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

Sponsor
Towson University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05419063
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
12
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: weight loss strategies
  • Behavioral: text-based and email feedback
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Accessible Weight Loss: Examining the Feasibility of a Technology-Based Weight Loss Program for Adults With Low Vision
Anticipated Study Start Date :
Jun 6, 2022
Anticipated Primary Completion Date :
Jun 5, 2023
Anticipated Study Completion Date :
Jun 5, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Usability and helpfulness of program components at week 4 [week 4]

    Using descriptive statistics, examine the usability and helpfulness based on Likert scale responses regarding specific program components at week 4.

Secondary Outcome Measures

  1. Usability and helpfulness of program components at week 8 [week 8]

    Using descriptive statistics, examine the usability and helpfulness based on Likert scale responses regarding specific program components at week 8.

  2. Program engagement at weeks 4 and 8 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Towson University Towson Maryland United States 21252

Sponsors and Collaborators

  • Towson University

Investigators

  • Principal Investigator: Gerald Jerome, Towson University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Towson University
ClinicalTrials.gov Identifier:
NCT05419063
Other Study ID Numbers:
  • 1535
First Posted:
Jun 15, 2022
Last Update Posted:
Jun 15, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Vision, Low
Overweight
Weight Loss

Study Results

No Results Posted as of Jun 15, 2022