Evaluation of a Commercial Program on Weight Loss and Health Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 2
- 主要终点
- Weight Change
研究概览
简要总结
The purpose of this study is to examine the acceptability and efficacy of a modified Weight Watchers program over 24 weeks. Assessments will be conducted at 0, 3, and 6 months.
详细描述
The following assessment measures will be taken at 0, 3, and 6 months:
Weight measurements. Weight will be taken according to the National Health and Nutrition Examination survey anthropometry procedures manual. Weight will be measured in kilograms to the nearest 0.1 kg using a calibrated digital scale (Tanita, Inc.) with participants in light clothing and no shoes. Two measurements will be taken. and if the measures differ by more than 0.2 kg, a third measure will be taken. An average of the closest two measures will be calculated and used for data entry.
Waist circumference. Waist circumference will be assessed at baseline, 3 and 6 months. Waist circumference will be taken according to the National Health and Nutrition Examination survey anthropometry procedures manual. Measurements will be taken to the nearest 0.1cm, at the top of the pelvis ilium (just above the hip bone) with a non-stretchable tape measure, without compressing the skin, at the end of normal expiration. Two measurements will be taken with a third if the first two do not fall within 0.5 cm.
Aerobic stamina. Aerobic stamina will be assessed using the 6 minute walk test. Distance traveled in meters (m) is the outcome.
Flexibility. Flexibility will be assessed with the Classic Sit and Reach Test and reported in inches less than or greater than reached on a 20 inch reference mark as measured on a yard stick placed between the legs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index (BMI) between 25 and 43 kg/m²
- •Ability to read and speak English
- •All ethnic groups will be recruited
- •Self-report desire to lose weight and willing to follow study recommendations
- •Use of an iPhone with iOS 8.0 or later for use on a daily basis, and basic app skills
- •Have access to the internet via a computer, and basic computer skills
排除标准
- •Currently following a commercial weight-loss program (including Weight Watchers) or who followed a weight loss program in the previous 6 months or who were members of Weight Watchers within the past 12 months
- •Another member of the household participating in the study.
- •Pregnant or nursing, or planning on becoming pregnant over the next 9 months.
- •Planning to relocate in the next 9 months
- •Involvement in another research study that would interfere with participation in this study
- •Excessive alcohol intake or dependence
- •Recent weight loss of ≥ 5 kg in the previous 6 months.
- •Report health problems that make weight loss or unsupervised exercise unsafe or unreasonable (e.g., orthopedic limitations, heart problems, history or heart attack or stroke)
- •History of clinically diagnosed eating disorder.
- •Untreated thyroid disease or and changes in dose or type of thyroid medication over previous 6 months
- •Chronic/inflammatory gastrointestinal disorders (Irritable Bowel Syndrome acceptable)
- •Taking any prescription medication with known effects on appetite or weight
- •Previous surgical procedure for weight loss.
- •Major surgery within the previous 6 months.
- •Resting systolic blood pressure >160 mmHg or resting diastolic blood pressure >100 mmHg
- •Diuretic use over 1.5mg per day
- •Diagnosis of type 1 or type 2 diabetes
- •Presence of implanted cardiac defibrillator or pacemaker.
- •History of presence of cancer within past 5 years or current treatment for cancer (completely resected basal or squamous cell carcinoma acceptable if treatment
研究组 & 干预措施
Modified Weight Watchers plan
Modified Weight Watchers Plan which includes a food plan, activity plan, group support and cognitive behavior modification. Weekly study-specific group meetings; electronic tools through iPhone app for 24 weeks.
干预措施: Modified Weight Watchers plan (Behavioral)
结局指标
主要结局
Weight Change
时间窗: 0 - 6 months
Mean Change in body weight (kg) Body weight will be assessed on a calibrated digital scale and recorded to the nearest 0.1 kg.
次要结局
- Achieving a weight loss of 5% or more(0 - 3 months)
- Weight Change(0 - 3 months)
- Waist circumference change (cm) (mean)(0 - 6 months)
- Relationship between fitness, flexibility and psychosocial measures with weight change(0 - 6 months)