ObesityNCT04025268
Development of a Group Prenatal Care Intervention to Address Maternal and Child Non-Communicable Disease (NCD) Risk in American Samoa
A study testing Group Prenatal Care (GPNC) in people with Obesity, run by Yale University.
Trial summary
To test the efficacy of a group prenatal care intervention to reduce the risk of obesity related health conditions during and after pregnancy in obese mothers and their infants. 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
- What is being tested?
- Group Prenatal Care (GPNC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2016to 30 Jun 2019
- 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
- ≥18 years of age. We will exclude younger pregnant women because adolescents may still be experiencing their own growth and development, which would be a source of confounding for our study outcomes.
- Self-reported Samoan ethnicity. Based on all four grandparents (of the participant) being reported as Samoa. Other ethnic groups make up approximately 2% of the American Samoan population but we are specifically interested in determining the efficacy of this intervention fro Samoan women, who have considerably poorer health outcomes in this setting.
- English speaking. The intervention will be delivered primarily in English, as is usual for standard prenatal care in this setting, with some Samoan language likely to be used in group discussions. Take home materials will be provided in both English and Samoan.
- Planning to reside in American Samoa for the duration of pregnancy and until at least 6 weeks postpartum. Some women travel from the neighboring country of Samoa (Independent/Western Samoa) to receive prenatal care at LBJTMC. These women will be excluded based on the need to receive all intervention sessions and a postpartum follow up.
- Singleton, viable pregnancy. A twin pregnancy reduced to singleton before 140 weeks by project gestational age is acceptable. An ultrasound must be conducted before randomization that shows a fetal heartbeat; there must be no evidence of more than one fetus on the most recent pre-randomization ultrasound. Including multiple pregnancies would confound study outcomes.
- Completed LBJTMC prenatal care enrollment visit. Participants must have enrolled in standard prenatal care and received a standard of care physical exam, ultrasound, confirmation of pregnancy dating, pregnancy history, and preliminary gestational diabetes screen to ensure that no pregnancy health-based exclusion criteria (see below) are met. Participants must obtain written documentation from their provider of this visit, and permission from them to participate in the GPNC study.
- Gestational age at randomization no earlier than 11 weeks 0 days and no later than 14 weeks 0 days based on an algorithm that compares the last menstrual period date and data from the enrollment ultrasound. This will ensure that each participant is exposed to the intervention for the same amount of time.
- Body mass index ≥ 26kg/m2 based on measured weight at enrollment and on measured height. The earliest weight measurement before randomization, measured specifically for the study will be used. A BMI cutpoint of 26 kg/m2 is used in line with the usual upward-adjusted criteria for overweight in populations of Polynesian descent.
Who cannot join
- Age less than 18 years because of the potential for growth during pregnancy and the need for participant informed consent.
- Diagnosis of diabetes prior to pregnancy or an HbA1C ≥ 6.5% or other glucose tolerance test result suggestive of pre-pregnancy diabetes. All potential participants will have HbA1C or an alternative test performed prior to randomization at their standard prenatal care enrollment visit.
- Gestational diabetes or preeclampsia in a previous pregnancy
- Known fetal anomaly/pregnancy health condition known to require specialist monitoring/treatment
- Planned termination of pregnancy
- Past history of anorexia or bulimia by medical history or patient report. Binge eating disorder (BED) is not an exclusion criterion.
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- Current eating disorder diagnosed by a clinician
- Prior bariatric surgery
- Current use of one or more of the following medications:
- Metformin
- Systemic steroids
- Antipsychotic agents (e.g. Abilify, Haldol, Risperdal, Seroquel, Zyprexa)
- Anti-seizure medications or mood stabilizers that would be expected to have a significant impact on body weight (e.g Depakote, Lamictal, Lithium, Neurontin, Tegretol, Topamax, Keppra)
- Medications for Attention Deficit Hyperactivity Disorder (ADHD) including amphetamines and methylphenidate
- Continued use of weight loss medication including Over The Counter (OTC) and dietary supplements for weight loss (e.g. Adipex, Suprenza, Tenuate, Xenical, Alli, conjugated linoleic acid, Hoodia, Green tea extract, Guar gum, Hydroxycut, Sensa, Corti-Slim, Chromium, Chitosan, Bitter Orange)
- Contraindications to aerobic exercise in pregnancy specified by the American College of Obstetrics and Gynocology (ACOG) committee Opinion #267, 2002 (re-affirmed 2009)
- Participation in another interventional study that influences weight control
- Participants unwillingness or inability to commit to a six-week postpartum follow up of herself or her child, including planning to move away
- Untreated medical or psychiatric condition (e.g. depression, bipolar disorder) that could impede study participation
- Hospitalization for hyperemesis
About this study
To test the efficacy of a group prenatal care intervention to reduce the risk of obesity related health conditions during and after pregnancy in obese mothers and their infants.
Read the detailed description
The purpose of this study is to test the feasibility, acceptability, and preliminary efficacy of a group prenatal care (GPNC) intervention designed to reduce the risk for obesity related health conditions during and after pregnancy in overweight/obese mothers and their infants in American Samoa.
- Conditions
- Obesity
- Being tested
- Group Prenatal Care (GPNC), Standard of Care
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Prenatal Care (GPNC)Behavioural
GPNC participants will attend 11 group sessions total: 10 during pregnancy and one postpartum. Each session will be 90-100 minutes long. Groups will collectively identify the preferred time of day for these sessions. Groups of 10 women will be led by a locally trained, Samoan nurse-midwife with the study Project Director as a co-facilitator. At each of the visits participants will engage in self-assessments of weight and blood pressure, including learning to take their blood pressure with a digital cuff, calculating BMI, and plotting their weight gain on a graph), receive short individual clinical examinations from a midwife, and participate in group discussions about prenatal care, childbirth preparation, and their postpartum care. The session at 6-weeks postpartum will allow women to introduce their babies to the group and share childbirth stories.
Standard of CareBehavioural
Standard of prenatal care
| Study group | Role | What they receive |
|---|---|---|
| pregnant women receiving group prenatal care (GPNC) | Active comparator | Overweight/obese pregnant women will be recruited from the prenatal care clinic at the Lyndon B Johnson Tropical Medical Center (LBJTMC) in Pago Pago, American Samoa. These women will be randomized to receive the 10-session GPNC intervention. Receives: Behavioral: Group Prenatal Care (GPNC) |
| pregnant women receiving standard of care (SOC) | Active comparator | Overweight/obese pregnant women will be recruited from the prenatal care clinic at the Lyndon B Johnson Tropical Medical Center (LBJTMC) in Pago Pago, American Samoa. These women will be randomized to continue with standard of care (SOC) prenatal care visits. Receives: Behavioral: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
limiting weight gain
initial weight measurement
Measured: week 0
limiting weight gain 0.5-0.7 lbs per week for overweight women
weight measurement
Measured: week 36 to week 40
limiting weight gain 0.4-0.6 lbs per week for obese women
weight measurement
Measured: week 36 to week 40
limiting weigh gain 0.4-0.6 lbs per week for obese women
weight measurement
Measured: 6 weeks postpartum
limiting weigh gain 0.5-0.7 lbs per week for overweight women
weight measurement
Measured: 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start1 Nov 2016
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
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 Yale 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 cohort double blinded randomized control trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Brown University
- Responsible party
- Sponsor
- Investigators
- Nicola Hawley, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04025268
- Sponsor's protocol ID
- 1609018463
- Status last verified
- Apr 2020
- First submitted
- 16 Jul 2019
- Last updated
- 15 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Group Prenatal Care Intervention to Address Maternal and Child Non-Communicable Disease (NCD) Risk in American Samoa
- ClinicalTrials.gov ID
- NCT04025268
- Acronym / sponsor ID
- 1609018463
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Brown University
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 18 Jul 2019 (actual)
- 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.
To test the efficacy of a group prenatal care intervention to reduce the risk of obesity related health conditions during and after pregnancy in obese mothers and their infants.
Detailed description
The purpose of this study is to test the feasibility, acceptability, and preliminary efficacy of a group prenatal care (GPNC) intervention designed to reduce the risk for obesity related health conditions during and after pregnancy in overweight/obese mothers and their infants in American Samoa.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- 2 cohort double blinded randomized control trial
| Arm | Type | Receives |
|---|---|---|
| pregnant women receiving group prenatal care (GPNC) | Active comparator | Behavioral: Group Prenatal Care (GPNC)Overweight/obese pregnant women will be recruited from the prenatal care clinic at the Lyndon B Johnson Tropical Medical Center (LBJTMC) in Pago Pago, American Samoa. These women will be randomized to receive the 10-session GPNC intervention. |
| pregnant women receiving standard of care (SOC) | Active comparator | Behavioral: Standard of CareOverweight/obese pregnant women will be recruited from the prenatal care clinic at the Lyndon B Johnson Tropical Medical Center (LBJTMC) in Pago Pago, American Samoa. These women will be randomized to continue with standard of care (SOC) prenatal care visits. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≥18 years of age. We will exclude younger pregnant women because adolescents may still be experiencing their own growth and development, which would be a source of confounding for our study outcomes.
- Self-reported Samoan ethnicity. Based on all four grandparents (of the participant) being reported as Samoa. Other ethnic groups make up approximately 2% of the American Samoan population but we are specifically interested in determining the efficacy of this intervention fro Samoan women, who have considerably poorer health outcomes in this setting.
- English speaking. The intervention will be delivered primarily in English, as is usual for standard prenatal care in this setting, with some Samoan language likely to be used in group discussions. Take home materials will be provided in both English and Samoan.
- Planning to reside in American Samoa for the duration of pregnancy and until at least 6 weeks postpartum. Some women travel from the neighboring country of Samoa (Independent/Western Samoa) to receive prenatal care at LBJTMC. These women will be excluded based on the need to receive all intervention sessions and a postpartum follow up.
- Singleton, viable pregnancy. A twin pregnancy reduced to singleton before 140 weeks by project gestational age is acceptable. An ultrasound must be conducted before randomization that shows a fetal heartbeat; there must be no evidence of more than one fetus on the most recent pre-randomization ultrasound. Including multiple pregnancies would confound study outcomes.
Key exclusion criteria (20 listed)
- Age less than 18 years because of the potential for growth during pregnancy and the need for participant informed consent.
- Diagnosis of diabetes prior to pregnancy or an HbA1C ≥ 6.5% or other glucose tolerance test result suggestive of pre-pregnancy diabetes. All potential participants will have HbA1C or an alternative test performed prior to randomization at their standard prenatal care enrollment visit.
- Gestational diabetes or preeclampsia in a previous pregnancy
- Known fetal anomaly/pregnancy health condition known to require specialist monitoring/treatment
- Planned termination of pregnancy
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 |
|---|---|---|
| Group Prenatal Care (GPNC)GPNC participants will attend 11 group sessions total: 10 during pregnancy and one postpartum. Each session will be 90-100 minutes long. Groups will collectively identify the preferred time of day for these sessions. Groups of 10 women will be led by a locally trained, Samoan nurse-midwife with the study Project Director as a co-facilitator. At each of the visits participants will engage in self-assessments of weight and blood pressure, including learning to take their blood pressure with a digital cuff, calculating BMI, and plotting their weight gain on a graph), receive short individual clinical examinations from a midwife, and participate in group discussions about prenatal care, childbirth preparation, and their postpartum care. The session at 6-weeks postpartum will allow women to introduce their babies to the group and share childbirth stories. | Behavioural | pregnant women receiving group prenatal care (GPNC) |
| Standard of CareStandard of prenatal care | Behavioural | pregnant women receiving standard of care (SOC) |
Primary outcome
limiting weight gain
Time frame: week 0
initial weight measurement
limiting weight gain 0.5-0.7 lbs per week for overweight women
Time frame: week 36 to week 40
weight measurement
limiting weight gain 0.4-0.6 lbs per week for obese women
Time frame: week 36 to week 40
weight measurement
limiting weigh gain 0.4-0.6 lbs per week for obese women
Time frame: 6 weeks postpartum
weight measurement
limiting weigh gain 0.5-0.7 lbs per week for overweight women
Time frame: 6 weeks postpartum
weight measurement
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 15 Apr 2020.
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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.
Nicola Hawley, PhD principal investigator
Yale University
Questions about this trial
What is this clinical trial studying?
A study testing Group Prenatal Care (GPNC) in people with Obesity, run by Yale 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 8 inclusion and 20 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 15 Apr 2020. 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. 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?
limiting weight gain (time frame: week 0). 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?
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 15 Apr 2020.