NCT05059938

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2022

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 28, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

May 9, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

July 20, 2023

Status Verified

July 1, 2023

Enrollment Period

1.1 years

First QC Date

September 17, 2021

Last Update Submit

July 18, 2023

Conditions

Weight Reduction

Outcome Measures

Primary Outcomes (1)

  • Rate of Weight Loss

    Weight will be measured in pounds and recorded at each visit

    1-6 months

Secondary Outcomes (2)

  • Change in Waist Circumference

    1-6 months

  • Change in Blood Pressure

    1-6 months

Other Outcomes (2)

  • Pre-Screen survey

    First visit

  • Post intervention survey

    3 to 6 months

Study Arms (2)

MyFitnessPal user

EXPERIMENTAL

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

Traditional Weight Loss Counseling

NO INTERVENTION

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

Interventions

MyFitnessPal userBEHAVIORAL

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.

MyFitnessPal user

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI\>/= 25
  • Have a smart phone
  • Patient is willing to lose weight

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician Primary Care

Study Record Dates

First Submitted

September 17, 2021

First Posted

September 28, 2021

Study Start

May 9, 2022

Primary Completion

July 1, 2023

Study Completion

August 1, 2023

Last Updated

July 20, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share