Deaf Weight Wise 2.0: A Healthy Lifestyle Intervention With Deaf Adults Who Are Overweight or Obese (DWW2)

January 26, 2024 updated by: Steve Barnett, University of Rochester

Deaf Weight Wise 2.0: Clinical Trial of a Healthy Lifestyle Intervention With Deaf Adults Ages 21 to 70

The purpose of the Deaf Weight Wise 2.0 (DWW 2.0) study is to test an evidence-based, comprehensive program to modify obesity-related health behaviors with Deaf people ages 21 to 70 who use American Sign Language (ASL) as their primary language. Participants will be randomized to one of four arms: immediate intervention vs. intervention delayed one year, and in-person group intervention vs. individual intervention delivered via videophone. The investigators' primary hypothesis is that participants in the immediate DWW 2.0 intervention will increase their physical activity and reduce their caloric intake and body weight compared with those in the delayed intervention group (no intervention yet).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
76

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester; National Center for Deaf Health Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Deaf men and women ages 21-70 years who use sign language and live in the Rochester Metropolitan Statistical Area (MSA),
  • have a body mass index (BMI) of 25-45.
  • Eligible subjects must also have permission to participate from a primary healthcare provider if: 1) self-reported diagnosis of a recent cardiovascular disease event (heart attack or stroke in past 6 months), 2) self-reported heart condition, chest pain, dizziness, or other reason not to participate in physical activity, 3) had weight loss surgery in the previous 2 years (self-reported), and 4) are pregnant (self-reported).
  • Subjects must also be willing to follow a healthy dietary pattern and to abstain from using weight loss medications during the study, and be willing and able to attend either group or videophone sessions, and to participate in data collection requirements.

Exclusion Criteria:

  • Exclusion criteria include: subjects without medical clearance who had 1) a cardiovascular disease event in the past six months, 2) or heart condition, chest pain, dizziness, or other reason not to participate in physical activity, 3) or weight loss surgery in the past two years, or 4) are pregnant. Participants with these conditions (as determined by the PAR-Q Physical Activity Readiness-Questionnaire and other questions administered during the initial study screening visit) must obtain medical clearance from their primary healthcare clinician (or maternity care clinician for pregnancy) to be eligible. Those who are unable or unwilling to provide written, informed consent, and inability to see and interact with computer-based questionnaires and educational interventions will be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Immediate Group Intervention
This arm will receive the DWW 2.0 Group intervention in Year 1 of the clinical trial. The group intervention will consist of groups of approximately 6-8 subjects who meet together for 16 weeks, for two hours each week. A trained, deaf, American Sign Language (ASL)-fluent DWW 2.0 counselor will lead the sessions. Subjects will be asked to complete a daily food and physical activity diary during the course of the 16-week intervention. Each intervention session will include a weigh-in, group sharing and problem solving, discussion of a weight management topic, which may include watching a powerpoint presentation and/or video; and a discussion on goal setting and action planning for the next week.
Behavioral: Deaf Weight Wise 2.0
Deaf Weight Wise 2.0 is a group or individual intervention lead by trained, American Sign Language fluent Deaf counselors, who utilize an existing evidence-based curriculum that emphasizes healthy eating, exercise, and lifestyle components. It is a behavior change intervention that uses motivational interviewing techniques to help participants identify/recognize their own unhealthy behaviors, help individuals build skills that will promote behavior change, and help group members to support each other to make behavior changes. The Curriculum includes group exercise activities ("Do It!"), experiential learning activities ("Try It!" such as learning how to read a nutrition label or modify a recipe to make it healthier), and group activities related to food preparation or sampling healthy foods ("Taste It!"). Self-monitoring using daily food diaries and weekly "weigh-ins" is also a key component. The intervention also includes a 6-month follow up and maintenance phase.
Experimental: Immediate Videophone Intervention
This arm will receive the DWW 2.0 Individual Videophone intervention in Year 1 of the clinical trial. The participant and their intervention counselor will have one-on-one sessions that take place via videophone (like a Skype call), for one hour each week. Each session will be led by a trained deaf, ASL-fluent DWW 2.0 counselor and will be held at a scheduled appointment time that is agreed upon by the subject and the counselor. Subjects will be asked to complete a daily food and physical activity diary during the course of the 16-week intervention. Each intervention session will include a weigh-in, personal sharing and problem solving, discussion of a weight management topic, which may include watching a powerpoint presentation and/or video; and a discussion on goal setting and action planning for the next week.
Behavioral: Deaf Weight Wise 2.0
Deaf Weight Wise 2.0 is a group or individual intervention lead by trained, American Sign Language fluent Deaf counselors, who utilize an existing evidence-based curriculum that emphasizes healthy eating, exercise, and lifestyle components. It is a behavior change intervention that uses motivational interviewing techniques to help participants identify/recognize their own unhealthy behaviors, help individuals build skills that will promote behavior change, and help group members to support each other to make behavior changes. The Curriculum includes group exercise activities ("Do It!"), experiential learning activities ("Try It!" such as learning how to read a nutrition label or modify a recipe to make it healthier), and group activities related to food preparation or sampling healthy foods ("Taste It!"). Self-monitoring using daily food diaries and weekly "weigh-ins" is also a key component. The intervention also includes a 6-month follow up and maintenance phase.
Other: Delayed Group Intervention
This arm will receive the DWW 2.0 Group intervention in Year 2 of the clinical trial. The group intervention will consist of groups of approximately 6-8 subjects who meet together for 16 weeks, for two hours each week. A trained, deaf, American Sign Language (ASL)-fluent DWW 2.0 counselor will lead the sessions. Subjects will be asked to complete a daily food and physical activity diary during the course of the 16-week intervention. Each intervention session will include a weigh-in, group sharing and problem solving, discussion of a weight management topic, which may include watching a powerpoint presentation and/or video; and a discussion on goal setting and action planning for the next week.
Behavioral: Deaf Weight Wise 2.0
Deaf Weight Wise 2.0 is a group or individual intervention lead by trained, American Sign Language fluent Deaf counselors, who utilize an existing evidence-based curriculum that emphasizes healthy eating, exercise, and lifestyle components. It is a behavior change intervention that uses motivational interviewing techniques to help participants identify/recognize their own unhealthy behaviors, help individuals build skills that will promote behavior change, and help group members to support each other to make behavior changes. The Curriculum includes group exercise activities ("Do It!"), experiential learning activities ("Try It!" such as learning how to read a nutrition label or modify a recipe to make it healthier), and group activities related to food preparation or sampling healthy foods ("Taste It!"). Self-monitoring using daily food diaries and weekly "weigh-ins" is also a key component. The intervention also includes a 6-month follow up and maintenance phase.
Other: Delayed Videophone Intervention
This arm will receive the DWW 2.0 Individual Videophone intervention in Year 2 of the clinical trial. The participant and their intervention counselor will have one-on-one sessions that take place via videophone (like a Skype call), for one hour each week. Each session will be led by a trained deaf, ASL-fluent DWW 2.0 counselor and will be held at a scheduled appointment time that is agreed upon by the subject and the counselor. Subjects will be asked to complete a daily food and physical activity diary during the the course of the 16-week intervention. Each intervention session will include a weigh-in, personal sharing and problem solving, discussion of a weight management topic, which may include watching a powerpoint presentation and/or video; and a discussion on goal setting and action planning for the next week.
Behavioral: Deaf Weight Wise 2.0
Deaf Weight Wise 2.0 is a group or individual intervention lead by trained, American Sign Language fluent Deaf counselors, who utilize an existing evidence-based curriculum that emphasizes healthy eating, exercise, and lifestyle components. It is a behavior change intervention that uses motivational interviewing techniques to help participants identify/recognize their own unhealthy behaviors, help individuals build skills that will promote behavior change, and help group members to support each other to make behavior changes. The Curriculum includes group exercise activities ("Do It!"), experiential learning activities ("Try It!" such as learning how to read a nutrition label or modify a recipe to make it healthier), and group activities related to food preparation or sampling healthy foods ("Taste It!"). Self-monitoring using daily food diaries and weekly "weigh-ins" is also a key component. The intervention also includes a 6-month follow up and maintenance phase.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Body Weight (kg)
Time Frame: 6 month weight (kg) - baseline weight (kg)
measure mean change = 6-month weight - baseline weight, for the immediate and delayed intervention groups (change from pre to post intervention).
6 month weight (kg) - baseline weight (kg)
Change in BMI (Body Mass Index)
Time Frame: 6-month BMI - baseline BMI
measure mean change = 6-month BMI - baseline BMI, for the immediate and delayed intervention groups (change from pre to post intervention).
6-month BMI - baseline BMI
Change in Physical Activity
Time Frame: 6-month MET-min/wk - baseline MET-min/wk
change in amount of physical activity = 6-month MET-minutes/week - baseline MET-minutes/week (change from pre to post intervention), using the International Physical Activity Questionnaire. IPAQ score is a continuous measure and reports median MET-minutes per week (a combination of walking met-minutes/week + moderate activity MET-minutes/week + vigorous activity MET-minutes/week).
6-month MET-min/wk - baseline MET-min/wk

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Rochester

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Steven L Barnett, MD, University of Rochester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 25, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 29, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 29, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 18, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Deaf Weight Wise 2.0

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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