Study of Novel Approaches for Prevention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 599
- 试验地点
- 4
- 主要终点
- Weight Changes From Baseline Over Follow-up.
研究概览
简要总结
The Study of Novel Approaches for Prevention (SNAP) is randomized trial designed to test whether behavioral interventions based on self-regulation can prevent weight gain in young adults (18-35 years; body mass index (BMI) 21-30 kg/m2). Two different self-regulation interventions for weight gain prevention will be compared in this trial; one intervention will focus on making small, consistent, changes in eating and exercise behavior to prevent weight gain or reverse weight gain if it occurs, whereas the other will emphasize larger changes in eating and exercise that occur periodically, with a goal of producing weight loss and thereby providing a buffer against anticipated weight gains. The primary aim of the trial is to test whether the magnitude of weight gain from baseline across an average three-year follow-up differs across the three groups, with the hypotheses that weight gain will be greater in the Control group than in either intervention and greater in the Small Changes than Large Changes group.
SNAP-E (Extension) will determine whether the effects of the intervention can be maintained over an additional 3 years (i.e. through a total of 6 years).
详细描述
Young adults, aged 20-35 years, experience the greatest rate of weight gain, averaging 1-2 lbs/yr. Over time, this weight gain is associated with a worsening in cardiovascular disease risk factors and an increase in the prevalence of metabolic syndrome. Given the difficulties in producing sustained weight loss later in life, preventing weight gain from occurring during this critical period is key to curbing the obesity epidemic. The Study of Novel Approaches for Prevention (SNAP) is a 2-center randomized trial designed to test whether behavioral interventions based on self-regulation can prevent weight gain in young adults (18-35 years; body mass index (BMI) 21-30 kg/m2). Approximately 600 participants will be recruited over two years and randomly assigned to a control condition (N=200), self-regulation with small changes (N=200) or self-regulation with large changes (N=200). The Small Changes group will be taught to make small, consistent, changes in eating and exercise behavior to prevent weight gain or reverse weight gain if it occurs whereas the Large Changes group will emphasize periodic, larger changes in eating and exercise, with a goal of producing weight loss and thereby providing a buffer against anticipated weight gain. The primary aim of the trial is to test whether the magnitude of weight gain from baseline across an average planned follow-up of three years differs across the three groups, with a priori hypotheses that weight gain will be greater in the Control group than in either intervention and greater in the Small Changes than Large Changes group. Secondary aims are to compare the three groups on a) the proportion of participants in the three groups who gain less than 1 pound over the planned follow-up, b) the mean difference in weight gain from baseline to 24-month follow-up, c) the changes in behaviors and psychosocial measures (diet, physical activity, dietary restraint, frequency of self-weighing,depression, and occurrence of abnormal eating behaviors), and d) the changes in cardiovascular disease risk factors (blood pressure, lipids, insulin sensitivity, and waist circumference). The trial will also examine the association among changes in behaviors, weight, and cardiovascular disease risk factors and examine variables that may moderate the effects of the intervention (including gender, ethnicity, initial BMI, age) and potential mediators of the effects of the intervention (including changes in diet, activity, and self-regulatory behaviors). SNAP is member of the Early Adult Reduction in Weight Through Lifestyle Interventions (EARLY) consortium of clinical trials funded by the National Heart, Lung, and Blood Institute.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI of 21 - 30 kg/m2
排除标准
- •Untreated hypertension, hyperlipidemia, or type 2 diabetes, unless permission is provided by their health care provider.
- •Heart disease, heart problems or report being prescribed drugs for blood pressure or a major heart condition, unless permission is provided by their health care provider.
- •Type 1 diabetes or treatment of type 2 diabetes with insulin or oral medication that may cause hypoglycemia.
- •Health problems which may influence the ability to walk for physical activity (e.g. lower limb amputation) or other reasons why a person should not do physical activity, unless permission is provided from their health care provider.
- •Health problems that may be associated with unintentional weight change or affect the safety of a weight loss program, including report of a heart attack or stroke, chest pain during periods of activity or rest, loss of consciousness, active tuberculosis, HIV, chronic hepatitis B or C, inflammatory bowel disease requiring treatment within the past year, thyroid disease, renal disease, liver disease, hospitalization for asthma in the past year, or cancer within the past 5 years (except for non-melanoma skin cancers or early stage cervical cancer) or chronic use of steroid medication.
- •Report of a past diagnosis of or treatment for a Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision (DSM-IV-TR) eating disorder (anorexia nervosa or bulimia nervosa) or meet criteria for anorexia or bulimia nervosa during screening for this trial
- •Report of a past diagnosis of or current symptoms of alcohol or substance dependence.
- •Currently pregnant, pregnant within the past 6 months, or planning to become pregnant within the next 6 months.
- •History of schizophrenia, manic depression, or bipolar disorder.
- •Hospitalization for depression or other psychiatric disorder within the past 12 months.
- •Having lost and maintained a weight loss of 10 pounds or more within the past 6 months or are currently participating in a weight loss program, trying to gain weight, using steroids for muscle mass or weight gain, taking weight loss medication, or have had surgery for weight loss.
- •Participation in another weight loss or physical activity study that would interfere with this study.
- •Another member of the household (or roommate) is a participant or staff member on this trial.
- •Reason to suspect that the participant would not adhere to the study intervention or assessment schedule (i.e., can't come to group on a regular basis; will be away for more than two weeks during initial intervention phase or planning to move from the area within next year).
- •Not able to speak and understand English.
- •Residence or place of work further than 30 miles from the intervention site.
- •Perceived inability to attend the 2 year data collection visit.
- •Does not have Internet access on a regular basis.
结局指标
主要结局
Weight Changes From Baseline Over Follow-up.
时间窗: 3 years
Mean weight change from baseline across an average planned follow-up of three years. These mean changes will be compared among the three arms of the trial.
次要结局
- Weight Gain 1 Pound or More at Any Time Over Follow-up(3 years)
- Mean Weight Changes(2 years)
- Mean Changes in Systolic Blood Pressure(Measured at 2 Years)
- Mean Changes From Baseline in Diastolic Blood Pressure(2 years)
- Mean Changes From Baseline to 2 Years in Total Cholesterol(2 years)
- Obesity(3 years)
- Dietary Restraint: Mean Change From Baseline to 2 Years(2 years)
- Disinhibition(Changes at 2 years)
- General Health Index(Changes from baseline to 2 years)
- Flexible Dietary Control(Changes from baseline to 2 years)
- Rigid Dietary Control(Changes from baseline to 2 years)
- Mean Changes in High Density Lipoprotein Cholesterol (HDL-C)(2 years)
- Mean Changes in Low Density Lipoprotein Cholesterol (LDL-C)(2 years)
- Mean Change in Fasting Glucose From Baseline to 2 Years(2 years)
- Mean Change in Fasting Insulin From Baseline to 2 Years(2 years)
- Depression Symptomatology(2 years)
- Insulin Resistance(Change from baseline to 2 years)
- Total Energy Dietary Intake Per Day (Kcals)(Changes from baseline to 2 years in kilocalories)
- Change in Waist Circumference (cm)(Change from baseline to 2 years)
- Self-weighing(2 years)