University of Virginia
Charlottesville, Virginia, 22901, United States
Location status: Recruiting
Location contact
Maddie Glover, B.S.
CONTACT
Teace Markwalter, MPH, CHES
CONTACT
NCT Number: NCT07292389
The purpose of this research study is to learn how to identify the most effective ways to provide weekly feedback on participants' progress toward intervention goals during a weight loss program.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Charlottesville, Virginia, 22901, United States
Location status: Recruiting
Maddie Glover, B.S.
CONTACT
Teace Markwalter, MPH, CHES
CONTACT
This micro-randomized factorial trial is designed to provide information about how to optimize self-monitoring feedback within a behavioral weight management intervention. All participants will attend a "Weight Loss 101" session that covers foundational weight loss education and behavioral skills training. During this session, they will also learn how to use study-provided tools to track their dietary intake, physical activity, and weight.
Each weekly feedback message will be composed by a trained interventionist. Participants will be randomized each week to one of the two conditions to examine how the tone and composition of feedback messages impact participant behaviors and weight loss.
The main questions that this study aims to answer are:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Feedback composed by a study interventionist that focuses exclusively on positively reinforcing the participant's progress toward achieving their goals.
Feedback provided by a study interventionist that combines positive reinforcement of the participant's progress with constructive guidance on areas for improvement to support successful goal attainment.
Time frame: 7 days
Mixed-effects models will be used to investigate the impact of each feedback condition on our primary outcome of weight change. Fitted model estimates will be used to calculate the slope of weight change from day 1 (the day a feedback message is delivered) through day 7 of each week. Positive slopes indicate weight gain, while negative slopes indicate weight loss.
Time frame: 7 days
Frequency of self-monitoring weight will be defined as the number of days (0-7) in the week following a feedback message (from day 1, the day that a feedback message is received, to day 7) in which the participant records a valid (non-outlier) e-scale weight.
Time frame: 7 days
A valid "day" of dietary self-monitoring will be defined as ≥ 800 kcal recorded, consistent with prior research. Frequency is calculated as the number of valid days (0-7) recorded the week after a feedback message is delivered (from day 1, the day that a feedback message is received, to day 7).
Time frame: 7 days
Total caloric intake will be calculated by summing calories consumed during the week following a feedback message is received (from day 1, the day that a feedback message is received, to day 7)
Time frame: 7 days
Calorie goal attainment for each day during the week after a feedback message is received (from day 1, the day a feedback message is received, to day 7). Calorie goal attainment will be calculated as [TOTAL KCAL INTAKE FOR THE DAY] - [CALORIE GOAL]. Daily difference scores for the 7 days will be averaged across the week to determine overall adherence to the caloric intake goal.
Time frame: 7 days
Frequency of self-monitoring physical activity will be defined as the number of "valid" days (0-7) of Fitbit use the week after a feedback message is received (from day 1, the day that a feedback message is received, to day 7).
Time frame: 7 days
Total minutes of physical activity will be calculated by summing each days' total "active zone minutes" during the week after a feedback message is delivered (from day 1, the day that a feedback message is received, to day 7)
Time frame: 7 days
Physical activity goal attainment for each day of the week after a feedback message is received (from day 1, the day that a feedback message is received, to day 7) will be calculated as [TOTAL PHYSICAL ACTIVITY MINUTES] - [PHYSICAL ACTIVITY GOAL]. Daily difference scores will be averaged over the week to assess overall adherence to the physical activity goal during that study week.
Contact information is provided by the study sponsor or research team.
Maddie Glover, B.S.
CONTACT
Teace Markwalter, M.P.H., CHES
CONTACT
University of Virginia
Other
Examining Valence-based Effects in Self-monitoring Feedback Messages, in the Development of a Novel Semi-automated Self-monitoring Feedback System for Obesity Treatment
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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