ObesityPhase 3NCT00647595
Effect of Physical Activity on Metabolic Syndrome in Pregnancy & Fetal Outcome
A Phase 3 study testing Experimental group in people with Obesity and Pregnancy, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
The purpose of this study is to examine the effect of exercise during pregnancy upon maternal metabolism, including weight gain, fat distribution, and levels of glucose and cholesterol. We will also conduct a pilot study to examine the feasibility of studying the health of infants born to women in this study. 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
- Obesity, Pregnancy, Diabetes Mellitus
- What is being tested?
- Experimental group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Dec 2008
- Phase
- Phase 3
- 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
- Pregnant women 18-45 years old receiving prenatal care at MAMC
Who cannot join
- Women do not have a gallbladder
- Who do not speak English
- Are over 14 weeks pregnant at study entry
- Do not plan to deliver at MAMC
- Have medical contraindications
- Unwilling to participate in exercise intervention program
- Are under 18 years of age
- Currently engaged in a regular vigorous exercise program
Trial locations and contacts
1 site in 1 country.
United States1 site
Madigan Army Medical Center
Joint Base Lewis McChord, Washington, 98431
About this study
The purpose of this study is to examine the effect of exercise during pregnancy upon maternal metabolism, including weight gain, fat distribution, and levels of glucose and cholesterol. We will also conduct a pilot study to examine the feasibility of studying the health of infants born to women in this study.
Read the detailed description
Obesity and overweight have become important public health problems in the United States, and measures are urgently needed to address these issues. For many women, pregnancy is a time of excessive weight gain and decreases in physical fitness, both of which may be followed by postpartum weight retention. Women who develop hypertension or diabetes mellitus during pregnancy are at higher risk for development of these disorders in the future. Because of the implications of pregnancy-related weight gain and the metabolic changes during pregnancy for future maternal health, interventions to maintain or improve fitness during pregnancy may have important downstream health effects. In addition, maternal metabolic parameters and the intra-uterine environment have important implications for neonatal outcomes and subsequent child health. This study will provide data about the effects of an intervention to increase vigorous physical activity during pregnancy on short-term maternal and fetal outcomes.
- Conditions
- Obesity, Pregnancy, Diabetes Mellitus
- Being tested
- Experimental group
- Keywords
- Obesity, Physical activity, Pregnancy, Diabetes mellitus
- Medical subject headings
- Obesity, Diabetes Mellitus, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental groupBehavioural
Intervention group will exercise 3 times per week at moderate-vigorous intensity for 45 minutes per session. Control group women will continue their usual physical activity throughout pregnancy.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Women in this group will exercise 3x per week at a moderate/vigorous level for 45 min per session through their 36 week of pregnancy. Receives: Behavioral: Experimental group |
| B | No intervention | Women in this group will continue their usual activities throughout their pregnancy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central adiposity
Measured: 6-8 weeks postpartum
Secondary outcomes (6)
Leptin levels
Measured: during pregnancy and postpartum
glucose
Measured: during pregnancy and postpartum
insulin
Measured: during pregnancy and postpartum
cholesterol
Measured: during pregnancy and postpartum
fetal adiposity
Measured: 35-36 weeks gestation
neonatal adiposity
Measured: birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2008 (estimated)
- Study startOct 2007
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Cynthia W Ko, MD MS, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00647595
- Sponsor's protocol ID
- R03 DK74683 (completed)
- Other IDs
- NIH # 1 R03 DK074683-01A1, R03DK074683
- Status last verified
- Feb 2010
- First submitted
- 27 Mar 2008
- Last updated
- 22 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Physical Activity on Metabolic Syndrome in Pregnancy & Fetal Outcome
- ClinicalTrials.gov ID
- NCT00647595
- Acronym / sponsor ID
- R03 DK74683 (completed)
- Conditions
- Obesity, Pregnancy, Diabetes Mellitus
- Keywords
- Obesity, Physical activity, Pregnancy, Diabetes mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- Oct 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 31 Mar 2008 (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 purpose of this study is to examine the effect of exercise during pregnancy upon maternal metabolism, including weight gain, fat distribution, and levels of glucose and cholesterol. We will also conduct a pilot study to examine the feasibility of studying the health of infants born to women in this study.
Detailed description
Obesity and overweight have become important public health problems in the United States, and measures are urgently needed to address these issues. For many women, pregnancy is a time of excessive weight gain and decreases in physical fitness, both of which may be followed by postpartum weight retention. Women who develop hypertension or diabetes mellitus during pregnancy are at higher risk for development of these disorders in the future. Because of the implications of pregnancy-related weight gain and the metabolic changes during pregnancy for future maternal health, interventions to maintain or improve fitness during pregnancy may have important downstream health effects. In addition, maternal metabolic parameters and the intra-uterine environment have important implications for neonatal outcomes and subsequent child health. This study will provide data about the effects of an intervention to increase vigorous physical activity during pregnancy on short-term maternal and fetal outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Behavioral: Experimental groupWomen in this group will exercise 3x per week at a moderate/vigorous level for 45 min per session through their 36 week of pregnancy. |
| B | No intervention | –Women in this group will continue their usual activities throughout their pregnancy. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Pregnant women 18-45 years old receiving prenatal care at MAMC
Key exclusion criteria (8 listed)
- Women do not have a gallbladder
- Who do not speak English
- Are over 14 weeks pregnant at study entry
- Do not plan to deliver at MAMC
- Have medical contraindications
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 |
|---|---|---|
| Experimental groupIntervention group will exercise 3 times per week at moderate-vigorous intensity for 45 minutes per session. Control group women will continue their usual physical activity throughout pregnancy. | Behavioural | A |
Primary outcome
Central adiposity
Time frame: 6-8 weeks postpartum
6 secondary outcomes
Leptin levels
Time frame: during pregnancy and postpartum
glucose
Time frame: during pregnancy and postpartum
insulin
Time frame: during pregnancy and postpartum
cholesterol
Time frame: during pregnancy and postpartum
fetal adiposity
Time frame: 35-36 weeks gestation
neonatal adiposity
Time frame: 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 22 Apr 2015.
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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.
Cynthia W Ko, MD MS principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Experimental group in people with Obesity and Pregnancy, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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 1 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 22 Apr 2015. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Central adiposity (time frame: 6-8 weeks postpartum). 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 22 Apr 2015.