- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06428695
Education Session to Improve Program Adherence
September 24, 2024 updated by: Wake Forest University Health Sciences
Implementation of Education on Calorie Tracking Application to Improve Adherence to a Calorie Restricted Weight Management Program
To examine is user knowledge of a dietary self-monitoring (DSM) calorie tracking app and improving patient adherence to daily caloric food intake to help with weight loss.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The research question guiding this project is: In adults with a BMI greater than 25 kg/m2, does a 1-hour education session on using a calorie-tracking application improve adherence to a calorie-restricted weight management program over eight weeks?
This project aimed to increase patient knowledge with the DSM tool.
To Increase adherence to the calorie-restricted diet program and, finally, to increase weight loss in the program participants of the 8-week program
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
-
Winston-Salem, North Carolina, United States, 27157
- Wake Forest University Health Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 18 years of age and older with a Body Mass Index (BMI) greater than 25 kg/m2
Exclusion Criteria:
- Younger than18 years of age with a Body Mass Index (BMI) less than 25 kg/m2
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: dietary self-monitoring tool education session
access the impact of a one-hour dietary self-monitoring tool education session for participants in a calorie-restricted weight management program on their knowledge of the use of the tool to help them adhere to a calorie-restricted weight management program
|
access the impact of a one-hour dietary self-monitoring tool education session for participants in a calorie-restricted weight management program on their knowledge of the use of the tool to help them adhere to a calorie-restricted weight management program
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived Competence Scale (PCS) Score
Time Frame: Baseline
|
The Perceived Competence Scale (PCS) will be the open-access validated tool used for this project.
This will be the 4 questions pretest/posttest utilized.
A 1-hour education session will provide training on the use of a DSM calorie-tracking app.
Following this will be an 8-week in-person weight management program focusing on a daily calorie and carb restriction and protein goal.
Each item is scored from 1 to 4, where a score of 1 indicates low perceived competence and a score of 4 reflects high perceived competence.
Scores are summed and then averaged for each subscale, resulting in four separate subscale means.
|
Baseline
|
|
Perceived Competence Scale (PCS) Score
Time Frame: Week 8
|
The Perceived Competence Scale (PCS) will be the open-access validated tool used for this project.
This will be the 4 questions pretest/posttest utilized.
A 1-hour education session will provide training on the use of a DSM calorie-tracking app.
Following this will be an 8-week in-person weight management program focusing on a daily calorie and carb restriction and protein goal.
Each item is scored from 1 to 4, where a score of 1 indicates low perceived competence and a score of 4 reflects high perceived competence.
Scores are summed and then averaged for each subscale, resulting in four separate subscale means.
|
Week 8
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Melanie Smith, DO, Wake Forest University Health Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 10, 2024
Primary Completion (Actual)
August 16, 2024
Study Completion (Actual)
August 16, 2024
Study Registration Dates
First Submitted
May 20, 2024
First Submitted That Met QC Criteria
May 20, 2024
First Posted (Actual)
May 24, 2024
Study Record Updates
Last Update Posted (Actual)
September 26, 2024
Last Update Submitted That Met QC Criteria
September 24, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00110851
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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