Helping Moms to be Healthy After Baby
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 4
- 主要终点
- Acceptability of a Weight Loss Intervention
研究概览
简要总结
Low-income and minority women are at increased risk for postpartum weight retention (i.e. retaining weight after pregnancy) and consequent persistent obesity. Women who are obese pre-pregnancy are 3-5 times more likely to gain weight, rather than lose weight, in the postpartum period than non-obese women. Aims for this pilot study are listed below:
Aim 1: To evaluate the feasibility and acceptability of a multi-component novel weight loss intervention delivered in a WIC setting to a population of low-income, predominantly racial/ethnic minority, obese, postpartum women.
Aim 2: To evaluate differences in weight change, diet, physical activity, self-efficacy, readiness to change, motivations to eat between intervention and control participants to determine preliminary intervention efficacy over a 12-week period.
详细描述
Low-income and minority women are at increased risk for postpartum weight retention (i.e. retaining weight after pregnancy) and consequent persistent obesity. Women who are obese pre-pregnancy are 3-5 times more likely to gain weight, rather than lose weight, in the postpartum period than non-obese women.
Obesity science supports that weight loss interventions should be multi-component with regular points of contact. Building upon this, we have designed a multi-component intervention that considers the demands on women in the postpartum period and utilizes technology for both provider decision support and for virtual contact with participants. The intervention will address diet, physical activity, and social support through the use of in-person meetings with WIC staff, text messaging, phone coaching, self-monitoring, and Facebook.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Adult woman (≥18 and <50 years old).
- •Enrolled in WIC or with an infant enrolled in WIC.
- •3-12 months postpartum.
- •A pre-pregnancy BMI of 25 - 40 kg/m2 (based on self-reported height and weight prior to pregnancy).
- •Postpartum body mass index between 25 and 50 kg/m
- •English- and/or Spanish-speaking.
- •Owns a mobile phone with texting functionality in order to receive texts during the trial.
排除标准
- •Health conditions impacting weight or ability to participate in a weight loss trial.
- •Pregnancy or planned pregnancy in next 5 months.
- •Any health problems or undergoing any treatments that might interfere with what participant eats or her ability to exercise.
- •Medical provider recommendation to avoid exercise.
- •Plans to be in a different geographic area within the next 5 months.
- •Plans to stop coming to Aurora WIC in the next 5 months.
- •Unable to give informed consent.
- •Not able to read and understand English or Spanish at an 8th grade level.
- •Not willing to create a Facebook account if they do not already have one.
- •Asked to follow-up in < 3 months at most recent WIC visit.
结局指标
主要结局
Acceptability of a Weight Loss Intervention
时间窗: 12 weeks
To determine acceptability, investigators will use qualitative interviews to ask open-ended questions on this topic including asking participants in the intervention whether they would participate again. The number of participants interviewed who indicated that they would participate again is reported.
Evaluation of the Use of Phone Coaching
时间窗: 12 weeks
Investigators will count the total number of times any participant used phone coaching.
Feasibility of Recruitment
时间窗: Once the final participant is recruited
The investigators plan to determine the feasibility of recruitment for a weight loss intervention by evaluating the rate of recruitment. Below describes number recruited/enrolled over 14 weeks of recruitment
Attrition Rate of Subjects Enrolled in the Study
时间窗: Once the final participant completes the 12 week visit
The investigators will measure the number of dropouts/withdrawn once final participant has completed the 12 week visit.
Visit Attendance
时间窗: Baseline through Week 12, reported at Week 12
The investigators will measure lifestyle group participant attendance from enrollment through the 12-week visit. The number of participants who attended their visits is reported
次要结局
- Change in Weight Between Visits(Intervention group: Baseline, 12 weeks; Control group: Baseline and 12 weeks)
- Changes in Readiness to Change(Baseline and 12 weeks)
- Changes in Diet and Physical Activity Self-efficacy(Baseline and 12 weeks)
- Changes in Diet: Intakes Measured in Cups(Baseline and 12 weeks)
- Changes in Diet: Intakes Measured in Grams(Baseline and 12 weeks)
- Changes in Motivations to Eat(Baseline and 12 weeks)
- Changes in Physical Activity(Baseline and 12 weeks)
- Changes in Diet: kCal Intake(Baseline and 12 weeks)