## Protocol Section
### Identification Module
**NCT ID:** NCT06428695

**Brief Title:** Education Session to Improve Program Adherence

**Official Title:** Implementation of Education on Calorie Tracking Application to Improve Adherence to a Calorie Restricted Weight Management Program

#### Organization Study ID Info
**ID:** IRB00110851
#### Organization
**Class:** OTHER
**Full Name:** Wake Forest University Health Sciences
### Status Module
#### Completion Date
**Date:** 2024-08

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-08

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Wake Forest University Health Sciences

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief 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.

**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

### Conditions Module

**Conditions:**

- Weight Management

**Keywords:**

- calorie tracking

- weight loss

- weight management program

- food intake

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

**Intervention Model Description:** The subject population will consist of adults 18 years of age and older with a Body Mass Index (BMI) greater than 25 kg/m2

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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

**Intervention Names:**

- Behavioral: one-hour dietary self-monitoring tool education session

**Label:** dietary self-monitoring tool education session

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- dietary self-monitoring tool education session

**Description:** 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

**Name:** one-hour dietary self-monitoring tool education session

**Other Names:**

- education session

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Perceived Competence Scale (PCS) Score

**Time Frame:** Baseline

**Description:** 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.

**Measure:** Perceived Competence Scale (PCS) Score

**Time Frame:** Week 8

### Eligibility Module

**Eligibility Criteria:** 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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** ben.ramirez2@aah.org

**Name:** Ben Ramirez, APNP, DNP

**Phone:** 414-219-4263

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Winston-Salem

**Contacts:**

***Contact 1:***

- **Email:** ben.ramirez2@aah.org

- **Name:** Ben Ramirez, APNP, DNP

- **Phone:** 414-219-4263

- **Role:** CONTACT

**Country:** United States

**Facility:** Wake Forest University Health Sciences

**State:** North Carolina

**Zip:** 27157

#### Overall Officials

**Official 1:**

**Affiliation:** Wake Forest University Health Sciences

**Name:** Melanie Smith, DO

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M18102

- Name: Weight Loss

- Relevance: LOW

- As Found: Unknown

- ID: M5114

- Name: Body Weight

- Relevance: HIGH

- As Found: Weight

### Condition Browse Module - Meshes

- ID: D000001835

- Term: Body Weight

### Misc Info Module

- Version Holder: 2024-05-31
