Comparative Health Improvements and Rate of Relapse in Weight-Centered vs. Wellness-Centered Interventions for Obese Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Blood Lipids
研究概览
简要总结
For over four decades the medical literature has observed a relationship between obesity and poorer health outcomes. The causal mechanisms of these poorer outcomes however are unclear. One assumption that has been supported by correlational data is that increased weight is associated with increased cardiovascular disease (CVD) risk factors (i.e., hypertension, dyslipidemia, and type 2 diabetes). Consequently, obese people are routinely prescribed weight loss programs in order to prevent or control these conditions. Unfortunately, long term weight loss has been met with minimal success for the large majority of people. Furthermore, the data suggesting that weight loss leads to long term health benefits and decreased mortality is limited and contradictory. The purpose of the proposed project is to perform a randomized controlled pilot study comparing the effectiveness of two lifestyle interventions for preventing CVD risk factors (hypertension, dyslipidemia, and type 2 diabetes). The interventions are constitutionally similar; however, the treatment condition is a wellness-focused intervention that teaches healthy living without consideration of weight. The control condition is a traditional curriculum where the prescribed outcome is weight loss. The primary goals of both programs are to reduce hypertension and total cholesterol, and to enhance glucose control. Secondary outcomes of interest are psychological and behavioral in nature (e.g., self-esteem; depressed mood; anxiety; stress; quality of life; dietary habits; and physical activity). We will compare the trajectories of the CVD and psychological/behavioral risk factors for a total period of 24 months (including the time from baseline to the end of the 6-month intervention). Our objectives are to collect data to a) determine whether participants in both programs reduce CVD and psychological/behavioral risk factors at the completion of the 6-month program, and b) compare the persistency of health improvements and rate of relapse at the end of the 18-month follow-up period between the traditional weight loss intervention and the wellness-focused intervention.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
There was full allocation concealment through the 3-month recruitment phase of the trial.
入排标准
- 年龄范围
- 30 Years 至 45 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women ages 30 to 45 years old (at intervention onset);
- •BMI between 30 and 45
- •Physically inactive
- •Practicing birth control if heterosexually active and pre-menopausal.
- •English speaking
排除标准
- •Current smoker
- •Use of medications known to affect weight/energy expenditure;
- •Pregnant, intending to get pregnant over next two years, or lactating;
- •Recent myocardial infarction (within 6 months);
- •Congestive heart failure
- •Active neoplasms
- •Type 1 and insulin-dependent Type 2 diabetes
- •Cerebrovascular disease
- •Renal disease
- •Bulimia nervosa
- •Alcohol and/or Substance Abuse
- •Major psychiatric disturbance (suicidality, psychosis, anti-social personality disorder, current manic episode)
- •Prior bariatric surgery
- •Plans to have bariatric surgery over next 2.5 years
结局指标
主要结局
Blood Lipids
时间窗: Baseline, post-intervention, 18-24 months post intervention
LDL, HDL, Total Cholesterol, Triglycerides (mg/dL)
Waist-to-Hip ratio
时间窗: Baseline, post-intervention, 18-24 months post intervention
waist in inches/hips in inches
Fasting Blood Glucose
时间窗: Baseline, post-intervention, 18-24 months post intervention
measured in mg/DL
Blood Pressure
时间窗: Baseline, post-intervention, 18-24 months post intervention
Systolic and Diastolic (mmHg)
Waist and Hip Circumference
时间窗: Baseline, post-intervention, 18-24 months post intervention
measured in inches
次要结局
- Disordered eating attitudes and behaviors(baseline, post intervention, 18-24 months post intervention)
- Intuitive eating behaviors(baseline, post intervention, 18-24 months post intervention)
- Maladaptive eating behaviors(baseline, post intervention, 18-24 months post intervention)
- Psychological distress(baseline, post intervention, 18-24 months post intervention)
- Dietary habits(baseline, post intervention, 18-24 months post intervention)
- Fruit and vegetable intake(baseline, post intervention, 18-24 months post intervention)
- Physical activity(baseline, post intervention, 18-24 months post intervention)
- Overall health and well-being status/Quality of life(baseline, post intervention, 18-24 months post intervention)
- Self-esteem(baseline, post intervention, 18-24 months post intervention)
研究者
Janell Mensinger, PhD, FAED
Associate Research Professor
Villanova University
