OverweightNCT00364403
A Low Glycemic Load Diet During Pregnancy in Overweight Women
A study testing Low glycemic load and Low fat diet in people with Overweight and Pregnancy, run by Boston Children's Hospital at 2 sites in United States.
Trial summary
This study will compare the effects of a low glycemic load versus standard diet for pregnancy on outcomes related to risk for obesity, diabetes, and heart disease in both mother and infant. Read more about this study
- Who is it for?
- Ages 25 years and older, women only
- Conditions the study is for
- Overweight, Pregnancy
- What is being tested?
- Low glycemic load and Low fat diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2007to Feb 2010
- 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 25 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant women with prepregnant or first trimester BMI equal to or greater than 25 kg/m2 and less than 45 kg/m2
- Singleton pregnancy
- Willing to consume the diets for duration of pregnancy
- Participant to be at week 28 or less of pregnancy at baseline visit
Who cannot join
- Smoking during pregnancy
- Major medical illness (e.g., diabetes mellitus, hypertension, thyroid disease)
- Patients taking prescription medication known to affect body weight
- Alcohol consumption during pregnancy
- Patients who declare their intention to deliver infants in the environment outside of Beth Israel Deaconess Medical Center, Boston
- High level of physical activity
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Hospital Boston
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts
About this study
Official title: Glycemic Load and Infant Birth Weight in Pregnant Overweight/Obese Women
This study will compare the effects of a low glycemic load versus standard diet for pregnancy on outcomes related to risk for obesity, diabetes, and heart disease in both mother and infant.
- Conditions
- Overweight, Pregnancy
- Being tested
- Low glycemic load, Low fat diet
- Keywords
- Glycemic index, Glycemic load, Low fat, Impaired glucose tolerance, Large for gestational age infant, Excessive body weight
- Medical subject headings
- Overweight, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low glycemic loadBehavioural
Provision of foods and dietary counseling to promote a low glycemic load diet
Low fat dietBehavioural
Provision of foods and dietary counseling to promote a low fat diet
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Low glycemic load diet Receives: Behavioral: Low glycemic load |
| 2 | Active comparator | Low fat diet Receives: Behavioral: Low fat diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Birth weight as assessed by z-scores
Measured: At birth
Secondary outcomes (8)
Maternal energy intake
Measured: During pregnancy
Maternal weight gain
Measured: During pregnancy
Maternal insulin resistance assessed by HOMA
Measured: During pregnancy
Maternal metabolic syndrome components
Measured: During pregnancy
Infant body composition (ponderal index, skinfold thickness)
Measured: At birth
Cord blood glucose
Measured: At birth
cord blood insulin
Measured: At birth
cord blood leptin
Measured: At birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2006 (estimated)
- Study startFeb 2007
- Primary completionDec 2009
- Study completionFeb 2010
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 Boston Children's HospitalThe 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
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Thrasher Research Fund, Beth Israel Deaconess Medical Center
- Investigators
- David S Ludwig, MD, PhD, Principal investigator, Boston Children's HospitalErinn Rhodes, MD, Study director, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00364403
- Sponsor's protocol ID
- R03DK073335
- Other IDs
- R03DK073335
- Status last verified
- Aug 2010
- First submitted
- 14 Aug 2006
- Last updated
- 30 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rhodes ET, Pawlak DB, Takoudes TC, Ebbeling CB, Feldman HA, Lovesky MM, Cooke EA, Leidig MM, Ludwig DS. Effects of a low-glycemic load diet in overweight and obese pregnant women: a pilot randomized controlled trial. Am J Clin Nutr. 2010 Dec;92(6):1306-15. doi: 10.3945/ajcn.2010.30130. Epub 2010 Oct 20.
PubMed 20962162
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycemic Load and Infant Birth Weight in Pregnant Overweight/Obese Women
- ClinicalTrials.gov ID
- NCT00364403
- Acronym / sponsor ID
- R03DK073335
- Conditions
- Overweight, Pregnancy
- Keywords
- Glycemic index, Glycemic load, Low fat, Impaired glucose tolerance, Large for gestational age infant, Excessive body weight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Thrasher Research Fund, Beth Israel Deaconess Medical Center
- Study start
- Feb 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 15 Aug 2006 (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.
This study will compare the effects of a low glycemic load versus standard diet for pregnancy on outcomes related to risk for obesity, diabetes, and heart disease in both mother and infant.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Low glycemic loadLow glycemic load diet |
| 2 | Active comparator | Behavioral: Low fat dietLow fat diet |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pregnant women with prepregnant or first trimester BMI equal to or greater than 25 kg/m2 and less than 45 kg/m2
- Singleton pregnancy
- Willing to consume the diets for duration of pregnancy
- Participant to be at week 28 or less of pregnancy at baseline visit
Key exclusion criteria (6 listed)
- Smoking during pregnancy
- Major medical illness (e.g., diabetes mellitus, hypertension, thyroid disease)
- Patients taking prescription medication known to affect body weight
- Alcohol consumption during pregnancy
- Patients who declare their intention to deliver infants in the environment outside of Beth Israel Deaconess Medical Center, Boston
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 glycemic loadProvision of foods and dietary counseling to promote a low glycemic load diet | Behavioural | 1 |
| Low fat dietProvision of foods and dietary counseling to promote a low fat diet | Behavioural | 2 |
Primary outcome
Birth weight as assessed by z-scores
Time frame: At birth
8 secondary outcomes
Maternal energy intake
Time frame: During pregnancy
Maternal weight gain
Time frame: During pregnancy
Maternal insulin resistance assessed by HOMA
Time frame: During pregnancy
Maternal metabolic syndrome components
Time frame: During pregnancy
Infant body composition (ponderal index, skinfold thickness)
Time frame: At birth
Cord blood glucose
Time frame: At birth
cord blood insulin
Time frame: At birth
cord blood leptin
Time frame: At birth
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 30 Aug 2010.
- Derived from this study: PubMed 20962162Rhodes ET, Pawlak DB, Takoudes TC, Ebbeling CB, Feldman HA, Lovesky MM, Cooke EA, Leidig MM, Ludwig DS. Effects of a low-glycemic load diet in overweight and obese pregnant women: a pilot randomized controlled trial. Am J Clin Nutr. 2010 Dec;92(6):1306-15. doi: 10.3945/ajcn.2010.30130. Epub 2010 Oct 20.
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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.
David S Ludwig, MD, PhD principal investigator
Boston Children's Hospital
Erinn Rhodes, MD study director
Boston Children's Hospital
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 glycemic load and Low fat diet in people with Overweight and Pregnancy, run by Boston Children's Hospital at 2 sites in United States.
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 6 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 30 Aug 2010. 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 United States. 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?
Birth weight as assessed by z-scores (time frame: At birth). 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 NCT00364403, 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 30 Aug 2010.