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

473 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of the proposed project is to test the effectiveness of an intervention (Connect4Health Engage) focused on motivating and guiding patients to use empirically supported, freely available online tools for weight loss. A randomized trial will be conducted in primary care clinics. Fifteen to twenty PCPs will be recruited, followed by 453 patients. Patients will complete either the 52-week Connect4Health Engage intervention or Connect4Health Discover, an educational control.

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.

How is the Connect4Health treatment for obesity different from other treatments?

Connect4Health is unique because it uses online tools to help manage obesity, focusing on user engagement and behavior change through web-based interventions. This approach is different from traditional in-person treatments, offering flexibility and accessibility for users. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Connect4Health Discover and Connect4Health Engage for obesity?

Research shows that using online and mobile tools for weight management can be effective, as seen in studies where web-based applications helped with weight loss and improved communication between patients and healthcare providers. These tools can facilitate better conversations about weight management, which is important for successful treatment. ^{4 6 7 8 9}

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

I have a doctor's appointment scheduled 30-45 days after the initial data request.

Speaks and reads English

Exclusion Criteria

BMI≥ 45 kg/m2

I had a heart attack or stroke in the last 60 days.

I am currently in a weight loss program.

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 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]

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]

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. China pubmed.ncbi.nlm.nih.gov

Longitudinal evaluation of an mHealth overweight and obesity management tool. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Development of an Assessment Tool for Completion by Patients with Overweight or Obesity. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Feasibility of a lifestyle intervention for overweight/obese endometrial and breast cancer survivors using an interactive mobile application. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Implications of differing attitudes and experiences between providers and persons with obesity: results of the national ACTION study. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Hospitalists' utilization of weight loss resources with discharge texts and primary care contact: a feasibility study. [2016]

6. Germany pubmed.ncbi.nlm.nih.gov

[User Acceptance of an Online-Intervention for Improving Depressive Symptoms in Adults with Obesity - Results of a Pilot Study]. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Process evaluation of an internet-based resource for weight control: use and views of an obese sample. [2015]

8. Canada pubmed.ncbi.nlm.nih.gov

Implementation of a Digital Health Tool for Patients Awaiting Input From a Specialist Weight Management Team: Observational Study. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

User Engagement Associated with Web-Intervention Features to Attain Clinically Meaningful Weight Loss and Weight Maintenance in Rural Women. [2020]