Overweight and ObesityNCT05419063
Accessible Weight Loss for Adults With Low Vision: A Feasibility Study
A study testing weight loss strategies and text-based and email feedback in people with Overweight and Obesity, run by Towson University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- weight loss strategies and text-based and email feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2022to 31 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accessible Weight Loss: Examining the Feasibility of a Technology-Based Weight Loss Program for Adults With Low Vision
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.
- Conditions
- Overweight and Obesity
- Being tested
- weight loss strategies, text-based and email feedback
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
weight loss strategiesBehavioural
Participants will receive recommendations on how to decrease caloric intake, monitor their weight and track the related behaviors and progress.
text-based and email feedbackBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: weight loss strategies; Behavioral: text-based and email feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: week 4
Secondary outcomes (2)
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.
Measured: 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.
Measured: week 4 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start6 Jun 2022
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Towson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gerald Jerome, Principal investigator, Towson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05419063
- Sponsor's protocol ID
- 1535
- Status last verified
- Nov 2023
- First submitted
- 10 Jun 2022
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37482499
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accessible Weight Loss: Examining the Feasibility of a Technology-Based Weight Loss Program for Adults With Low Vision
- ClinicalTrials.gov ID
- NCT05419063
- Acronym / sponsor ID
- 1535
- Conditions
- Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Towson UniversityUniversity, hospital or other
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 15 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| weight loss program | Experimental | Behavioral: weight loss strategies, Behavioral: text-based and email feedbackParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| weight loss strategiesParticipants will receive recommendations on how to decrease caloric intake, monitor their weight and track the related behaviors and progress. | Behavioural | weight loss program |
| text-based and email feedbackParticipants 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. | Behavioural | weight loss program |
Primary outcome
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.
2 secondary outcomes
Usability and helpfulness of program components at week 8
Time frame: week 8
Program engagement at weeks 4 and 8
Time frame: week 4 and 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Derived from this study: PubMed 37482499Depuy 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerald Jerome principal investigator
Towson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing weight loss strategies and text-based and email feedback in people with Overweight and Obesity, run by Towson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability and helpfulness of program components at week 4 (time frame: week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05419063, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2023; AzTrials last refreshed its copy on 6 Nov 2026.