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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Steve Barnett, University of Rochester
ClinicalTrials.gov Identifier:
NCT01452269
First received: September 21, 2011
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Overweight
Obesity
Behavioral: Deaf Weight Wise program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Deaf Weight Wise: A Healthy Lifestyle Intervention for Deaf Adults

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Weight change [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
  • Change in Dietary Risk Assessment (DRA) score [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
  • Change in Physical Activity Assessment (PAA) score [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]

Enrollment: 104
Study Start Date: October 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Immediate intervention group
This arm will receive the intervention immediately following baseline data collection.
Behavioral: Deaf Weight Wise program

Groups will consist of approximately 13 subjects who meet for 2 hours a week for 16 weeks. Group sessions will be offered at a variety of times and days of the week. A trained, deaf, ASL-fluent counselor will lead the sessions.

Subjects will be asked to complete a food and physical activity diary. Each intervention session will include a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Periodically, each subject will receive a Personal Feedback Report. Subjects will be able to earn points for complying with various aspects of the program. Points can be redeemed for small prizes (i.e. water bottles).

The maintenance phase consists of two meetings at the beginning of the 6-month maintenance period and three months later. This will consist of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program.

Experimental: Delayed intervention group
This arm will receive the intervention one year following the immediate intervention group.
Behavioral: Deaf Weight Wise program

Groups will consist of approximately 13 subjects who meet for 2 hours a week for 16 weeks. Group sessions will be offered at a variety of times and days of the week. A trained, deaf, ASL-fluent counselor will lead the sessions.

Subjects will be asked to complete a food and physical activity diary. Each intervention session will include a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Periodically, each subject will receive a Personal Feedback Report. Subjects will be able to earn points for complying with various aspects of the program. Points can be redeemed for small prizes (i.e. water bottles).

The maintenance phase consists of two meetings at the beginning of the 6-month maintenance period and three months later. This will consist of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program.


  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01452269

Locations
United States, New York
University of Rochester; National Center for Deaf Health Research
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Steven Barnett, MD University of Rochester
  More Information

No publications provided

Responsible Party: Steve Barnett, Director, Rochester Prevention Research Center, University of Rochester
ClinicalTrials.gov Identifier: NCT01452269     History of Changes
Other Study ID Numbers: Deaf Weight Wise
Study First Received: September 21, 2011
Last Updated: July 7, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 20, 2014