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Completed

NCT Number: NCT05419063

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

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.

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Key information

Conditions

Overweight and Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Towson University

Towson, Maryland, 21252, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

weight loss strategies

Behavioral

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

Behavioral

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 outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Towson University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 15, 2022
Registry last updated
Nov 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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