Remote dietitian supervised weight loss intervention and mobile app for Weight Loss
Massachusetts General Hospital, Boston, MATargeting 3 different conditionsRemote dietitian supervised weight loss intervention and mobile appN/AWaitlist AvailableLed by Antonia F Chen, MD, MBAResearch Sponsored by Brigham and Women's Hospital
Eligibility Criteria ChecklistSpecific guidelines that determine who can or cannot participate in a clinical trial
Subject would consider undergoing a total joint arthroplasty if eligible
Be older than 18 years old
Must not have
Be younger than 18 years old
Screening 3 weeks
Follow Upthis outcome will be evaluated at 3 months (10-14 weeks) after study enrollment.
Awards & highlights
No Placebo-Only Group
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.
- Weight Loss
- Joint Replacement
Inclusion CriteriaYou will be eligible if you check “Yes” for the criteria below
You would be willing to have a complete joint replacement surgery if you meet the requirements.
Screening ~ 3 weeks3 visits
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.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~this outcome will be evaluated at 3 months (10-14 weeks) after study enrollment.
Study ObjectivesOutcome 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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
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Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
1,532 Previous Clinical Trials
11,324,690 Total Patients Enrolled
1 Trials studying Weight Loss
20 Patients Enrolled for Weight Loss
Antonia F Chen, MD, MBAPrincipal InvestigatorBrigham and Women's Hospital
Remote dietitian supervised weight loss intervention and mobile app Clinical Trial Eligibility Overview. Trial Name: NCT04330391 — N/A
Weight Loss Research Study Groups: Usual Care, Intervention
Weight Loss Clinical Trial 2023: Remote dietitian supervised weight loss intervention and mobile app Highlights & Side Effects. Trial Name: NCT04330391 — N/A
Remote dietitian supervised weight loss intervention and mobile app 2023 Treatment Timeline for Medical Study. Trial Name: NCT04330391 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.Email
Who else is applying?
What state do they live in?
How old are they?
18 - 65
What site did they apply to?
Brigham and Women's Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
How responsive is this trial?
Typically responds via
Most responsive sites:
- Brigham and Women's Hospital: < 24 hours
Average response time
- < 1 Day
Recent research and studies
Archives of SurgeryJournalSurgery as a Teachable Moment
Obesity Research & Clinical PracticeJournalA Pilot Study Investigating Dietetic Weight Loss Interventions and 12 Month Functional Outcomes of Patients Undergoing Total Joint Replacement
Gandler, Naomi, Natalie Simmance, Jane Keenan, Peter F.M. Choong, and Michelle M. Dowsey. 2016. “A Pilot Study Investigating Dietetic Weight Loss Interventions and 12 Month Functional Outcomes of Patients Undergoing Total Joint Replacement”. Obesity Research & Clinical Practice. Elsevier BV. doi:10.1016/j.orcp.2016.03.006.
Scandinavian Journal of SurgeryJournalWeight Loss Intervention Before Total Knee Replacement: A 12-month Randomized Controlled Trial
Obesity Research & Clinical PracticeJournalComparison of a Patient-centered Weight Loss Program Starting Before Versus After Knee Replacement: A Pilot Study
Pellegrini, Christine A., Rowland W. Chang, Dorothy D. Dunlop, David E. Conroy, Jungwha Lee, Linda Van Horn, Bonnie Spring, and Kenzie A. Cameron. 2018. “Comparison of a Patient-centered Weight Loss Program Starting Before Versus After Knee Replacement: A Pilot Study”. Obesity Research & Clinical Practice. Elsevier BV. doi:10.1016/j.orcp.2018.06.009.