HealthyWE for Obesity

(HealthyWE Trial)

Overseen By Roshauna Follett

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rutgers, The State University of New Jersey

Disqualifiers: Disability, Dementia, Alzheimer's, others

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

Compensation: Varies

Number of Visits: 3

Duration: 16 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help people in Camden City, New Jersey, manage and reduce obesity while improving their quality of life and mental health. The program, called HealthyWE, includes a series of coaching sessions to support healthy weight maintenance. Participants must be adults over 19 with a BMI over 25, without significant physical or mental limitations affecting their activity. The goal is to foster a community effort to tackle obesity and related health issues. As an unphased trial, this study offers participants the chance to contribute to innovative community health solutions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the HealthyWE program is safe for participants?

Research shows that the HealthyWE program aims to help manage obesity and improve quality of life. This program uses a person-centered approach, focusing on each individual's unique needs and preferences.

Regarding safety, detailed information about side effects or negative outcomes for HealthyWE is not available. However, the trial's "Not Applicable" phase label likely indicates that HealthyWE is a behavioral or lifestyle program, not a new drug or medical device. Such programs typically involve coaching, education, and lifestyle changes instead of medications, making them generally well-tolerated.

HealthyWE has been tested in other settings and has effectively managed weight without major safety concerns. Consulting healthcare providers is advisable to determine how this program might fit personal health needs and circumstances. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about HealthyWE for obesity because it offers a personalized, coaching-based approach that differs from conventional treatments like medication and surgery. Unlike most treatments that focus on physical interventions, HealthyWE emphasizes behavioral change through four weekly coaching sessions tailored to individual needs. This method aims to improve treatment adherence by engaging participants in their own care, potentially leading to more sustainable weight management.

What evidence suggests that the HealthyWE program is effective for managing obesity?

Studies have shown that weight management programs like HealthyWE can help people lose a significant amount of weight. For instance, a web-based program helped many participants lose 5% or more of their body weight. Another study found that half of the people in a similar program saw meaningful results after one year. Participants in this trial will engage in the HealthyWE program, which aims to reduce obesity and improve health by offering personalized coaching and boosting confidence in making healthy choices. It uses techniques to help participants make lasting lifestyle changes. These findings suggest that HealthyWE could effectively manage obesity and improve overall quality of life. ^{1 6 7 8 9}

Who Is on the Research Team?

Thomas A Dahan, PhD

Principal Investigator

Rutgers, the State University of NJ

Are You a Good Fit for This Trial?

This trial is for adults aged 19 and older living in Camden City, New Jersey, who are struggling with obesity. It aims to help them achieve a healthier weight, reduce pain, and improve their overall quality of life and mental health.

Inclusion Criteria

BMI of > 25

I am over 19 years old.

Exclusion Criteria

My BMI is under 25.

I have limitations in activity due to a disability, impairment, or condition like dementia or Alzheimer's.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Recruitment and Initial Assessment

Recruitment of 60 overweight and obese participants and initial assessment of baseline metrics

4 months

1 visit (in-person) for baseline assessment

Treatment

Participants engage in the HealthyWE program, including nutrition, exercise, and mental health wellness activities

16 weeks

Weekly sessions (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 6-week and 14-week intervals

14 weeks

2 visits (in-person) for follow-up assessments

What Are the Treatments Tested in This Trial?

Interventions

• HealthyWE

Trial Overview The HealthyWE program is being tested to see if it can effectively manage obesity and increase self-efficacy in maintaining a healthy weight. The study focuses on overcoming personal, environmental, and systematic barriers to physical activity.

How Is the Trial Designed?

Group I: Healthy WE Experimental Treatment 1 Intervention

Sixty (60) adults residing in the Housing Authority of the City of Camden will be recruited to be engaged in HealthyWE program to be completed in 4 weekly coaching sessions. Treatment adherence refers to the extent to which interventions are delivered as prescribed

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07095673

HealthyWE: Achieving a Healthy Weight and Reducing Pain The goal of this project was to reduce and manage obesity and increase self-efficacy for keeping a healthy weight and improve pain, quality of life, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7451764/

Effectiveness of a web-based real-life weight management ... Healthy Weight Coaching (HWC) is a 12-month web-based intervention for the management of obesity. The program is based on the Acceptance and Commitment Therapy.

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2815174

Weight Loss Treatment and Longitudinal Weight Change ... These findings suggest WMT can support 5% or greater weight loss for individual patients, but low utilization limits their population-level potential.

4. jmir.org jmir.org/2025/1/e65122/

Weight Loss Patterns and Outcomes Over 12 Months on a ... This commercial weight loss program was shown to be effective, with 1 in 2 members achieving clinically significant results after 1 year.

5. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-024-21120-5

The effectiveness of a 10-week family-focused e-Health ... Mixed ANOVA confirmed BMI z-score decreased after 10 weeks of the program, irrespective of the Control group undergoing 10 weeks waiting period ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29401050/

Real-World Effectiveness of a Medically Supervised Weight ... The average weight loss after 5 years was 5.8% from baseline. 16.3% lost 5-9.9% and 35.2% lost 10% or more.

7. withpower.com withpower.com/trial/phase-obesity-5-2023-34730

HealthyWE for Obesity · Recruiting Participants ... The goal of this project was to reduce and manage obesity and increase self-efficacy for keeping a healthy weight and improve pain, quality of life, ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2667368125000506

Evaluating the Long-Term Effectiveness of a Structured ... Both groups achieved significant reductions in BMI SDS after 12 months, with sustained improvements in the telehealth group through 36 months (Δ ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9163343/

Effects of a 12-Week Web-Based Weight Loss Program for ... The present study demonstrated that a regularly used 12-week web-based health program facilitated weight loss of 4.2% in the intervention group and 1.4% in the ...