ObesityWEIGHTNCT02932202
Women Eating With Interactive Tracking to Gain Healthily Through Term Pregnancy Trial
A study testing Longitudinal Nutritional Counseling in people with Obesity and Pregnancy, run by Loyola University.
Trial summary
Obesity and excessive weight gain in pregnancy have significant associated maternal and fetal complications including gestational diabetes, large for gestational age infants, birth trauma, and stillbirth. 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
- Obesity, Pregnancy, Weight Gain
- What is being tested?
- Longitudinal Nutritional Counseling
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 8 Jul 2016to 17 May 2017
- 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
- Pregnancy identified less than 15 week 0 days gestational age
- Body mass index greater then or equal to 18
Who cannot join
- Multiple gestation
- Pre-pregnancy diabetes mellitus
- HIV
About this study
Official title: Women Eating With Interactive Tracking to Gain Healthily Through Term Pregnancy (WEIGHT) Trial
Obesity and excessive weight gain in pregnancy have significant associated maternal and fetal complications including gestational diabetes, large for gestational age infants, birth trauma, and stillbirth. The standard of care places the responsibility on the providers during prenatal visits to remind patients of their weight gain goals and provide appropriate counseling. The objective of this study is to evaluate a sustainable medical student-assisted longitudinal program of nutritional counseling and web based nutrition tracking for pregnant women on excessive weight gain during pregnancy and the effects on diet choices and fetal and maternal complications.
Read the detailed description
Obesity and excessive weight gain in pregnancy have significant associated maternal and fetal complications including gestational diabetes, large for gestational age infants, birth trauma, and stillbirth. The rates of obesity in American adults is 34.9% and the rates of excessive weight gain in pregnancy for all women range from 20-40% with even higher rates seen in the obese. Such high rates are putting mothers and infants at significant risk.· In 2009, the Institute of Medicine outlined clear guidelines for suggested weight gain goals based on pre-pregnancy BMI. Currently only 30-40% of pregnant women are meeting the suggested weight gain goals and the great majority not meeting the goals are gaining excessive weight. However, despite the high prevalence of excessive weight gain, there is little access to insurance covered nutrition counselling. The standard of care places the responsibility on the providers during prenatal visits to remind patients of their weight gain goals and provide appropriate counselling. This can be challenging due to limited time and resources. However, there is good evidence that diet intervention reduces the risk of excessive weight gain by up to 20%. If appropriate nutritional counselling were available to all patients, the rates of excessive weight gain could be significantly impacted and have widespread improvement in pregnancy outcomes. The CDC has made important progress in providing free nutrition resources online to all patients. This study aims to incorporate this free resource with a sustainable ongoing nutrition counselling to impact the rates of excessive weight gain in pregnancy.
The objective of this study is to evaluate a sustainable medical student-assisted longitudinal program of nutritional counseling and web based nutrition tracking for pregnant women on excessive weight gain during pregnancy and the effects on diet choices and fetal and maternal complications.
- Conditions
- Obesity, Pregnancy, Weight Gain
- Being tested
- Longitudinal Nutritional Counseling, Standard Care
- Keywords
- Obesity, Pregnancy, Weight Gain
- Medical subject headings
- Obesity, Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Longitudinal Nutritional CounselingOther
Standard CareOther
| Study group | Role | What they receive |
|---|---|---|
| Longitudinal Nutritional Counseling | Experimental | The intervention group will be contacted every 2 weeks by medical students over the phone to provide nutrition counseling and complete a verbal survey. During the phone calls, participants will be asked a series of questions regarding their dietary intake over the course of the last 2 weeks. If any deficiencies are identified, participants will be counseled on those topics Receives: Other: Longitudinal Nutritional Counseling |
| Standard Care Counseling | Placebo comparator | Participants in the control group will receive standard counseling, which includes weights at every visit, and counseling on weight gain goals as perceived necessary by the provider. Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of excessive weight gain
To compare the effect of a medical student assisted program of nutritional counseling and web based nutrition tracking to standard of care on the incidence of excessive weight gain in pregnancy based on the Institute of Medicine's guidelines.
Measured: At time of delivery
Secondary outcomes (2)
Healthy Eating Habits
To characterize how a medical student assisted program of nutritional counselling and web based nutrition tracking affects perception of healthy eating habits (e.g servings of dairy, vegetables, protein, healthy meals)
Measured: At time of delivery
Pregnancy Comorbidity
To compare the incidence of maternal outcomes including gestational diabetes, gestational hypertension and preeclampsia for patients receiving nutrition counselling and web based nutrition tracking compared to standard of care controls
Measured: At time of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study start8 Jul 2016
- Primary completion17 May 2017
- Study completion17 May 2017
Why it stopped: The trial was stopped due to no recruitment
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 ObesityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized to either a medical student assisted program comprising nutritional counselling and web based nutrition tracking methods (i.e., longitudinal nutritional counseling program) or routine follow-up with their primary healthcare specialist (standard of care) using a 1:1 random numbers block allocation
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loyola University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott Graziano, Loyola University
- Investigators
- Scott Graziano, MD, Principal investigator, Loyola University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02932202
- Sponsor's protocol ID
- 208756
- Acronym
- WEIGHT
- Status last verified
- May 2017
- First submitted
- 10 Oct 2016
- Last updated
- 1 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no individual participant data.
Publications
Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014 Feb 26;311(8):806-14. doi: 10.1001/jama.2014.732.
PubMed 24570244Asbee SM, Jenkins TR, Butler JR, White J, Elliot M, Rutledge A. Preventing excessive weight gain during pregnancy through dietary and lifestyle counseling: a randomized controlled trial. Obstet Gynecol. 2009 Feb;113(2 Pt 1):305-12. doi: 10.1097/AOG.0b013e318195baef.
PubMed 19155899
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Women Eating With Interactive Tracking to Gain Healthily Through Term Pregnancy (WEIGHT) Trial
- ClinicalTrials.gov ID
- NCT02932202
- Acronym / sponsor ID
- WEIGHT / 208756
- Conditions
- Obesity, Pregnancy, Weight Gain
- Keywords
- Obesity, Pregnancy, Weight Gain
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The trial was stopped due to no recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Loyola UniversityUniversity, hospital or other
- Study start
- 8 Jul 2016 (actual)
- Primary completion
- 17 May 2017 (actual)
- Study completion
- 17 May 2017 (actual)
- First posted
- 13 Oct 2016 (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.
Obesity and excessive weight gain in pregnancy have significant associated maternal and fetal complications including gestational diabetes, large for gestational age infants, birth trauma, and stillbirth. The standard of care places the responsibility on the providers during prenatal visits to remind patients of their weight gain goals and provide appropriate counseling. The objective of this study is to evaluate a sustainable medical student-assisted longitudinal program of nutritional counseling and web based nutrition tracking for pregnant women on excessive weight gain during pregnancy and the effects on diet choices and fetal and maternal complications.
Detailed description
Obesity and excessive weight gain in pregnancy have significant associated maternal and fetal complications including gestational diabetes, large for gestational age infants, birth trauma, and stillbirth. The rates of obesity in American adults is 34.9% and the rates of excessive weight gain in pregnancy for all women range from 20-40% with even higher rates seen in the obese. Such high rates are putting mothers and infants at significant risk.· In 2009, the Institute of Medicine outlined clear guidelines for suggested weight gain goals based on pre-pregnancy BMI. Currently only 30-40% of pregnant women are meeting the suggested weight gain goals and the great majority not meeting the goals are gaining excessive weight. However, despite the high prevalence of excessive weight gain, there is little access to insurance covered nutrition counselling. The standard of care places the responsibility on the providers during prenatal visits to remind patients of their weight gain goals and provide appropriate counselling. This can be challenging due to limited time and resources. However, there is good evidence that diet intervention reduces the risk of excessive weight gain by up to 20%. If appropriate nutritional counselling were available to all patients, the rates of excessive weight gain could be significantly impacted and have widespread improvement in pregnancy outcomes. The CDC has made important progress in providing free nutrition resources online to all patients. This study aims to incorporate this free resource with a sustainable ongoing nutrition counselling to impact the rates of excessive weight gain in pregnancy.
The objective of this study is to evaluate a sustainable medical student-assisted longitudinal program of nutritional counseling and web based nutrition tracking for pregnant women on excessive weight gain during pregnancy and the effects on diet choices and fetal and maternal complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomized to either a medical student assisted program comprising nutritional counselling and web based nutrition tracking methods (i.e., longitudinal nutritional counseling program) or routine follow-up with their primary healthcare specialist (standard of care) using a 1:1 random numbers block allocation
| Arm | Type | Receives |
|---|---|---|
| Longitudinal Nutritional Counseling | Experimental | Other: Longitudinal Nutritional CounselingThe intervention group will be contacted every 2 weeks by medical students over the phone to provide nutrition counseling and complete a verbal survey. During the phone calls, participants will be asked a series of questions regarding their dietary intake over the course of the last 2 weeks. If any deficiencies are identified, participants will be counseled on those topics |
| Standard Care Counseling | Placebo comparator | Other: Standard CareParticipants in the control group will receive standard counseling, which includes weights at every visit, and counseling on weight gain goals as perceived necessary by the provider. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Pregnancy identified less than 15 week 0 days gestational age
- Body mass index greater then or equal to 18
Key exclusion criteria (3 listed)
- Multiple gestation
- Pre-pregnancy diabetes mellitus
- HIV
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 |
|---|---|---|
| Longitudinal Nutritional Counseling | Other | Longitudinal Nutritional Counseling |
| Standard Care | Other | Standard Care Counseling |
Primary outcome
Incidence of excessive weight gain
Time frame: At time of delivery
To compare the effect of a medical student assisted program of nutritional counseling and web based nutrition tracking to standard of care on the incidence of excessive weight gain in pregnancy based on the Institute of Medicine's guidelines.
2 secondary outcomes
Healthy Eating Habits
Time frame: At time of delivery
Pregnancy Comorbidity
Time frame: At time of delivery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2017.
- Background: PubMed 24570244Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014 Feb 26;311(8):806-14. doi: 10.1001/jama.2014.732.
- Background: PubMed 19155899Asbee SM, Jenkins TR, Butler JR, White J, Elliot M, Rutledge A. Preventing excessive weight gain during pregnancy through dietary and lifestyle counseling: a randomized controlled trial. Obstet Gynecol. 2009 Feb;113(2 Pt 1):305-12. doi: 10.1097/AOG.0b013e318195baef.
- Individual participant dataSharing planned: No. There is no individual participant data.
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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.
Scott Graziano, MD principal investigator
Loyola University
Questions about this trial
What is this clinical trial studying?
A study testing Longitudinal Nutritional Counseling in people with Obesity and Pregnancy, run by Loyola University.
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 2 inclusion and 3 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: withdrawn, as of the sponsor's last update on 1 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Incidence of excessive weight gain (time frame: At time of delivery). 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 NCT02932202, 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 1 Jun 2017.