INTRODUCTION: This study assesses the impact of a culturally modified, motivationally targeted, individually tailored intervention on postpartum weight retention among Hispanic women with abnormal glucose tolerance during pregnancy. METHODS: Estudio Parto (Project Aiming to Reduce Type twO diabetes) was an RCT conducted in Western Massachusetts (collected 20132017, analyzed 2018-2020). Hispanic women with blood glucose > /=140 mg/dL (7.77 mmol/L) on routine nonfasting oral glucose challenge test were randomized to a Lifestyle Intervention (n=100) focusing on healthy exercise and diet or to a comparison Health and Wellness Intervention (n=104) with no mention of exercise or diet behavior changes. The primary outcome was change in weight, calculated as the difference between prepregnancy weight and 6-week, 6-month, and 12-month postpartum weight. The secondary outcome was achievement of weight reduction to prepregnancy weight if prepregnancy BMI was normal, or a 5% reduction if prepregnancy BMI was overweight/obese. RESULTS: In intent-to-treat analyses, there were no significant differences in weight change pattern between the intervention arms across all follow-up timepoints (beta=0.03, 95% CI= -3.38, 3.45). However, at 12 months postpartum, women in the Lifestyle Intervention arm had a statistically significant 2.5-fold higher odds of meeting the secondary weight reduction outcome (OR=2.52, 95% CI=1.09, 5.82) than women in the Health and Wellness arm. Regardless of intervention arm, women who reported higher levels of postpartum sports/exercise had a greater decrease in weight (beta= -2.39, 95% CI= -4.66, -0.13, p=0.04) than women reporting lower levels. CONCLUSIONS: In this randomized trial among Hispanic women, no significant overall differences in weight change pattern between intervention arms were observed. Higher levels of self-reported physical activity were associated with greater weight loss in both arms.

AIMS: To assess the impact of a culturally modified, motivationally targeted, individually-tailored intervention on postpartum physical activity (PA) and PA self-efficacy among Hispanic women. METHODS: Estudio PARTO was a randomized controlled trial conducted in Western Massachusetts from 2013-17. Hispanic women who screened positive for gestational diabetes mellitus were randomized to a Lifestyle Intervention (LI, n = 100) or to a comparison Health and Wellness (HW, n = 104) group during late pregnancy. Exercise goals in LI were to meet American College of Obstetrician and Gynecologists guidelines for postpartum PA. The Pregnancy Physical Activity Questionnaire (PPAQ) and the Self-Efficacy for Physical Activity Questionnaire were administered at 6 weeks, 6 months, and 1 year postpartum. RESULTS: Compared to baseline levels, both groups had significant increases in moderate-to-vigorous PA at 6 months and one year postpartum (i.e., LI: mean change = 30.9 MET-hrs/wk, p = 0.05; HW: 27.6 MET-hrs/wk, p = 0.01), with only LI group experiencing significant increases in vigorous PA (mean change = 1.3 MET-hrs/wk, p = 0.03). Based on an intent-to-treat analysis using mixed effects models, we observed no differences in pattern of change in PA intensity and type over time between intervention groups (all p > 0.10). However, there was the suggestion of a greater decrease in sedentary activity in the LI group compared to the HW group (beta = -3.56, p = 0.09). CONCLUSIONS: In this randomized trial among high-risk Hispanic women, both groups benefitted from participation in a postpartum intervention.

BACKGROUND: Lifestyle interventions regularly rely on study staff to implement the intervention and collect outcomes data directly from study participants. This study describes the experiences of project staff in two randomized controlled trials of a postpartum lifestyle intervention to reduce risk factors for type 2 diabetes in Latinas. Latinas are the fastest growing minority group in the U.S. and have the highest rates of type 2 diabetes after a diagnosis of gestational diabetes mellitus. The challenges of implementing lifestyle interventions for postpartum women have been poorly documented. METHODS: A qualitative focus group was conducted with eight staff members (five health educators and three health interviewers) involved in Proyecto Mama and Estudio Parto. The discussion was audio recorded, transcribed, and coded in NVivo. Focus group topics included: 1) participant recruitment, 2) participant retention, 3) implementation of the lifestyle intervention, 4) assessment of behavior change, 5) overall challenges and rewarding aspects of the trial, and 6) recommended changes for future trials. RESULTS: Key themes emerged regarding enabling factors and barriers to implementing a lifestyle intervention in postpartum Latinas. Enabling factors included: a) the staff's belief in the importance of the intervention, b) opportunities associated with the longitudinal nature of the trial, c) belief that the staff could empower participants to make behavior change, d) benefits of flexible intervention sessions, and e) connection with participants due to shared cultural backgrounds. Barriers included: a) participant stressors: home, food, and financial insecurity, b) low health literacy, c) issues related to recent immigration to the continental U.S., d) handling participant resistance to behavior change, e) involvement of family members in assessment visits, f) limitations of the assessment tools, and g) time limitations. CONCLUSIONS: Findings highlight the challenging contexts that many study participants face, and shed light on the potentially influential role of health educators and interviewers in intervention implementation and data collection. Specific recommendations are made for strategies to improve adherence to diabetes prevention programs in postpartum underserved and minority populations in this challenging, transitional period of life. TRIAL REGISTRATION: NCT01679210 . Registered 5 September 2012; NCT01868230 . Registered 4 June 2013.

Based on a collaborative symposium in 2014 hosted by the Society of Behavioral Medicine (SBM) and the American College of Sports Medicine (ACSM), this paper presents a model for physical activity counseling for primary care physicians (PCPs). Most US adults do not meet national recommendations for physical activity levels. Socioecological factors drive differences in physical activity levels by geography, sex, age, and racial/ethnic group. The recent Patient Protection and Affordable Care Act incentivizes PCPs to offer patients physical activity counseling. However, PCPs have reported socioecological barriers to physical activity counseling and also patient barriers to physical activity, spanning from the individual to the environmental (eg, lack of safe spaces for physical activity), policy (eg, reimbursement policies), and organizational (eg, electronic medical record protocols, worksite norms/policies) levels. The aims of this paper are to: 1) discuss barriers to PCP counseling for physical activity; 2) provide evidence-based strategies and techniques to help PCPs address these counseling barriers; and 3) suggest practical steps for PCPs to counsel patients on physical activity using strategies and supports from policy, the primary care team, and other support networks.

BACKGROUND: The proportion of women entering pregnancy overweight or obese has been rising and, in turn, is associated with adverse maternal and fetal outcomes. Gestational weight gain (GWG) exceeding Institute of Medicine (IOM) guidelines further increases health risks and has been independently associated with postpartum weight retention. Hispanic women are disproportionately affected by overweight and obesity, but have had limited access to interventions that promote healthy lifestyles due to cultural, socioeconomic, and language barriers. Therefore, the overall goal of this randomized controlled trial is to test the efficacy of a culturally and linguistically modified, individually-tailored lifestyle intervention to reduce excess GWG, increase postpartum weight loss, and improve maternal metabolic status among overweight/obese Hispanic women. METHODS/DESIGN: Overweight/obese Hispanic women are recruited in early pregnancy and randomly assigned to a Lifestyle Intervention (n = 150) or a Comparison Health and Wellness (control) intervention (n = 150). Multimodal contacts (i.e., in-person, telephone counseling, and mailed print-based materials) are used to deliver the intervention from early pregnancy (12 weeks gestation) to 6 months postpartum, with follow-up to 1 year postpartum. Targets of the intervention are to achieve IOM Guidelines for GWG and postpartum weight loss; American Congress of Obstetrician and Gynecologist guidelines for physical activity; and American Diabetes Association guidelines for diet. The intervention draws from Social Cognitive Theory and the Transtheoretical Model and includes strategies to address the specific social, cultural, and economic challenges faced by low-income Hispanic women. Assessments are conducted at baseline (~10 weeks gestation), mid pregnancy (24-28 weeks gestation), late pregnancy (32-34 weeks gestation) and postpartum at 6-weeks, 6-months, and 12-months by bicultural and bilingual personnel blinded to the intervention arm. Efficacy is assessed via GWG, postpartum weight loss, and biomarkers of glycemic control, insulin resistance, and cardiovascular disease risk factors. Changes in physical activity and diet are measured via 7-day accelerometer data and 24-h dietary recalls at each assessment time period. DISCUSSION: Hispanic women are the fastest growing minority group in the U.S. and are disproportionately affected by overweight and obesity. This randomised trial uses a high-reach, low-cost strategy that can readily be translated into clinical practice in underserved and minority populations. TRIAL REGISTRATION: NCT01868230 May 29, 2013.

BACKGROUND: Diabetes and obesity have reached epidemic proportions in the U.S. with rates consistently higher among Hispanics as compared to non-Hispanic whites. Among Hispanic women diagnosed with gestational diabetes mellitus (GDM), 50% will go on to develop type 2 diabetes within 5 years of the index pregnancy. Although randomised controlled trials among adults with impaired glucose tolerance have shown that diet and physical activity reduce the risk of type 2 diabetes, such programs have not been tested in high-risk postpartum women. The overall goal of this randomised controlled trial is to test the efficacy of a culturally and linguistically modified, individually-tailored lifestyle intervention to reduce risk factors for type 2 diabetes and cardiovascular disease among postpartum Hispanic women with a history of abnormal glucose tolerance during pregnancy. METHODS/DESIGN: Hispanic pregnant women who screen positive for GDM will be recruited and randomly assigned to a Lifestyle Intervention (n = 150) or a Health and Wellness (control) Intervention (n = 150). Multimodal contacts (i.e., in-person, telephone, and mailed materials) will be used to deliver the intervention from late pregnancy (29 weeks gestation) to 12 months postpartum. Targets of the intervention are to achieve Institute of Medicine Guidelines for postpartum weight loss; American Congress of Obstetrician and Gynecologist guidelines for physical activity; and American Diabetes Association guidelines for diet. The intervention draws from Social Cognitive Theory and the Transtheoretical Model and addresses the specific cultural and environmental challenges faced by low-income Hispanic women. Assessments will be conducted at enrollment, and at 6-weeks, 6-months, and 12-months postpartum by trained bicultural and bilingual personnel blinded to the intervention arm. Efficacy will be assessed via postpartum weight loss and biomarkers of insulin resistance and cardiovascular risk. Changes in physical activity and diet will be measured via 7-day actigraph data and three unannounced 24-hour dietary recalls at each assessment time period. DISCUSSION: Hispanic women are the fastest growing minority group in the U.S. and have the highest rates of sedentary behavior and postpartum diabetes after a diagnosis of GDM. This randomised trial uses a high-reach, low-cost strategy that can readily be translated into clinical practice in underserved and minority populations. TRIAL REGISTRATION: NCT01679210.