Single Arm Trial of a Multi-component Commercial Digital Weight Loss Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 153
- 试验地点
- 1
- 主要终点
- Percent of Days Diet Tracking Feature Was Used in App
研究概览
简要总结
The goal of the proposed research project is to evaluate the acceptability and efficacy of an online multicomponent commercial weight loss program and to understand the relationship between program engagement and weight loss and health outcomes.
详细描述
Technology is changing the opportunities to deliver behavioral weight loss programs and providing a way to extend their reach to wider audiences. Commercial programs that were once completely delivered via in person meetings at brick-and-mortar businesses are now expanding to virtual programs. WW (formerly known as Weight Watchers) is an industry leader and one of few commercial programs that has significant evidence for efficacy on weight loss. Their program currently includes a mobile app - that helps people follow the WW Program, rewards for consistent tracking and achieving milestones, an online community to connect with other users, and a 24/7 text chat with coaches.
Previous research by the investigators and others reveals that greater engagement in an online group-based weight loss program is associated with greater weight loss. We have found that an online group coaching program paired with a calorie tracking mobile app is effective at producing weight loss. WW is testing a new comprehensive program that involves an updated program paired with virtual workshops that offer actionable behavior change techniques for members, led by a trained WW coach. They have agreed to fund us to perform a one-arm trial of their new comprehensive program that includes a holistic approach to healthy lifestyle (activity, diet, and mindset). Findings will inform the continued development of this program. Our aims are as follows: 1) To examine the preliminary outcomes and acceptability of a multicomponent online commercial weight loss program that includes a mobile app, incentives for tracking, weekly virtual workshops, and an online community. Preliminary outcome is defined as weight change from baseline to 3 and 6-months. Secondary preliminary outcomes include changes in diet quality, physical activity, quality of life, sleep quality, and food cravings from baseline to 6 months. Acceptability of each program component and the overall program will be evaluated at 6 months. 2) To examine whether greater app use, greater engagement in the online community, and engagement with a higher number of peers (in the online community) predict greater weight loss at 3- and 6-months. 3) To examine the associations between total use of program components (and each individual program component) and change in weight. We hypothesize that greater use of program components (individually and total) will predict greater weight loss.
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
- 是
入选标准
- •18-75 years old.
- •BMI 25-45 kg/m
- •Has Wi-Fi connectivity at home
- •Able to participate in the study in English.
- •Self-reported desire to lose weight.
- •Willing to follow recommendations required by study protocol.
- •Willing to include demographic information (e.g., ethnicity, income and education)
- •Lives in the United States
排除标准
- •Pregnant, lactating, or plans to become pregnant during study period.
- •Bipolar disorder, substance abuse, psychosis, bulimia, binge eating disorder, or severe depression.
- •Had bariatric surgery or plans to have any surgery during the study
- •Unable to make dietary changes or increase physical activity.
- •Unable to walk ¼ mile unaided without stopping
- •Smoker or use nicotine vape daily.
- •Participants that are currently, or within the last 6 months, 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 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, etc.) with the exception of subjects on a stable dose of SSRIs for 6 months.
- •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 (completely resected basal or squamous cell carcinoma acceptable if treatment completed more than 6 months prior to enrollment).
- •Meets criteria for severe depression on the PHQ-9 (score of >20) or endorsement of "Thoughts that you would be better off dead, or of hurting yourself in some way".
- •Hospitalization for psychiatric disorders during the past 12 months.
- •Not willing to sign an NDA; or indicated they do not want to agree to NDA's terms.
- •Unable to attend any virtual workshop meeting times.
- •Does not have an iPhone.
研究组 & 干预措施
Lifestyle Modification Program
This 6-month intervention includes the use of three components: WW's mobile app, virtual workshops, and a private online community. The WW Program involves: self-monitoring of weight, dietary intake, and physical activity; making dietary changes; increasing physical activity; shifting to a more helpful mindset; and learning behavioral strategies to manage these goals. Each week, participants will set goals and weigh-in with a coach via virtual workshop. Participants will be encouraged to use the app and private online community daily and attend weekly virtual workshops. The weekly virtual workshop led by a trained WW Coach features a behavior change technique and enables the participant to practice it to support their goals. These are actionable techniques and strategies that are grounded in scientific research.
干预措施: myWW App, Virtual Workshops, and Private Facebook Group (Behavioral)
结局指标
主要结局
Percent of Days Diet Tracking Feature Was Used in App
时间窗: 6 months
Percent of days participants used the diet tracking feature in the WW app during the intervention to track their daily food intake. A day of use will be defined as a day where participants tracked any food item in the WW app.
Intervention Acceptability
时间窗: 6 months
Percent of participants who agree or strongly agree that the program made them feel healthier.
Percent Change in Weight From Baseline to 3 Months
时间窗: Baseline to 3-months
Weight was measured using a smart scale at baseline and at the three month assessment.
Weight Change in Pounds From Baseline to 6 Months
时间窗: Baseline to 6-months
Weight will be measured using a smart scale at all assessments. Weight change will be calculated as weight at 6 months in pounds minus baseline weight in pounds. Lower values mean more weight loss.
Number of Days Physical Activity Tracking Feature Was Used in App
时间窗: 6 months
Number of days participants used the physical activity feature in the WW app during the intervention. A day of use will be defined as any day in which any physical activity was logged. Total days possible = 168 days.
Number of Weekly Virtual Workshops Attended
时间窗: 6 months
Number of weekly workshops attended by participants during the program. During the 6-month intervention, there were a total of 24 weekly workshops.
Number of Weekly Check Ins Attended
时间窗: 6 months
Number of weekly check ins completed by participants during the program. During the 6-month intervention, there were 24 opportunities for weekly check ins. Higher numbers mean more weekly check ins were completed.
Number of Weeks Participants Engaged in the Private, Online Community
时间窗: 6 months
All posts, comments, and reactions made in the Facebook group were captured using Grytics for Facebook each of the 24 weeks of the intervention. Participants were considered engaged with the intervention by making at least one post, one comment, and/or one reaction (e.g., like) during the intervention week. Values could range from 0 to 24 weeks with higher numbers indicating more frequent engagement in the intervention.
Weight Change in Pounds From Baseline to 3 Months
时间窗: 3 months
Weight will be assessed via digital scales provided to participants. Weight change will be calculated by subtracting weight in pounds at 3 months from baseline weight. Lower values indicate greater weight loss in pounds.
Percent Weight Change From Baseline to 6 Months
时间窗: 6 months
Weight is assessed via digital scales provided to participants. Percent weight change will be calculated by subtracting 6 month weight in pounds from baseline weight in pounds, dividing by baseline weight in pounds, and then multiplying this number by 100. Lower values indicated greater weight loss.
次要结局
- Change in Vegetable Intake Score(baseline to 6 months)
- Changes in Sleep Quality(Baseline to 6-months)
- Changes in Food Cravings(Baseline to 6-months)
- Changes in Hunger(Baseline to 6-months)
- Changes in Positive Behavioral Automaticity(Baseline to 6-months)
- Change in Salad Intake Score(baseline and 6 months)
- Changes in Self-Compassion(Baseline to 6-months)
- Change in Well-being(Baseline to 6-months)
- Changes in Food Cravings(Baseline to 6-months)
- Change in Fruit Intake Score(Baseline to 6-months)
- Change in Physical Activity(Baseline to 6-months)
- Changes in Quality of Life(Baseline to 6-months)
- Changes in Sleep Quality(Baseline to 6-months)
- Changes in Hunger(Baseline to 6-months)
- Changes in Positive Behavioral Automaticity(Baseline to 6-months)
- Changes in Self-Compassion(Baseline to 6-months)
- Change in Well-being(Baseline to 6-months)
- Change in Vegetable Intake Score(baseline to 6 months)
- Change in Salad Intake Score(baseline and 6 months)
研究者
Sherry Pagoto
Professor
University of Connecticut