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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05419063
Other study ID # 1535
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 6, 2022
Est. completion date January 31, 2023

Study information

Verified date November 2023
Source Towson University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will examine the feasibility of an all-remote approach to enrollment in and implementation of an 8-week weight loss program for adults with low vision. The weight loss program will provide asynchronous support (information, automated texting feedback, tailored emails) for adopting and maintaining lifestyle-based strategies for safe and effective weight loss.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date January 31, 2023
Est. primary completion date January 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age =18 - English speaking - BMI = 25 and weight < 300lbs (weight limit due to scale limitations) - Legally blind - Have an email for personal use and ability to check and respond to email daily - Have a smart phone with texting for personal use - Sufficient internet plan for daily email checking - Sufficient phone plan for 12 or more texts per week - Ability to send and receive emails and text messages - Ability to join a zoom call on a personal phone, tablet, or computer - Ability to complete Qualtrics surveys - Willing to lose weight through recommended dietary changes, weight tracking and physical activity - Interest in one of the specific dietary strategies supported by the text messaging platform - Willing to use the study scale with cellular technology to report weights - Willing to join an 8-week weight loss program and interested in losing weight - Completion of screening, enrollment and baseline data collection Exclusion Criteria: - Lost 5% of body weight in the last 6 months - Currently participating in a weight loss program or another weight loss study - Previously diagnosed eating disorder, or treatment for an eating disorder - Pregnant, nursing, or planned pregnancy in the next 6 months - Planned weight loss surgery or procedure in the next 6 months - Currently using medication for weight loss (prescribed or over the counter) - History of cardiovascular events - History of type 1 or type 2 diabetes - Prescribed medication that might promote weight change such as lithium, steroids, or antipsychotics - Medical contraindicate to weight loss (e.g., end-stage renal disease, cancer diagnosis with active/planned treatment) - Psychiatric hospitalization in the past 12 months - Investigator discretion for safety or to ensure appropriate treatment of study staff

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
weight loss strategies
Participants will receive recommendations on how to decrease caloric intake, monitor their weight and track the related behaviors and progress.
text-based and email feedback
Participants will receive weekly text-based feedback based on dietary strategy tracking and weight tracking. Participants will receive tailored email support and synchronous problem solving sessions as needed.

Locations

Country Name City State
United States Towson University Towson Maryland

Sponsors (1)

Lead Sponsor Collaborator
Towson University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Usability and helpfulness of program components at week 4 Using descriptive statistics, examine 5-point Likert scale responses for the usability (0 = not at all easy to use; 4= extremely easy to use) and helpfulness (0 = not at all helpful; 4= extremely helpful) of specific program components at week 4. week 4
Secondary Usability and helpfulness of program components at week 8 Using descriptive statistics, examine 5-point Likert scale responses for the usability (0 = not at all easy to use; 4= extremely easy to use) and helpfulness (0 = not at all helpful; 4= extremely helpful) of specific program components at week 8. week 8
Secondary Program engagement at weeks 4 and 8 Examine the percentage of weeks with at least one study weight and the percentage of days with responses to dietary tracking at weeks 4 and 8. week 4 and 8
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