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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06428695
Other study ID # IRB00110851
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 2024
Est. completion date August 2024

Study information

Verified date May 2024
Source Wake Forest University Health Sciences
Contact Ben Ramirez, APNP, DNP
Phone 414-219-4263
Email ben.ramirez2@aah.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date August 2024
Est. primary completion date August 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
one-hour 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

Locations

Country Name City State
United States Wake Forest University Health Sciences Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Perceived Competence Scale (PCS) Score 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
Primary Perceived Competence Scale (PCS) Score 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
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