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临床试验/NCT03652766
NCT03652766已完成不适用

A Pilot and Feasibility Study of Daily Weight Tracking to Manage Gestational Weight Gain During Pregnancy

University of Minnesota2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2019年1月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
2
主要终点
Adherence (protocol feasibility)

研究概览

简要总结

This pilot study will examine perceptions about daily weighing for pregnant women with overweight or obesity by testing the feasibility, acceptability, and preliminary efficacy of daily weighing for reducing excess gestational weight gain (GWG) within the context of a low intensity, digital-health based intervention delivered remotely with electronic feedback to participants.

详细描述

Excessive weight gain during pregnancy is predictive of a host of health outcomes in both the mother and child, particularly among women who are overweight or obese pre-pregnancy. Gaining too much weight is associated with higher risk of gestational diabetes, large birth weight for the baby and its corresponding risks, and postpartum obesity. Alarmingly, these outcomes persist for years after birth. For adults who are overweight or obese and interested in weight management, a key element of behavioral weight control is self-monitoring. Supported by self-regulation theory, the effectiveness of daily weighing is likely a function of the self-regulatory processes that are activated as a result of this behavior. Receiving feedback daily on weight proximal to diet and exercise behaviors may increase awareness how of behaviors impact weight and allow for small changes in weight to be understood and resolved through subsequent behavior change. Given the improvements in self-regulation as a result of daily weighing, it may be an effective strategy for reducing excessive gestational weight gain during pregnancy. It is not clear, however, whether pregnant women would engage in this behavior and whether daily weighing would be effective in promoting recommended levels of weight gain during pregnancy.

To determine the feasibility of a six-week, digital health daily weighing pilot intervention to monitor gestational weight gain among overweight and obese pregnant women, participants will be recruited at up to 20 weeks' gestation (consistent with prior studies) and will receive a digital wireless Bluetooth-enabled scale to track weight for six weeks during pregnancy. They will receive tailored feedback via weekly emails in response to adherence to daily weighing and whether weight gains are in accordance with recommended levels and healthy standards for pregnancy; weekly emails will also communicate healthy eating and physical activity tips for pregnancy. They will be asked to complete surveys at baseline (before using scales) and follow-up (after using scales) that focus on experiences with weight monitoring, GWG knowledge and expectations, and perceptions of the intervention process.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Ages 18-35
  • Up to 20 weeks' gestation in their first pregnancy
  • Low-risk uncomplicated pregnancy
  • Have overweight or obesity just prior to becoming pregnant
  • Have an iPhone or Android smartphone with wireless/Bluetooth capability

排除标准

  • Individuals who are not pregnant
  • Second or subsequent pregnancy
  • No iPhone or Android smartphone with Bluetooth capacity
  • No wifi network at home
  • Expecting twins or other multiple
  • More than 20 weeks gestation
  • High-risk or complicated pregnancy for which participation would be contraindicated
  • Of advanced maternal age according to obstetric guidelines (i.e., age 36 or older)
  • Diabetes or history of eating disorders
  • Pre-pregnancy weight less than 25 kg/m2 or greater than 36 kg/m2 (either not overweight or with extreme obesity)

结局指标

主要结局

Adherence (protocol feasibility)

时间窗: 6 weeks

Frequency of bathroom scale use under daily weight tracking instruction condition

次要结局

  • Gestational Weight Gain Knowledge(6 weeks)
  • Acceptability (protocol)(6 weeks)
  • Gestational Weight Gain(6 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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