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Study of a Healthy Lifestyle Intervention for Deaf Adults Who Are Overweight or Obese (DWW)

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University of Rochester

Status

Completed

Conditions

Overweight
Obesity

Treatments

Behavioral: Deaf Weight Wise program

Study type

Interventional

Funder types

Other

Identifiers

NCT01452269
Deaf Weight Wise

Details and patient eligibility

About

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.

Enrollment

104 patients

Sex

All

Ages

40 to 70 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

104 participants in 2 patient groups

Immediate intervention group
Experimental group
Description:
This arm will receive the intervention immediately following baseline data collection.
Treatment:
Behavioral: Deaf Weight Wise program
Delayed intervention group
Experimental group
Description:
This arm will receive the intervention one year following the immediate intervention group.
Treatment:
Behavioral: Deaf Weight Wise program

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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