NCT06428695

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

May 20, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 24, 2024

Completed
17 days until next milestone

Study Start

First participant enrolled

June 10, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2024

Completed
Last Updated

September 26, 2024

Status Verified

May 1, 2024

Enrollment Period

2 months

First QC Date

May 20, 2024

Last Update Submit

September 24, 2024

Conditions

Keywords

calorie trackingweight lossweight management programfood intake

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (1)

dietary self-monitoring tool education session

EXPERIMENTAL

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

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

Interventions

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

Also known as: education session
dietary self-monitoring tool education session

Eligibility Criteria

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

You may qualify if:

  • years of age and older with a Body Mass Index (BMI) greater than 25 kg/m2

You may not qualify if:

  • Younger than18 years of age with a Body Mass Index (BMI) less than 25 kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Melanie Smith, DO

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: The subject population will consist of adults 18 years of age and older with a Body Mass Index (BMI) greater than 25 kg/m2
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2024

First Posted

May 24, 2024

Study Start

June 10, 2024

Primary Completion

August 16, 2024

Study Completion

August 16, 2024

Last Updated

September 26, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations