Browsing by keyword "Randomised controlled trial"
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Perspectives of health educators and interviewers in a randomized controlled trial of a postpartum diabetes prevention program for Latinas: a qualitative assessmentBACKGROUND: 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.
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Proyecto Mama: a lifestyle intervention in overweight and obese Hispanic women: a randomised controlled trial--study protocolBACKGROUND: 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.
