Deaf Weight Wise 2.0: A Healthy Lifestyle Intervention With Deaf Adults Who Are Overweight or Obese

NCT03060525 | Completed Results DMC

• 1 other identifier: Deaf Weight Wise 2.0
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the Deaf Weight Wise 2.0 (DWW 2.0) study is to test an evidence-based, comprehensive program to modify obesity-related health behaviors with Deaf people ages 21 to 70 who use American Sign Language (ASL) as their primary language. Participants will be randomized to one of four arms: immediate intervention vs. intervention delayed one year, and in-person group intervention vs. individual intervention delivered via videophone. The investigators' primary hypothesis is that participants in the immediate DWW 2.0 intervention will increase their physical activity and reduce their caloric intake and body weight compared with those in the delayed intervention group (no intervention yet).

Conditions

Overweight; Obesity

Keywords

Deaf; American Sign Language; Overweight; Obese

Outcome Measures

Primary Outcomes (3)

• Change in Body Weight (kg)

  measure mean change = 6-month weight - baseline weight, for the immediate and delayed intervention groups (change from pre to post intervention).

  6 month weight (kg) - baseline weight (kg)

• Change in BMI (Body Mass Index)

  measure mean change = 6-month BMI - baseline BMI, for the immediate and delayed intervention groups (change from pre to post intervention).

  6-month BMI - baseline BMI

• Change in Physical Activity

  change in amount of physical activity = 6-month MET-minutes/week - baseline MET-minutes/week (change from pre to post intervention), using the International Physical Activity Questionnaire. IPAQ score is a continuous measure and reports median MET-minutes per week (a combination of walking met-minutes/week + moderate activity MET-minutes/week + vigorous activity MET-minutes/week).

  6-month MET-min/wk - baseline MET-min/wk

Study Arms (4)

Immediate Group Intervention

EXPERIMENTAL

This arm will receive the DWW 2.0 Group intervention in Year 1 of the clinical trial. The group intervention will consist of groups of approximately 6-8 subjects who meet together for 16 weeks, for two hours each week. A trained, deaf, American Sign Language (ASL)-fluent DWW 2.0 counselor will lead the sessions. Subjects will be asked to complete a daily food and physical activity diary during the course of the 16-week intervention. Each intervention session will include a weigh-in, group sharing and problem solving, discussion of a weight management topic, which may include watching a powerpoint presentation and/or video; and a discussion on goal setting and action planning for the next week.

Behavioral: Deaf Weight Wise 2.0

Immediate Videophone Intervention

EXPERIMENTAL

This arm will receive the DWW 2.0 Individual Videophone intervention in Year 1 of the clinical trial. The participant and their intervention counselor will have one-on-one sessions that take place via videophone (like a Skype call), for one hour each week. Each session will be led by a trained deaf, ASL-fluent DWW 2.0 counselor and will be held at a scheduled appointment time that is agreed upon by the subject and the counselor. Subjects will be asked to complete a daily food and physical activity diary during the course of the 16-week intervention. Each intervention session will include a weigh-in, personal sharing and problem solving, discussion of a weight management topic, which may include watching a powerpoint presentation and/or video; and a discussion on goal setting and action planning for the next week.

Behavioral: Deaf Weight Wise 2.0

Delayed Group Intervention

OTHER

This arm will receive the DWW 2.0 Group intervention in Year 2 of the clinical trial. The group intervention will consist of groups of approximately 6-8 subjects who meet together for 16 weeks, for two hours each week. A trained, deaf, American Sign Language (ASL)-fluent DWW 2.0 counselor will lead the sessions. Subjects will be asked to complete a daily food and physical activity diary during the course of the 16-week intervention. Each intervention session will include a weigh-in, group sharing and problem solving, discussion of a weight management topic, which may include watching a powerpoint presentation and/or video; and a discussion on goal setting and action planning for the next week.

Behavioral: Deaf Weight Wise 2.0

Delayed Videophone Intervention

OTHER

This arm will receive the DWW 2.0 Individual Videophone intervention in Year 2 of the clinical trial. The participant and their intervention counselor will have one-on-one sessions that take place via videophone (like a Skype call), for one hour each week. Each session will be led by a trained deaf, ASL-fluent DWW 2.0 counselor and will be held at a scheduled appointment time that is agreed upon by the subject and the counselor. Subjects will be asked to complete a daily food and physical activity diary during the the course of the 16-week intervention. Each intervention session will include a weigh-in, personal sharing and problem solving, discussion of a weight management topic, which may include watching a powerpoint presentation and/or video; and a discussion on goal setting and action planning for the next week.

Behavioral: Deaf Weight Wise 2.0

Interventions

Deaf Weight Wise 2.0 BEHAVIORAL

Deaf Weight Wise 2.0 is a group or individual intervention lead by trained, American Sign Language fluent Deaf counselors, who utilize an existing evidence-based curriculum that emphasizes healthy eating, exercise, and lifestyle components. It is a behavior change intervention that uses motivational interviewing techniques to help participants identify/recognize their own unhealthy behaviors, help individuals build skills that will promote behavior change, and help group members to support each other to make behavior changes. The Curriculum includes group exercise activities ("Do It!"), experiential learning activities ("Try It!" such as learning how to read a nutrition label or modify a recipe to make it healthier), and group activities related to food preparation or sampling healthy foods ("Taste It!"). Self-monitoring using daily food diaries and weekly "weigh-ins" is also a key component. The intervention also includes a 6-month follow up and maintenance phase.

Delayed Group Intervention; Delayed Videophone Intervention; Immediate Group Intervention; Immediate Videophone Intervention

Eligibility Criteria

• Age: 21 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 21-70 years who use sign language and live in the Rochester Metropolitan Statistical Area (MSA),
• have a body mass index (BMI) of 25-45.
• Eligible subjects must also have 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), 2) self-reported heart condition, chest pain, dizziness, or other reason not to participate in physical activity, 3) had weight loss surgery in the previous 2 years (self-reported), and 4) are pregnant (self-reported).
• Subjects must also be willing to follow a healthy dietary pattern and to abstain from using weight loss medications during the study, and be willing and able to attend either group or videophone sessions, and to participate in data collection requirements.

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

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

585-273-2548

Study Officials

• Steven L 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: February 18, 2017
• First Posted: February 23, 2017
• Study Start: January 25, 2017
• Primary Completion: August 29, 2019
• Study Completion: August 29, 2019
• Last Updated: July 5, 2024
• Results First Posted: July 5, 2024

Record last verified: 2024-01

Locations

US (1)