Building Habits Together: Feasibility Trial of an Integrated Mobile and Social Network Weight Loss Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Mean Number of Uses of the Temptation Tracker
研究概览
简要总结
The purpose of this 6 week single-arm pilot is to evaluate the feasibility of the Habit app plus Facebook group intervention in 20 adults with obesity. Participants will participate in a 6-week version of the intervention which involves receiving a feed based on the Diabetes Prevention Program in a private Facebook group, access to a professional weight loss counselor in the Facebook group, MyFitnessPal, and the Habit app.
详细描述
The purpose of this single-arm pilot is to evaluate the feasibility of the intervention in 20 adults with obesity. We define feasibility as use of the mobile app features (dietary self-monitoring, slip tracker, and problem sharing/solving), retention, engagement (overall, problem solving), acceptability, and burden. This study will give us information that we can use to modify the intervention and our procedures before the larger pilot study. We will enroll 20 adults with obesity to participate in the 6-week pilot. Eligible participants will receive a link to complete surveys, mailed a wifi scale, and asked to provide staff with login information for the scale so weight can be recorded during assessments. They will then have a 60-minute call with a counselor to 1) download and receive training on program technology (MyFitnessPal, Habit app, and Fitbit scale) and 2) be entered into the Facebook group. Participants will participate in a 6-week version of the intervention which involves receiving a feed based on the Diabetes Prevention Program in a private Facebook group, access to a professional weight loss counselor in the Facebook group, MyFitnessPal, and the Habit app. Every Monday in the group, participants will be given one diet and one exercise goal for the week and every Sunday they will be asked to share their progress on those goals. Every Friday they will participate in a "weigh in" thread in the group. In addition to the group, for the first two weeks, participants will be asked to use MyFitnessPal; for the second two weeks, they will be asked to use the Temptation/Slip Tracker and Exercise Planner; and for the final two weeks they will be asked to use the Problem Solver. We will ask each participant to share at least one diet or exercise problem with the group over the 6 weeks and to participate in each other's problem solving posts. Participants may attend optional weekly breakout sessions where weight loss related problems will be discussed. On the final day of the intervention, a post will go up in the group asking for a volunteer who used the app enough to brainstorm how to improve it to participate in a team meeting to discuss how to improve the program. If more than one participant volunteers, one will be randomly selected to participate. After the 6-week intervention, participants will complete the weight loss problem solving skills survey, provide a final weight, and complete individual phone interviews to discuss their experience. We will convene a team meeting with the investigators, interventionists, and a participant to discuss the results and any modifications that should be made to the program before progressing to the pilot study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •BMI 30-45 kg/m2
- •has wifi connectivity at home (for wifi scale)
- •logs into Facebook at least 5 days per week over the past 2 weeks, and has posted/replied at least once a week in the past 2 weeks
- •able to participate in the study in English.
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 surgery during the study
- •currently taking medication affecting weight
- •has lost ≥10% of weight in past year
- •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
- •Type 1 or 2 Diabetes
- •unable to make dietary changes or increase physical activity
- •unable to walk ¼ mile unaided without stopping
- •currently smokes or vapes nicotine
- •does not live in the United States
- •had major surgery in past 6 months
- •hospitalized for psychiatric reasons in past 12 months
- •has concerns about being audiotaped during the focus groups
- •does not have or not willing to create Fitbit account for study
- •unable to access smartphone at home and at work
- •does not have FB
- •has done a study with this PI before
- •has concerns about being in FB group with faculty/students of same university in which they work/attend
- •does not have smartphone
- •smartphone type/version not meeting app requirements
- •unable to provide consent
- •does not complete onboarding steps for the study
结局指标
主要结局
Mean Number of Uses of the Temptation Tracker
时间窗: 2 weeks
Participants were asked to use the temptation tracker on weeks 3 and 4 of the intervention. Uses were extracted from the app's backend server.
Mean Number of Slips Reported
时间窗: 2 weeks
Participants were asked to report whether a temptation led to a slip or if they resisted on weeks 3 and 4 of the intervention. Uses were extracted from the app's backend server.
Mean Number of Temptations Resisted
时间窗: 2 weeks
Participants were asked to report whether a temptation led to a slip or if they resisted on weeks 3 and 4 of the intervention. Uses were extracted from the app's backend server.
Mean Number of Exercises Planned
时间窗: 2 weeks
Participants were asked to plan their exercise in advance on weeks 3 and 4 of the intervention. Uses were extracted from the app's backend server.
Mean Number of Total Problems Solved
时间窗: 2 weeks
Participants were asked to use the app problem solver on weeks 5 and 6 of the intervention. Uses were extracted from the app's backend server.
Mean Number of Diet Problems Solved
时间窗: 2 weeks
Participants were asked to use the app problem solver on weeks 5 and 6 of the intervention. Uses were extracted from the app's backend server.
Mean Number of Exercise Problems Solved
时间窗: 2 weeks
Participants were asked to use the app problem solver on weeks 5 and 6 of the intervention. Uses were extracted from the app's backend server.
Number of Participants Saying They Agree or Strongly Agree They Would Continue to Use the Habit App if Given the Chance
时间窗: 6 weeks
Participants will rate how much they agree with the statement "I would continue to use the Habit app after the study if given the chance" on 5-point Likert scales.
Number of Participants Saying They Agree or Strongly Agree That They Would Recommend the Habit App to a Friend
时间窗: 6 weeks
Participants will rate how much they agree with the following statement "I would recommend the Habit app to a friend who is trying to lose weight" on a 5-point Likert scale.
Number of Participants Rating the Temptation and Slip Tracker as Time-consuming
时间窗: 6 weeks
Participants will rate their agreement with statements about how time-consuming participation in the program and use of each component (temptation/slip tracker, problem solver, etc) is on 5-point Likert scales. This outcome counts number of participants that Strongly Agree or Agree.
Number of Participants Rating the Problem Solver as Time-consuming
时间窗: 6 weeks
Participants will rate their agreement with statements about how time-consuming participation in the program and use of each component (slip tracker, problem solver, etc) is on 5-point Likert scales. This outcome counts number of participants that Strongly Agree or Agree.
Number of Participants Rating the Exercise Planner as Time-consuming
时间窗: 6 weeks
Participants will rate their agreement with statements about how time-consuming participation in the program and use of each component (slip tracker, problem solver, etc) is on 5-point Likert scales. This outcome counts number of participants that Strongly Agree or Agree.
Median Total Engagements in the Facebook Group
时间窗: 6 weeks
Using Grytics, we will retrieve objective engagement data from the Facebook group, including the date and content of all posts, replies, reactions, and poll votes. We will calculate the total number of posts, replies, reactions, and poll votes per participant.
次要结局
未报告次要终点
研究者
Sherry Pagoto
Professor
University of Connecticut