Feedback Optimization for Obesity

Overseen By Teace Markwalter, M.P.H., CHES

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Must not be taking: Weight loss medications

Disqualifiers: Bariatric surgery, Cancer, Dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the best method for providing weekly feedback to help individuals achieve their weight loss goals. Participants will receive guidance on calorie intake, diet quality, and physical activity through weekly feedback messages. The study tracks daily dietary intake, physical activity, and weight using tools provided by the trial. It suits adults with a body mass index (BMI) of 25 or higher who own a smartphone compatible with fitness tracking apps. As an unphased trial, this study offers a unique opportunity to contribute to innovative weight loss strategies and receive personalized support.

Do I have to stop taking my current medications for the trial?

The trial requires that you are not currently using weight loss medications and have not used them in the past 6 months. If your medications affect weight, you should not have changed them in the past 6 months. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

What prior data suggests that this feedback optimization method is safe for participants?

Research has shown that receiving feedback on diet and exercise safely aids weight loss. Studies have found that feedback helps individuals meet diet goals and may improve weight loss outcomes. Participants receive comments on food choices and physical activity, which can help them stay on track.

Reports from similar studies suggest that people generally find this approach helpful for maintaining health goals. No serious side effects have been reported from receiving this kind of feedback.

In summary, incorporating feedback into a weight loss program appears safe and supports healthy lifestyle changes without significant risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Feedback Optimization for Obesity trial because it explores a fresh approach to weight management by focusing on personalized feedback and goal setting. Unlike traditional treatments that often rely on medication or generic diet plans, this method harnesses technology to provide tailored feedback on calorie intake, dietary quality, and physical activity. This personalized feedback, delivered weekly, aims to empower individuals by making them more aware of their behaviors and progress, potentially leading to more sustainable lifestyle changes. By focusing on self-monitoring and personalized encouragement, this approach could offer a more engaging and motivating experience for those seeking to manage their weight effectively.

What evidence suggests that this trial's treatments could be effective for obesity?

Research shows that feedback on diet and exercise goals can aid weight loss. In this trial, participants will receive feedback on calorie goal attainment, dietary quality, and physical activity goal attainment. Some studies suggest that feedback helps individuals adhere to diet plans and monitor progress. One study found that text messages for long-term feedback supported weight loss. Other research indicates that mobile health tools, which include feedback, often lead to significant weight loss in people with obesity. Overall, feedback plays a crucial role in helping individuals follow their weight loss plans. ^{1 2 3 6 7}

Who Is on the Research Team?

Kathryn M. Ross, Ph.D., M.P.H.

Principal Investigator

Aurora Research Institute LLC

Rebecca A. Krukowski, Ph.D.

Principal Investigator

University of Virginia

Are You a Good Fit for This Trial?

This trial is for individuals seeking to manage overweight and obesity issues. Participants should be interested in receiving weekly feedback on their progress towards weight loss goals, including dietary quality and physical activity.

Inclusion Criteria

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

I am 18 years old or older.

Exclusion Criteria

Weight greater than 175 kg (due to a weight limit of the study-provided scale)

Currently participating in a weight-loss program

Use of a pacemaker or other implanted medical device

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Weight Loss 101 Session

Participants attend a 60-minute session providing weight loss education and behavioral skills training

1 week

1 visit (in-person)

Run-in Period

Participants engage in self-monitoring of dietary intake, physical activity, and weight for one week

1 week

Intervention

Participants receive weekly feedback messages based on self-monitoring data, with randomized additional feedback components

Ongoing, weekly feedback

Follow-up

Participants are monitored for adherence to self-monitoring and weight change

7 days

What Are the Treatments Tested in This Trial?

Interventions

• Feedback on Calorie Goal Attainment
• Feedback on Dietary Quality
• Feedback on Physical Activity Goal Attainment
• Goal Setting Prompt

Trial Overview The study is testing different methods of providing feedback to participants about reaching calorie, diet quality, and physical activity targets. It aims to determine the most effective way of delivering this information during a weight loss program.

How Is the Trial Designed?

Group I: Self Monitoring Feedback Experimental Treatment 4 Interventions

Participants enrolled in the Feedback Optimization trial will be asked to complete a 60-minute Weight Loss 101 session and to track their dietary intake, physical activity, and weight each day using study-provided tools. After the first week of self-monitoring (used as a run-in), participants will be provided with weekly feedback messages. The focus and content of these messages will vary, based on a 2x2x2x2 factorial design.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

University of Virginia

Collaborator

Trials

802

Recruited

1,342,000+

University of Florida

Collaborator

Trials

1,428

Recruited

987,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07227051?term=physio+OR+physical+therapy+OR+exercise+therapy+OR+physiotherapy

Study Details | NCT07227051 | Optimizing Self-Monitoring ... The goal of this micro-randomized factorial trial is to learn how to best deliver self-monitoring feedback during a behavioral weight ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7269678/

The SMARTER Trial: Design of a trial testing tailored mHealth ... Our SMART Trial tested the use of one of three tools for self-monitoring (SM) dietary intake and physical activity (PA): paper diary, personal digital assistant ...

3. mhealth.jmir.org mhealth.jmir.org/2015/3/e88/PDF

Efficacy of a Text Message-Delivered Extended Contact ... Objective: This study investigated whether extended contact via text message was efficacious in supporting long-term weight loss and physical ...

4. ijbnpa.biomedcentral.com ijbnpa.biomedcentral.com/articles/10.1186/s12966-023-01555-6

Impact of feedback generation and presentation on self ... Impact of feedback provision​​ Studies yielded mixed results. Six studies reported benefits of feedback such as reaching diet goals [40], self- ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2589537023004868

Effectiveness of holistic mobile health interventions on diet ... Of 15 studies reporting on weight change, 9 showed significant reductions (6 targeted on individuals with overweight or obesity), and in 10 studies reporting ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11363047/

Personal goal setting eHealth component associated with ... Greater use of a personal goal-setting feature was associated with improved weight loss outcomes among active users.

7. scholarcommons.sc.edu scholarcommons.sc.edu/cgi/viewcontent.cgi?article=6986&context=etd

Characterizing Patterns of Adherence to Physical Activity ... Key strategies for behavior change included goal setting, self-monitoring, facilitator feedback, action planning, problem solving, relapse prevention, and ...