Development of a Group Prenatal Care Intervention to Address Maternal and Child Non-Communicable … (NCT04025268) | Clinical Trial Compass
CompletedNot Applicable
Development of a Group Prenatal Care Intervention to Address Maternal and Child Non-Communicable Disease (NCD) Risk in American Samoa
80 participantsStarted 2016-11-01
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion Criteria:
* ≥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 …
What they're measuring
1
limiting weight gain
Timeframe: week 0
2
limiting weight gain 0.5-0.7 lbs per week for overweight women
Timeframe: week 36 to week 40
3
limiting weight gain 0.4-0.6 lbs per week for obese women
Timeframe: week 36 to week 40
4
limiting weigh gain 0.4-0.6 lbs per week for obese women
Timeframe: 6 weeks postpartum
5
limiting weigh gain 0.5-0.7 lbs per week for overweight women