Diet, Physical Activity, and Weight Trends Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- 24-hour Dietary Recall
研究概览
简要总结
The purpose of this investigation is to is to examine if self-weighing with feedback, in which the feedback is matched to the timeframe of self-weighing, in the absence of a standard behavioral intervention assists with the self-regulation of energy balance behaviors among young adults. Participants will be randomized to one of three groups: 1) daily weighing; 2) weekly weighing; 3) no weighing for 4 weeks.
详细描述
All eligible participants will be scheduled for a baseline assessment at the Healthy Eating and Activity Laboratory (HEAL) that will last approximately 60 minutes. During this assessment, interested participants will sign the consent form. After signing the consent from, eligibility will be confirmed by taking height and weight measures and completing questionnaires assessing eating disorder risk and unhealthy weight control behaviors. Participants will also be given questionnaires assessing self-esteem and mood. Demographic information and contact information will be obtained. Next, eligible participants will be registered for the Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24) and provided instructions on how to complete 24-hour recalls using ASA24. Throughout the next week, participants will be randomly emailed on three days to complete three 24-hour recalls (1 weekend day, 2 weekdays). Participants will also be given a SenseWear Armband and provided instructions on how to use and care for the Armband. Participants will be instructed to wear the Armband for a minimum of 10 hours each day for the next week. At the conclusion of the session, participants will be scheduled to return to HEAL lab one week later.
This session one week later will last approximately 30 minutes. The investigator will confirm through ASA24 that the participant successfully completed three 24-hour recalls. To confirm that the participant successfully wore the Armband for at least 10 hours on the days the 24-hour recalls were completed, the investigator will download the Armband data using SenseWear software. After it has been confirmed that the participant completed these diet and physical activity measures, the participant will be randomized to the daily weighing group, weekly weighing group, or no weighing control group based on weight status. Participants in all groups will be provided with a handout containing general nutrition information about how to build a healthy eating pattern based on the 2015-2020 Dietary Guidelines for Americans.
Daily Weighing- Participants in the daily weighing group will be given a Yunmai SE Weight Scale and instructions for its use. Next, participants will be given instructions to download the Yunmai mobile app and create a user profile. Participants will be instructed to weigh themselves using the Yunmai SE Scale and app one time each day upon rising from bed (and before noon) after urination and in light clothing beginning in one week, every day for four weeks. Participants will be instructed to only weigh themselves using the scale provided during the duration of the study and to not allow others in their household use the scale. A reminder text and email will be sent to the participant to remind them to begin weighing on the assigned day. If on any day the participant has not weighed by 11am, the participant will receive an email and text reminder. After 2 weights have been collected, participants will begin to receive daily feedback on their change in weight and suggestions to maintain energy balance. They will receive an email between 12-1pm with this feedback stating, "Your weight today is _______. Your weight has (increased/decreased) _____ pounds since yesterday." If their weight has increased, the email will also contain a message stating, "If your goal is to maintain your weight, you may consider decreasing your energy balance by 150 calories" and will include one example of how to decrease their energy balance by 150 calories. If participants' weight has decreased, the participants will receive a message in addition to their feedback on change in weight stating, "If your goal is to maintain your weight, you may consider increasing your energy balance by 150 calories" and will include one example of how to increase energy balance by 150 calories.
Weekly Weighing- Participants in the weekly weighing intervention group will be given a Yunmai SE Weight Scale and instructions for its use. Next, participants will be given instructions to download the Yunmai mobile app and create a user profile. Participants will be instructed to weigh themselves using the Yunmai SE Scale and app one time each week upon rising from bed (and before noon) after urination in light clothing beginning the following day for four weeks. Participants will be instructed to only weigh themselves using the scale provided during the duration of the study and to not allow others in their household use the scale. If the participant has not weighed by 11am, the participant will receive an email and text reminder. After two weights have been collected, participants will begin to receive weekly feedback on their week and suggestions to maintain energy balance. Feedback and suggestions will be given as previously described above.
No Weighing Control- Participants in the non-weighing control group will be asked to refrain from weighing themselves for the next four weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 29 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •between the ages of 18 and 29 years
- •body mass index (BMI) 19.0-29.9 kg/m^2
- •weight goal of maintaining current weight/preventing weight gain
- •own and iPhone or Android phone to download the Yunmai app for the scale used for self-weighing
- •daily access to a computer with internet to complete dietary assessments online through ASA24
- •regularly wake up before 12pm (noon) on weekdays (Monday-Friday) and weekend days (Saturday-Sunday)
- •present on campus for time period required to complete the study
排除标准
- •self-reported previous or current diagnoses of an eating disorder, or at risk for an eating disorder defined as a score of ≥20 on EAT-26 and/or a score >27 on BES, and/or report of any extreme unhealthy weight control behaviors
- •participating in a program that sets dietary or physical activity goals
- •health condition that influences eating or physical activity or requires a therapeutic diet or physical activity restrictions
- •allergy to metal making the participant unable to wear BodyMedia SenseWear Armband.
结局指标
主要结局
24-hour Dietary Recall
时间窗: Change in diet from Week 1 to Week 5
Dietary intake data for 24-hour recalls will be collected using the Automated Self-Administered 24-Hour (ASA24), Dietary Assessment Tool, version 2016, developed by the National Cancer Institute, Bethesda, MD. Participants will be registered for ASA24 at the baseline appointment. Throughout the week following the baseline appointment, participants will be randomly emailed on three days to complete three 24-hour recalls (1 weekend day, 2 weekdays) through ASA24. Participants will be randomly emailed again on three days to complete three 24-hour recalls (1 weekend day, 2 weekdays) through ASA24 during the final week of the self-weighing condition.
Physical Activity
时间窗: Change in physical activity from Week 1 to Week 5
Activity will be collected with SenseWear Armbands worn by participants for at least 10 hours/day for one week after the baseline appointment and during the final week of the self-weighing condition. The SenseWear Armband utilizes a 2-axis accelerometer to detect motion, a heat flux sensor, galvanic skin response sensor (GSR), skin temperature sensor, and a near-body ambient temperature to calculate energy expenditure. The dependent variables will be total energy expenditure (kJ), moderate- to vigorous-intensity physical activity duration (3.0 METs and higher), and number of steps.
次要结局
- Weight(Baseline appointment and follow-up appointment 5 weeks later)
- Binge Eating(Baseline appointment and follow-up appointment 5 weeks later)
- Eating Attitudes(Baseline appointment and follow-up appointment 5 weeks later)
- Unhealthy Weight-Control Behaviors(Baseline appointment and follow-up appointment 5 weeks later)
- Self-Esteem(Baseline appointment and follow-up appointment 5 weeks later)
- Mood(Baseline appointment and follow-up appointment 5 weeks later)
- Participant Feedback(End of study 5 weeks after baseline appointment)
研究者
Hollie Raynor
Professor
The University of Tennessee, Knoxville