A Smartphone Application (HealthyMoms) to Promote Healthy Weight Gain, Diet and Physical Activity During Pregnancy: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 305
- 试验地点
- 1
- 主要终点
- Gestational weight gain
研究概览
简要总结
Excessive gestational weight gain is a major public health problem. Traditional face-to-face intervention programs has been shown to be succesful in order to promote healthier weight gains, however, they are time-consuming and expensive. The objectives of this study are to assess whether a 6-month smartphone application can promote healthy gestational weight gain, dietary habits and physical activity in pregnant women.
详细描述
Excessive gestational weight gain (GWG) increases risks for pregnancy complications, postpartum weight retention and offspring obesity. Traditional intervention programs are time and cost intensive. Mobile technology (mHealth) has been successful for weight loss and behavior changes; however, their use in pregnancy need to be further examined. This study aims to evaluate the impact of a smartphone application (app) intervention on GWG, diet, physical activity and glucose homeostasis.
HealthyMoms is a randomized controlled trial recruiting women at the first maternity clinic visit (week 6-10) in the Linköping area, Sweden. Women will be randomized to the control or intervention group (n=150 per group). All women will receive standard care. The intervention group will also receive the HealthyMoms smartphone app promoting healthy eating, activity and GWG during 6 months. Pregnancy outcomes are GWG (primary), food intake (web-based questionnaire), fat mass (BodPod), glucose homeostasis, activity (accelerometer) in week 37. Maternal and infant body fatness will be assessed one week post partum.
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
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •a single pregnancy
- •aged 18 years or above
- •be able to speak and read Swedish sufficiently well.
排除标准
- •previous diagnosed eating disorder
- •pre-pregnancy diabetes or medical conditions or pharmacological treatments prior to pregnancy that may affect body weight
结局指标
主要结局
Gestational weight gain
时间窗: At the end of the intervention which is 23 weeks after baseline
Body weight in gestational week 37 minus body weight in gestational week 14
次要结局
- Glycemia(At the end of the intervention which is 23 weeks after baseline)
- Maternal body fatness post partum(One week post partum)
- Body fatness using air-displacement plethysmography(At the end of the intervention which is 23 weeks after baseline)
- Physical activity using accelerometry(At the end of the intervention which is 23 weeks after baseline)
- Diet quality using a web-based questionnaire(At the end of the intervention which is 23 weeks after baseline)
- Infant body fatness(One week of age)
研究者
Marie Löf, docent
Senior researcher, associate professor
Karolinska Institutet