Pregnancy-Related Condition, UnspecifiedSLIMNCT04826861
Supporting Lifestyle Change in Obese Pregnant Mothers Through Wearable Internet-of-Things (SLIM)
A study testing SLIM intervention in people with Pregnancy-Related Condition, Unspecified and Overweight or Obesity, run by University of Turku at 1 site in Finland.
Trial summary
Maternal obesity increases risks for the mother and her child. It is crucial to arouse the pregnant and postpartum women´s willingness of change and motivation to take care of their own and their unborn child´s health. Wearable devices can be helpful for weight-management, e.g. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Pregnancy-Related Condition, Unspecified, Overweight or Obesity
- What is being tested?
- SLIM intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteFinland
- Study dates
- 1 Apr 2021to 15 May 2023
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- pregnancy maximum 15 gestational weeks
- BMI >25
- finnish language
Who cannot join
- women who don´t have smart device
- severe mental illness (such as schizophrenia)
- diabetes mellitus type 1
- limitation of motility
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Implementation of Supporting Lifestyle Change in Obese Pregnant Mothers Through Wearable Internet-of-Things (SLIM) Intervention
Maternal obesity increases risks for the mother and her child. It is crucial to arouse the pregnant and postpartum women´s willingness of change and motivation to take care of their own and their unborn child´s health. Wearable devices can be helpful for weight-management, e.g. in improving participant's self-efficacy in making healthy behavior changes, improving self-awareness, in goal setting and getting feedback. More comprehensive research is required to implement the optimal weight-management intervention for overweight women during pregnancy and the postpartum period and to develop appropriate and feasible implementation strategies to support nurses to deliver interventions in maternity clinics.
The aim of this study is to evaluate the effectiveness of the Supporting Lifestyle Change in Obese Pregnant Mothers Through Wearable Internet-of-Things (SLIM) intervention. Secondary aim is to evaluate the implementation of SLIM intervention in maternity care.
Read more
Intervention was developed based on findings of overweight women and their care givers interview study. The intervention targeting overweight pregnant women to improve their weight-management will be delivered during routine perinatal visits from the first visit to three months after child birth. Interventions core components will be goalsetting, motivational interviewing, feedback and health technology. Health technology includes Oura-ring and ZotCare -application. ZotCare -application combines data from Oura Smart Ring, electronic food diary and it´s also platform for researchers to send e.g. questionnaires and surveys to participants. Oura-smartring is an advanced technology ring that monitors e.g. heart rate, heart rate variability (HRV), steps, body temperature and sleep) and a smartphone application that includes data from Oura, and electronic food diary. Data collected with Oura -smartrings will be transmitted to cloud servers via a smartphone. The cloud will be responsible for storing the data and for performing the data preprocessing and analysis methods. Interventions primary outcome will be self-efficacy. Secondary outcomes will be womens weight, depression symptoms, quality of life, pregnancy anxiety, perceived stress, sence of coherence and acceptability, appropriateness and feasibility of Intervention.
Data will be collected via Oura smartring, electronic food diary and validated measures: Weight Efficacy Life-Style Questionnaire (WEL), Self-Efficacy for Physical Activity Scale (PASE), six-factor questionnaire (6-FQ), Three Factor Eating Questionnaire (TFEQ-R18), WHOQOL-BREF, Sense of coherence (SOC-13), Pregnancy anxiety (PRAQ-R2), Perceived stress and Edinburgh Postnatal Depression scale (EPDS). Intervention implementation will be evaluated with process evaluation. Data will be collected from public health nurses working in maternity clinics using focus group interviews and workshops.
Read the detailed description
Maternal obesity increases risks for the mother and her child. It is crucial to arouse the pregnant and postpartum women´s willingness of change and motivation to take care of their own and their unborn child´s health. Researchers have suggested that refining the pre-existing prenatal care models, possibly incorporating diet and physical activity into interventions, could be useful. Continuous monitoring can provide real-time information between scheduled appointments and thus may be helpful for targeting and tailoring pregnancy follow-up. Wearable devices can be helpful for weight-management, e.g. in improving participant's self-efficacy in making healthy behavior changes, improving self-awareness, in goal setting and getting feedback. However, it's very important to identify and tailor the intervention into individual motivations in order to facilitate technology adoption. Technological solutions designed for the pregnant women, can balance the gap between limited resources and growing demand of maternity care service. More comprehensive research is required to implement the optimal weight-management intervention for overweight women during pregnancy and the postpartum period and to develop appropriate and feasible implementation strategies to support nurses to deliver interventions in maternity clinics.
The aim of this study is to evaluate the effectiveness of the Supporting Lifestyle Change in Obese Pregnant Mothers Through Wearable Internet-of-Things (SLIM) intervention. Secondary aim is to evaluate the implementation of SLIM intervention in maternity care.
Intervention was developed based on findings of overweight women and their care givers interview study. In addition, intervention was planned in collaboration with public health nurses working in maternity clinics in workshops. The intervention targeting overweight pregnant women to improve their weight-management will be delivered during routine perinatal visits from the first visit to three months after child birth. Interventions core components will be goalsetting, motivational interviewing, feedback and health technology. Health technology includes Oura-ring and ZotCare -application. ZotCare -application combines data from Oura Smart Ring, electronic food diary and it´s also platform for researchers to send e.g. questionnaires and surveys to participants. Oura-smartring is an advanced technology ring that monitors e.g. heart rate, heart rate variability (HRV), steps, body temperature and sleep) and a smartphone application that includes data from Oura, and electronic food diary. Data collected with Oura -smartrings will be transmitted to cloud servers via a smartphone. The cloud will be responsible for storing the data and for performing the data preprocessing and analysis methods. Interventions primary outcome will be self-efficacy. Secondary outcomes will be womens weight, depression symptoms, quality of life and sence of coherence.
Data will be collected via Oura smartring, electronic food diary and validated measures: Weight Efficacy Life-Style Questionnaire (WEL), Self-Efficacy for Physical Activity Scale (PASE), six-factor questionnaire (6-FQ), Three Factor Eating Questionnaire (TFEQ-R18), WHOQOL-BREF, Sense of coherence (SOC-13), Pregnancy anxiety (PRAQ-R2), Perceived stress and Edinburgh Postnatal Depression scale (EPDS). Intervention implementation will be evaluated with process evaluation. Interventions acceptability, appropriateness and feasibility will be assessed with validated measures: Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM). Data will be collected from public health nurses working in maternity clinics using focus group interviews and workshops.
- Being tested
- SLIM intervention
- Keywords
- Pregnancy, Overweight, Obesity, Wearable Electronic Devices, Technology, Internet-Based Intervention
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SLIM interventionBehavioural
Core components: 1) goal setting, 2) motivational interviewing, 3) feedback, 4) health technology
| Study group | Role | What they receive |
|---|---|---|
| Intervention for overweight pregnant women | Other | Intervention will be delivered during antenatal visits in maternity care Receives: Behavioral: SLIM intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of eating self-efficacy of overweight women
Validated measurement tool:
Weight Efficacy Life-Style Questionnaire (WEL) The 20-item questionnaire asks participants to rate their confidence in their ability to avoid eating on a 10-point Likert scale, 0 (not confident) to 9 (very confident). Scores range from 0 to 180 with higher scores indicating greater levels of self-efficacy.
Measured: Change from first trimester Self-efficacy at third trimester and further at two months after delivery
Change of physical activity self-efficacy of overweight women
Validated measurement tool:
Self-Efficacy for Physical Activity Scale (PASE). The 5-item questionnaire asks participants to rate their confidence in their ability to regular physical activity on a 5-point Likert scale, 1 (not confident) to 5 (very confident). Scores range from 5 to 25 with higher scores indicating greater levels of self-efficacy.
Measured: Change from first trimester Self-efficacy at third trimester and further at two months after delivery
Secondary outcomes (7)
Weight during pregnancy and after delivery
Measurement: Womens weight (patient records)
Measured: Through study completion, an average of 11 to 12 months.
Change of depression symptoms of overweight women
Validated measurement tool:
Perceived stress and Edinburgh Postnatal Depression scale (EPDS). The 10-item questionnaire asks participants to rate their depression symptoms on a 4-point Likert scale. Scores range from 0 to 30 with higher scores indicating greater levels of depression.
Measured: From first trimester depression symptoms at third trimester and further at two months after delivery
Change of overweight womens quality of life
Validated measurement tool:
WHO quality of life (WHOQOL-BREF). The 26-item questionnaire asks participants to rate their quality of life on a 5-point Likert scale, 1 to 5. Scores range from 0 to 100 with higher scores indicating better quality of life.
Measured: Change from first trimester quality of life at third trimester and further at two months after delivery
Change of overweight womens sense of coherence
Validated measurement tool:
Sense of coherence (SOC-13).
The 13-item questionnaire asks participants to rate their sence of coherence on a 7-point Likert scale, 1 to 7. Higher scores indicate better sence of coherence.
Measured: Change from first trimester sence of coherence at third trimester and further at two months after delivery
Change of pregnancy anxiety.
Validated tool:
Pregnancy anxiety questionnaire-revised for all pregnant women regardless of parity:(PRAQ-R2) The 10-item questionnaire asks participants to rate their pregnancy anxiety on a 5-point Likert scale, 1 to 5. Higher scores indicate higher pregnancy anxiety.
Measured: Change from first trimester anxiety at third trimester and further at two months after delivery
Change of perceived stress
Validated tool: A global measure of perceived stress (original versions). The 10-item questionnaire asks participants to rate their pregnancy anxiety on a 5-point Likert scale, 1 to 5. Higher scores indicate higher perceived stress.
Measured: Change from first trimester perceived stress at third trimester and further at two months after delivery
Interventions acceptability, appropriateness and feasibility
Validated measures: Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM) and Feasibility of Intervention Measure (FIM).
The 15-item questionnaire asks participants to rate interventions acceptability, appropriateness and feasibility on a 5-point Likert scale, 1 to 5. Higher scores indicate higher acceptability, appropriateness and feasibility.
Measured: At gestational week 20, 34 and three months after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start1 Apr 2021
- Primary completion15 May 2023
- Study completion15 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pregnancy-Related Condition, UnspecifiedStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hannakaisa Niela-Vilen, University of Turku
- Investigators
- Hannakaisa Niela-vilen, PhD, Principal investigator, University of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04826861
- Sponsor's protocol ID
- SLIM
- Acronym
- SLIM
- Status last verified
- Sep 2023
- First submitted
- 17 Mar 2021
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Saarikko J, Axelin A, Huvinen E, Rahmani AM, Kolari T, Niela-Vilen H. Effectiveness of supporting lifestyle change in pregnant mothers with obesity through the wearable internet-of-things (SLIM) -intervention on self-efficacy in weight management in pregnant women: A quasi-experimental trial. Midwifery. 2025 Jan;140:104235. doi: 10.1016/j.midw.2024.104235. Epub 2024 Nov 9.
PubMed 39549539Saarikko J, Axelin A, Huvinen E, Rahmani AM, Azimi I, Pasanen M, Niela-Vilen H. Supporting lifestyle change in obese pregnant mothers through the wearable internet-of-things (SLIM) -intervention for overweight pregnant women: Study protocol for a quasi-experimental trial. PLoS One. 2023 Jan 19;18(1):e0279696. doi: 10.1371/journal.pone.0279696. eCollection 2023.
PubMed 36656819
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Implementation of Supporting Lifestyle Change in Obese Pregnant Mothers Through Wearable Internet-of-Things (SLIM) Intervention
- ClinicalTrials.gov ID
- NCT04826861
- Acronym / sponsor ID
- SLIM / SLIM
- Keywords
- Pregnancy, Overweight, Obesity, Wearable Electronic Devices, Technology, Internet-Based Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Collaborators
- University of California, Irvine, Helsinki University Central Hospital
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 1 Apr 2021 (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.
Maternal obesity increases risks for the mother and her child. It is crucial to arouse the pregnant and postpartum women´s willingness of change and motivation to take care of their own and their unborn child´s health. Wearable devices can be helpful for weight-management, e.g. in improving participant's self-efficacy in making healthy behavior changes, improving self-awareness, in goal setting and getting feedback. More comprehensive research is required to implement the optimal weight-management intervention for overweight women during pregnancy and the postpartum period and to develop appropriate and feasible implementation strategies to support nurses to deliver interventions in maternity clinics.
The aim of this study is to evaluate the effectiveness of the Supporting Lifestyle Change in Obese Pregnant Mothers Through Wearable Internet-of-Things (SLIM) intervention. Secondary aim is to evaluate the implementation of SLIM intervention in maternity care.
Intervention was developed based on findings of overweight women and their care givers interview study. The intervention targeting overweight pregnant women to improve their weight-management will be delivered during routine perinatal visits from the first visit to three months after child birth. Interventions core components will be goalsetting, motivational interviewing, feedback and health technology. Health technology includes Oura-ring and ZotCare -application. ZotCare -application combines data from Oura Smart Ring, electronic food diary and it´s also platform for researchers to send e.g. questionnaires and surveys to participants. Oura-smartring is an advanced technology ring that monitors e.g. heart rate, heart rate variability (HRV), steps, body temperature and sleep) and a smartphone application that includes data from Oura, and electronic food diary. Data collected with Oura -smartrings will be transmitted to cloud servers via a smartphone. The cloud will be responsible for storing the data and for performing the data preprocessing and analysis methods. Interventions primary outcome will be self-efficacy. Secondary outcomes will be womens weight, depression symptoms, quality of life, pregnancy anxiety, perceived stress, sence of coherence and acceptability, appropriateness and feasibility of Intervention.
Data will be collected via Oura smartring, electronic food diary and validated measures: Weight Efficacy Life-Style Questionnaire (WEL), Self-Efficacy for Physical Activity Scale (PASE), six-factor questionnaire (6-FQ), Three Factor Eating Questionnaire (TFEQ-R18), WHOQOL-BREF, Sense of coherence (SOC-13), Pregnancy anxiety (PRAQ-R2), Perceived stress and Edinburgh Postnatal Depression scale (EPDS). Intervention implementation will be evaluated with process evaluation. Data will be collected from public health nurses working in maternity clinics using focus group interviews and workshops.
Detailed description
Maternal obesity increases risks for the mother and her child. It is crucial to arouse the pregnant and postpartum women´s willingness of change and motivation to take care of their own and their unborn child´s health. Researchers have suggested that refining the pre-existing prenatal care models, possibly incorporating diet and physical activity into interventions, could be useful. Continuous monitoring can provide real-time information between scheduled appointments and thus may be helpful for targeting and tailoring pregnancy follow-up. Wearable devices can be helpful for weight-management, e.g. in improving participant's self-efficacy in making healthy behavior changes, improving self-awareness, in goal setting and getting feedback. However, it's very important to identify and tailor the intervention into individual motivations in order to facilitate technology adoption. Technological solutions designed for the pregnant women, can balance the gap between limited resources and growing demand of maternity care service. More comprehensive research is required to implement the optimal weight-management intervention for overweight women during pregnancy and the postpartum period and to develop appropriate and feasible implementation strategies to support nurses to deliver interventions in maternity clinics.
The aim of this study is to evaluate the effectiveness of the Supporting Lifestyle Change in Obese Pregnant Mothers Through Wearable Internet-of-Things (SLIM) intervention. Secondary aim is to evaluate the implementation of SLIM intervention in maternity care.
Intervention was developed based on findings of overweight women and their care givers interview study. In addition, intervention was planned in collaboration with public health nurses working in maternity clinics in workshops. The intervention targeting overweight pregnant women to improve their weight-management will be delivered during routine perinatal visits from the first visit to three months after child birth. Interventions core components will be goalsetting, motivational interviewing, feedback and health technology. Health technology includes Oura-ring and ZotCare -application. ZotCare -application combines data from Oura Smart Ring, electronic food diary and it´s also platform for researchers to send e.g. questionnaires and surveys to participants. Oura-smartring is an advanced technology ring that monitors e.g. heart rate, heart rate variability (HRV), steps, body temperature and sleep) and a smartphone application that includes data from Oura, and electronic food diary. Data collected with Oura -smartrings will be transmitted to cloud servers via a smartphone. The cloud will be responsible for storing the data and for performing the data preprocessing and analysis methods. Interventions primary outcome will be self-efficacy. Secondary outcomes will be womens weight, depression symptoms, quality of life and sence of coherence.
Data will be collected via Oura smartring, electronic food diary and validated measures: Weight Efficacy Life-Style Questionnaire (WEL), Self-Efficacy for Physical Activity Scale (PASE), six-factor questionnaire (6-FQ), Three Factor Eating Questionnaire (TFEQ-R18), WHOQOL-BREF, Sense of coherence (SOC-13), Pregnancy anxiety (PRAQ-R2), Perceived stress and Edinburgh Postnatal Depression scale (EPDS). Intervention implementation will be evaluated with process evaluation. Interventions acceptability, appropriateness and feasibility will be assessed with validated measures: Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM). Data will be collected from public health nurses working in maternity clinics using focus group interviews and workshops.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention for overweight pregnant women | Other | Behavioral: SLIM interventionIntervention will be delivered during antenatal visits in maternity care |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- pregnancy maximum 15 gestational weeks
- BMI >25
- finnish language
Key exclusion criteria (4 listed)
- women who don´t have smart device
- severe mental illness (such as schizophrenia)
- diabetes mellitus type 1
- limitation of motility
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 |
|---|---|---|
| SLIM interventionCore components: 1) goal setting, 2) motivational interviewing, 3) feedback, 4) health technology | Behavioural | Intervention for overweight pregnant women |
Primary outcome
Change of eating self-efficacy of overweight women
Time frame: Change from first trimester Self-efficacy at third trimester and further at two months after delivery
Validated measurement tool: Weight Efficacy Life-Style Questionnaire (WEL) The 20-item questionnaire asks participants to rate their confidence in their ability to avoid eating on a 10-point Likert scale, 0 (not confident) to 9 (very confident). Scores range from 0 to 180 with higher scores indicating greater levels of self-efficacy.
Change of physical activity self-efficacy of overweight women
Time frame: Change from first trimester Self-efficacy at third trimester and further at two months after delivery
Validated measurement tool: Self-Efficacy for Physical Activity Scale (PASE). The 5-item questionnaire asks participants to rate their confidence in their ability to regular physical activity on a 5-point Likert scale, 1 (not confident) to 5 (very confident). Scores range from 5 to 25 with higher scores indicating greater levels of self-efficacy.
7 secondary outcomes
Weight during pregnancy and after delivery
Time frame: Through study completion, an average of 11 to 12 months.
Change of depression symptoms of overweight women
Time frame: From first trimester depression symptoms at third trimester and further at two months after delivery
Change of overweight womens quality of life
Time frame: Change from first trimester quality of life at third trimester and further at two months after delivery
Change of overweight womens sense of coherence
Time frame: Change from first trimester sence of coherence at third trimester and further at two months after delivery
Change of pregnancy anxiety.
Time frame: Change from first trimester anxiety at third trimester and further at two months after delivery
Change of perceived stress
Time frame: Change from first trimester perceived stress at third trimester and further at two months after delivery
Interventions acceptability, appropriateness and feasibility
Time frame: At gestational week 20, 34 and three months after delivery
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 21 Sep 2023.
- Derived from this study: PubMed 39549539Saarikko J, Axelin A, Huvinen E, Rahmani AM, Kolari T, Niela-Vilen H. Effectiveness of supporting lifestyle change in pregnant mothers with obesity through the wearable internet-of-things (SLIM) -intervention on self-efficacy in weight management in pregnant women: A quasi-experimental trial. Midwifery. 2025 Jan;140:104235. doi: 10.1016/j.midw.2024.104235. Epub 2024 Nov 9.
- Derived from this study: PubMed 36656819Saarikko J, Axelin A, Huvinen E, Rahmani AM, Azimi I, Pasanen M, Niela-Vilen H. Supporting lifestyle change in obese pregnant mothers through the wearable internet-of-things (SLIM) -intervention for overweight pregnant women: Study protocol for a quasi-experimental trial. PLoS One. 2023 Jan 19;18(1):e0279696. doi: 10.1371/journal.pone.0279696. eCollection 2023.
- Individual participant dataSharing planned: Undecided
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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.
Hannakaisa Niela-vilen, PhD principal investigator
University of Turku
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SLIM intervention in people with Pregnancy-Related Condition, Unspecified and Overweight or Obesity, run by University of Turku at 1 site 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 3 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 21 Sep 2023. 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 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?
Change of eating self-efficacy of overweight women (time frame: Change from first trimester Self-efficacy at third trimester and further at two months after delivery). The study lists 2 primary outcomes in all. 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 NCT04826861, which also lists 2 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 21 Sep 2023.