Reaching High Risk Post-partum Women for Nutritional Assessment and Counseling Via a Telephone-based Coaching Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 181
- 试验地点
- 2
- 主要终点
- Behavior change
研究概览
简要总结
The purpose of the STAR-MAMA intervention is to develop a patient-tailored telephone-base counseling intervention for young Latino women who are at high risk of diabetes. The intervention will focus at the end of pregnancy and the 9 months post-partum period to improve education and behavioral counseling on nutrition and other related health topics .
The following hypotheses will be formally tested:
Compared with controls at 9 months post-partum:
- Women in the STAR-Moms program will have improved self-reported behavioral outcomes for minutes of physical activity, lower fat diet, and breast-feeding duration (in weeks);
- Women in the STAR-Moms program will have improved diabetes prevention knowledge;
- Women in the STAR-Moms program will have increased diabetes-relevant screening rates.
Women in the STAR-MAMA will have lost more weight than women in the control group.
详细描述
The STAR-MAMA intervention builds on theoretical constructs found in Social Cognitive Theory, Theory of Planned Behavior, and Theories of Social Support found to be effective in weight loss, physical activity and dietary change, based on a recent meta-analysis and other studies. The investigators proposed development of STAR-MAMA will incorporate specific behavior change techniques associated with these theories, including: "self-regulatory" intervention techniques (specific goal setting, prompting self-monitoring, providing feedback on performance, goal review), self-efficacy building intervention techniques (motivational interviewing, using decisional balance and relapse prevention), individual tailoring techniques (information on content and resources), and culturally tailored social support, and which incorporates family needs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postpartum Latino women (English or Spanish speakers) with history of gestational diabetes.
- •18 years or older
排除标准
- •Do not have type 1 or type 2 diabetes.
- •Do not have access to phone line or a cellphone to receive weekly calls of health coaching education over the phone.
结局指标
主要结局
Behavior change
时间窗: 6 month -12 months post-partum
Women in the intervention arm of the study (Star-Mama) will have behavior changes that lower their risk of developing gestational diabetes in the next pregnancy of type 2 diabetes later in life.
次要结局
- Weight loss(6-12 months post-partum)