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

University of Rochester

Status: Completed

Conditions: Overweight; Obesity

Treatments: Behavioral: Deaf Weight Wise 2.0

Study type: Interventional

Funder types: Other

Identifiers

NCT03060525

Deaf Weight Wise 2.0

Details and patient eligibility

About

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).

Enrollment: 76 patients

Sex: All

Ages: 21 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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76 participants in 4 patient groups

Immediate Group Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Deaf Weight Wise 2.0

Immediate Videophone Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Deaf Weight Wise 2.0

Delayed Group Intervention

Other group

Description:

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.

Treatment:

Behavioral: Deaf Weight Wise 2.0

Delayed Videophone Intervention

Other group

Description:

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.

Treatment:

Behavioral: Deaf Weight Wise 2.0