dietary intervention1619
- Keywords
- dietary intervention, gestational weight gain, gestational diabetes, overweight, obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of Eastern FinlandUniversity, hospital or other
- Study start
- 6 Jun 2017 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 19 Jun 2017 (actual)
- 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.
The aim of this pilot study is to conduct a dietary intervention for overweight (body maas index BMI≥25) and obese (BMI≥30) pregnant women in two maternity care clinics and explore the effect of the intervention on gestational weight gain and the prevalence of gestational diabetes between the intervention and control groups.
Detailed description
Half of the women are allocated to the intervention group and another half for the control group. The intervention group will get written material of healthy diet during pregnancy as well as emphasized nutritional guidance given by public health nurses at each visit in the maternity care clinic. There will also be two group meetings with a dietitian. The control group will get the same written material, but otherwise basic care and guidance at each visit in the maternity care clinics. The collected data of both groups include the information on weight gain, the result of an oral glucose tolerance test and 4 day food records, Three factor eating questionnaire (TFEQ R-18) and Binge Eating Scale (BES).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- intervention group and control group.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Dietary interventionDietary intervention. Intervention group will receive written material on healthy diet during pregnancy, nutritional guidance given by public health nurses at each maternity care clinic visit and group meeting with dietician x2. |
| Control group | No intervention | –The control group will receive written material on healthy diet during pregnancy, otherwise basic care and guidance at maternity care clinics. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age less than 35 years
- BMI 25 or over
- healthy, no chronic medical conditions
- singleton pregnancy
- first trimester of pregnancy at the time of recruitment
Key exclusion criteria (5 listed)
- Age 35 and older
- BMI less than 25
- chronic medical conditions
- multiple pregnancy
- pregnancy at second or third trimester at the time of recruitment
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 |
|---|---|---|
| Dietary interventionWritten material on healthy diet during pregnancy, dietary counseling at each maternity clinic visit given by public health nurse, group meeting with a dietician x2. | Behavioural | Intervention group |
Primary outcome
gestational weight gain (GWG)
Time frame: from first to third trimester of pregnancy, gestational weeks
gestational weight gain from 1st trimester of pregnancy until childbirth, measured at each maternity clinic visit
4 secondary outcomes
gestational diabetes mellitus (GDM),
Time frame: gestational weeks 12-16
eating habits
Time frame: 1st, 2nd and 3rd trimester of pregnancy, gestational weeks
eating habits
Time frame: 1st, 2nd and 3rd trimester, gestational weeks
Eating habits
Time frame: 1st, 2nd and 3rd trimester, gestational weeks
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 27 Mar 2020.
- Individual participant dataSharing planned: No
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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.
Reeta Lamminpää, PhD principal investigator
University of Eastern Finland, Department of Nursing Science
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary intervention in people with Dietary Habits and Gestational Diabetes, run by University of Eastern Finland at 2 sites in Finland.
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 5 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 27 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. 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?
gestational weight gain (GWG) (time frame: from first to third trimester of pregnancy, gestational weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2020.