NCT00859989Unknown3 期
Obesity Reduction Black Intervention Trial (ORBIT)
适应症
试验速览
- 阶段
- 3 期
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Body mass index as assessed at baseline, 24 weeks, and 18 months
研究概览
简要总结
RATIONALE: A diet and physical activity program followed by a weight-loss maintenance program may help obese black women lose weight. It is not yet known whether a weight-loss program is more effective than a general health education program in helping obese black women lose weight. Weight loss may reduce a person's risk of developing cancer.
PURPOSE: This randomized phase III trial is studying a weight-loss program to see how well it works in helping obese black women lose weight.
详细描述
OBJECTIVES:
Primary
- To estimate the effectiveness of a 24-week diet and physical activity intervention and a 1-year maintenance intervention designed to produce and maintain weight loss in obese black women.
- To estimate the effect of these interventions on changes in fasting serum insulin, glucose, and free IGF-1, IGFBP-1, and IGFBP-2 levels as well as total IGF-1 and IGFBP-3 levels.
Secondary
- To compare changes in dietary consumption of total calories, total fat, fruits, vegetables, and fiber as well as physical activity in participants undergoing a weight-loss intervention vs a control intervention.
- To compare changes in knowledge, attitudes, self-efficacy, and social support related to diet, physical activity, and weight loss in participants undergoing a weight-loss intervention vs a control intervention.
- Assess the efficacy of a weight-loss intervention mechanism and the association between weight loss and weight loss maintenance with potential biologic mediators of breast cancer risk.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Body mass index as assessed at baseline, 24 weeks, and 18 months
Changes in glucose, insulin, and IGF levels as assessed at baseline, 24 weeks, and 18 months
次要结局
- Changes in diet and physical activity as assessed by Block 98 FFQ and Stanford 7-Day Physical Activity Recall questionnaires at baseline, 24 weeks, and 18 months
- Changes in knowledge, attitudes, self-efficacy, and social support related to diet, physical activity, and weight loss as assessed by Nutrition Attitudes Scale, Self-Efficacy for Eating and Exercise Behaviors, and Social Support for Eating and Exerci ...
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Enhancing Physical Function in the Long-term for Older AdultsWeight Loss MaintenanceNCT04490356Duke University14
已完成
2 期
Can Diet- and Exercise-Induced Weight Loss Improve Asthma Control in Adults?ObesityAsthmaNCT00901095Palo Alto Medical Foundation330
撤回
早期 1 期
Diet and Exercise in Overweight Children PostburnBurnsObesityNCT00537160Shriners Hospitals for Children
已完成
不适用
APEX: Adiposity Prevention by Exercise in Black GirlsCardiovascular DiseasesHeart DiseasesObesityNCT00006405National Heart, Lung, and Blood Institute (NHLBI)
已完成
不适用
Exercise and Diet Intervention Attenuated Inflammation Through ASC Gene and Inflammatory Markers in Obese AdultsInflammatory ResponseAbdominal ObesityDiet HabitExerciseObesityNCT04315376University of Guadalajara37