Dietary HabitsIDDPNCT04690907
Intervention, Dietary, Diabetes, Pregnancy
A study testing Dietary intervention in people with Dietary Habits and Obesity, run by University of Eastern Finland at 2 sites in Finland.
Trial summary
The aim of this rct -study is to explore the effect of a dietary intervention for overweight (body maas index BMI≥25) and obese (BMI≥30) pregnant women on gestational weight gain and the prevalence of gestational diabetes. 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
- Dietary Habits, Obesity, Gestational Diabetes
- 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
- 33 participants
- Where
- 2 sitesFinland
- Study dates
- 3 Dec 2020to 31 Dec 2022
- 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
- BMI 25 or higher
- healthy, no chronic medical conditions that can prevent participating to the study
- singleton pregnancy
- first trimester of pregnancy at the time of recruitment
Who cannot join
- 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
Antenatal maternity care clinics (n=6)
Joensuu
Antenatal maternity care clinics (n=12)
Kuopio
About this study
Official title: Dietary Intervention for Obese Pregnant Women - a Randomized Controlled Trial
The aim of this rct -study is to explore the effect of a dietary intervention for overweight (body maas index BMI≥25) and obese (BMI≥30) pregnant women on gestational weight gain and the prevalence of gestational diabetes.
Read the detailed description
Pregnant women are recruited for the study from 18 maternity care clinics in Northern Savo and Northern Karelia area. The participants will be randomized into intervention and control groups. All the participants will have access to the study web-pages, which includes written material of healthy diet during pregnancy as well as all the study material (4 day food records, Three factor eating questionnaire (TFEQ R-18) and Binge Eating Scale (BES)). In addition, intervention group will get two virtual dietary counseling sessions by a dietician. The information on participants' gestational weight gain and the result of oral glucose tolerance tests will be collected by the public health nurses after birth.
- Conditions
- Dietary Habits, Obesity, Gestational Diabetes, Gestational Weight Gain
- Being tested
- Dietary intervention
- Medical subject headings
- Feeding Behavior, Obesity, Diabetes, Gestational, 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 and 2 virtual dietary counseling sessions.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Dietary intervention: Written material on healthy diet during pregnancy, 2 virtual dietary counseling sessions given by a dietician. Otherwise basic care and counseling at maternity care clinics. Receives: Behavioral: Dietary intervention |
| Control group | No intervention | Written material on healthy diet during pregnancy, otherwise basic care and counseling 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 pre-pregnancy weight until childbirth), measured at maternity care clinic.
Measured: immediately after the intervention
Secondary outcomes (4)
Gestational diabetes mellitus (GDM)
GDM is measured by the result of an oral glucose tolerance test (OGTT)
Measured: immediately after the intervention
Eating habits I
eating habits are measured by 4 day food records
Measured: During the intervention up to gestational weeks 36-37
Eating habits II
Eating habits are measured by TFEQ R-18 questionnaire
Measured: During the intervention up to gestational weeks 37-42
Eating habits III
Eating habits are measured by Binge Eating Scale (BES)
Measured: During the intervention up to gestational weeks 37-42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start3 Dec 2020
- Primary completion31 Oct 2022
- Study completion31 Dec 2022
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention group and control group.
- Masking
- None (open label)
- Enrolment
- 33 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, Principal investigator, University of Eastern Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04690907
- Sponsor's protocol ID
- 031220
- Acronym
- IDDP
- Status last verified
- Nov 2023
- First submitted
- 3 Dec 2020
- Last updated
- 29 Nov 2023
- 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 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Intervention for Obese Pregnant Women - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04690907
- Acronym / sponsor ID
- IDDP / 031220
- Conditions
- Dietary Habits, Obesity, Gestational Diabetes, Gestational Weight Gain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of Eastern FinlandUniversity, hospital or other
- Study start
- 3 Dec 2020 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 31 Dec 2020 (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 rct -study is to explore the effect of a dietary intervention for overweight (body maas index BMI≥25) and obese (BMI≥30) pregnant women on gestational weight gain and the prevalence of gestational diabetes.
Detailed description
Pregnant women are recruited for the study from 18 maternity care clinics in Northern Savo and Northern Karelia area. The participants will be randomized into intervention and control groups. All the participants will have access to the study web-pages, which includes written material of healthy diet during pregnancy as well as all the study material (4 day food records, Three factor eating questionnaire (TFEQ R-18) and Binge Eating Scale (BES)). In addition, intervention group will get two virtual dietary counseling sessions by a dietician. The information on participants' gestational weight gain and the result of oral glucose tolerance tests will be collected by the public health nurses after birth.
Study design
- Primary purpose
- Prevention
- Allocation
- 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: Written material on healthy diet during pregnancy, 2 virtual dietary counseling sessions given by a dietician. Otherwise basic care and counseling at maternity care clinics. |
| Control group | No intervention | –Written material on healthy diet during pregnancy, otherwise basic care and counseling at maternity care clinics. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- BMI 25 or higher
- healthy, no chronic medical conditions that can prevent participating to the study
- singleton pregnancy
- first trimester of pregnancy at the time of recruitment
Key exclusion criteria (4 listed)
- 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 and 2 virtual dietary counseling sessions. | Behavioural | Intervention group |
Primary outcome
Gestational weight gain (GWG)
Time frame: immediately after the intervention
gestational weight gain (from pre-pregnancy weight until childbirth), measured at maternity care clinic.
4 secondary outcomes
Gestational diabetes mellitus (GDM)
Time frame: immediately after the intervention
Eating habits I
Time frame: During the intervention up to gestational weeks 36-37
Eating habits II
Time frame: During the intervention up to gestational weeks 37-42
Eating habits III
Time frame: During the intervention up to gestational weeks 37-42
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 29 Nov 2023.
- 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 principal investigator
University of Eastern Finland
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 Obesity, 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 4 inclusion and 4 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 29 Nov 2023. 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: immediately after the intervention). 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 29 Nov 2023.