The Use of Liquid Meal Replacements in Conjunction With Lifestyle Intervention in Overweight Adolescents: A 12 Week Safety and Efficacy Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Outcome measures include for efficacy of intervention, height, weight, BMI, waist circumference, percent body fat, height Z-score, weight Z-score, BMI-Z score, degree of change in weight Z-score, BMI Z-score, and percent body.
研究概览
简要总结
In this 3-month pilot study, we will introduce to 40 adolescents "at risk for overweight" (i.e., a BMI/age >85th percentile) a structured meal plan consisting of meal replacements, fruits, vegetables, whole grains, lean protein and dairy products. We will encourage and invite at least one parent to the scheduled visits, however, no subject will be eliminated because of lack of parental involvement. In this study, we will conduct behavior modification group sessions using lessons which are structured and patterned after the suggestions documented in the LEARNÒ Program for Weight Control. Diet instruction by a registered dietitian will include the appropriate use of meal replacements for a low-fat, low-calorie meal plan. Portion sizes of all foods recommended will be reviewed and a structured meal plan will be developed by the dietitian for subjects to follow.
Subjects will return on a weekly basis for behavioral modification groups sessions in conjunction with the liquid meal replacement diet. Blood work and physical examinations will occur pre and post intervention.
详细描述
In this 3-month pilot study, we will introduce to 40 adolescents "at risk for overweight" (i.e., a BMI/age >85th percentile), a structured meal plan consisting of meal replacements, fruits, vegetables, whole grains, lean protein and dairy products. We will encourage and invite at least one parent to the scheduled visits, however, no subject will be eliminated because of lack of parental involvement. Parents will be encouraged to attend group sessions designed to include behavior modification, nutrition education, physical activity recommendations, and food demonstrations as a means of family support for the subject. In this study, we will conduct behavior modification group sessions using lessons which are structured and patterned after the suggestions documented in the LEARN Program for Weight Control. Diet instruction by a registered dietitian will include the appropriate use of meal replacements for a low-fat, low-calorie meal plan. Portion sizes of all foods recommended will be reviewed and a structured meal plan will be developed by the dietitian for subjects to follow. Subjects will return for 12 weekly group sessions.
For the purposes of this pilot study, mild hypertension is defined as a systolic blood pressure of >130 but <140 mm Hg and a diastolic blood pressure of >85 but <90 mm Hg. Dyslipidemia will be defined as a total cholesterol of >200 mg/dl, LDL >130 mg/dl, HDL <40 mg/dl for male subjects and <50 mg/dl for female subjects, and triacylglycerol of >150 mg/dl. Insulin resistance/diabetes shall be defined as a fasting glucose of >110 mg/dl.
Calculating Estimated Caloric Need:
Total caloric needs for subjects with a BMI >85th% for age and sex shall be calculated using the Basal Energy Expenditure multiplied by an Activity Factor (for an estimate of total energy requirements), then subtracting 250-500 calories (to achieve a 0.5 to 1 pound weight loss per week). Basal Energy Expenditure will be calculated by using the Harris-Benedict equation as follows:
Females = 655 + 4.4(wt. in lbs) + 4.3(ht. in inches) - 4.7(age in yrs) x AF Males = 66 + 6.2(wt. in lbs) +12.7(ht. in inches) - 6.8(age in yrs) x AF
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI >85th% for age and sex
- •Weight gain over the last 6 months of >5% than expected on the growth curve
- •12-17 years of age
排除标准
- •Subjects with intolerance to dairy products (e.g., lactose intolerance) will be excluded from entering into the study.
- •Subjects must not have a history of clinically significant cardiac disease, congenital heart disease, any clinically significant abnormal cardiac condition, or be known to have a clinically significantly abnormal ECG. Specifically excluded conditions include coronary artery disease, clinically significant cardiac arrhythmias, and congestive heart failure.
- •Subjects must not have a history of anorexia nervosa, untreated hypothyroidism (TSH greater than 4.0 mU/L for a second generation test), malignancy, pathophysiologic or genetic syndromes associated with obesity (i.e., Cushing's syndrome, Turner's syndrome, Prader Willi syndrome), major psychiatric illness such as bi-polar disorder, ADD, major depression, bulimia, schizophrenia, or psychosis.
- •Subjects may not participate in any weight management program, except for that in this study, during this pilot. Subjects may not use prescription or over-the-counter (or herbal) weight control medication during the trial.
- •Subjects must not have a history of alcohol or drug addiction or substance abuse within the previous 2 years.
结局指标
主要结局
Outcome measures include for efficacy of intervention, height, weight, BMI, waist circumference, percent body fat, height Z-score, weight Z-score, BMI-Z score, degree of change in weight Z-score, BMI Z-score, and percent body.
次要结局
- Include laboratory parameters such as lipids and HbA1c.