Clinical trial NCT01452269: Study of a Healthy Lifestyle Intervention for Deaf Adults Who Are Overweight or Obese
Official title: Deaf Weight Wise: A Healthy Lifestyle Intervention for Deaf Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2011-10-14
Enrollment: 104
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Weight Change
timeFrame: Baseline and 6 months
measure: Change in Dietary Risk Assessment (DRA) Score
timeFrame: Baseline and 6 months
measure: Change in Physical Activity Assessment (PAA) Score
timeFrame: Baseline and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester; National Center for Deaf Health Research
state: New York
Study officials:
affiliation: University of Rochester
name: Steven Barnett, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Samuel-Hodge CD, Johnston LF, Gizlice Z, Garcia BA, Lindsley SC, Bramble KP, Hardy TE, Ammerman AS, Poindexter PA, Will JC, Keyserling TC. Randomized trial of a behavioral weight loss intervention for low-income women: the Weight Wise Program. Obesity (Silver Spring). 2009 Oct;17(10):1891-9. doi: 10.1038/oby.2009.128. Epub 2009 Apr 30.
citation: Barnett S, Matthews K, DeWindt L, Sutter E, Samuel-Hodge C, Yang H, Pearson TA; Deaf Weight Wise Study Group. Deaf Weight Wise: A novel randomized clinical trial with Deaf sign language users. Obesity (Silver Spring). 2023 Apr;31(4):965-976. doi: 10.1002/oby.23702. Epub 2023 Mar 8.