Efficacy of Self-hypnosis for Weight Loss in Type 2 Diabetics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 主要终点
- Change in weight (BMI)
研究概览
简要总结
Randomized study evaluating self-hypnosis versus certified diabetes educator training for weight loss in type 2 diabetics.
详细描述
Study Subjects: Approximately 74 type II diabetics will be randomized. Key inclusion criteria: overweight (BMI≥25), motivated to lose weight, and are at least 18 years of age.
Key exclusion criteria: pregnant women or women of childbearing age, currently taking medications for weight loss, enrolled in another clinical trial, or planning on having bariatric surgery. Any patient who is taking medication prescribed by a physician for depression, anxiety, or any other psychiatric disorder will be excluded. Patients on glucocorticoids in excess of Prednisone 7.5 mg or equivalent will also be excluded.
Study Design: All patients who pass screening will be administered the IPQ Test®[6]. This test stratifies patients on how they use their imagination, an important factor necessary to reach their goals. This is predictive of their potential to "persist" toward agreed upon goals. Patients will be divided into groups as follows: (Raw score 49-96 = high responders; Raw score 0-48 = Low responders).
Ultimately, subjects will be divided into four groups: The assignment of "high" versus "low" responders will be based on the results of the IPQ® test. Subjects will then be randomly assigned to intervention versus control in a 1:1 fashion. Optimally, there should be equal numbers in each group; however, the group sizes may be unequal depending on the relative proportions of high versus low responders. The four groups will be as follows:
Group I (high responders) will receive self-hypnosis using the GIFT™ (Goal Image Focusing Technique)[7] as the main means of autosuggestion and self/group motivation to lose weight.
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
- 否
入选标准
- •Diagnosis of Type 2 Diabetes
- •BMI greater than 25
排除标准
- •pregnant women of of childbearing age
- •currently taking weight loss medications
- •enrolled in another clinical trial
- •currently taking medications for depression or anxiety
- •currently taking Prednisone >7.5 mg day
研究组 & 干预措施
Self-hypnosis
Subjects underwent two group sessions one week apart with a certified hypnotherapist to teach them the process of self-hypnosis for the purpose of attaining weight loss. Subjects were asked to perform self-hypnosis once or twice a day for the duration of the one year trial.
干预措施: Self-hypnosis (Behavioral)
CDE training
Subjects underwent two group sessions one week apart with a certified diabetes educator to teach them re: diet and nutrition specifically as regards to a diabetic striving to lose weight. Subjects were asked to remain compliant with dietary restrictions for the duration of the one year trial.
干预措施: CDE training (Behavioral)
结局指标
主要结局
Change in weight (BMI)
时间窗: one year
Comparison of subject's weight (BMI) from screening visit to last study visit.
次要结局
- Waist circumference(One year)
- hemoglobin A1c(one year)
- fasting glucose(one year)
- High versus low imagery(one year)
- Compliance(one year)
- Reproducibility of IPQ(one year)
- Degree of weight loss in obese versus overweight(one year)
研究者
David I. Levenson, MD
PI
Levenson, David I., M.D.
