MyFitnessPal Pilot Study

Sponsor

Geisinger Clinic (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05059938

Collaborator

(none)

Enrollment

Arms

2.9

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Weight Reduction	Behavioral: MyFitnessPal user	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Promoting the Use of Free Smartphone App (MyFitnessPal) for Weight Loss by Primary Care Provider in Overweight Patients: A Randomized Controlled Pilot Study

Anticipated Study Start Date :

Feb 1, 2022

Anticipated Primary Completion Date :

Mar 1, 2022

Anticipated Study Completion Date :

May 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MyFitnessPal user Patients will be shown how to download and use MyFitnessPal onto the patient's smartphone. The patient will be asked to use the application to aid in the patient's weight loss plan over up to six months.	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.
No Intervention: Traditional Weight Loss Counseling Patients will be given traditional weight loss counseling from the physician and monitored over up to six months.

Arm

Intervention/Treatment

Experimental: MyFitnessPal user

Patients will be shown how to download and use MyFitnessPal onto the patient's smartphone. The patient will be asked to use the application to aid in the patient's weight loss plan over up to six months.

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.

No Intervention: Traditional Weight Loss Counseling

Patients will be given traditional weight loss counseling from the physician and monitored over up to six months.

Outcome Measures

Primary Outcome Measures

Rate of Weight Loss [1-6 months]
Weight will be measured in pounds and recorded at each visit

Secondary Outcome Measures

Change in Waist Circumference [1-6 months]
Waist Circumference will be measured in centimeters and recorded at each visit
Change in Blood Pressure [1-6 months]
Blood pressure will be measured and recorded at each visit

Other Outcome Measures

Pre-Screen survey [First visit]
Patients will be asked about willingness to participate in weight loss and other inclusion/exclusion questions
Post intervention survey [3 to 6 months]
Patients will be asked about overall use of the application and how it affected weight loss.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 89 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Geisinger Clinic

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kristin Simmons Bennie, Physician Primary Care, Geisinger Clinic

ClinicalTrials.gov Identifier:

NCT05059938

Other Study ID Numbers:

2021-0452

First Posted:

Sep 28, 2021

Last Update Posted:

Jan 10, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Weight Loss

Study Results

No Results Posted as of Jan 10, 2022