Gestational Weight GainGLOWNCT07635628
Motivational Interviewing on Diet, Lifestyle and Gestational Weight Gain of Pregnant Women
A study testing Motivational Interview (MI) in people with Gestational Weight Gain, run by IRCCS Burlo Garofolo at 1 site in Italy.
Trial summary
It is widely recognized that nutrition, metabolism and physical activity during pregnancy play a central role in several aspects of the health and well-being of pregnant women and their offspring. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Weight Gain
- What is being tested?
- Motivational Interview (MI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 1 siteItaly
- Study dates
- 23 Apr 2025to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant women >=18 years, accessing hospital for the first scheduled ultrasound scan at 11-13 weeks of gestation and who express the intention of giving birth in the recruiting hospital
Who cannot join
- gestational age at enrollment > 15 weeks
- preexisting type 1 diabetes
- multiple pregnancy
- insufficient knowledge of the Italian language.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"
Trieste, 34137
About this study
Official title: Effectiveness on Gestational Weight Gain of Pregnant Women of Motivational Interviewing on Diet and Lifestyle: a Randomized Controlled Trial
It is widely recognized that nutrition, metabolism and physical activity during pregnancy play a central role in several aspects of the health and well-being of pregnant women and their offspring. Pre-pregnancy Body Mass Index (BMI) and Gestational Weight Gain (GWG) are important predictors of maternal and neonatal health outcomes. In particular, excessive maternal pre-pregnancy BMI (BMI ≥ 25) and GWG outside the range recommended by the Institute of Medicine (IOM), may put mothers at risk of complications during pregnancy and delivery and can affect the short and long-term health of the offspring. They are also predicting factors of postpartum weight retention and long-term risk of offspring overweight or higher BMI. Similarly to obesity, also maternal pre-pregnancy underweight can cause negative health effects with short and long-term consequences for the mother and the foetus.
The most recent scientific evidence acknowledges the complex interplay between factors that influence the nutritional status and GWG of pregnant women, suggesting the need for multifaceted interventions that include counselling approaches, implemented during routine antenatal care for broad public health benefits. In particular, interventions based on health-related behavioural changes such as motivational interviewing (MI), used to address motivation, self-efficacy and self-regulation, have shown to have high chances of success. MI is a person-centred technique for communication that is effective for overcoming ambivalence and eliciting motivation for change.
The starting hypothesis is that inadequate GWG at the end of pregnancy may bear some relation with dietary habits and lifestyle before and during pregnancy and that MI might be effective in initiating and sustaining behavioural changes, including weight control. The study will compare a group of pregnant women, randomly assigned to receive, as part of the hospital-based prenatal care program, a behavioral intervention based on the MI methodology focused on dietary habits and lifestyle, with a group of women randomly assigned to the standard prenatal care program. It is expected that the dietary habits of women in the MI group will change as a result of the intervention, and that the resulting effective management of weight gain during pregnancy will contribute to improved maternal and neonatal outcomes.
- Conditions
- Gestational Weight Gain
- Being tested
- Motivational Interview (MI)
- Keywords
- Motivational interview, Gestational Weight Gain, Pregnancy, Lifestyle intervention
- Medical subject headings
- Gestational Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Interview (MI)Behavioural
The four MI sessions, centered on eating habits, physical activity and lifestyle behaviours, will be led by a multidisciplinary group of health professionals - dieticians/nutritionists/ expert in motor sciences/psychologist - trained by a psychologist with expertise in MI. During the motivational sessions, personal barriers to behavioural change will be explored and positive verbal reinforcement will be given to increase self-confidence and self-efficacy. Women will be asked to identify the lifestyle behaviours they need to change and to set small stepwise goals based on their own intention to achieve a healthier lifestyle. Weight will be measured and GWG monitored at each of the four sessions.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group (EG) | Experimental | In addition to usual antenatal care (UC), the Experimental Group (EG) will receive four prenatal MI sessions between 11 and 15 weeks of gestation (T1), between 18 and 22 weeks (T2), between 24 and 28 weeks (T3), and between 30 and 34 weeks (T4). Receives: Behavioral: Motivational Interview (MI) |
| Control Group (CG) | No intervention | The Control Group (CG) will only receive the usual antenatal care (UC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Women With Adequate Gestational Weight Gain According to Institute of Medicine Guidelines
Gestational weight gain will be calculated as maternal weight at delivery minus self-reported pre-pregnancy weight. Adequate gestational weight gain will be defined according to the Institute of Medicine guidelines, based on pre-pregnancy body mass index category. The outcome will be reported as the percentage of women with gestational weight gain within the recommended range:
number of women with adequate gestational weight gain / total number of women assessed x100
Measured: At delivery
Secondary outcomes (11)
Gestational age at delivery
Gestational age at delivery will be calculated in completed weeks of gestation, based on the first day of the last menstrual period and/or obstetric dating. The outcome will be reported as a continuous variable.
Measured: At delivery
Mode of delivery
Mode of delivery will be categorized as spontaneous vaginal delivery, assisted vaginal delivery by vacuum or forceps, or cesarean delivery. The outcome will be reported as the number and percentage of women in each category.
Measured: At delivery
Newborn birth weight
Newborn birth weight will be measured in grams and abstracted from the delivery or neonatal medical record. The outcome will be reported as a continuous variable
Measured: within 30 minute after birth
Newborn birth length
Newborn birth length will be measured in centimeters and abstracted from the delivery or neonatal medical record. The outcome will be reported as a continuous variable
Measured: within 30 minute after birth
Apgar Score at 1 Minute After Birth
Neonatal well-being will be assessed using the Apgar score at 1 minute after birth. The Apgar score ranges from 0 to 10, with higher scores indicating better neonatal condition. The outcome will be reported as a score or, if pre-specified, as the number and percentage of newborns with Apgar score less than 7
Measured: 1 minutes after birth
Apgar Score at 5 Minute After Birth
Neonatal well-being will be assessed using the Apgar score at 5 minute after birth. The Apgar score ranges from 0 to 10, with higher scores indicating better neonatal condition. The outcome will be reported as a score or, if pre-specified, as the number and percentage of newborns with Apgar score less than 7
Measured: 5 minutes after birth
Exclusive breastfeeding at Hospital Discharge
Exclusive breastfeeding at hospital discharge will be defined as the newborn receiving only breast milk, with no formula or other liquids/foods, except medications or vitamin/mineral supplements if applicable. The outcome will be reported as the percentage of mother-newborn dyads with exclusive breastfeeding at discharge.
Measured: At hospital discharge, expected within 2-5 days after delivery
Change in Dietary Behaviours from Baseline to 34 Weeks of Gestation
Differences in consumption frequency by food group. To evaluate consumption frequency a validated self-reported food frequency questionnaire will be used Dietary behaviours will be assessed using a validated self-reported food frequency questionnaire. Dietary behaviours changes will be evaluated within and between groups and compared with the national dietary recommendations. The outcome will be reported as the change from baseline to 34 weeks of gestation.
Measured: Baseline and 34 weeks of gestation
Gestational Weight Gain at 18-22 Weeks of Gestation
Gestational weight gain at 18-22 weeks of gestation will be calculated as maternal weight measured between 18 weeks 0 days and 22 weeks 6 days of gestation minus self-reported pre-pregnancy weight. The outcome will be reported in kilograms
Measured: 18 weeks 0 days to 22 weeks 6 days of gestation
Gestational Weight Gain at 24-28 Weeks of Gestation
Gestational weight gain at 24-28 weeks of gestation will be calculated as maternal weight measured between 24 weeks 0 days and 28 weeks 6 days of gestation minus self-reported pre-pregnancy weight. The outcome will be reported in kilograms
Measured: 24 weeks 0 days to 28 weeks 6 days of gestation.
Gestational Weight Gain at 30-34 Weeks of Gestation
Gestational weight gain at 30-34 weeks of gestation will be calculated as maternal weight measured between 30 weeks 0 days and 34 weeks 6 days of gestation minus self-reported pre-pregnancy weight. The outcome will be reported in kilograms
Measured: 30 weeks 0 days to 34 weeks 6 days of gestation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start23 Apr 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Weight GainStudies 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
- Randomized controlled open-label superiority trial
- Masking
- None (open label)
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Burlo Garofolo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paola Pani, PhD, Principal investigator, Institute for Maternal and Child Health IRCCS Burlo Garofolo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07635628
- Sponsor's protocol ID
- RC 07/24
- Acronym
- GLOW
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness on Gestational Weight Gain of Pregnant Women of Motivational Interviewing on Diet and Lifestyle: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07635628
- Acronym / sponsor ID
- GLOW / RC 07/24
- Conditions
- Gestational Weight Gain
- Keywords
- Motivational interview, Gestational Weight Gain, Pregnancy, Lifestyle intervention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 228 participants (actual)
- Lead sponsor
- IRCCS Burlo GarofoloUniversity, hospital or other
- Study start
- 23 Apr 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 9 Jun 2026 (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.
It is widely recognized that nutrition, metabolism and physical activity during pregnancy play a central role in several aspects of the health and well-being of pregnant women and their offspring. Pre-pregnancy Body Mass Index (BMI) and Gestational Weight Gain (GWG) are important predictors of maternal and neonatal health outcomes. In particular, excessive maternal pre-pregnancy BMI (BMI ≥ 25) and GWG outside the range recommended by the Institute of Medicine (IOM), may put mothers at risk of complications during pregnancy and delivery and can affect the short and long-term health of the offspring. They are also predicting factors of postpartum weight retention and long-term risk of offspring overweight or higher BMI. Similarly to obesity, also maternal pre-pregnancy underweight can cause negative health effects with short and long-term consequences for the mother and the foetus.
The most recent scientific evidence acknowledges the complex interplay between factors that influence the nutritional status and GWG of pregnant women, suggesting the need for multifaceted interventions that include counselling approaches, implemented during routine antenatal care for broad public health benefits. In particular, interventions based on health-related behavioural changes such as motivational interviewing (MI), used to address motivation, self-efficacy and self-regulation, have shown to have high chances of success. MI is a person-centred technique for communication that is effective for overcoming ambivalence and eliciting motivation for change.
The starting hypothesis is that inadequate GWG at the end of pregnancy may bear some relation with dietary habits and lifestyle before and during pregnancy and that MI might be effective in initiating and sustaining behavioural changes, including weight control. The study will compare a group of pregnant women, randomly assigned to receive, as part of the hospital-based prenatal care program, a behavioral intervention based on the MI methodology focused on dietary habits and lifestyle, with a group of women randomly assigned to the standard prenatal care program. It is expected that the dietary habits of women in the MI group will change as a result of the intervention, and that the resulting effective management of weight gain during pregnancy will contribute to improved maternal and neonatal outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled open-label superiority trial
| Arm | Type | Receives |
|---|---|---|
| Experimental Group (EG) | Experimental | Behavioral: Motivational Interview (MI)In addition to usual antenatal care (UC), the Experimental Group (EG) will receive four prenatal MI sessions between 11 and 15 weeks of gestation (T1), between 18 and 22 weeks (T2), between 24 and 28 weeks (T3), and between 30 and 34 weeks (T4). |
| Control Group (CG) | No intervention | –The Control Group (CG) will only receive the usual antenatal care (UC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pregnant women >=18 years, accessing hospital for the first scheduled ultrasound scan at 11-13 weeks of gestation and who express the intention of giving birth in the recruiting hospital
Key exclusion criteria (4 listed)
- gestational age at enrollment > 15 weeks
- preexisting type 1 diabetes
- multiple pregnancy
- insufficient knowledge of the Italian language.
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 |
|---|---|---|
| Motivational Interview (MI)The four MI sessions, centered on eating habits, physical activity and lifestyle behaviours, will be led by a multidisciplinary group of health professionals - dieticians/nutritionists/ expert in motor sciences/psychologist - trained by a psychologist with expertise in MI. During the motivational sessions, personal barriers to behavioural change will be explored and positive verbal reinforcement will be given to increase self-confidence and self-efficacy. Women will be asked to identify the lifestyle behaviours they need to change and to set small stepwise goals based on their own intention to achieve a healthier lifestyle. Weight will be measured and GWG monitored at each of the four sessions. | Behavioural | Experimental Group (EG) |
Primary outcome
Percentage of Women With Adequate Gestational Weight Gain According to Institute of Medicine Guidelines
Time frame: At delivery
Gestational weight gain will be calculated as maternal weight at delivery minus self-reported pre-pregnancy weight. Adequate gestational weight gain will be defined according to the Institute of Medicine guidelines, based on pre-pregnancy body mass index category. The outcome will be reported as the percentage of women with gestational weight gain within the recommended range: number of women with adequate gestational weight gain / total number of women assessed x100
11 secondary outcomes
Gestational age at delivery
Time frame: At delivery
Mode of delivery
Time frame: At delivery
Newborn birth weight
Time frame: within 30 minute after birth
Newborn birth length
Time frame: within 30 minute after birth
Apgar Score at 1 Minute After Birth
Time frame: 1 minutes after birth
Apgar Score at 5 Minute After Birth
Time frame: 5 minutes after birth
Exclusive breastfeeding at Hospital Discharge
Time frame: At hospital discharge, expected within 2-5 days after delivery
Change in Dietary Behaviours from Baseline to 34 Weeks of Gestation
Time frame: Baseline and 34 weeks of gestation
Gestational Weight Gain at 18-22 Weeks of Gestation
Time frame: 18 weeks 0 days to 22 weeks 6 days of gestation
Gestational Weight Gain at 24-28 Weeks of Gestation
Time frame: 24 weeks 0 days to 28 weeks 6 days of gestation.
Gestational Weight Gain at 30-34 Weeks of Gestation
Time frame: 30 weeks 0 days to 34 weeks 6 days of gestation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
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Excessive Gestational Weight Gain, Pregnancy
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Mother and Offspring's Nutritional Status -Pregnancy After Maternal Bariatric Surgery
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Time-restricted Eating Among Pregnant Females With Severe Obesity
Obesity, Morbid, Time Restricted Eating
Recruiting
Continuous Glucose and E-Monitoring to Support Healthy Weight Gain in Pregnancies - The GEM Study
Pregnancies at Increased Risk for Excessive Gestational Weight Gain, Ecological Momentary Assessment and Intervention
Not yet recruiting
Healthy Adaptation to Pregnancy, Postpartum and Parenthood
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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.
Paola Pani, PhD principal investigator
Institute for Maternal and Child Health IRCCS Burlo Garofolo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interview (MI) in people with Gestational Weight Gain, run by IRCCS Burlo Garofolo at 1 site in Italy.
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 1 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: under way, not looking for participants, as of the sponsor's last update on 10 Jun 2026. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
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?
Percentage of Women With Adequate Gestational Weight Gain According to Institute of Medicine Guidelines (time frame: At delivery). 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 10 Jun 2026.