MyFitnessPal Pilot Study
Primary Purpose
Weight Reduction
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MyFitnessPal user
Sponsored by
About this trial
This is an interventional treatment trial for Weight Reduction
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
MyFitnessPal user
Traditional Weight Loss Counseling
Arm Description
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.
Patients will be given traditional weight loss counseling from the physician and monitored over up to six months.
Outcomes
Primary Outcome Measures
Rate of Weight Loss
Weight will be measured in pounds and recorded at each visit
Secondary Outcome Measures
Change in Waist Circumference
Waist Circumference will be measured in centimeters and recorded at each visit
Change in Blood Pressure
Blood pressure will be measured and recorded at each visit
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05059938
Brief Title
MyFitnessPal Pilot Study
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Investigator changed positions
Study Start Date
May 9, 2022 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Geisinger Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Reduction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MyFitnessPal user
Arm Type
Experimental
Arm Description
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.
Arm Title
Traditional Weight Loss Counseling
Arm Type
No Intervention
Arm Description
Patients will be given traditional weight loss counseling from the physician and monitored over up to six months.
Intervention Type
Behavioral
Intervention Name(s)
MyFitnessPal user
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of Weight Loss
Description
Weight will be measured in pounds and recorded at each visit
Time Frame
1-6 months
Secondary Outcome Measure Information:
Title
Change in Waist Circumference
Description
Waist Circumference will be measured in centimeters and recorded at each visit
Time Frame
1-6 months
Title
Change in Blood Pressure
Description
Blood pressure will be measured and recorded at each visit
Time Frame
1-6 months
Other Pre-specified Outcome Measures:
Title
Pre-Screen survey
Description
Patients will be asked about willingness to participate in weight loss and other inclusion/exclusion questions
Time Frame
First visit
Title
Post intervention survey
Description
Patients will be asked about overall use of the application and how it affected weight loss.
Time Frame
3 to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
MyFitnessPal Pilot Study
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