OverweightNCT01628835
Low Glycemic Index (GI) Diet Management for Pregnant Woman With Overweight
A study testing Low dietary glycemic index diet and National recommendation diet in people with Overweight and Pregnant Women, run by Children's Hospital of Fudan University at 2 sites in China.
Trial summary
The study is a randomized, single-blinded, controlled intervention trial to compare the effect of a low glycemic index diet versus diet recommended by the Chinese Dietary Guide for Pregnant Women on maternal and neonatal insulin resistance and adverse gestational events. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Overweight, Pregnant Women
- What is being tested?
- Low dietary glycemic index diet and National recommendation diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesChina
- Study dates
- Jun 2012to Mar 2016
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Singleton pregnancy;
- Pregnant women with BMI≥24 kg/m2 at first antenatal examination;
- aged 18 years to 45 years;
- The week of first prenatal examination equal to or less than 12 weeks;
- Take routine prenatal examination;
- Willing and able to give informed consent. Exclusion
Show all 9Show fewer
- Artificial impregnation;
- History of hypertension, diabetes, coronary heart disease or mental disorder;
- With Special diet habit(e.g. vegetarianism/ veganism).
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Kunshan Maternal and Child Health Care Hospital
Kunshan, Jiangsu
International Peace Maternity and Child Care Centers of Communications University
Shanghai, 201102
About this study
Official title: Low Glycemic Index Diet Intervention on Insulin Resistance of Overweight Pregnant Women.
The study is a randomized, single-blinded, controlled intervention trial to compare the effect of a low glycemic index diet versus diet recommended by the Chinese Dietary Guide for Pregnant Women on maternal and neonatal insulin resistance and adverse gestational events.
Read the detailed description
Overweight in pregnant women increases maternal insulin resistance and risk of adverse pregnancy outcomes. Recent evidence from both animal studies and human subject studies shows that adverse environmental exposures during pregnancy result in adverse influence on offsprings. The hypothesis of the current study is that the healthy intervention during pregnancy to overweight pregnant women--low glycemic diet, may improve the maternal and neonatal insulin resistance at birth.
The current study adopts randomized, single-blinded, controlled intervention trial, gives low glycemic index diet intervention based on the national diet and physical activity recommendations for pregnant women to the intervention group and only national diet recommendations to the control group. Four diet consultation interviews will be done,at baseline (first prenatal examination), the end of the 1st trimester, the 2nd trimester and the 3rd trimester respectively, including diet assessment and diet consultation specifically to adopting low glycemic diet. Glycemic load of diet will be calculated based on 24 hour diet recall data for each individual at every visit to help to lower their diet glycemic load by modifying some daily foods. The effect of intervention is investigated by comparing the insulin resistance levels between the two arms at birth and when infants are at age 2. For discrete traits, such as incidence of gestational diabetes and gestational hypertension, Person's chi-square tests were used. For continuous traits, such as insulin resistance index, maternal weight gain and neonatal birth weight, we use t-tests for comparisons between two groups. The study expects that long-term low GI diet intervention have beneficial effects on controlling maternal and neonatal insulin resistance to overweight women and long term health.
- Conditions
- Overweight, Pregnant Women
- Being tested
- Low dietary glycemic index diet, National recommendation diet
- Keywords
- overweight, pregnancy, diet counselling, glycemic
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dietary glycemic index dietBehavioural
Based on the national diet and physical activity recommendations for pregnant women (total energy intake, protein and vitamin etc.), counseling for a low dietary glycemic index diet will be provided
National recommendation dietBehavioural
Also called recommended diet for pregnant women
Provision of food and dietary counseling according to the national prenatal nutrition recommendation without GI information
| Study group | Role | What they receive |
|---|---|---|
| Low dietary glycemic index diet | Experimental | Based on the national diet and physical activity recommendations for pregnant women (total energy intake, protein and vitamin etc.), counseling for a low dietary glycemic index diet will be provided. Receives: Behavioral: Low dietary glycemic index diet |
| National recommendation diet | Active comparator | Provision of food and dietary counseling according to the national prenatal nutrition recommendation without GI information Receives: Behavioral: National recommendation diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal insulin resistance
Measured: During pregnancy
Cord blood C-peptide
Measured: at delivery
Maternal weight gain
measured before delivery (minus pre-conceptual body weight)
Measured: measured before delivery
Incidence of gestational diabetes
from 1st antenatal visit to delivery
Measured: during pregnancy
Incidence of macrosomia
birth weight >= 4000g
Measured: at delivery
Secondary outcomes (6)
Incidence of gestational hypertension
proportion of patients with SBP/SBP>=140/90 for 3 visits
Measured: during pregnancy
Mean infant birth weight
Measured: at delivery
cesarean
Measured: at delivery
head circumference
Measured: at delivery
Mean gestational age
Measured: at delivery
Incidence of premature delivery
gestational age <37 week at delivery
Measured: at delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionFeb 2016
- Study completionMar 2016
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.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Kunshan City Maternal and Child Health, Shanghai Jiao Tong University School of Medicine
- Responsible party
- Principal investigator, Weili Yan, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01628835
- Sponsor's protocol ID
- version1.0
- Other IDs
- NSFC 81273168
- Status last verified
- Aug 2016
- First submitted
- 10 May 2012
- Last updated
- 24 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zhang Y, Wang L, Yang W, Niu D, Li C, Wang L, Gu P, Xia Y, Shen Y, Yan J, Zhao Q, Mu K, Yan W. Effectiveness of Low Glycemic Index Diet Consultations Through a Diet Glycemic Assessment App Tool on Maternal and Neonatal Insulin Resistance: A Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Apr 18;7(4):e12081. doi: 10.2196/12081.
PubMed 30998227
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Glycemic Index Diet Intervention on Insulin Resistance of Overweight Pregnant Women.
- ClinicalTrials.gov ID
- NCT01628835
- Acronym / sponsor ID
- version1.0
- Conditions
- Overweight, Pregnant Women
- Keywords
- overweight, pregnancy, diet counselling, glycemic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Collaborators
- Kunshan City Maternal and Child Health, Shanghai Jiao Tong University School of Medicine
- Study start
- Jun 2012
- Primary completion
- Feb 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 27 Jun 2012 (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.
The study is a randomized, single-blinded, controlled intervention trial to compare the effect of a low glycemic index diet versus diet recommended by the Chinese Dietary Guide for Pregnant Women on maternal and neonatal insulin resistance and adverse gestational events.
Detailed description
Overweight in pregnant women increases maternal insulin resistance and risk of adverse pregnancy outcomes. Recent evidence from both animal studies and human subject studies shows that adverse environmental exposures during pregnancy result in adverse influence on offsprings. The hypothesis of the current study is that the healthy intervention during pregnancy to overweight pregnant women--low glycemic diet, may improve the maternal and neonatal insulin resistance at birth.
The current study adopts randomized, single-blinded, controlled intervention trial, gives low glycemic index diet intervention based on the national diet and physical activity recommendations for pregnant women to the intervention group and only national diet recommendations to the control group. Four diet consultation interviews will be done,at baseline (first prenatal examination), the end of the 1st trimester, the 2nd trimester and the 3rd trimester respectively, including diet assessment and diet consultation specifically to adopting low glycemic diet. Glycemic load of diet will be calculated based on 24 hour diet recall data for each individual at every visit to help to lower their diet glycemic load by modifying some daily foods. The effect of intervention is investigated by comparing the insulin resistance levels between the two arms at birth and when infants are at age 2. For discrete traits, such as incidence of gestational diabetes and gestational hypertension, Person's chi-square tests were used. For continuous traits, such as insulin resistance index, maternal weight gain and neonatal birth weight, we use t-tests for comparisons between two groups. The study expects that long-term low GI diet intervention have beneficial effects on controlling maternal and neonatal insulin resistance to overweight women and long term health.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low dietary glycemic index diet | Experimental | Behavioral: Low dietary glycemic index dietBased on the national diet and physical activity recommendations for pregnant women (total energy intake, protein and vitamin etc.), counseling for a low dietary glycemic index diet will be provided. |
| National recommendation diet | Active comparator | Behavioral: National recommendation dietProvision of food and dietary counseling according to the national prenatal nutrition recommendation without GI information |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Singleton pregnancy;
- Pregnant women with BMI≥24 kg/m2 at first antenatal examination;
- aged 18 years to 45 years;
- The week of first prenatal examination equal to or less than 12 weeks;
- Take routine prenatal examination;
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Low dietary glycemic index dietBased on the national diet and physical activity recommendations for pregnant women (total energy intake, protein and vitamin etc.), counseling for a low dietary glycemic index diet will be provided | Behavioural | Low dietary glycemic index diet |
| National recommendation dietAlso: recommended diet for pregnant womenProvision of food and dietary counseling according to the national prenatal nutrition recommendation without GI information | Behavioural | National recommendation diet |
Primary outcome
Maternal insulin resistance
Time frame: During pregnancy
Cord blood C-peptide
Time frame: at delivery
Maternal weight gain
Time frame: measured before delivery
measured before delivery (minus pre-conceptual body weight)
Incidence of gestational diabetes
Time frame: during pregnancy
from 1st antenatal visit to delivery
Incidence of macrosomia
Time frame: at delivery
birth weight >= 4000g
6 secondary outcomes
Incidence of gestational hypertension
Time frame: during pregnancy
Mean infant birth weight
Time frame: at delivery
cesarean
Time frame: at delivery
head circumference
Time frame: at delivery
Mean gestational age
Time frame: at delivery
Incidence of premature delivery
Time frame: at 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 24 Aug 2016.
- Derived from this study: PubMed 30998227Zhang Y, Wang L, Yang W, Niu D, Li C, Wang L, Gu P, Xia Y, Shen Y, Yan J, Zhao Q, Mu K, Yan W. Effectiveness of Low Glycemic Index Diet Consultations Through a Diet Glycemic Assessment App Tool on Maternal and Neonatal Insulin Resistance: A Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Apr 18;7(4):e12081. doi: 10.2196/12081.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low dietary glycemic index diet and National recommendation diet in people with Overweight and Pregnant Women, run by Children's Hospital of Fudan University at 2 sites in China.
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 9 inclusion and 0 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 24 Aug 2016. 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 China. 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?
Maternal insulin resistance (time frame: During pregnancy). The study lists 5 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 NCT01628835, 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 24 Aug 2016.