Testing the Effect of Multiple Weight Management Modalities for Chronic Disease Risk Reduction in a Clinical Setting (LIHT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Rate of Retention
研究概览
简要总结
This project will test 3 methods of dietary changes in a weight loss clinic. Participants will be randomized to one of 3 arms: low-carbohydrate diet, intermittent energy restriction, or Hunger Training. A maximum of 30 participants will be assigned to each arm. The goal of the proposed study is to determine the feasibility, early efficacy, and patient satisfaction of each weight loss modality in a population of patients seeking care at a weight loss clinic.
详细描述
Adult obesity, a common condition in the United States, is a well-established risk factor for the development of chronic diseases, including diabetes, heart disease, hypertension, and many types of cancer. However, research has not determined what type of diet is best for reducing weight and achieving optimal health outcomes. In this randomized trial, participants seeking care at a weight loss clinic will be assigned to one of three diets: low-carbohydrate, intermittent energy restriction, or Hunger Training. On the low-carbohydrate diet, participants will be instructed to consume less than 30 grams of carbohydrates per day. The intermittent energy restriction protocol will require participants to choose 2 non-consecutive days per week in which they will consume 500-650 calories. Hunger Training is a relatively new approach that involves teaching people to monitor their hunger symptoms and blood glucose, and to eat only when blood glucose is below a certain level. To our knowledge, these weight loss modalities have not been compared in a single, clinical study. The goal of the proposed study is to determine the feasibility, early efficacy, and patient satisfaction of each weight loss modality in a population of patients seeking care at a weight loss clinic. The goal will be achieved though the successful completion of the following aims:
Aim 1: To determine the feasibility of recruiting, retaining and maintaining the adherence participants in a randomized clinical trial testing 3 weight loss modalities.
Aim 2: To examine and compare the effect of 3 weight loss modalities on changes in anthropometric measures and metabolic and cancer-related health markers.
Aim 3: To evaluate and compare patients' perceived satisfaction with each weight loss modality.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Overweight/obese as indicated by BMI >27
- •HbA1C <8.0
- •Fluent in English
排除标准
- •Cognitive state that precludes informed consent or adherence to study protocols
- •Pregnant, breast-feeding, or planning to become pregnant within 6 months
- •A1C ≥ 8.0
- •Taking an anti-obesity medication
- •Insulin-dependence
- •prior metabolic surgery
- •current laparoscopic adjustable gastric band ("lap band") use
- •Experience of substantial weight changes (±5 kg or ±10 lbs) in the past 3 months
结局指标
主要结局
Rate of Retention
时间窗: 1 year
Feasibility of retaining participants in a randomized dietary intervention in a clinic setting as measured by the number of participants completing all study visits
Change in BMI
时间窗: baseline to 3 months
Participant BMI will be measured
Change in C-Reactive Protein (CRP)
时间窗: baseline to 3 months
Participant CRP will be measured
Change in Fasting Glucose
时间窗: baseline to 3 months
Participant fasting glucose will be measured
Change in Low Density Lipoprotein (LDL)
时间窗: baseline to 3 months
Participant LDL will be measured
Change in Insulin-like Growth Factor 2 (IGF-2)
时间窗: baseline to 3 months
Participant IGF-2 will be measured
Change in Adiponectin
时间窗: baseline to 3 months
Participant adiponectin will be measured
Change in Insulin-like Growth Factor Binding Protein 3 (IGFBP-3)
时间窗: baseline to 3 months
Participant IGFBP-3 will be measured
Rate of Recruitment
时间窗: 1 year
Feasibility of recruiting participants into a randomized dietary intervention in a clinic setting as measured by the total number of individuals who are screened as eligible and enrolled into the study
Adherence to the Intervention
时间窗: 1 year
Feasibility of maintaining participant adherence in a randomized dietary intervention in a clinic setting will be measured by attendance at scheduled clinic visits
Change in Fasting Insulin
时间窗: baseline to 3 months
Participant fasting insulin will be measured
Change in Weight
时间窗: baseline to 3 months
Participant weight will be measured
Change in HbA1c
时间窗: baseline to 3 months
Participant HbA1c will be measured
Change in High Density Lipoprotein (HDL)
时间窗: baseline to 3 months
Participant HDL will be measured
Change in Insulin-like Growth Factor 1 (IGF-1)
时间窗: baseline to 3 months
Participant IGF-1 will be measured
Change in Leptin
时间窗: baseline to 3 months
Participant leptin will be measured
Change in Total Cholesterol
时间窗: baseline to 3 months
Participant total cholesterol will be measured
Change in Triglycerides
时间窗: baseline to 3 months
Participant triglycerides will be measured
Participant Satisfaction
时间窗: 3 months
Participants will complete a questionnaire at the end of the study to assess the acceptability of and satisfaction with the weight loss diet intervention they received. We will assess overall satisfaction, enjoyment, likeliness to recommend, and ease of following the diet. Aggregated scores will be compared across weight loss modality.
次要结局
未报告次要终点