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

November 20, 2023 updated by: Towson University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Towson, Maryland, United States, 21252
        • Towson University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: weight loss program
Participants will receive recommendations on how to decrease caloric intake, monitor their weight and track the related behaviors and progress. 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.
Behavioral: weight loss strategies
Participants will receive recommendations on how to decrease caloric intake, monitor their weight and track the related behaviors and progress.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usability and helpfulness of program components at week 4
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usability and helpfulness of program components at week 8
Time Frame: 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
Program engagement at weeks 4 and 8
Time Frame: week 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Towson University

Investigators

  • Principal Investigator: Gerald Jerome, Towson University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2022

Primary Completion (Actual)

January 31, 2023

Study Completion (Actual)

January 31, 2023

Study Registration Dates

First Submitted

June 10, 2022

First Submitted That Met QC Criteria

June 10, 2022

First Posted (Actual)

June 15, 2022

Study Record Updates

Last Update Posted (Estimated)

November 21, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1535

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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