Trial Outcomes & Findings for Deaf Weight Wise 2.0: A Healthy Lifestyle Intervention With Deaf Adults Who Are Overweight or Obese (NCT NCT03060525)

NCT ID: NCT03060525

Last Updated: 2024-07-05

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

76 participants

Primary outcome timeframe

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

Results posted on

2024-07-05

Participant Flow

This study recruited participants using a variety of methods, and had a rolling enrollment (in 4 waves). The first participant was enrolled on Jan. 25, 2017 and the last participant was enrolled on Sept. 22, 2017.

Participant milestones

Participant milestones
Measure
Immediate Group Intervention
Participants received the DWW 2.0 Group intervention in Year 1 of the clinical trial. The group intervention consisted 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 led the sessions. Subjects were asked to complete a daily food and physical activity diary during the course of the 16-week intervention. Each intervention session included a weigh-in, group sharing and problem solving, discussion of a weight management topic, and a discussion on goal setting and action planning for the next week. 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 unhealthy behaviors, build skills that will promote behavior change, and help group members to support each other to make behavior changes. The Curriculum includes group exercise ("Do It!"), experiential learning ("Try It!" such as learning how to read a nutrition label), and group activities such as sampling healthy foods ("Taste It!"). Self-monitoring using daily food diaries and weekly "weigh-ins" are encouraged. The intervention also includes a 6-month follow up and maintenance phase.
Immediate Videophone Intervention
Participants received the DWW 2.0 Individual Videophone intervention in Year 1 of the clinical trial. The participant and their intervention counselor had one-on-one sessions via videophone, for one hour each week. Each session was led by a trained deaf, ASL-fluent DWW 2.0 counselor. Subjects were asked to complete a daily food and physical activity diary during the course of the 16-week intervention. Each intervention session included a weigh-in, personal sharing and problem solving, discussion of a weight management topic, and a discussion on goal setting and action planning for the next week. 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 unhealthy behaviors, build skills that will promote behavior change, and help group members to support each other to make behavior changes. The Curriculum includes group exercise ("Do It!"), experiential learning ("Try It!" such as learning how to read a nutrition label), and group activities such as sampling healthy foods ("Taste It!"). Self-monitoring using daily food diaries and weekly "weigh-ins" are encouraged. The intervention also includes a 6-month follow up and maintenance phase.
Delayed Group Intervention
Participants received the DWW 2.0 Group intervention in Year 2 of the clinical trial. The group intervention consisted 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 led the sessions. Subjects were asked to complete a daily food and physical activity diary during the course of the 16-week intervention. Each intervention session included a weigh-in, group sharing and problem solving, discussion of a weight management topic, and a discussion on goal setting and action planning for the next week. 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 unhealthy behaviors, build skills that will promote behavior change, and help group members to support each other to make behavior changes. The Curriculum includes group exercise ("Do It!"), experiential learning ("Try It!" such as learning how to read a nutrition label), and group activities such as sampling healthy foods ("Taste It!"). Self-monitoring using daily food diaries and weekly "weigh-ins" are encouraged. The intervention also includes a 6-month follow up and maintenance phase.
Delayed Videophone Intervention
Participants received the DWW 2.0 Individual Videophone intervention in Year 2 of the clinical trial. The participant and their intervention counselor had one-on-one sessions via videophone, for one hour each week. Each session was led by a trained deaf, ASL-fluent DWW 2.0 counselor. Subjects were asked to complete a daily food and physical activity diary during the course of the 16-week intervention. Each intervention session included a weigh-in, personal sharing and problem solving, discussion of a weight management topic, and a discussion on goal setting and action planning for the next week. 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 unhealthy behaviors, build skills that will promote behavior change, and help group members to support each other to make behavior changes. The Curriculum includes group exercise ("Do It!"), experiential learning ("Try It!" such as learning how to read a nutrition label), and group activities such as sampling healthy foods ("Taste It!"). Self-monitoring using daily food diaries and weekly "weigh-ins" are encouraged. The intervention also includes a 6-month follow up and maintenance phase.
Overall Study
STARTED
16
18
21
21
Overall Study
COMPLETED
13
14
17
18
Overall Study
NOT COMPLETED
3
4
4
3

Reasons for withdrawal

Reasons for withdrawal
Measure
Immediate Group Intervention
Participants received the DWW 2.0 Group intervention in Year 1 of the clinical trial. The group intervention consisted 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 led the sessions. Subjects were asked to complete a daily food and physical activity diary during the course of the 16-week intervention. Each intervention session included a weigh-in, group sharing and problem solving, discussion of a weight management topic, and a discussion on goal setting and action planning for the next week. 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 unhealthy behaviors, build skills that will promote behavior change, and help group members to support each other to make behavior changes. The Curriculum includes group exercise ("Do It!"), experiential learning ("Try It!" such as learning how to read a nutrition label), and group activities such as sampling healthy foods ("Taste It!"). Self-monitoring using daily food diaries and weekly "weigh-ins" are encouraged. The intervention also includes a 6-month follow up and maintenance phase.
Immediate Videophone Intervention
Participants received the DWW 2.0 Individual Videophone intervention in Year 1 of the clinical trial. The participant and their intervention counselor had one-on-one sessions via videophone, for one hour each week. Each session was led by a trained deaf, ASL-fluent DWW 2.0 counselor. Subjects were asked to complete a daily food and physical activity diary during the course of the 16-week intervention. Each intervention session included a weigh-in, personal sharing and problem solving, discussion of a weight management topic, and a discussion on goal setting and action planning for the next week. 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 unhealthy behaviors, build skills that will promote behavior change, and help group members to support each other to make behavior changes. The Curriculum includes group exercise ("Do It!"), experiential learning ("Try It!" such as learning how to read a nutrition label), and group activities such as sampling healthy foods ("Taste It!"). Self-monitoring using daily food diaries and weekly "weigh-ins" are encouraged. The intervention also includes a 6-month follow up and maintenance phase.
Delayed Group Intervention
Participants received the DWW 2.0 Group intervention in Year 2 of the clinical trial. The group intervention consisted 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 led the sessions. Subjects were asked to complete a daily food and physical activity diary during the course of the 16-week intervention. Each intervention session included a weigh-in, group sharing and problem solving, discussion of a weight management topic, and a discussion on goal setting and action planning for the next week. 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 unhealthy behaviors, build skills that will promote behavior change, and help group members to support each other to make behavior changes. The Curriculum includes group exercise ("Do It!"), experiential learning ("Try It!" such as learning how to read a nutrition label), and group activities such as sampling healthy foods ("Taste It!"). Self-monitoring using daily food diaries and weekly "weigh-ins" are encouraged. The intervention also includes a 6-month follow up and maintenance phase.
Delayed Videophone Intervention
Participants received the DWW 2.0 Individual Videophone intervention in Year 2 of the clinical trial. The participant and their intervention counselor had one-on-one sessions via videophone, for one hour each week. Each session was led by a trained deaf, ASL-fluent DWW 2.0 counselor. Subjects were asked to complete a daily food and physical activity diary during the course of the 16-week intervention. Each intervention session included a weigh-in, personal sharing and problem solving, discussion of a weight management topic, and a discussion on goal setting and action planning for the next week. 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 unhealthy behaviors, build skills that will promote behavior change, and help group members to support each other to make behavior changes. The Curriculum includes group exercise ("Do It!"), experiential learning ("Try It!" such as learning how to read a nutrition label), and group activities such as sampling healthy foods ("Taste It!"). Self-monitoring using daily food diaries and weekly "weigh-ins" are encouraged. The intervention also includes a 6-month follow up and maintenance phase.
Overall Study
moved out of state
1
1
1
1
Overall Study
unable to meet time commitment required of study
2
3
3
1
Overall Study
no longer interested in doing intervention
0
0
0
1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Immediate Group Intervention
n=16 Participants
Participants received the DWW 2.0 Group intervention in Year 1 of the clinical trial. The group intervention consisted 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 led the sessions. Subjects were asked to complete a daily food and physical activity diary during the course of the 16-week intervention. Each intervention session included a weigh-in, group sharing and problem solving, discussion of a weight management topic, and a discussion on goal setting and action planning for the next week. 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 unhealthy behaviors, build skills that will promote behavior change, and help group members to support each other to make behavior changes. The Curriculum includes group exercise ("Do It!"), experiential learning ("Try It!" such as learning how to read a nutrition label), and group activities such as sampling healthy foods ("Taste It!"). Self-monitoring using daily food diaries and weekly "weigh-ins" are encouraged. The intervention also includes a 6-month follow up and maintenance phase.
Immediate Videophone Intervention
n=18 Participants
Participants received the DWW 2.0 Individual Videophone intervention in Year 1 of the clinical trial. The participant and their intervention counselor had one-on-one sessions via videophone, for one hour each week. Each session was led by a trained deaf, ASL-fluent DWW 2.0 counselor. Subjects were asked to complete a daily food and physical activity diary during the course of the 16-week intervention. Each intervention session included a weigh-in, personal sharing and problem solving, discussion of a weight management topic, and a discussion on goal setting and action planning for the next week. 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 unhealthy behaviors, build skills that will promote behavior change, and help group members to support each other to make behavior changes. The Curriculum includes group exercise ("Do It!"), experiential learning ("Try It!" such as learning how to read a nutrition label), and group activities such as sampling healthy foods ("Taste It!"). Self-monitoring using daily food diaries and weekly "weigh-ins" are encouraged. The intervention also includes a 6-month follow up and maintenance phase.
Delayed Group Intervention
n=21 Participants
Participants received the DWW 2.0 Group intervention in Year 2 of the clinical trial. The group intervention consisted 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 led the sessions. Subjects were asked to complete a daily food and physical activity diary during the course of the 16-week intervention. Each intervention session included a weigh-in, group sharing and problem solving, discussion of a weight management topic, and a discussion on goal setting and action planning for the next week. 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 unhealthy behaviors, build skills that will promote behavior change, and help group members to support each other to make behavior changes. The Curriculum includes group exercise ("Do It!"), experiential learning ("Try It!" such as learning how to read a nutrition label), and group activities such as sampling healthy foods ("Taste It!"). Self-monitoring using daily food diaries and weekly "weigh-ins" are encouraged. The intervention also includes a 6-month follow up and maintenance phase.
Delayed Videophone Intervention
n=21 Participants
Participants received the DWW 2.0 Individual Videophone intervention in Year 2 of the clinical trial. The participant and their intervention counselor had one-on-one sessions via videophone, for one hour each week. Each session was led by a trained deaf, ASL-fluent DWW 2.0 counselor. Subjects were asked to complete a daily food and physical activity diary during the course of the 16-week intervention. Each intervention session included a weigh-in, personal sharing and problem solving, discussion of a weight management topic, and a discussion on goal setting and action planning for the next week. 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 unhealthy behaviors, build skills that will promote behavior change, and help group members to support each other to make behavior changes. The Curriculum includes group exercise ("Do It!"), experiential learning ("Try It!" such as learning how to read a nutrition label), and group activities such as sampling healthy foods ("Taste It!"). Self-monitoring using daily food diaries and weekly "weigh-ins" are encouraged. The intervention also includes a 6-month follow up and maintenance phase.
Total
n=76 Participants
Total of all reporting groups
Age, Continuous
42.3 years
STANDARD_DEVIATION 13.1 • n=99 Participants
43.4 years
STANDARD_DEVIATION 13.4 • n=107 Participants
38.9 years
STANDARD_DEVIATION 16.8 • n=206 Participants
45.2 years
STANDARD_DEVIATION 15.4 • n=7 Participants
42.4 years
STANDARD_DEVIATION 14.8 • n=31 Participants
Sex: Female, Male
Female
12 Participants
n=99 Participants
13 Participants
n=107 Participants
18 Participants
n=206 Participants
13 Participants
n=7 Participants
56 Participants
n=31 Participants
Sex: Female, Male
Male
4 Participants
n=99 Participants
5 Participants
n=107 Participants
3 Participants
n=206 Participants
8 Participants
n=7 Participants
20 Participants
n=31 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=99 Participants
2 Participants
n=107 Participants
1 Participants
n=206 Participants
0 Participants
n=7 Participants
3 Participants
n=31 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
16 Participants
n=99 Participants
16 Participants
n=107 Participants
20 Participants
n=206 Participants
21 Participants
n=7 Participants
73 Participants
n=31 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
Race (NIH/OMB)
Asian
0 Participants
n=99 Participants
1 Participants
n=107 Participants
1 Participants
n=206 Participants
1 Participants
n=7 Participants
3 Participants
n=31 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=99 Participants
3 Participants
n=107 Participants
2 Participants
n=206 Participants
3 Participants
n=7 Participants
9 Participants
n=31 Participants
Race (NIH/OMB)
White
13 Participants
n=99 Participants
13 Participants
n=107 Participants
17 Participants
n=206 Participants
17 Participants
n=7 Participants
60 Participants
n=31 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=99 Participants
1 Participants
n=107 Participants
1 Participants
n=206 Participants
0 Participants
n=7 Participants
2 Participants
n=31 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
2 Participants
n=31 Participants
Age became deaf
Became deaf at age 3 or younger (including born deaf)
14 Participants
n=99 Participants
17 Participants
n=107 Participants
18 Participants
n=206 Participants
20 Participants
n=7 Participants
69 Participants
n=31 Participants
Age became deaf
Became deaf at age 4 or older
1 Participants
n=99 Participants
1 Participants
n=107 Participants
3 Participants
n=206 Participants
0 Participants
n=7 Participants
5 Participants
n=31 Participants
Age became deaf
Unknown
1 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
1 Participants
n=7 Participants
2 Participants
n=31 Participants

PRIMARY outcome

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

Population: 62 cases were included in analysis of primary outcomes (out of 76 enrolled). 14 cases were excluded from analysis because they had data for only one timepoint out of five timepoints.

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

Outcome measures

Outcome measures
Measure
Immediate Group Intervention
n=14 Participants
Participants received the DWW 2.0 Group intervention in Year 1 of the clinical trial. The group intervention consisted 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 led the sessions. Subjects were asked to complete a daily food and physical activity diary during the course of the 16-week intervention. Each intervention session included a weigh-in, group sharing and problem solving, discussion of a weight management topic, and a discussion on goal setting and action planning for the next week. 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 unhealthy behaviors, build skills that will promote behavior change, and help group members to support each other to make behavior changes. The Curriculum includes group exercise ("Do It!"), experiential learning ("Try It!" such as learning how to read a nutrition label), and group activities such as sampling healthy foods ("Taste It!"). Self-monitoring using daily food diaries and weekly "weigh-ins" are encouraged. The intervention also includes a 6-month follow up and maintenance phase.
Immediate Videophone Intervention
n=14 Participants
Participants received the DWW 2.0 Individual Videophone intervention in Year 1 of the clinical trial. The participant and their intervention counselor had one-on-one sessions via videophone, for one hour each week. Each session was led by a trained deaf, ASL-fluent DWW 2.0 counselor. Subjects were asked to complete a daily food and physical activity diary during the course of the 16-week intervention. Each intervention session included a weigh-in, personal sharing and problem solving, discussion of a weight management topic, and a discussion on goal setting and action planning for the next week. 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 unhealthy behaviors, build skills that will promote behavior change, and help group members to support each other to make behavior changes. The Curriculum includes group exercise ("Do It!"), experiential learning ("Try It!" such as learning how to read a nutrition label), and group activities such as sampling healthy foods ("Taste It!"). Self-monitoring using daily food diaries and weekly "weigh-ins" are encouraged. The intervention also includes a 6-month follow up and maintenance phase.
Delayed Group Intervention
n=17 Participants
Participants received the DWW 2.0 Group intervention in Year 2 of the clinical trial. The group intervention consisted 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 led the sessions. Subjects were asked to complete a daily food and physical activity diary during the course of the 16-week intervention. Each intervention session included a weigh-in, group sharing and problem solving, discussion of a weight management topic, and a discussion on goal setting and action planning for the next week. 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 unhealthy behaviors, build skills that will promote behavior change, and help group members to support each other to make behavior changes. The Curriculum includes group exercise ("Do It!"), experiential learning ("Try It!" such as learning how to read a nutrition label), and group activities such as sampling healthy foods ("Taste It!"). Self-monitoring using daily food diaries and weekly "weigh-ins" are encouraged. The intervention also includes a 6-month follow up and maintenance phase.
Delayed Videophone Intervention
n=17 Participants
Participants received the DWW 2.0 Individual Videophone intervention in Year 2 of the clinical trial. The participant and their intervention counselor had one-on-one sessions via videophone, for one hour each week. Each session was led by a trained deaf, ASL-fluent DWW 2.0 counselor. Subjects were asked to complete a daily food and physical activity diary during the course of the 16-week intervention. Each intervention session included a weigh-in, personal sharing and problem solving, discussion of a weight management topic, and a discussion on goal setting and action planning for the next week. 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 unhealthy behaviors, build skills that will promote behavior change, and help group members to support each other to make behavior changes. The Curriculum includes group exercise ("Do It!"), experiential learning ("Try It!" such as learning how to read a nutrition label), and group activities such as sampling healthy foods ("Taste It!"). Self-monitoring using daily food diaries and weekly "weigh-ins" are encouraged. The intervention also includes a 6-month follow up and maintenance phase.
Change in Body Weight (kg)
-2.36 kg
Standard Error 1.56
-3.09 kg
Standard Error 1.54
1.02 kg
Standard Error 1.49
0.26 kg
Standard Error 1.37

PRIMARY outcome

Timeframe: 6-month BMI - baseline BMI

Population: 62 cases were included in analysis of primary outcomes (out of 76 enrolled). 14 cases were excluded from analysis because they had data for only one timepoint out of five timepoints.

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

Outcome measures

Outcome measures
Measure
Immediate Group Intervention
n=14 Participants
Participants received the DWW 2.0 Group intervention in Year 1 of the clinical trial. The group intervention consisted 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 led the sessions. Subjects were asked to complete a daily food and physical activity diary during the course of the 16-week intervention. Each intervention session included a weigh-in, group sharing and problem solving, discussion of a weight management topic, and a discussion on goal setting and action planning for the next week. 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 unhealthy behaviors, build skills that will promote behavior change, and help group members to support each other to make behavior changes. The Curriculum includes group exercise ("Do It!"), experiential learning ("Try It!" such as learning how to read a nutrition label), and group activities such as sampling healthy foods ("Taste It!"). Self-monitoring using daily food diaries and weekly "weigh-ins" are encouraged. The intervention also includes a 6-month follow up and maintenance phase.
Immediate Videophone Intervention
n=14 Participants
Participants received the DWW 2.0 Individual Videophone intervention in Year 1 of the clinical trial. The participant and their intervention counselor had one-on-one sessions via videophone, for one hour each week. Each session was led by a trained deaf, ASL-fluent DWW 2.0 counselor. Subjects were asked to complete a daily food and physical activity diary during the course of the 16-week intervention. Each intervention session included a weigh-in, personal sharing and problem solving, discussion of a weight management topic, and a discussion on goal setting and action planning for the next week. 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 unhealthy behaviors, build skills that will promote behavior change, and help group members to support each other to make behavior changes. The Curriculum includes group exercise ("Do It!"), experiential learning ("Try It!" such as learning how to read a nutrition label), and group activities such as sampling healthy foods ("Taste It!"). Self-monitoring using daily food diaries and weekly "weigh-ins" are encouraged. The intervention also includes a 6-month follow up and maintenance phase.
Delayed Group Intervention
n=17 Participants
Participants received the DWW 2.0 Group intervention in Year 2 of the clinical trial. The group intervention consisted 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 led the sessions. Subjects were asked to complete a daily food and physical activity diary during the course of the 16-week intervention. Each intervention session included a weigh-in, group sharing and problem solving, discussion of a weight management topic, and a discussion on goal setting and action planning for the next week. 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 unhealthy behaviors, build skills that will promote behavior change, and help group members to support each other to make behavior changes. The Curriculum includes group exercise ("Do It!"), experiential learning ("Try It!" such as learning how to read a nutrition label), and group activities such as sampling healthy foods ("Taste It!"). Self-monitoring using daily food diaries and weekly "weigh-ins" are encouraged. The intervention also includes a 6-month follow up and maintenance phase.
Delayed Videophone Intervention
n=17 Participants
Participants received the DWW 2.0 Individual Videophone intervention in Year 2 of the clinical trial. The participant and their intervention counselor had one-on-one sessions via videophone, for one hour each week. Each session was led by a trained deaf, ASL-fluent DWW 2.0 counselor. Subjects were asked to complete a daily food and physical activity diary during the course of the 16-week intervention. Each intervention session included a weigh-in, personal sharing and problem solving, discussion of a weight management topic, and a discussion on goal setting and action planning for the next week. 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 unhealthy behaviors, build skills that will promote behavior change, and help group members to support each other to make behavior changes. The Curriculum includes group exercise ("Do It!"), experiential learning ("Try It!" such as learning how to read a nutrition label), and group activities such as sampling healthy foods ("Taste It!"). Self-monitoring using daily food diaries and weekly "weigh-ins" are encouraged. The intervention also includes a 6-month follow up and maintenance phase.
Change in BMI (Body Mass Index)
-0.91 kg/m^2
Standard Error 0.61
-1.05 kg/m^2
Standard Error 0.60
0.39 kg/m^2
Standard Error 0.58
0.20 kg/m^2
Standard Error 0.53

PRIMARY outcome

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

Population: 56 cases were included in analysis of this physical activity primary outcomes (out of 76 enrolled). 14 cases were excluded from analysis because they had data for only one timepoint out of five timepoints (76-14=62); an additional 6 cases were excluded from the physical activity analysis due to missing physical activity data at the 6-month time point (n=56 for analysis).

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).

Outcome measures

Outcome measures
Measure
Immediate Group Intervention
n=12 Participants
Participants received the DWW 2.0 Group intervention in Year 1 of the clinical trial. The group intervention consisted 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 led the sessions. Subjects were asked to complete a daily food and physical activity diary during the course of the 16-week intervention. Each intervention session included a weigh-in, group sharing and problem solving, discussion of a weight management topic, and a discussion on goal setting and action planning for the next week. 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 unhealthy behaviors, build skills that will promote behavior change, and help group members to support each other to make behavior changes. The Curriculum includes group exercise ("Do It!"), experiential learning ("Try It!" such as learning how to read a nutrition label), and group activities such as sampling healthy foods ("Taste It!"). Self-monitoring using daily food diaries and weekly "weigh-ins" are encouraged. The intervention also includes a 6-month follow up and maintenance phase.
Immediate Videophone Intervention
n=13 Participants
Participants received the DWW 2.0 Individual Videophone intervention in Year 1 of the clinical trial. The participant and their intervention counselor had one-on-one sessions via videophone, for one hour each week. Each session was led by a trained deaf, ASL-fluent DWW 2.0 counselor. Subjects were asked to complete a daily food and physical activity diary during the course of the 16-week intervention. Each intervention session included a weigh-in, personal sharing and problem solving, discussion of a weight management topic, and a discussion on goal setting and action planning for the next week. 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 unhealthy behaviors, build skills that will promote behavior change, and help group members to support each other to make behavior changes. The Curriculum includes group exercise ("Do It!"), experiential learning ("Try It!" such as learning how to read a nutrition label), and group activities such as sampling healthy foods ("Taste It!"). Self-monitoring using daily food diaries and weekly "weigh-ins" are encouraged. The intervention also includes a 6-month follow up and maintenance phase.
Delayed Group Intervention
n=14 Participants
Participants received the DWW 2.0 Group intervention in Year 2 of the clinical trial. The group intervention consisted 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 led the sessions. Subjects were asked to complete a daily food and physical activity diary during the course of the 16-week intervention. Each intervention session included a weigh-in, group sharing and problem solving, discussion of a weight management topic, and a discussion on goal setting and action planning for the next week. 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 unhealthy behaviors, build skills that will promote behavior change, and help group members to support each other to make behavior changes. The Curriculum includes group exercise ("Do It!"), experiential learning ("Try It!" such as learning how to read a nutrition label), and group activities such as sampling healthy foods ("Taste It!"). Self-monitoring using daily food diaries and weekly "weigh-ins" are encouraged. The intervention also includes a 6-month follow up and maintenance phase.
Delayed Videophone Intervention
n=17 Participants
Participants received the DWW 2.0 Individual Videophone intervention in Year 2 of the clinical trial. The participant and their intervention counselor had one-on-one sessions via videophone, for one hour each week. Each session was led by a trained deaf, ASL-fluent DWW 2.0 counselor. Subjects were asked to complete a daily food and physical activity diary during the course of the 16-week intervention. Each intervention session included a weigh-in, personal sharing and problem solving, discussion of a weight management topic, and a discussion on goal setting and action planning for the next week. 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 unhealthy behaviors, build skills that will promote behavior change, and help group members to support each other to make behavior changes. The Curriculum includes group exercise ("Do It!"), experiential learning ("Try It!" such as learning how to read a nutrition label), and group activities such as sampling healthy foods ("Taste It!"). Self-monitoring using daily food diaries and weekly "weigh-ins" are encouraged. The intervention also includes a 6-month follow up and maintenance phase.
Change in Physical Activity
2.75 MET-minutes/wk
Interval -1658.0 to 839.25
543.50 MET-minutes/wk
Interval -174.0 to 786.0
-82.50 MET-minutes/wk
Interval -1074.0 to 480.0
66.00 MET-minutes/wk
Interval -381.0 to 612.0

Adverse Events

Immediate Group Intervention

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Immediate Videophone Intervention

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Delayed Group Intervention

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Delayed Videophone Intervention

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Steven Barnett

University of Rochester

Phone: 585-273-2548

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place