NCT02260518.

Trial name or title	Promoting health in pregnancy and postpartum (HIPP) among overweight/obese women
Methods	Parallel RCT.
Participants	400 participants Setting: USA Inclusion criteria Aged 18‐44 years White or African American woman Overweight or obese (prepregnancy BMI 25‐45 kg/m2) ≤ 16 weeks' gestation at screening No plan to move out of the greater Columbia area in next 18 months Regular and consistent telephone access Availability for telephone calls Willing to accept random assignment Exclusion criteria Uncontrolled hypertension Fetal anomaly Taking insulin for diabetes Uncontrolled or untreated thyroid disease Mental health or substance‐abuse hospitalisation in last 6 months Multiple gestation Persistent bleeding in the first trimester History of > 3 miscarriages History of an eating disorder or current eating disorder History of an incompetent cervix Physical disability that prevents exercise Told by healthcare provider not to exercise Any other medical conditions that might be a contraindication to exercise or dietary change
Interventions	Intervention The intervention will focus on women gaining the recommended amount of weight, increasing physical activity to 150 min/week and meeting health eating guidelines. This will be during pregnancy through 1 face‐to‐face counselling session, 10 podcasts and weekly phone calls until delivery. 1 group session on breastfeeding also provided. A private Facebook group will be available for participants to participate in during the prenatal and postnatal periods. Postpartum, participants will be provided with 1 face‐to‐face counselling session, 16 behavioural podcasts, brief weekly check‐in telephone calls for 6 weeks, and up to 8 telephone counselling calls through 6 months after delivery. Control Women will received standard care with usual nutritional advice from physicians, nurses, nutritionists and counsellors. They will receive monthly mailings and podcasts related to healthy pregnancy and on fetal development. Postpartum the mailings will focus on infant development and parenting.
Outcomes	Primary outcome measures Gestational weight gain in pounds ‐ defined as delivery room weight minus pre‐pregnancy weight Secondary outcome measures Gestational weight gain category: categorised as inadequate, adequate, excessive Postpartum weight retention at the 6‐ and 12‐month postpartum visits Physical activity at 32 weeks' gestation, 6 months postpartum and 12 months postpartum: Sense Wear Armband and self‐report measure Dietary intake at 32 weeks' gestation, 6 months postpartum and 12 months postpartum: 2 x 24‐h dietary recalls using the National Cancer Institute's Automated Self‐Administered 24‐h Dietary Recall (ASA‐24) will assess dietary intake Depressive symptoms at 32 weeks' gestation and 6 and 12 months postpartum: assessed with the Edinburgh Prenatal/Postnatal Depression Scale Quality of life at 32 weeks' gestation, 6 and 12 months postpartum: assessed using the Short Form‐12 (SF‐12) questionnaire Child adiposity at 6 and 12 months postpartum: measured using Z‐scores and skinfolds Other outcome measures Self‐efficacy for diet and physical activity at 32 weeks' gestation, 6 months and 12 months postpartum: self‐report measure Social support for diet and physical activity at 32 weeks' gestation, 6 and 12 months postpartum: self‐report measure Decisional balance for diet and physical activity at 32 weeks' gestation, 6 and 12 months postpartum: self‐report measure Self‐regulation for diet and physical activity at 32 weeks' gestation, 6 and 12 months postpartum: self‐report measure
Starting date	January 2015
Contact information	Sara Wilcox and Jihong Liu University of South Carolina Prevention Research Center
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