Table 2.

Overview of the seven trials in the LIFE-Moms Consortium

Study	Healthy Beginnings	Lifestyle Intervention for Two (LIFT)	Pregnancy and EARly Life improvement Study (PEARLS)	Maternal- Offspring Metabolics: Family Intervention Trial (MOMFIT)	PreGO	Expecting Success	LIFE-Moms Phoenix
Institution	California Polytechnic State University & Brown University	St. Luke’s – Roosevelt Hospital and Columbia University	University of Puerto Rico	Northwestern University	Washington University in St Louis	Pennington Biomedical Research Center	NIDDK/Phoenix Indian Medical Center (PIMC)
Recruitment location	OB practices servicing major delivery hospitals in San Luis Obispo and Women & Infants Hospital in Providence	OB practices and clinics whose patients deliver at St. Luke’s – Roosevelt	University of Puerto Rico Hospital	OB practices whose patients deliver at Prentice Women’s Hospital	Women’s Health Clinic at Washington University	OB practices and clinics whose patients deliver at Women’s Hospital Baton Rouge	Women’s Clinic at the PIMC
Trial primary outcome	GWG per week	Newborn percent body fat by air displacement plethysmography	GWG per week below or above IOM guidelines	Total GWG	Total GWG exceeding IOM guidelines	GWG per week exceeding IOM guidelines	Total GWG
Target sample size	350, 175 per arm	210, 105 per arm	200, 100 per arm	300, 150 per arm	266, 133 per arm	306, 102 per arm	200, 100 per arm
Common inclusion criteria	Singleton viable pregnancy, gestational age at randomization no earlier than 9 weeks 0 days and no later than 15 weeks 6 days, body mass index ≥ 25 based on first trimester measured weight (with adjustments) and height
Trial specific inclusion criteria	None	BMI ≤ 35 if having MRI	None	BMI ≤ 40	African American, SES disadvantaged, BMI ≤ 45	Gestational age < 13 weeks, 5 days	Receiving prenatal care at PIMC, 75g oral glucose tolerance test at < 16 weeks
Common exclusion criteria	Age < 18 years, diagnosis of diabetes prior to pregnancy, or an HbA1c ≥ 6.5% or other test result suggestive of pre-pregnancy diabetes, known fetal anomaly, planned termination of pregnancy, history of three or more consecutive first trimester miscarriages, past history of anorexia or bulimia, current eating disorder, active suicidal ideation, prior or planned bariatric surgery, current use of exclusionary medications, contraindications to aerobic exercise in pregnancy, participation in another interventional study that influences weight control, enrollment in this trial in a previous pregnancy, intention of the participant or of the care provider for the delivery to be outside the LIFE-Moms Consortium hospital, participant’s unwillingness or inability to commit to a 1 year follow-up of herself or her child
Trial specific exclusion criteria	Untreated medical or psychiatric complication	Asthma, smoking, drugs / alcohol, chronic health problems, binge-eating disorder, claustrophobia & implanted metal objects (when MRI is involved), medical/ psychiatric/ social/ behavioral factors	IV drug use, HIV infection, inability to participate in group sessions, non-Spanish speaking	Maternal age > 45, IVF conception / ovulation induction with gonadotropins, weight gain > 15 lbs from pre-pregnancy weight, smoking, in weight loss program within 3 months of conception, drugs/alcohol, no access to internet, condition that limits walking or following diet, not fluent in English	Maternal age > 45, prior unexplained spontaneous preterm birth < 34 weeks, drugs/alcohol	Maternal age > 40, not fluent in English, not medically cleared, not willing to avoid pregnancy for 12 months following delivery, smoking, drugs/alcohol, psychotic disorder, HIV, contraindications to physical activity	Unwilling to provide informed consent in English, conditions that interfere with consent, treatment or follow-up
Treatment groups
Intervention	Antepartum Individual counseling session (2/mo to 20 wks GA; 1–2/mo from 20 wks to delivery); meal replacement product; weight graphing; weekly behavior change materials, physical activity (30 mins most days of week / 10,000 steps)	Antepartum Individual counseling(biweekly in-person on diet modification & physical activity, with behavioral modification and social support strategies); weekly phone/e-mail contacts; group classes every 8 wks to aid in weight loss and support a healthy lifestyle Postpartum Group classes every 8 wks to aid in weight loss and support a healthy lifestyle	Antepartum 2 individual, 7 group sessions & monthly calls for improving dietary carbohydrate & fat quality; providing food – brown rice, whole grain pasta; physical activity (NEAT), decrease sitting time; breastfeeding Postpartum 2 individual, 2 group sessions and monthly calls on infant feeding practices, sleep and physical activity	Antepartum 6 group and 3 individual sessions with phone coaching on diet and physical activity (30 mins or 10,000 steps at least 5 days a week); weekly electronic feedback from participant self-monitoring using the “Loseit!” app Postpartum 1 group,2 individual sessions, monthly emails on weight loss, diet physical activity, infant nutrition	Antepartum 10 Parents as Teachers (PAT) home visits incorporating diet and exercise (150 mins / wk or 10,000 steps/days) focusing on control of weight gain reflecting the PAT philosophy Postpartum 18 monthly PAT visits focused on returning to pre-pregnancy weight, positive child-feeding behaviors and interactive parent-child activities	Antepartum Two groups (clinic vs phone) with similar dietary intake (55% carbs, 15% protein, 30% fat) and exercise (150 mins / wk) advice through 18 lessons; focus on appropriate weight gain, postpartum weight loss and infant health (breastfeeding); clinic group has individual and group sessions and phone group receives feedback from weight and physical activity data transmitted to the center	Antepartum Weekly group or individual sessions focused on individualized managed weight gain goals through caloric and fat gram recommendations, physical activity, decreased sedentary time
Control	Antepartum Usual obstetric care; newsletters	Antepartum Usual obstetric care; educational materials; group meetings every 8 wks until delivery based on wellness curriculum for the Look AHEAD Diabetes Support and Education (DSE) group Postpartum 3 group meetings based on LA DSE	Antepartum Usual obstetric care (brochures for improving diet quality and WIC); 2 group sessions on pregnancy health related issues Postpartum 1 group session	Antepartum Usual obstetric care; websites with diet and physical activity recommendations, 2 group sessions (infant CPR, newborn care), educational materials on childcare Postpartum 2 group sessions on infant CPR, care for newborns	Antepartum Usual obstetric care plus usual 10 PAT home visits focused on parenting and child development Postpartum 18 monthly PAT visits using standard PAT curriculum	Antepartum Usual obstetric care	Antepartum Usual obstetric care; educational materials to promote healthy pregnancy behaviors