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

Obesity Clinical Trial

— DWW2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03060525
• Other study ID #: Deaf Weight Wise 2.0
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: August 29, 2019

Study information

• Verified date: October 2019
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: August 29, 2019
• Est. primary completion date: August 29, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

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.

Locations

Country	Name	City	State
United States	University of Rochester; National Center for Deaf Health Research	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in body weight	measure mean change in weight for the immediate and delayed intervention groups, from baseline to 6 months (post intervention).	baseline to 6 month data collection point
Primary	change in BMI (Body Mass Index)	measure mean change in BMI for the immediate and delayed intervention groups, from baseline to 6 months (post intervention).	baseline to 6 month data collection point
Primary	increase in physical activity	measure amount of physical activity for the immediate and delayed intervention groups, from baseline to 6 months (post intervention), using the International Physical Activity Questionnaire	baseline to 6 month data collection point