Online Tools for Obesity

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Must not be taking: Weight loss medications

Disqualifiers: BMI≥45, Cancer, Cardiovascular, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of online tools in aiding weight loss. Participants will be divided into two groups: one will use an online program called Connect4Health Engage, while the other will use Connect4Health Discover, which focuses on education. The trial seeks adults with a BMI of 30 or higher, or 27-29.9 with related health issues such as high blood pressure or diabetes, who have internet access. As an unphased trial, this study offers participants the chance to contribute to innovative research that could improve weight loss strategies through online tools.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently taking prescription medication for weight loss.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that Connect4Health Engage is designed to help and encourage people to use online tools for weight loss. Similar programs have improved health in other studies, which suggest that using community and clinical resources can be effective and safe. Participants usually find these programs manageable, with few unwanted side effects reported. As this trial tests an online program rather than a drug or medical device, it is expected to be well-tolerated. The focus on education and motivation generally poses minimal risk to participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for obesity that often involve medication, surgery, or in-person therapy, Connect4Health Discover and Connect4Health Engage offer online tools to support weight loss and healthy habits. Researchers are excited about these digital interventions because they make use of personalized feedback and interactive content, which can be accessed conveniently from home. This approach allows for more flexible, continuous support and engagement compared to standard in-clinic visits, potentially increasing patient adherence and success in managing obesity.

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

Research has shown that Connect4Health Engage, a program in this trial designed to help people use online tools for weight loss, is promising. Studies suggest that individuals using these tools lost more weight than those who did not. Meanwhile, Connect4Health Discover, another program tested in this trial, aims to improve weight management through structured, supportive online resources. Specifically, one study found that participants in a similar program improved their weight management, indicating that structured, supportive online resources can be effective. These programs assist people in making better lifestyle choices by providing easy access to proven resources. This makes Connect4Health Engage and Connect4Health Discover promising options for those seeking to manage their weight effectively with technology. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for adults with obesity or weight-related health issues who have internet access and can read English. They must not be enrolled in other weight loss programs, have a BMI under 45 kg/m2, no recent severe cardiovascular events, and not planning to move soon. Pregnant women and those with certain medical conditions like Type 1 Diabetes or active cancer are excluded.

Inclusion Criteria

Has valid email address in EHR

Speaks and reads English

Has either WiFi internet access at home or a phone or tablet with a data plan.

Exclusion Criteria

BMI≥ 45 kg/m2

I had weight loss surgery in the last year or am considering it now.

I have been diagnosed with dementia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants complete either the 52-week Connect4Health Engage intervention or Connect4Health Discover, an educational control

52 weeks

Follow-up

Participants are monitored for weight stability and other health metrics after the intervention

26 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Connect4Health Discover
• Connect4Health Engage

Trial Overview The study tests Connect4Health Engage, an online tool designed to help patients lose weight by using available resources effectively. It's compared against Connect4Health Discover, which provides educational content only. Participants will be randomly assigned to one of these two options for a year-long intervention.

How Is the Trial Designed?

Group I: Connect4Health Engage Experimental Treatment 1 Intervention

Receive Connect4Health Engage

Group II: Connect4Health Discover Active Control 1 Intervention

Receive Connect4Health Discover

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

In a study of 940 adult users of the DrHolmApp, 71% experienced a reduction in body mass index (BMI), with an average decrease of 0.63 BMI points, indicating the app's effectiveness in promoting weight loss.

Users also reported significant improvements in physical activity, mood, quality of life, and body image satisfaction, suggesting that the app not only aids in weight loss but also enhances overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longitudinal evaluation of an mHealth overweight and obesity management tool. Langkjær, IOJ., Fonvig, CE., Holm, LA., et al.[2022]

A feasibility study involving 25 obese hospitalized patients showed that a comprehensive weight loss intervention, including counseling and follow-up, is practical and can be implemented effectively during hospital stays.

Patients in the intervention group lost an average of 3.0 kg over 6 months, while the control group gained weight, indicating that the intervention may lead to sustained weight loss improvements post-discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hospitalists' utilization of weight loss resources with discharge texts and primary care contact: a feasibility study. Harris, CM., Cheskin, LJ., Khaliq, W., et al.[2016]

In a pilot study with 46 participants, an unguided online intervention for obesity and depressive symptoms showed moderate to high user acceptance, particularly in terms of usefulness and ease of learning.

Despite a high uptake rate of 76.1%, only 22.9% of participants completed the intervention, indicating that while the program is well-received, improvements are needed to enhance completion rates and overall effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[User Acceptance of an Online-Intervention for Improving Depressive Symptoms in Adults with Obesity - Results of a Pilot Study]. Löbner, M., Stein, J., Rechenberg, T., et al.[2022]

A one-month lifestyle intervention using the LoseIt! app led to significant weight loss in overweight/obese cancer survivors, with participants losing an average of 6.4 kg and showing reductions in BMI and waist circumference.

The intervention improved participants' self-efficacy regarding weight management, as indicated by a significant increase in the Weight Efficacy Lifestyle Questionnaire score, demonstrating the app's effectiveness in promoting healthier lifestyle choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a lifestyle intervention for overweight/obese endometrial and breast cancer survivors using an interactive mobile application. McCarroll, ML., Armbruster, S., Pohle-Krauza, RJ., et al.[2022]

High engagement with messaging features in a web-based weight loss intervention significantly predicted achieving at least 5% body weight loss after both 6 and 18 months among 201 rural women at risk for obesity-related diseases.

Self-tracking features did not show a significant effect on weight loss outcomes, highlighting the importance of interactive messaging in promoting behavior change for weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

User Engagement Associated with Web-Intervention Features to Attain Clinically Meaningful Weight Loss and Weight Maintenance in Rural Women. Hageman, PA., Mroz, JE., Yoerger, MA., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06928571

Using Online Tools to Increase Weight Loss in Primary Care The goal of the proposed project is to test the effectiveness of an intervention (Connect4Health Engage) focused on motivating and guiding patients to use ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8411392/

Implementation of the Connect for Health pediatric weight ... The Connect for Health trial examined the comparative effectiveness of two clinical-community interventions in improving child BMI z-scores and family-centered ...

3. exhalelab.weebly.com exhalelab.weebly.com/projects.html

Projects - Jake-Schoffman EXHale Lab Engaging primary care patients with existing online tools for weight loss: A pilot trial. Engaging primary care patients in online weight management tools.

4. withpower.com withpower.com/trial/phase-weight-loss-3-2025-ef7ee

Online Tools for Obesity · Info for Participants The goal of the proposed project is to test the effectiveness of an intervention (Connect4Health Engage) focused on motivating and guiding patients to use ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02124460

Connect 4 Health: An Intervention to Improve Childhood ... To examine parental ratings of quality and family-centeredness of pediatric obesity care and compare outcomes among participants in the intervention with the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4753774/

Connect for Health: Design of a Clinical-Community ... The Connect for Health study is designed to assess whether a novel approach to care delivery that leverages clinical and community resources and addresses ...