Obesity, Overweight
Conditions
Keywords
Deaf, American Sign Language, Overweight, Obese
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).
Interventions
BEHAVIORALDeaf Weight Wise 2.0
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.
Sponsors
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight (kg) | 6 month weight (kg) - baseline weight (kg) | measure mean change = 6-month weight - baseline weight, for the immediate and delayed intervention groups (change from pre to post intervention). |
| Change in BMI (Body Mass Index) | 6-month BMI - baseline BMI | measure mean change = 6-month BMI - baseline BMI, for the immediate and delayed intervention groups (change from pre to post intervention). |
| Change in Physical Activity | 6-month MET-min/wk - baseline MET-min/wk | 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). |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 16 |
| 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. | 18 |
| 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. | 21 |
| 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. | 21 |
| Total | 76 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | moved out of state | 1 | 1 | 1 | 1 |
| Overall Study | no longer interested in doing intervention | 0 | 0 | 0 | 1 |
| Overall Study | unable to meet time commitment required of study | 2 | 3 | 3 | 1 |
Baseline characteristics
| Characteristic | Total | Delayed Videophone Intervention | Delayed Group Intervention | Immediate Videophone Intervention | Immediate Group Intervention |
|---|---|---|---|---|---|
| Age became deaf Became deaf at age 3 or younger (including born deaf) | 69 Participants | 20 Participants | 18 Participants | 17 Participants | 14 Participants |
| Age became deaf Became deaf at age 4 or older | 5 Participants | 0 Participants | 3 Participants | 1 Participants | 1 Participants |
| Age became deaf Unknown | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Age, Continuous | 42.4 years STANDARD_DEVIATION 14.8 | 45.2 years STANDARD_DEVIATION 15.4 | 38.9 years STANDARD_DEVIATION 16.8 | 43.4 years STANDARD_DEVIATION 13.4 | 42.3 years STANDARD_DEVIATION 13.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 73 Participants | 21 Participants | 20 Participants | 16 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 3 Participants | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 60 Participants | 17 Participants | 17 Participants | 13 Participants | 13 Participants |
| Sex: Female, Male Female | 56 Participants | 13 Participants | 18 Participants | 13 Participants | 12 Participants |
| Sex: Female, Male Male | 20 Participants | 8 Participants | 3 Participants | 5 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 18 | 0 / 21 | 0 / 21 |
| other Total, other adverse events | 0 / 16 | 0 / 18 | 0 / 21 | 0 / 21 |
| serious Total, serious adverse events | 0 / 16 | 0 / 18 | 0 / 21 | 0 / 21 |
Outcome results
Primary
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).
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Immediate Group Intervention | Change in BMI (Body Mass Index) | -0.91 kg/m^2 | Standard Error 0.61 |
| Immediate Videophone Intervention | Change in BMI (Body Mass Index) | -1.05 kg/m^2 | Standard Error 0.6 |
| Delayed Group Intervention | Change in BMI (Body Mass Index) | 0.39 kg/m^2 | Standard Error 0.58 |
| Delayed Videophone Intervention | Change in BMI (Body Mass Index) | 0.20 kg/m^2 | Standard Error 0.53 |
Comparison: Difference in Body Mass Index (BMI) change from Baseline to 6months, between Immediate Intervention participants (group and videophone combined) vs. Delayed Intervention participants (group and videophone combined). \[analysis of 2 arms, immediate intervention vs. delayed intervention\]p-value: 0.0395% CI: [-2.42, -0.12]Mixed Models Analysis
Primary
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).
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Immediate Group Intervention | Change in Body Weight (kg) | -2.36 kg | Standard Error 1.56 |
| Immediate Videophone Intervention | Change in Body Weight (kg) | -3.09 kg | Standard Error 1.54 |
| Delayed Group Intervention | Change in Body Weight (kg) | 1.02 kg | Standard Error 1.49 |
| Delayed Videophone Intervention | Change in Body Weight (kg) | 0.26 kg | Standard Error 1.37 |
Comparison: Difference in weight change from Baseline to 6months, between Immediate Intervention participants (group and videophone combined) vs. Delayed Intervention participants (group and videophone combined). \[analysis of 2 arms, immediate intervention vs. delayed intervention\]p-value: 0.02695% CI: [-6.32, -0.41]Mixed Models Analysis
Primary
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).
Time frame: 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).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Immediate Group Intervention | Change in Physical Activity | 2.75 MET-minutes/wk |
| Immediate Videophone Intervention | Change in Physical Activity | 543.50 MET-minutes/wk |
| Delayed Group Intervention | Change in Physical Activity | -82.50 MET-minutes/wk |
| Delayed Videophone Intervention | Change in Physical Activity | 66.00 MET-minutes/wk |
Comparison: 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). \[analysis of 2 arms, immediate intervention vs. delayed intervention\]p-value: 0.63Wilcoxon (Mann-Whitney)