Accessible Weight Loss for Adults With Low Vision: A Feasibility Study

Overweight and Obesity Clinical Trial

Official title:

Accessible Weight Loss: Examining the Feasibility of a Technology-Based Weight Loss Program for Adults With Low Vision

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05419063
• Other study ID #: 1535
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity
• Vision, Low
• Weight Loss

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