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

NCT01452269 | Completed Results DMC

• 1 other identifier: Deaf Weight Wise
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight; Obesity

Outcome Measures

Primary Outcomes (3)

• 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.

  Baseline and 6 months

• 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).

  Baseline and 6 months

• 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).

  Baseline and 6 months

Study Arms (2)

Immediate intervention group

EXPERIMENTAL

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

Behavioral: Deaf Weight Wise program

Delayed intervention group

EXPERIMENTAL

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

Behavioral: Deaf Weight Wise program

Interventions

Deaf Weight Wise program BEHAVIORAL

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.

Delayed intervention group; Immediate intervention group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester; National Center for Deaf Health Research

Rochester, New York, 14642, United States

Location

Related Publications (2)

• 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.

  PMID: 19407810 BACKGROUND

• 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.

  PMID: 36890106 RESULT

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Steven Barnett
• Organization: University of Rochester

steven_barnett@urmc.rochester.edu

Study Officials

• Steven Barnett, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Rochester Prevention Research Center

Study Record Dates

• First Submitted: September 21, 2011
• First Posted: October 14, 2011
• Study Start: October 1, 2011
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: September 6, 2023
• Results First Posted: July 9, 2015

Record last verified: 2023-08

Locations

US (1)