Community-based Obesity Treatment in African American Women After Childbirth: a Randomized Controlled Trial of Women Infant Children (WIC) Mothers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Weight loss (kilograms)
研究概览
简要总结
The purpose of this study is to determine the effect of the community-based obesity treatment (PP), compared to usual care (UC), on changes in maternal weight over 12 months.
详细描述
The investigators propose to randomize overweight or obese, African American postpartum WIC participants (n=300) to either usual care (UC) or a community-based obesity treatment (PP) arm. Recruitment will occur in 6 of Philadelphia Women Infants Children's (WIC) clinic sites in the early postpartum period (≤ 6 months after birth). Once enrolled, participants will complete surveys and baseline assessments of their weight, waist circumference, blood pressure, and height at The Center for Obesity Research and Education (CORE). Participants will also have a fasting blood sample taken. Study staff will administer a number of questionnaires assessing demographics, psychosocial factors, contextual factors, and behavioral targets via questionnaires prior to randomization. Participants will then be randomized to the 12-month postpartum weight loss intervention (PP) or usual care (UC). Additional assessments will be conducted at 6 and 12 months post baseline. The PP arm includes expanded obesogenic behavior change goals, tailored skills training materials, interactive self-monitoring text messages, video testimonials, and interpersonal counseling support through health coach calls and Facebook. Data will be analyzed using an intent-to-treat (ITT) approach where subjects are analyzed according to their treatment assignment at randomization, regardless of level of engagement. The primary outcome is weight loss at 12 months. If successful, the expected results could provide a sustainable, low-cost, postpartum weight loss intervention model for widespread dissemination to reduce disparities in obesity and cardiometabolic comorbidities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Self-identification as African American
- •Self-report pre-pregnancy BMI between 25-49.9 kg/m2
- •Measured BMI at baseline between 25-49.9 kg/m2
- •Philadelphia WIC participant
- •Singleton birth
- •Between 1 and 6 months postpartum
- •Own a cell phone with an unlimited text messaging plan
- •Able to participate in light physical activity (walking)
- •Participants must be willing to comply with all study-related procedures
- •Participants must be able to read and write fluently in English
排除标准
- •BMI ≤ 24.9 or ≥ 50.0 kg/m2
- •Uncontrolled hypertension (systolic blood pressure > 160 or diastolic blood pressure > 95 mmHg). Participants with controlled hypertension on medication for at least three months are allowable.
- •Known atherosclerotic cardiovascular disease
- •Known congestive heart failure
- •Known diabetes mellitus (type 1 or type 2)
- •Known thyroid disease
- •Any major active rheumatologic, pulmonary, hepatic, dermatologic disease or inflammatory condition requiring steroids or immune modulating medications
- •History of testing HIV positive
- •Current smoker or tobacco user. Participants with < 5 cigarettes daily are allowable
- •Current or recent history (past 6 months) of drug or alcohol abuse or dependence
- •Participation in any weight control or investigational drug study within 6 weeks of screening
- •Current consumption of any of the following medications: appetite suppressants, anti-psychotics, lipase inhibitors
- •Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety for successful participation in the study
- •Gastrointestinal Disorders (gallbladder disease, Crohn's disease, etc)
- •Previous weight loss surgery
- •History of bulimia or anorexia
结局指标
主要结局
Weight loss (kilograms)
时间窗: At baseline and 12 months
Weight will be measured using a calibrated scale at baseline and 12-month follow-up. Weight loss will be calculated as the difference between mean 12-month and baseline weight in kilograms.
次要结局
- Obesogenic dietary behaviors(At baseline and 12 months)
- Insulin Resistance(At baseline and 12 months)
- Health-related quality of life(At baseline and 12 months)
- Hemoglobin A1c (HbA1c)(At baseline and 12 months)
- Lipids(At baseline and 12 months)
- Physical Activity(At baseline and 12 months)
- Sleep(At baseline and 12 months)