Obesity
Conditions
Brief 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.
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.
Interventions
BEHAVIORALGroup 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.
BEHAVIORALStandard of Care
Standard of prenatal care
Sponsors
Brown University
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
double blinded
Intervention model description
2 cohort double blinded randomized control trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| limiting weight gain 0.5-0.7 lbs per week for overweight women | week 36 to week 40 | weight measurement |
| limiting weight gain 0.4-0.6 lbs per week for obese women | week 36 to week 40 | weight measurement |
| limiting weight gain | week 0 | initial weight measurement |
| limiting weigh gain 0.4-0.6 lbs per week for obese women | 6 weeks postpartum | weight measurement |
| limiting weigh gain 0.5-0.7 lbs per week for overweight women | 6 weeks postpartum | weight measurement |
Outcome results
None listed