N/A
N=76
Deaf Weight Wise 2.0: A Healthy Lifestyle Intervention With Deaf Adults Who Are Overweight or Obese
Overweight · Obesity
Bottom Line
View on ClinicalTrials.gov: NCT03060525 ↗Enrolled (actual)
76
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Change in Body Weight (kg) — -2.36; -3.09; 1.02; 0.26 kg — p=0.026
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Deaf Weight Wise 2.0 (Behavioral)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of Rochester
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Body Weight (kg) |
-2.36; -3.09; 1.02; 0.26 | 0.026 sig |
| PRIMARY Change in BMI (Body Mass Index) |
-0.91; -1.05; 0.39; 0.20 | 0.03 sig |
| PRIMARY Change in Physical Activity |
2.75; 543.50; -82.50; 66.00 | 0.63 |
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).
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03060525). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.