Optimizing Self-Monitoring Feedback Delivery for the Treatment of Overweight and Obesity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWake Forest University Health Sciences
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age greater than or equal to 18 years
BMI greater than or equal to 25.0 kg/m2
Weight less than or equal to 175 kg (due to scale limit)
Own a smartphone compatible with Fitbit (e.g., an Apple iPhone running iOS 16.4 or higher or Android smartphone running Android 11 or higher) with a cellular and data plan
Disqualifiers
Weight greater than 175 kg (due to a weight limit of the study-provided scale)
Smartphone device owned deemed incompatible with the Fitbit App
History of bariatric surgery or plans to obtain bariatric surgery during the study period
Current use of weight loss medications, or use of weight loss medications in the 6 months prior to initial pre-screening
Trial design
Design model
Single group
Treatments tested in this trial
Feedback on Calorie Goal Attainment
BehavioralFeedback composed by a study interventionist that focuses on the participant's progress toward meeting their caloric intake goal.
Feedback on Dietary Quality
BehavioralFeedback composed by a study interventionist that provides comments on specific dietary choices that may impact weight loss success.
Feedback on Physical Activity Goal Attainment
BehavioralFeedback composed by a study interventionist that focuses on the participant's progress toward meeting their physical activity goal.
Goal Setting Prompt
BehavioralAn open-text goal setting prompt, composed by the study interventionist, that encourages the participant to set a behavioral goal for the following week.
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: Self Monitoring FeedbackExperimental treatment 4 interventions
Trial outcomes
Primary outcomes
1
Weight change
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 daysSecondary outcomes
1
Frequency of self-monitoring weight
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 days2
Frequency of self-monitoring dietary intake
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 days3
Total caloric intake
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 days4
Calorie goal attainment
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 daysOther outcomes
1
Time to compose intervention messages (intervention costs)
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
Time frame
through study completion, an average of 7 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Wake Forest University Health Sciences
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
University of Virginia
Collaborator
University of Florida
Collaborator
Source ClinicalTrials.gov