N/A
Completed N=104
Study of a Healthy Lifestyle Intervention for Deaf Adults Who Are Overweight or Obese
Source: ClinicalTrials.gov NCT01452269 ↗Enrolled (actual)
104
Serious AEs
0.0%
Results posted
Jul 2015
Primary outcomePrimary: Weight Change — -5.33; -1.98 kilograms
Summary
The purpose of the Deaf Weight Wise study is to test a 16 week, evidence-based, comprehensive program to change obesity-related health behaviors in Deaf people who use American Sign Language (ASL) as their primary language.
Participants will be randomized to one of two study arms - immediate intervention or delayed intervention. In addition to the intervention activities, participants will also take part in five study visits over the course of two years. At these study visits, the investigators will administer several surveys as well as conduct biometric assessments.
The investigators primary hypothesis is that the immediate intervention group will increase their levels of physical activity and reduce their caloric intake and body weight immediately following the intervention, compared to the delayed intervention group.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Weight Change |
-5.33; -1.98 | — |
| PRIMARY Change in Dietary Risk Assessment (DRA) Score |
-6.3; -3.7 | — |
| PRIMARY Change in Physical Activity Assessment (PAA) Score |
1.6; 1.0 | — |
Eligibility Criteria
Inclusion Criteria
- Deaf men and women ages 40-70 years who use sign language and live in the Rochester Metropolitan Statistical Area (MSA), have a body mass index (BMI) of 25-45
- 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), and 2) self-reported heart condition, chest pain, dizziness, or other reason not to participate in physical activity 3) self-reported weight loss surgery in the past two years
- Must be willing to follow a healthy dietary pattern and to abstain from using weight loss medications during the study
- Must be willing and able to attend group sessions and to participate in data collection requirements
Exclusion Criteria
- Participants who had a cardiovascular disease event in the past 6 months who did not obtain medical clearance from their provider
- Participants who had self-reported heart condition, chest pain, dizziness, or other reason not to participate in physical activity who did not obtain medical clearance from their provider
- Participants who had weight loss surgery in the past two years and who did not obtain medical clearance from their provider
- Pregnancy, breastfeeding, or planning a pregnancy during the study period (each of which will be determined by subject self-report through an in-person interview with a research team member)
- Those people who are unable or unwilling to provide written, informed consent
- Those people who are unable to see and interact with computer-based questionnaires and educational interventions
Data sourced from ClinicalTrials.gov (NCT01452269). 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. Informational only — not medical advice.