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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05059938
Other study ID # 2021-0907
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date May 9, 2022
Est. completion date August 2023

Study information

Verified date July 2023
Source Geisinger Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This project is studying whether patients who use MyFitnessPal as an aid to weight loss have more success than patients who are only given traditional medical guidance from the patient's physician.


Description:

Patients will be given a survey determining the patient's eligibility to be part of the study. Based on the results patients will be consented and then randomized into two arms. The intervention group will download MyFitnessPal onto the patient's smartphone and given guidance on how to use the application in order to help with weight loss. The control group will receive traditional weight loss counseling from the physician. Both groups will have measurement recorded for weight, blood pressure, and waist circumference at the patient's initial visit. All patients will be asked to return to the clinic at no cost to the patient to have measurements recorded for the patient's weight, blood pressure, and waist circumference at 1 month, 3 months, and 6 months after the patient's initial visit. At the conclusion of the study, patients who were in the intervention group will be asked to take a final survey regarding the patient's use of the MyFitnessPal application.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date August 2023
Est. primary completion date July 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 89 Years
Eligibility Inclusion Criteria: - BMI>/= 25 - Have a smart phone - Patient is willing to lose weight Exclusion Criteria: - Do not have a smart phone - pregnant (current, planned, or previous pregnancy within 6 months) - have already seen a nutritionist - on weight loss medication - using outside weight loss programs - lack interest in weight loss - hemodialysis patient - has a life expectancy less than 6 months

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
MyFitnessPal user
Patients will be counseled on how to use the MyFitnessPal application to help with the patient's weight loss goals. The physician will monitor the patient's weight, blood pressure, and waist circumference over up to a six month period with visits at 1, 3, and 6 months. Patients will be asked about the patient's use of the application at the end of the study.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Geisinger Clinic

Outcome

Type Measure Description Time frame Safety issue
Other Pre-Screen survey Patients will be asked about willingness to participate in weight loss and other inclusion/exclusion questions First visit
Other Post intervention survey Patients will be asked about overall use of the application and how it affected weight loss. 3 to 6 months
Primary Rate of Weight Loss Weight will be measured in pounds and recorded at each visit 1-6 months
Secondary Change in Waist Circumference Waist Circumference will be measured in centimeters and recorded at each visit 1-6 months
Secondary Change in Blood Pressure Blood pressure will be measured and recorded at each visit 1-6 months
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