Madres Para la Salud (Mothers for Health)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 177
- 试验地点
- 2
- 主要终点
- Change from Baseline Body Fat Percentage at 6 months
研究概览
简要总结
The purpose of "Madres Para la Salud" [Mothers for Their Health] is to see how support and encouragement can help women to make positive changes in their health. This program tested if supportive information, encouragement, and walking as a group would increase physical activity and health benefits, such as weight loss and postpartum depression.
Participants in this study were randomly assigned to one of two groups, a walking or a non-walking group. The walking group met weekly. Participants were given a pedometer to record the number of steps taken daily.
Participants met one time each week with our study staff. Participants walked four other days per week on their own, or with other group members. Participants measurements included body fat, waist, and hip at the beginning of the study, and at 3, 6, 9, and 12 months. The non-walking group received a weekly mailed newsletter about topics such as parenting, infant growth and development, and reproductive health. Non-walking group participants' measurements included body fat, waist, and hip at the beginning of the study and at 6 and 12 months.
详细描述
Project Summary
The purpose of "Madres para la Salud" (Mothers for Health) was to explore the effectiveness of a culturally specific intervention using walking "bouts" to affect changes in the health of Hispanic women following childbirth. The project will advance our understanding of the relationship between moderate increases in physical activity and consequent body fat loss and decreased postpartum depression symptoms in sedentary Hispanic women during the postpartum period. This was accomplished by having a group of women who participated in supportive information and walking sessions, both alone and with study personnel, and an attention control group who received monthly phone calls to address common postpartum health concerns, but who did not participate in the walking program. Both groups received weekly health-focused newsletters with no content related to the intervention. The women had a random assignment to a group.
Study Aims
The purpose of this social support intervention program was to test the theory-driven Madres para la Salud with Hispanic women by conducting a formative evaluation of the intervention:
Aim 1: Examine the effectiveness of the Madres para la Salud, a theoretically driven social support intervention for reducing the distal outcomes in: (a) body fat; (b) systemic and fat tissue inflammation; and (c) PPD symptoms among postpartum Hispanic women compared with an attention control group, at 6 and 12 months, after controlling for dietary intake.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Hispanic descendent
- •Between 18 and 40 years old
- •At least 6-weeks but less than 6-months post childbirth
- •Sedentary (according to the American College of Sports Medicine)
- •Have the ability to participate in moderate intensity physical activity (according to the Physical Activity Readiness Questionnaire (PAR-Q))
排除标准
- •Pregnant or planning a pregnancy in the next 12 months
- •Have a BMI less than 25 or greater than 35
- •Take anti-depressant medications
- •Take anticoagulants or herbal therapy to thin the blood
- •Participate in regular, strenuous physical activity (exceeding 150 minutes of moderate physical activity per week)
- •Severe musculoskeletal or cardiorespiratory problems that would preclude physical activity
- •Infectious illness
- •Acute inflammation (white blood count outside the normal range of 4.8-10.8 of 1000/mm3)
- •Chronic systemic inflammatory diseases (e.g., rheumatoid arthritis), or other acute illness that may affect systemic inflammation at the time of blood draw and fat tissue biopsy
- •Regularly taking high doses of oral steroid medication (more than typical basal replacement levels)
- •High doses of aspirin (above 1 g/day), or high doses of nonsteroidal anti-inflammatory drugs (e.g., 3-4 times/day)
结局指标
主要结局
Change from Baseline Body Fat Percentage at 6 months
时间窗: 6 months
Body fat was measured using bioelectric impedance (BIA), with portable four-terminal BIA measurement system (Tanita Corporation of America, Inc, Arlington Heights, IL). Instrument calibration was performed internally prior to each estimate of body composition. Measurement of body composition using BIA analysis followed the method outlined by Ritchie, Miller, and Smiciklas-Wright (Ritchie, Miller, \& Smiciklas-Wright, 2005). A subsample of the intervention group had body fat measured with state-of-the-art dual energy x-ray absorptiometry (DEXA) at baseline and 12 months.
Change from Baseline Body Fat Percentage at 12 months
时间窗: 12 Months
Body fat was measured using bioelectric impedance (BIA), with portable four-terminal BIA measurement system (Tanita Corporation of America, Inc, Arlington Heights, IL).
Change from Baseline Systemic and fat tissue inflammation at 12 months
时间窗: 12 months
Systemic and fat tissue inflammation was measured through a fat biopsy that was conducted by a trained physician (M.D.)
Change from Baseline in Edinburgh Postnatal Depression Scale at 6 months
时间窗: 6 months
Postpartum Depression Symptoms were measured with the Edinburgh Postnatal Depression Scale (EPDS)questionnaire.
Change from Baseline in Edinburgh Postnatal Depression Scale at 12 months
时间窗: 12 months
Postpartum Depression Symptoms were measured with the Edinburgh Postnatal Depression Scale (EPDS)questionnaire.
次要结局
- Change from baseline in Medical Outcomes Study (MOS) Social Support Survey at 6 months(6 months)
- Change from baseline in Medical Outcomes Study (MOS) Social Support Survey at 12 months(12 months)
- Change from baseline in Neighborhood Health Questionnaire at 6 months(6 months)
- Change from baseline in Neighborhood Health Questionnaire at 12 months(12 months)
研究者
Colleen Keller
Colleen Keller, PhD, RN-C, FNP, FAHA, FNAP
Arizona State University