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MyFitnessPal Pilot Study

Primary Purpose

Weight Reduction

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

MyFitnessPal user

About this trial

This is an interventional treatment trial for Weight Reduction

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

NCT ID

NCT05059938

First Posted

September 17, 2021

Last Updated

July 18, 2023

Sponsor

Geisinger Clinic

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Withdrawn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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

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

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

Learn more about this trial

MyFitnessPal Pilot Study

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