NCT03928483已完成早期 1 期
Evaluation of a Commercial Program on Weight Loss and Health Outcomes
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 143
- 试验地点
- 2
- 主要终点
- body weight change (kg)
研究概览
简要总结
To examine weight loss and acceptability of a modified WW program. This study is designed to detect differences in weight loss at the end of 24 weeks of intervention.
详细描述
This trial is an examination of a modified WW food program. The intention is to document the acceptability and efficacy of the dietary plan over 24 weeks. Subjects will participate in a program similar to WW Freestyle and have access to study-specific weekly workshops and a suite of study-specific digital tools for tracking eating, activity, and weight. Within a WW program, participants are provided instructions on calculating points for the foods and beverages they eat and drink. This study will examine the impact of the modified WW food program on weight and fitness levels of adults with overweight and obesity.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages 18-75 years
- •Body Mass Index (BMI) of 25 to 43
- •Self-reported desire to lose weight
- •Willing to discontinue any current over-the-counter (OTC) supplements not recommended/prescribed by physician, with the exception of multivitamins or other vitamin supplement
- •Willing to follow recommendations required by study protocol
- •Willing to include demographic information (e.g., ethnicity, income and education)
- •Use of a personal iPhone on a daily basis
- •Basic app skills
- •Reliable home Wi-Fi access
- •Ability to commit to attending up to 27 study visits in approximately 26 weeks
- •Exclusion Criteria
- •Participants that are currently, or within the last 6 months, trying to lose weight by following guidelines (e.g., self-initiated programs) or a structured weight-loss program (e.g., at a medical center, university, commercial programs)
- •Participants who were a member of WW within the past 12 months.
- •Participants who are involved in any other research studies at this time (also, cannot join other research studies while in this study, over the next 6 months).
- •Pregnant, nursing, or planning on becoming pregnant over the next 9 months.
- •Weight loss of ≥ 5 kg in the previous 6 months.
- •History of clinically diagnosed eating disorder.
- •Reported health problems that make weight loss or unsupervised exercise unsafe or unreasonable (e.g., orthopedic limitations, heart problems)
- •Untreated thyroid disease or any changes (type or dose) in thyroid medication in last 6 months.
- •Taking any prescription medication with known effects on appetite or weight (e.g., oral steroids, weight loss medications such as Qysmia, Contrave, etc.) with the exception of subjects on a stable dose of SSRIs for 6 months
- •Diuretic use, unless taken on a regular, daily basis for hypertension and on a stable dose for at least 30 days
- •Chronic/inflammatory gastrointestinal disorders (irritable bowel syndrome is acceptable).
- •History of heart problems (e.g., angina, bypass surgery, myocardial infarction, etc.) within previous 6 months.
- •Resting systolic blood pressure >160 mmHg or resting diastolic blood pressure >100 mmHg
- •Diagnosis of type 1 or type 2 diabetes
- •Previous surgical procedure for weight loss.
- •Major surgery within the previous 6 months.
- •Presence of implanted cardiac defibrillator or pacemaker.
- •History of cancer within past 5 years or current treatment for cancer (completely resected basal or squamous cell carcinoma acceptable if treatment completed more than 6 months prior to enrollment).
- •Hospitalization for psychiatric disorders during the past 12 months
- •Self-reported alcohol use > 7/week standard drinks for females and > 14/week for males or meets DSM-5 criteria for mild or greater, Alcohol Use Disorder
- •Planning to relocate in the next 9 months
排除标准
- 未提供
结局指标
主要结局
body weight change (kg)
时间窗: baseline to six months
average body weight change (kg) from baseline to six months
次要结局
- flexibility(baseline, 3-months and 6-months)
- aerobic stamina(baseline, 3-months and 6-months)
- happiness(baseline, 3-months and 6-months)
- 3-month change in weight (kg)(baseline to 3-months)
- 6-month changes in body weight as a percentage of start weight(baseline to 6-months)
- changes in Body Mass Index (BMI)(baseline, 3-months and 6-months)
- 3-month change in weight, as a percentage of start weight(baseline to 3-months)
- waist circumference(baseline, 3-months and 6-months)
- food cravings(baseline, 3-months and 6-months)
- health related quality of life: SF-36(baseline, 3-months and 6-months)
- weight related quality of life: Impact of Weight Related Quality of Life- Lite (IWQOL-Lite)(baseline, 3-months and 6-months)
- personal food assessment(baseline and 6-months)
- blood pressure(baseline, 3-months and 6-months)
- subjective sensations of hunger(baseline, 3-months and 6-months)
- program satisfaction: WW generated satisfaction questionnaire(3-months and 6-months)
- sleep quality and duration: Pittsburgh Sleep Quality Index(baseline, 3-months and 6-months)
研究者
研究点 (2)
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