MyFitnessPal Pilot Study

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Weight Reduction
• Intervention / Treatment: Behavioral: MyFitnessPal user

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Angela Thomas, MD; Phone Number: 570-808-8780; Email: athomas9@geisinger.edu
• Study Contact Backup: Name: Jessica Webster, BS; Phone Number: 570-214-8079; Email: jlwebster@geisinger.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Weight Loss	Weight will be measured in pounds and recorded at each visit	1-6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Waist Circumference	Waist Circumference will be measured in centimeters and recorded at each visit	1-6 months
Change in Blood Pressure	Blood pressure will be measured and recorded at each visit	1-6 months

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Geisinger Clinic

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2022
• Primary Completion (Estimated): July 1, 2023
• Study Completion (Estimated): August 1, 2023

Study Registration Dates

• First Submitted: September 17, 2021
• First Submitted That Met QC Criteria: September 27, 2021
• First Posted (Actual): September 28, 2021

Study Record Updates

• Last Update Posted (Actual): July 20, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: 2021-0907

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No