NCT05419063

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 6, 2022

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

June 10, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 15, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

November 21, 2023

Status Verified

November 1, 2023

Enrollment Period

8 months

First QC Date

June 10, 2022

Last Update Submit

November 20, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    week 4

Secondary Outcomes (2)

  • Usability and helpfulness of program components at week 8

    week 8

  • Program engagement at weeks 4 and 8

    week 4 and 8

Study Arms (1)

weight loss program

EXPERIMENTAL

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 strategiesBehavioral: text-based and email feedback

Interventions

Participants will receive recommendations on how to decrease caloric intake, monitor their weight and track the related behaviors and progress.

weight loss program

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.

weight loss program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +1 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Towson University

Towson, Maryland, 21252, United States

Location

Related Publications (1)

  • Depuy J, Molina-Morales J, Conover AJ, Jerome GJ. Accessible weight loss program for adults who are legally blind: A pilot study. Disabil Health J. 2023 Oct;16(4):101502. doi: 10.1016/j.dhjo.2023.101502. Epub 2023 Jul 4.

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gerald Jerome

    Towson University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2022

First Posted

June 15, 2022

Study Start

June 6, 2022

Primary Completion

January 31, 2023

Study Completion

January 31, 2023

Last Updated

November 21, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations