Clinical trial NCT05419063: 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
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Lead sponsor: Towson University
Sponsor class: OTHER
First posted: 2022-06-15
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Usability and helpfulness of program components at week 4
timeFrame: week 4
Secondary outcomes:
measure: Usability and helpfulness of program components at week 8
timeFrame: week 8
measure: Program engagement at weeks 4 and 8
timeFrame: week 4 and 8
Other outcomes:
Locations:
city: Towson
country: United States
facility: Towson University
state: Maryland
Study officials:
affiliation: Towson University
name: Gerald Jerome
role: PRINCIPAL_INVESTIGATOR
References: