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

Not Applicable

Completed

• Conditions: Obesity; Overweight
• Interventions: Behavioral: Deaf Weight Wise program

• Registration Number: NCT01452269
• Lead Sponsor: University of Rochester

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2011-09-21
• Study Start: 2011-10
• Study First Submitted QC: 2011-10-10
• Study First Posted: 2011-10-14
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Results First Submitted: 2015-06-16
• Results First Submitted QC: 2015-06-16
• Results First Posted: 2015-07-09
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-23
• Last Update Posted: 2023-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Delayed intervention group	Deaf Weight Wise program	This arm will receive the intervention one year following the immediate intervention group.
Immediate intervention group	Deaf Weight Wise program	This arm will receive the intervention immediately following baseline data collection.

Primary Outcome Measures

Name	Time	Method
Weight Change	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.
Change in Dietary Risk Assessment (DRA) Score	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).
Change in Physical Activity Assessment (PAA) Score	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).

Trial Locations

Locations (1)

University of Rochester; National Center for Deaf Health Research; 🇺🇸 Rochester, New York, United States