Back to resultsAccessible Weight Loss for Adults With Low Vision: A Feasibility Study
Primary Purpose
Overweight and Obesity
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
weight loss strategies
text-based and email feedback
Sponsored by
About this trial
This is an interventional treatment trial for Overweight and Obesity
Eligibility Criteria
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
Sites / Locations
- Towson University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
weight loss program
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05419063
Brief Title
Accessible Weight Loss for Adults With Low Vision: A Feasibility Study
Official Title
Accessible Weight Loss: Examining the Feasibility of a Technology-Based Weight Loss Program for Adults With Low Vision
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 6, 2022 (Actual)
Primary Completion Date
June 5, 2023 (Anticipated)
Study Completion Date
June 5, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Towson University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
weight loss program
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
weight loss strategies
Intervention Description
Participants will receive recommendations on how to decrease caloric intake, monitor their weight and track the related behaviors and progress.
Intervention Type
Behavioral
Intervention Name(s)
text-based and email feedback
Intervention Description
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.
Primary Outcome Measure Information:
Title
Usability and helpfulness of program components at week 4
Description
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.
Time Frame
week 4
Secondary Outcome Measure Information:
Title
Usability and helpfulness of program components at week 8
Description
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.
Time Frame
week 8
Title
Program engagement at weeks 4 and 8
Description
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.
Time Frame
week 4 and 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerald Jerome
Organizational Affiliation
Towson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Towson University
City
Towson
State/Province
Maryland
ZIP/Postal Code
21252
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Accessible Weight Loss for Adults With Low Vision: A Feasibility Study
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