Development of a Group Prenatal Care Intervention to Address Maternal and Child Non-Communicable Disease (NCD) Risk in American Samoa

NCT04025268 | Completed DMC

• 1 other identifier: 1609018463
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (5)

• limiting weight gain

  initial weight measurement

  week 0

• limiting weight gain 0.5-0.7 lbs per week for overweight women

  weight measurement

  week 36 to week 40

• limiting weight gain 0.4-0.6 lbs per week for obese women

  weight measurement

  week 36 to week 40

• limiting weigh gain 0.4-0.6 lbs per week for obese women

  weight measurement

  6 weeks postpartum

• limiting weigh gain 0.5-0.7 lbs per week for overweight women

  weight measurement

  6 weeks postpartum

Study Arms (2)

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.

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.

Behavioral: Standard of Care

Interventions

Group Prenatal Care (GPNC) BEHAVIORAL

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.

pregnant women receiving group prenatal care (GPNC)

Standard of Care BEHAVIORAL

Standard of prenatal care

pregnant women receiving standard of care (SOC)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: pregnant women of self-reported Samoan ethnicity.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

• 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.
• 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
• 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

Sponsors & Collaborators

• Yale University: lead
• Brown University: collaborator

MeSH Terms

Conditions

Obesity

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Nicola Hawley, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: double blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2 cohort double blinded randomized control trial

Study Record Dates

• First Submitted: July 16, 2019
• First Posted: July 18, 2019
• Study Start: November 1, 2016
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: April 15, 2020

Record last verified: 2020-04