PregnancyPhase 4NCT01084941
Lifestyle Intervention to Limit Excessive Weight Gain During Pregnancy in Minority Women
A Phase 4 study testing Lifestyle Intervention group in people with Pregnancy and Weight Gain, run by Guillermo Umpierrez at 1 site in United States.
Trial summary
The prevalence of overweight and obesity is increasing among pregnant women in the United States. More than one-third of women of reproductive age in the US are overweight or obese, and two thirds of women gain more weight in pregnancy than is recommended by the Institute of Medicine guidelines. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Weight Gain
- What is being tested?
- Lifestyle Intervention group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Dec 2012
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Blacks and Hispanic
- women between 18-45 years of age;
- 2) overweight and obese (BMI > 25 kg/m2),
- 3) have a sedentary lifestyle (<30 minutes/day of moderate physical activity), and
- 4) prenatal care established at less than 20 weeks of gestation,
- 5) with a singleton pregnancy.
Who cannot join
- Women with 1) age < 18 or > 45 years,
- 2) > 20 weeks gestation,
- 3) history of diagnosis of type 2 diabetes, hypertension, cardiovascular disease, chronic renal disease, and active liver disease (AST > 3 ULN),
- 4) anemia (hemoglobin < 10 g, hematocrit < 32%);
- 5) current medications which adversely influence glucose tolerance (corticosteroids),
- 6) multiple pregnancy,
- 7) women not planning to continue pregnancy to term, 7) contraindications to participate in regular physical activity,
- 8) patients with mental conditions rendering them unable to understand the nature, scope, and possible consequences of the study
Trial locations and contacts
1 site in 1 country.
About this study
The prevalence of overweight and obesity is increasing among pregnant women in the United States. More than one-third of women of reproductive age in the US are overweight or obese, and two thirds of women gain more weight in pregnancy than is recommended by the Institute of Medicine guidelines. Maternal obesity during pregnancy increases the risk of complications to both mother and child. Minority women (Blacks and Hispanics) have higher rates of overweight and obesity when they become pregnant, experience higher rates of excessive weight gain during pregnancy, and experience higher rates of maternal and neonatal complications after adjusting for sociodemographic characteristics and comorbidities than Caucasian women. Epidemiologic studies indicate that lifestyle modification programs based on diet and exercise are promising approaches in controlling weight gain as well as in preventing type 2 diabetes in populations at risk. We hypothesize that overweight/obese minority women (Blacks and Hispanics) assigned to a culturally-grounded lifestyle intervention program based on diet and moderate exercise will result in higher compliance with Institute of Medicine guidelines for weight gain than women receiving standard care. Such lifestyle modifications should reduce risk of maternal and neonatal complications. We propose 1) to determine whether a lifestyle intervention program, based on diet and moderate physical activity implemented shortly after first recognition of pregnancy, will result in higher compliance with Institute of Medicine guidelines for weight gain compared to women receiving standard care; 2) to determine the occurrence of carbohydrate intolerance and GDM at 24-28 weeks gestation (after the first 10-12 weeks of intervention) and at 6 weeks postpartum between women in the lifestyle intervention group and women receiving standard care; and 3) to explore the impact of the lifestyle intervention on the development of maternal and fetal complications during pregnancy. By limiting excessive weight gain, the lifestyle intervention program may prevent the burden of obesity-related complications during pregnancy and reduce risk of subsequently developing overt diabetes.
- Conditions
- Pregnancy, Weight Gain
- Being tested
- Lifestyle Intervention group, Standard of Care
- Keywords
- pregnancy, weight gain, obesity, pregnancy and weight gain
- Medical subject headings
- Weight Gain, Obesity, Gestational Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle Intervention groupBehavioural
Women on the intervention group will participate in a lifestyle program based on diet and moderate physical activity implemented shortly after first recognition of pregnancy. These women will attend monthly nutrition and physical activity educational sessions, and receive booster every 2 weeks.
Standard of CareBehavioural
Patients randomized to the standard of care group will receive counseling routinely provided to all prenatal care women as recommended by the Institute of Medicine for appropriate nutrition and weight gain and ACOG guidelines for appropriate physical activity during pregnancy.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle intervention | Experimental | Women on the intervention group will participate in a lifestyle program based on diet and moderate physical activity implemented shortly after first recognition of pregnancy. These women will attend monthly nutrition and physical activity educational sessions, and receive booster every 2 weeks. Receives: Behavioral: Lifestyle Intervention group |
| Standard of care group | Active comparator | Patients randomized to the standard of care group will receive counseling routinely provided to all prenatal care women as recommended by the Institute of Medicine for appropriate nutrition and weight gain and ACOG guidelines for appropriate physical activity during pregnancy. Receives: Behavioral: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is whether a woman's weight gain follows the Institute of Medicine's recommendations for pregnancy weight gain.
Measured: 36 weeks
Secondary outcomes (2)
To compare the occurrence of carbohydrate intolerance and GDM at 24-28 weeks gestation and after delivery between women in the lifestyle intervention group and women receiving standard care.
Measured: 36 weeks
To explore the impact of the lifestyle intervention in preventing maternal and fetal complications between women in the lifestyle intervention group and women receiving standard care.
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2010 (estimated)
- Study startApr 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guillermo Umpierrez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Guillermo Umpierrez, Emory University
- Investigators
- Guillermo Umpierrez, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01084941
- Sponsor's protocol ID
- IRB00030742
- Status last verified
- Jul 2013
- First submitted
- 9 Mar 2010
- Last updated
- 21 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle Intervention to Limit Excessive Weight Gain During Pregnancy in Minority Women
- ClinicalTrials.gov ID
- NCT01084941
- Acronym / sponsor ID
- IRB00030742
- Conditions
- Pregnancy, Weight Gain
- Keywords
- pregnancy, weight gain, obesity, pregnancy and weight gain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Guillermo UmpierrezUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 11 Mar 2010 (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 prevalence of overweight and obesity is increasing among pregnant women in the United States. More than one-third of women of reproductive age in the US are overweight or obese, and two thirds of women gain more weight in pregnancy than is recommended by the Institute of Medicine guidelines. Maternal obesity during pregnancy increases the risk of complications to both mother and child. Minority women (Blacks and Hispanics) have higher rates of overweight and obesity when they become pregnant, experience higher rates of excessive weight gain during pregnancy, and experience higher rates of maternal and neonatal complications after adjusting for sociodemographic characteristics and comorbidities than Caucasian women. Epidemiologic studies indicate that lifestyle modification programs based on diet and exercise are promising approaches in controlling weight gain as well as in preventing type 2 diabetes in populations at risk. We hypothesize that overweight/obese minority women (Blacks and Hispanics) assigned to a culturally-grounded lifestyle intervention program based on diet and moderate exercise will result in higher compliance with Institute of Medicine guidelines for weight gain than women receiving standard care. Such lifestyle modifications should reduce risk of maternal and neonatal complications. We propose 1) to determine whether a lifestyle intervention program, based on diet and moderate physical activity implemented shortly after first recognition of pregnancy, will result in higher compliance with Institute of Medicine guidelines for weight gain compared to women receiving standard care; 2) to determine the occurrence of carbohydrate intolerance and GDM at 24-28 weeks gestation (after the first 10-12 weeks of intervention) and at 6 weeks postpartum between women in the lifestyle intervention group and women receiving standard care; and 3) to explore the impact of the lifestyle intervention on the development of maternal and fetal complications during pregnancy. By limiting excessive weight gain, the lifestyle intervention program may prevent the burden of obesity-related complications during pregnancy and reduce risk of subsequently developing overt diabetes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle intervention | Experimental | Behavioral: Lifestyle Intervention groupWomen on the intervention group will participate in a lifestyle program based on diet and moderate physical activity implemented shortly after first recognition of pregnancy. These women will attend monthly nutrition and physical activity educational sessions, and receive booster every 2 weeks. |
| Standard of care group | Active comparator | Behavioral: Standard of CarePatients randomized to the standard of care group will receive counseling routinely provided to all prenatal care women as recommended by the Institute of Medicine for appropriate nutrition and weight gain and ACOG guidelines for appropriate physical activity during pregnancy. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Blacks and Hispanic
- women between 18-45 years of age;
- 2) overweight and obese (BMI > 25 kg/m2),
- 3) have a sedentary lifestyle (<30 minutes/day of moderate physical activity), and
- 4) prenatal care established at less than 20 weeks of gestation,
Key exclusion criteria (8 listed)
- Women with 1) age < 18 or > 45 years,
- 2) > 20 weeks gestation,
- 3) history of diagnosis of type 2 diabetes, hypertension, cardiovascular disease, chronic renal disease, and active liver disease (AST > 3 ULN),
- 4) anemia (hemoglobin < 10 g, hematocrit < 32%);
- 5) current medications which adversely influence glucose tolerance (corticosteroids),
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 |
|---|---|---|
| Lifestyle Intervention groupWomen on the intervention group will participate in a lifestyle program based on diet and moderate physical activity implemented shortly after first recognition of pregnancy. These women will attend monthly nutrition and physical activity educational sessions, and receive booster every 2 weeks. | Behavioural | Lifestyle intervention |
| Standard of CarePatients randomized to the standard of care group will receive counseling routinely provided to all prenatal care women as recommended by the Institute of Medicine for appropriate nutrition and weight gain and ACOG guidelines for appropriate physical activity during pregnancy. | Behavioural | Standard of care group |
Primary outcome
The primary outcome is whether a woman's weight gain follows the Institute of Medicine's recommendations for pregnancy weight gain.
Time frame: 36 weeks
2 secondary outcomes
To compare the occurrence of carbohydrate intolerance and GDM at 24-28 weeks gestation and after delivery between women in the lifestyle intervention group and women receiving standard care.
Time frame: 36 weeks
To explore the impact of the lifestyle intervention in preventing maternal and fetal complications between women in the lifestyle intervention group and women receiving standard care.
Time frame: 36 weeks
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 Nov 2013.
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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.
Guillermo Umpierrez, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lifestyle Intervention group in people with Pregnancy and Weight Gain, run by Guillermo Umpierrez at 1 site 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 6 inclusion and 8 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 Nov 2013. 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The primary outcome is whether a woman's weight gain follows the Institute of Medicine's recommendations for pregnancy weight gain. (time frame: 36 weeks). 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 21 Nov 2013.