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Remote Dietitian + Mobile App for Obesity

N/A

Waitlist Available

Led By Antonia F Chen, MD, MBA

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up this outcome will be evaluated at 3 months (10-14 weeks) after study enrollment.

Awards & highlights

Study Summary

This trial is testing a weight loss intervention and mobile app to see if it helps people with morbid obesity lose weight and become eligible for surgery.

Who is the study for?

This trial is for adults over 18 with severe obesity (BMI > 40 kg/m2) considering hip or knee joint replacement surgery at specific hospitals. Participants must own a smartphone or have internet and webcam access, be willing to follow the study's rules, and provide informed consent. People with BMIs over 47 kg/m2, needing revision surgeries, non-English speakers, those planning bariatric surgery or pregnancy within six months are excluded.Check my eligibility

What is being tested?

The trial tests a weight loss program supervised by dietitians through video calls and a mobile app for obese patients before joint replacement surgery. It aims to achieve more significant weight loss than usual care, reduce BMI below the cutoff of 40 kg/m2 making them eligible for surgery, and increase the number undergoing surgery within six months.See study design

What are the potential side effects?

Since this intervention involves dietary changes and physical activity monitored remotely rather than medication or invasive procedures, side effects may include typical reactions to dieting such as fatigue, hunger pangs or digestive changes but should generally be minimal.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ this outcome will be evaluated at 3 months (10-14 weeks) after study enrollment.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~this outcome will be evaluated at 3 months (10-14 weeks) after study enrollment.

This trial's timeline: 3 weeks for screening, Varies for treatment, and this outcome will be evaluated at 3 months (10-14 weeks) after study enrollment. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of weight lost or gained from baseline

Secondary outcome measures

Change from baseline in HbA1c

Change from baseline in Paving Wheel Wellness score

Change from baseline in serum albumin

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 Intervention

Intervention subjects will use the Nutrimedy mobile app and be connected at enrollment with a registered dietitian who will contact intervention participants weekly or bi-weekly via video calls and unlimited in-app text messaging for up to three months. The first week will include either one 55-minute video session or two 25-minute sessions. Weeks 2-4 will have weekly 25-minute video calls, and weeks 5-12 will have biweekly 25-minute sessions for a total of 8-9 sessions over 12 weeks. Together, participants and dietitians will come up with goals for the 12 weeks, and dietitians will check on progress toward these goals using in-app tools such as food logs and messaging between video calls. All patients will be encouraged to lose at least 20 pounds with a goal BMI<40 kg/m2 after 12 weeks. The intervention group will also receive all aspects of the usual care arm including the opportunity to have a physical therapist and/or nutritionist referral.

Group II: Usual CareActive Control1 Intervention

Individuals randomized to the usual care group will receive standard care. This may include a physical therapist and/or nutritionist referral. Brigham and Women's Hospital offers several programs for patients interested in losing weight, including the Nutrition Wellness Service (NWS) and Program for Weight Management (PWM). Insurance coverage for these programs varies by patient insurance.

Do I qualify?Apply below to find out