Building Habits Together Online Weight Loss Program: Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Mobile App Use
研究概览
简要总结
The purpose of this pilot trial is to evaluate the feasibility of a lifestyle intervention where participants will all receive online weight loss counseling delivered via a private Facebook group, but be randomized to the Habit app (developed by the investigators) or MyFitnessPal, a commercial calorie tracking app.
详细描述
The purpose of this pilot trial is to evaluate the feasibility of a program where 70 adults with overweight or obesity will receive online weight loss counseling delivered via a private Facebook group, but be randomized to the Habit app (developed by the investigators) or MyFitnessPal, a commercial calorie tracking app. Participants randomized to the Habit app will be asked to record their weight daily, monitor their dietary temptations, plan their exercise, and solve diet and exercise related problems. The temptation tracker helps users identify triggers and track when and why those triggers lead to dietary lapses. The exercise planner allows users to plan their exercise for the week and track whether they completed or missed the exercise and why they missed it. The Habit app provides insights to users about the patterns of their dietary lapses and exercise habits. The problem solver feature helps users identify their biggest problem with diet/exercise and then asks a series of questions to help the app provide tailored solutions to the participant to work on. Participants randomized to MyFitnessPal will track their calorie intake and exercise daily during the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-65 years old
- •Body mass index (BMI) 27-45 kg/m2
- •Wi-Fi connectivity at home
- •Logs into Facebook at least 5 days per week over the past 2 weeks
- •Has posted/replied on Facebook at least once a week in the past 2 weeks
- •Able to participate in the study in English
- •Interested in losing weight
排除标准
- •Under the age of 18 and over the age of 65
- •BMI under 27 or over 45 at screening; then under 27 at the point of the first weight on scale
- •Does not have Wi-Fi connectivity at home
- •Does not have a Facebook account
- •Does not log into Facebook at least 5 days per week over the past 2 weeks
- •Did not post/reply on Facebook once a week over the past 2 weeks
- •Not able to participate in the study in English
- •Does not live in the United States
- •Not interested in losing weight
- •Pregnant/lactating or plans to become pregnant during study period
- •Reports having bipolar disorder, substance abuse, psychosis, an eating disorder, or severe depression
- •Had bariatric surgery or plans to have surgery during the study
- •Currently taking medication affecting weight
- •Has lost ≥5% of weight in past 3 months
- •Is participating or intends to participate in another weight loss program during the study that provides coaching or problem solving
- •Chronic pain that interferes with the ability to exercise
- •Has Type 1 Diabetes
- •Has Type 2 Diabetes
- •Unable to make dietary changes or increase physical activity
- •Unable to walk ¼ mile unaided without stopping
- •Currently smokes or vapes nicotine
- •No phone connectivity at home and work
- •Has a digestive disorder/condition that precludes dietary changes
- •Meets criteria for severe depression on the Patient Health Questionnaire (PHQ)-8 (score of >19)
- •Does not currently own a smartphone
- •Smartphone type and/or version not meeting app requirements
- •Participated in previous weight loss studies under the PI
- •Unable to attend the orientation webinar
- •If University of Connecticut (UConn) employee/student has concerns about being in a Facebook group with other UConn faculty, staff, and students
- •Had major surgery in past 6 months and have not been cleared by their doctor to resume physical activity and diet changes
- •Plans to have major surgery in the next 6-months
- •Has an implanted cardiac defibrillator or pacemaker
- •Did not complete screening and on-board processes of study (screening survey, webinar, e-consent, baseline survey, app set-up, scale set-up, etc.)
- •Not willing to be audiotaped for focus groups
- •Prisoner; or
- •Unable to provide consent
结局指标
主要结局
Mobile App Use
时间窗: 24 weeks
Investigators will calculate the number of days participants used their assigned app
Retention
时间窗: 24 weeks
Investigators will calculate retention as the proportion of participants who provide weight data at the 24 week follow-up
Engagement Per Participant in the Facebook Group
时间窗: 24 weeks
For each participant, investigators will calculate total engagement in the Facebook group as defined as reactions (e.g., like, care, wow, etc.), replies, posts, and poll votes during the 24-week program. Then we will calculate mean or median engagement per participant over 24 weeks.
Ease of Use (Acceptability)
时间窗: 24 weeks
Participants will rate how easy it was to use their assigned app (% who strongly agree/agree)
Contamination
时间窗: 24 weeks
Investigators will report the percent of participants in the Habit condition that used MyFitnessPal or other calorie tracking apps during the program.
Time Consuming (Burden)
时间窗: 24 weeks
Participants will rate their assigned app in terms of whether they felt it took too much time out of their day (% who strongly agree/agree)
次要结局
- Percentage of Baseline Weight Lost at 24 Weeks(24 weeks)
研究者
Sherry Pagoto
Professor
University of Connecticut