Clinical trial NCT03609983: Diet, Physical Activity, and Weight Trends Study
Official title: Diet, Physical Activity, and Weight Trends Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Self-Regulation
Lead sponsor: The University of Tennessee, Knoxville
Sponsor class: OTHER
First posted: 2018-08-01
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: A 3x2 mixed factorial design will be used, with a between-subject factor will of self-weighing group (daily weighing; weekly weighing; and no weighing control group) and within-subject factor will of time (prior to self-weighing and feedback and during self-weighing and feedback).
Primary purpose: SCREENING

Brief summary: 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.

Detailed description: 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.

At the conclusion of the session, participants will be scheduled to return to HEAL lab three weeks later. This session three weeks later will last approximately 5 minutes. Participants will receive the Armband and be instructed to wear the Armband for a minimum of 10 hours each day during for the next week and reminded 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). At the end of session, the participants will be scheduled to return to HEAL lab one week later. This session one week later will last approximately 60 minutes. Participants will be weighed and measured and be asked to complete follow-up questionnaires for eating attitudes, binge eating, unhealthy weight control behaviors, mood, and self-esteem. Participants will also be asked questions regarding their thoughts and feelings about self-regulation. Participants will also return the Armband and Yunmai SE Scale (intervention groups only) to the researcher. Handouts generated from ASA24 and SenseWear software that summarize the participant's dietary intake data from ASA24 and physical activity data from the Armband will be provided to the participants.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: 24-hour Dietary Recall
timeFrame: Change in diet from Week 1 to Week 5
measure: Physical Activity
timeFrame: Change in physical activity from Week 1 to Week 5
Secondary outcomes:
measure: Weight
timeFrame: Baseline appointment and follow-up appointment 5 weeks later
measure: Eating Attitudes
timeFrame: Baseline appointment and follow-up appointment 5 weeks later
measure: Binge Eating
timeFrame: Baseline appointment and follow-up appointment 5 weeks later
measure: Unhealthy Weight-Control Behaviors
timeFrame: Baseline appointment and follow-up appointment 5 weeks later
measure: Self-Esteem
timeFrame: Baseline appointment and follow-up appointment 5 weeks later
measure: Mood
timeFrame: Baseline appointment and follow-up appointment 5 weeks later
measure: Participant Feedback
timeFrame: End of study 5 weeks after baseline appointment
Other outcomes:
Locations:
city: Knoxville
country: United States
facility: Healthy Eating and Activity Laboratory, University of Tennessee
state: Tennessee
Study officials:
affiliation: University of Tennessee
name: Genevieve Prushinski
role: PRINCIPAL_INVESTIGATOR
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