WW Improving Nutrition Study: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 376
- 试验地点
- 2
- 主要终点
- Diet quality (Healthy Eating Index - 2015 score)
研究概览
简要总结
The main objective of this study is to determine whether a behavior change weight management and wellness program (WW) delivered via an app for 6-months will be effective in improving diet quality in U.S. adult participants, relative to a control group through a randomized controlled trial.
详细描述
The WW Unlimited Workshops and Digital Program is an evidence-based behavioral weight management program that guides members toward personal weight and wellness goals through a personalized curriculum, complemented with behavioral weekly goals to drive healthy habits. The program includes foods that can be eaten in moderation without the need to tracking, as well as a points system that rates foods. In addition, members have access to food, activity, water, sleep, and weight trackers, meal planning tools, recipes, guided meditations and workouts, peer support, and access to online workshops and WW-trained behavior change coach.
To compare the 6-month changes in diet quality (HEI-2015 total score), in adult participants enrolled in a commercial weight-loss program (WW) vs. control, a total of 376 adults will be recruited via social media and other online platforms in the contiguous 48 States of the US. Participants will be randomly assigned to access the WW app, or a control, and will be followed-up for 6 months.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Self-reported desire to lose weight
- •English proficiency
- •Ages: 18 - 70 years old
- •BMI between 27-45 kg/m2
- •Owns a smartphone with a camera
- •Wi-Fi connectivity at home
- •Willing to follow recommendations required by study protocol
- •Willing to actively participate in a behavioral weight loss program for 6 months and to attend virtual workshop meetings
- •Willing to include demographic information (e.g., ethnicity, income, and education)
- •US residence (48 contiguous States)
- •Must be able to receive in the mail a weight scale.
排除标准
- •Pregnant, lactating, or plans to become pregnant during study period
- •Self-reported bipolar disorder, substance abuse, psychosis, bulimia.
- •Meets criteria for severe depression on the Patient Health Questionnaire-8 (PHQ-8) (score of >20)
- •All other mental health, including other eating disorders will be assessed using a self-report question on the initial screening survey.
- •Had bariatric surgery or plans to have any surgery during the study
- •Unable or not willing to make dietary changes or increase physical activity
- •Unable to walk ¼ mile unaided without stopping
- •Daily nicotine user: smoke, vape, tobacco, other
- •Participants that are currently trying to lose weight via 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
- •Weight loss of ≥ 5 kg (11 lb) in the previous 6 months
- •Reported health problems that make weight loss or unsupervised exercise unsafe or unreasonable (e.g., chronic pain, 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, Phentermine (Adipex-P, Lomaira) and others except for subjects on a stable dose of Selective serotonin reuptake inhibitors (SSRIs) for 6 months or longer
- •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
- •Diagnosis of type 1 or type 2 diabetes
- •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
- •Hospitalization for psychiatric disorders during the past 12 months
结局指标
主要结局
Diet quality (Healthy Eating Index - 2015 score)
时间窗: Baseline to 6-months
Diet quality scores (HEI-2015 total score), measured with the Automated Self-Administered Dietary Assessment Tool 24-hour dietary recalls (ASA 24)
次要结局
- Achievement of 3% weight loss(Baseline to 6-months)
- Achievement of 10% weight loss(Baseline to 6-months)
- Impact of weight on quality of life(Baseline to 6-months)
- Self-reported physical activity over the past 7 days(Baseline to 6-months)
- Percent (%) body weight loss(Baseline to 6-months)
- Habit strength(Baseline to 6-months)
- Dietary intake(Baseline to 6-months)
- Feelings of hunger over the past 7 days(Baseline to 6-months)
- Achievement of 5% weight loss(Baseline to 6-months)
- Self-reported sleep quality(Baseline to 6-months)
- Food cravings(Baseline to 6-months)
- Perceived stress(Baseline to 6-months)
- Self-reported Wellbeing(Baseline to 6-months)
- HEI-2015 component-scores(Baseline to 6-months)
- Alternate Mediterranean Diet Score (AMED)(Baseline to 6-months)
研究者
Ana Palacios
Assistant Professor
Georgia Southern University