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

Primary Purpose

Overweight, Obesity

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Deaf Weight Wise program

About this trial

This is an interventional treatment trial for Overweight

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

University of Rochester; National Center for Deaf Health Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Immediate intervention group

Delayed intervention group

Arm Description

This arm will receive the intervention immediately following baseline data collection.

This arm will receive the intervention one year following the immediate intervention group.

Outcomes

Primary Outcome Measures

Weight Change

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

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

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT01452269

First Posted

September 21, 2011

Last Updated

August 23, 2023

Sponsor

University of Rochester

1. Study Identification

Unique Protocol Identification Number

NCT01452269

Brief Title

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

Acronym

DWW

Official Title

Deaf Weight Wise: A Healthy Lifestyle Intervention for Deaf Adults

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

October 2011 (undefined)

Primary Completion Date

July 2014 (Actual)

Study Completion Date

July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Rochester

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overweight, Obesity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

104 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Immediate intervention group

Arm Type

Experimental

Arm Description

This arm will receive the intervention immediately following baseline data collection.

Arm Title

Delayed intervention group

Arm Type

Experimental

Arm Description

This arm will receive the intervention one year following the immediate intervention group.

Intervention Type

Behavioral

Intervention Name(s)

Deaf Weight Wise program

Intervention Description

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 Outcome Measure Information:

Title

Weight Change

Description

Time Frame

Baseline and 6 months

Title

Change in Dietary Risk Assessment (DRA) Score

Description

Time Frame

Baseline and 6 months

Title

Change in Physical Activity Assessment (PAA) Score

Description

Time Frame

Baseline and 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Steven Barnett, MD

Organizational Affiliation

University of Rochester

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Rochester; National Center for Deaf Health Research

City

Rochester

State/Province

New York

ZIP/Postal Code

14642

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

19407810

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.

Results Reference

background

PubMed Identifier

36890106

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.

Results Reference

result

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

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