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

• ClinicalTrials.gov Identifier: NCT01452269
• Recruitment Status: Completed
• First Posted: October 14, 2011
• Results First Posted: July 9, 2015
• Last Update Posted: June 28, 2018
• Sponsor: University of Rochester
• Information provided by (Responsible Party): Steve Barnett, University of Rochester

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Overweight; Obesity	Behavioral: Deaf Weight Wise program	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 104 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Deaf Weight Wise: A Healthy Lifestyle Intervention for Deaf Adults
• Study Start Date: October 2011
• Actual Primary Completion Date: July 2014
• Actual Study Completion Date: July 2014

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. Weight Change [ Time Frame: Baseline and 6 months ]
   We measured the mean change in weight for the immediate and delayed groups, from baseline to 6 months (post-intervention for the immediate group; no intervention yet for the delayed group). We used intention to treat analyses, with any missing values carried forward from baseline to the 6-month data point.
2. Change in Dietary Risk Assessment (DRA) Score [ Time Frame: Baseline and 6 months ]
   We measured the mean change in DRA score for the immediate and delayed groups, from baseline to 6 months (post-intervention for the immediate group; no intervention yet for the delayed group). We used intention to treat analyses, with any missing values carried forward from baseline to the 6-month data point. DRA scores range from 0-96; lower scores are better (improved dietary quality).
3. Change in Physical Activity Assessment (PAA) Score [ Time Frame: Baseline and 6 months ]
   We measured the mean change in the moderate PAA score for the immediate and delayed groups, from baseline to 6 months (post-intervention for the immediate group; no intervention yet for the delayed group). We used intention to treat analyses, with any missing values carried forward from baseline to the 6-month data point. PAA moderate activity scores range from 0-27; higher scores are better (more physical activity).

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: Steve Barnett, Director, Rochester Prevention Research Center, University of Rochester
• ClinicalTrials.gov Identifier: NCT01452269
• Other Study ID Numbers: Deaf Weight Wise
• First Posted: October 14, 2011
• Results First Posted: July 9, 2015
• Last Update Posted: June 28, 2018
• Last Verified: May 2018

Additional relevant MeSH terms:

Overweight; Body Weight