ObesityNCT06508580
Optimizing Self-Monitoring Feedback for the Treatment of Obesity
A study testing Component 1: Calorie Goal Attainment, Component 2: Diet Quality and Component 3: Physical Activity Goal Attainment in people with Obesity and Weight Loss, run by University of Florida at 1 site in United States.
Trial summary
Self-monitoring (of weight, intake, and activity) is a core component in evidence-based lifestyle interventions for obesity. Research has shown that interventionist feedback increases adherence to self-monitoring and improves weight loss outcomes; however, little empirical evidence exists on how this feedback should… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Weight Loss
- What is being tested?
- Component 1: Calorie Goal Attainment, Component 2: Diet Quality and Component 3: Physical Activity Goal Attainment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2024to 3 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- BMI ≥ 30.0 kg/m2
- ≤ 175 kg (due to scale limit)
- Own a smartphone (Apple iPhone running iOS 15 or higher or Android smartphone running Android 10 or higher) with a cellular and data plan
Who cannot join
- Weight > 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
- Currently participating in a weight-loss program
- Weight loss of ≥ 10 lbs in the 6 months prior to initial pre-screening
Show all 24Show fewer
- Physical limitations that prevent walking 1/4 mile without stopping
- Use of a pacemaker or other implanted medical device
- Currently pregnant
- Currently breastfeeding
- Less than 1-year post-partum
- Plans to become pregnant within the study period
- Lack of written approval for participation from potential participant's physician if the participant has been diagnosed with diabetes, hypertension, or has a history of coronary heart disease
- One or more study participants living in the household (enrollment limited to one participant per household)
- Medical conditions that contraindicate weight loss or prevent completion of the study (e.g., current diagnosis of cancer or terminal illness, dementia, etc.)
- Self-reported eating disorder within past 5 years
- Unable to complete the 17-week study (due to plans to relocate during the study period, etc.)
- Unable or unwilling to provide informed consent
- Unable to read English at the 5th grade level
- Unwilling to accept random assignment
- Unable or unwilling to download the study smartphone applications, wear the physical activity monitor, or use the study e-scale
- Failure to complete baseline assessment measures
- Failure to complete at least 5 out of 7 days of self-monitoring dietary and weight self-monitoring during the behavioral run-in period
- Other conditions which in the opinion of the Principal Investigator would adversely affect participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimizing Self-Monitoring Feedback Delivery for the Treatment of Obesity
Self-monitoring (of weight, intake, and activity) is a core component in evidence-based lifestyle interventions for obesity. Research has shown that interventionist feedback increases adherence to self-monitoring and improves weight loss outcomes; however, little empirical evidence exists on how this feedback should be provided. This research study aims to optimize the provision of self-monitoring feedback.
Read the detailed description
Self-monitoring (e.g., of weight, dietary intake, and physical activity) is a core component in evidence-based comprehensive lifestyle interventions for obesity, and greater adherence to self-monitoring has been associated both with better short-term weight loss and long-term weight loss maintenance. Importantly, research has demonstrated that the provision of interventionist feedback on self-monitoring increases adherence to self-monitoring and improves weight loss outcomes. Little empirical evidence exists, however, to provide guidance on how this feedback should be provided. One study conducted in this area demonstrated that intentions to self-monitor differ by feedback complexity, such that too little (and, conversely, too much) feedback reduces future intentions to self-monitor and engage in related health behavior change; however, less is known regarding how the type and complexity of feedback messages affect actual self-monitoring behavior and subsequent weight loss outcomes. Importantly, provision of this feedback also represents a substantial investment of clinician time; research demonstrated that feedback messages incorporating self-monitoring data related to weight, dietary intake, and physical activity can take ~26 minutes per person to compose. Thus, the investigators propose a line of research that aims to optimize the provision of self-monitoring feedback (i.e., identifying the optimal number and type of feedback messages) for supporting adherence to weight-management behaviors. For the current study, the investigators propose to assess the feasibility and acceptability of a micro-randomized, factorial trial design that will ultimately be used (in a future, fully-powered trial) evaluate the proximal impact of different types and amount of feedback on change in weight and weight-related behaviors (e.g., adherence to self-monitoring, caloric goal attainment, physical activity goal attainment). Using a 2x2x2x2 factorial model, participants will be randomized each week for 16 weeks to one of 16 possible feedback conditions, allowing us to efficiently test four feedback components (i.e., feedback on calorie goal attainment, dietary quality, physical activity goal attainment, or on goal setting) in one study.
- Conditions
- Obesity, Weight Loss
- Being tested
- Component 1: Calorie Goal Attainment, Component 2: Diet Quality, Component 3: Physical Activity Goal Attainment, Component 4: Goal Setting
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Component 1: Calorie Goal AttainmentBehavioural
On weeks that participants are randomized to receive this component, they will be provided with feedback on the number of days that they met their calorie goal.
Component 2: Diet QualityBehavioural
On weeks that participants are randomized to receive this component, they will receive three comments regarding specific dietary choices that may impact weight loss success, including reinforcing comments for behaviors consistent with weight loss and potential areas for change.
Component 3: Physical Activity Goal AttainmentBehavioural
On weeks that participants are randomized to receive this component, they will receive feedback related to attainment of that week's physical activity goal.
Component 4: Goal SettingBehavioural
On weeks that participants are randomized to receive the goal setting component, they will be asked to complete an open-text prompt encouraging them to set a specific weight-related behavior change goal for the next week.
| Study group | Role | What they receive |
|---|---|---|
| Component 1: Calorie Goal Attainment | Experimental | Participants will be randomized to either receive or not receive feedback based on calorie goal attainment. Receives: Behavioral: Component 1: Calorie Goal Attainment |
| Component 2: Diet Quality | Experimental | Participants will be randomized to either receive or not receive feedback based on diet quality. Receives: Behavioral: Component 2: Diet Quality |
| Component 3: Physical Activity Goal Attainment | Experimental | Participants will be randomized to either receive or not receive feedback based on physical activity goal attainment. Receives: Behavioral: Component 3: Physical Activity Goal Attainment |
| Component 4: Goal Setting | Experimental | Participants will be randomized to either receive or not receive feedback based on weekly goal setting. Receives: Behavioral: Component 4: Goal Setting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Weight will be assessed using the study-provided e-scales
Measured: Daily throughout the study period (up to 17 weeks)
Secondary outcomes (8)
Frequency of Self-Monitoring Weight
Frequency of self-monitoring of weight will be defined as the number of days (0-7) each study week that a participant had a valid (e.g., non-outlier) weight recorded via the study-provided e-scale.
Measured: Weekly throughout the study period (up to 17 weeks)
Frequency of Self-Monitoring Dietary Intake
A valid "day" of self-monitoring dietary intake will be defined as ≥ 800 kcal recorded via the Fitbit app or website, consistent with prior research. For each study week, frequency of self-monitoring dietary intake will be defined as the number of valid days (0-7) recorded.
Measured: Weekly throughout the study period (up to 17 weeks)
Total Caloric Intake
For each study week, total caloric intake will be calculated by summing calories recorded via the Fitbit app or website each day of that week between 12:00 AM and 11:59 PM local time.
Measured: Weekly throughout the study period (up to 17 weeks)
Calorie Goal Attainment
Calorie goal attainment each day of the week will be calculated as [TOTAL KCAL INTAKE FOR THE DAY] - [CALORIE GOAL], using calorie data recorded via the Fitbit app or website. Difference scores for the 7 days will be averaged over the week to assess overall adherence to the caloric intake goal during each study week.
Measured: Weekly throughout the study period (up to 17 weeks)
Frequency of Self-Monitoring Physical Activity
Consistent with the broader accelerometry literature, a "valid day" of self-monitoring physical activity will be defined as a day with ≥10 hours of Fitbit wear time, assessed as minutes of non-zero heart rate measurements captured by the Fitbit device. For each study week, frequency of self-monitoring physical activity will be defined as the number of "valid" days (0-7) of Fitbit use.
Measured: Weekly throughout the study period (up to 17 weeks)
Physical Activity Minutes
For each study week, total minutes of physical activity will be calculated by summing the total "active zone minutes" recorded via a Fitbit activity monitor for each day of the week.
Measured: Weekly throughout the study period (up to 17 weeks)
Physical Activity Goal Attainment
For each study week, physical activity goal attainment will be calculated as [TOTAL PHYSICAL ACTIVITY MINUTES] - [PHYSICAL ACTIVITY GOAL], with physical activity minutes recorded via a Fitbit activity monitor.
Measured: Weekly throughout the study period (up to 17 weeks)
Feedback Message Acceptability
Participants will be asked to rate the helpfulness of feedback messages received each week by selecting a "thumbs up" or "thumbs down" button displayed beneath the message.
Measured: Weekly throughout the study period (up to 17 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start23 Jul 2024
- Primary completion3 Feb 2025
- Study completion3 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Micro-randomized 2x2x2x2 factorial model; participants randomized to receive or not receive one of 4 feedback conditions each week for 16 weeks
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kathryn M Ross, PhD, MPH, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06508580
- Sponsor's protocol ID
- IRB202400735
- Status last verified
- Apr 2025
- First submitted
- 12 Jul 2024
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be shared upon request following the establishment of an appropriate data use agreement.
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Self-Monitoring Feedback Delivery for the Treatment of Obesity
- ClinicalTrials.gov ID
- NCT06508580
- Acronym / sponsor ID
- IRB202400735
- Conditions
- Obesity, Weight Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 23 Jul 2024 (actual)
- Primary completion
- 3 Feb 2025 (actual)
- Study completion
- 3 Feb 2025 (actual)
- First posted
- 18 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Self-monitoring (of weight, intake, and activity) is a core component in evidence-based lifestyle interventions for obesity. Research has shown that interventionist feedback increases adherence to self-monitoring and improves weight loss outcomes; however, little empirical evidence exists on how this feedback should be provided. This research study aims to optimize the provision of self-monitoring feedback.
Detailed description
Self-monitoring (e.g., of weight, dietary intake, and physical activity) is a core component in evidence-based comprehensive lifestyle interventions for obesity, and greater adherence to self-monitoring has been associated both with better short-term weight loss and long-term weight loss maintenance. Importantly, research has demonstrated that the provision of interventionist feedback on self-monitoring increases adherence to self-monitoring and improves weight loss outcomes. Little empirical evidence exists, however, to provide guidance on how this feedback should be provided. One study conducted in this area demonstrated that intentions to self-monitor differ by feedback complexity, such that too little (and, conversely, too much) feedback reduces future intentions to self-monitor and engage in related health behavior change; however, less is known regarding how the type and complexity of feedback messages affect actual self-monitoring behavior and subsequent weight loss outcomes. Importantly, provision of this feedback also represents a substantial investment of clinician time; research demonstrated that feedback messages incorporating self-monitoring data related to weight, dietary intake, and physical activity can take ~26 minutes per person to compose. Thus, the investigators propose a line of research that aims to optimize the provision of self-monitoring feedback (i.e., identifying the optimal number and type of feedback messages) for supporting adherence to weight-management behaviors. For the current study, the investigators propose to assess the feasibility and acceptability of a micro-randomized, factorial trial design that will ultimately be used (in a future, fully-powered trial) evaluate the proximal impact of different types and amount of feedback on change in weight and weight-related behaviors (e.g., adherence to self-monitoring, caloric goal attainment, physical activity goal attainment). Using a 2x2x2x2 factorial model, participants will be randomized each week for 16 weeks to one of 16 possible feedback conditions, allowing us to efficiently test four feedback components (i.e., feedback on calorie goal attainment, dietary quality, physical activity goal attainment, or on goal setting) in one study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Micro-randomized 2x2x2x2 factorial model; participants randomized to receive or not receive one of 4 feedback conditions each week for 16 weeks
| Arm | Type | Receives |
|---|---|---|
| Component 1: Calorie Goal Attainment | Experimental | Behavioral: Component 1: Calorie Goal AttainmentParticipants will be randomized to either receive or not receive feedback based on calorie goal attainment. |
| Component 2: Diet Quality | Experimental | Behavioral: Component 2: Diet QualityParticipants will be randomized to either receive or not receive feedback based on diet quality. |
| Component 3: Physical Activity Goal Attainment | Experimental | Behavioral: Component 3: Physical Activity Goal AttainmentParticipants will be randomized to either receive or not receive feedback based on physical activity goal attainment. |
| Component 4: Goal Setting | Experimental | Behavioral: Component 4: Goal SettingParticipants will be randomized to either receive or not receive feedback based on weekly goal setting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- BMI ≥ 30.0 kg/m2
- ≤ 175 kg (due to scale limit)
- Own a smartphone (Apple iPhone running iOS 15 or higher or Android smartphone running Android 10 or higher) with a cellular and data plan
Key exclusion criteria (24 listed)
- Weight > 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
- Currently participating in a weight-loss program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Component 1: Calorie Goal AttainmentOn weeks that participants are randomized to receive this component, they will be provided with feedback on the number of days that they met their calorie goal. | Behavioural | Component 1: Calorie Goal Attainment |
| Component 2: Diet QualityOn weeks that participants are randomized to receive this component, they will receive three comments regarding specific dietary choices that may impact weight loss success, including reinforcing comments for behaviors consistent with weight loss and potential areas for change. | Behavioural | Component 2: Diet Quality |
| Component 3: Physical Activity Goal AttainmentOn weeks that participants are randomized to receive this component, they will receive feedback related to attainment of that week's physical activity goal. | Behavioural | Component 3: Physical Activity Goal Attainment |
| Component 4: Goal SettingOn weeks that participants are randomized to receive the goal setting component, they will be asked to complete an open-text prompt encouraging them to set a specific weight-related behavior change goal for the next week. | Behavioural | Component 4: Goal Setting |
Primary outcome
Weight
Time frame: Daily throughout the study period (up to 17 weeks)
Weight will be assessed using the study-provided e-scales
8 secondary outcomes
Frequency of Self-Monitoring Weight
Time frame: Weekly throughout the study period (up to 17 weeks)
Frequency of Self-Monitoring Dietary Intake
Time frame: Weekly throughout the study period (up to 17 weeks)
Total Caloric Intake
Time frame: Weekly throughout the study period (up to 17 weeks)
Calorie Goal Attainment
Time frame: Weekly throughout the study period (up to 17 weeks)
Frequency of Self-Monitoring Physical Activity
Time frame: Weekly throughout the study period (up to 17 weeks)
Physical Activity Minutes
Time frame: Weekly throughout the study period (up to 17 weeks)
Physical Activity Goal Attainment
Time frame: Weekly throughout the study period (up to 17 weeks)
Feedback Message Acceptability
Time frame: Weekly throughout the study period (up to 17 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Individual participant dataSharing planned: Yes. De-identified data will be shared upon request following the establishment of an appropriate data use agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathryn M Ross, PhD, MPH principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Component 1: Calorie Goal Attainment, Component 2: Diet Quality and Component 3: Physical Activity Goal Attainment in people with Obesity and Weight Loss, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: Daily throughout the study period (up to 17 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.