Advocate Aurora Research Institute
Milwaukee, Wisconsin, 53204, United States
Location status: Recruiting
Location contact
Kathryn M. Ross, Ph.D., M.P.H.
PRINCIPAL_INVESTIGATOR
Tejashri Ganbote, MBA, MBBS
CONTACT
NCT Number: NCT07227051
The purpose of this research study is to learn how to best provide weekly feedback on individual progress toward intervention goals during a weight loss program.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Milwaukee, Wisconsin, 53204, United States
Location status: Recruiting
Kathryn M. Ross, Ph.D., M.P.H.
PRINCIPAL_INVESTIGATOR
Tejashri Ganbote, MBA, MBBS
CONTACT
The goal of this micro-randomized factorial trial is to learn how to best deliver self-monitoring feedback during a behavioral weight management intervention. All study participants will be provided with a "Weight Loss 101" session that provides weight loss education and behavioral skills training. At this meeting, participants will be taught how to use study-provided tools to self-monitor their dietary intake, physical activity, and weight. At the end of each week of the intervention, participants will receive an interventionist-composed feedback message based on their self-monitoring data. Every message will contain feedback about how often the participant self-monitored their dietary intake, physical activity, and weight (that is, the number of days each week that the participant monitored each) along with a message about their weight trajectory. Participants will be randomized each week to receive (or not receive) four additional feedback components each week.
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 on the participant's progress toward meeting their caloric intake goal.
Feedback composed by a study interventionist that provides comments on specific dietary choices that may impact weight loss success.
Feedback composed by a study interventionist that focuses on the participant's progress toward meeting their physical activity goal.
An open-text goal setting prompt, composed by the study interventionist, that encourages the participant to set a behavioral goal for the following week.
Time frame: 7 days
Fitted model values will then be used to estimate the slope of weight change from day 1 (the day a feedback message is received) to day 7 of each week, with positive values representing weight gain and negative values representing weight loss.
Time frame: 7 days
Frequency of self-monitoring weight will be defined as the number of days (0-7) for the week after a feedback message is received (from day 1, the day that a feedback message is received, to day 7) that a participant has a valid (non-outlier) e-scale weight.
Time frame: 7 days
A valid "day" of self-monitoring dietary intake will be defined as ≥ 800 kcal, consistent with prior research. Frequency of self-monitoring dietary intake will be defined as the number of valid days (0-7) recorded 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 caloric intake will be calculated by summing calories consumed 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
Calorie goal attainment for each day during 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 KCAL INTAKE FOR THE DAY] - [CALORIE GOAL]. Difference scores for the 7 days will be averaged over the week to assess overall adherence to the caloric intake goal during that study week.
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 received (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]. Difference scores for the 7 days will be averaged over the week to assess overall adherence to the physical activity goal during that study week
Time frame: through study completion, an average of 7 days
Interventionists will log the time needed to compose each message (including a starting time and an ending time for each message) in our administrative dashboard
Contact information is provided by the study sponsor or research team.
Teace Markwalter, M.P.H., CHES
CONTACT
Tejashri Ganbote, MBA, MBBS
CONTACT
Wake Forest University Health Sciences
Other
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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