Overview

This trial is active, not recruiting.

Conditions overweight, obesity
Treatment deaf weight wise program
Sponsor University of Rochester
Start date October 2011
End date July 2014
Trial size 104 participants
Trial identifier NCT01452269, Deaf Weight Wise

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
This arm will receive the intervention immediately following baseline data collection.
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)
This arm will receive the intervention one year following the immediate intervention group.
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.

Primary Outcomes

Measure
Weight change
time frame: Baseline and 6 months
Change in Dietary Risk Assessment (DRA) score
time frame: Baseline and 6 months
Change in Physical Activity Assessment (PAA) score
time frame: Baseline and 6 months

Eligibility Criteria

Male or female participants from 40 years up to 70 years old.

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

Additional Information

Official title Deaf Weight Wise: A Healthy Lifestyle Intervention for Deaf Adults
Principal investigator Steven Barnett, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by University of Rochester.