Obesity, Overweight
Conditions
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.
Interventions
BEHAVIORALDeaf Weight Wise program
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.
Sponsors
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight Change | Baseline and 6 months | 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 | Baseline and 6 months | 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 | Baseline and 6 months | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Immediate Intervention Group This arm received the Group intervention immediately following baseline data collection. Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions.
Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles).
The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program. | 48 |
| Delayed Intervention Group This arm received the intervention one year following the immediate intervention group.Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions.
Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles).
The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program. | 56 |
| Total | 104 |
Baseline characteristics
| Characteristic | Immediate Intervention Group | Total | Delayed Intervention Group |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 7 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 44 Participants | 97 Participants | 53 Participants |
| Age, Continuous | 53.6 years STANDARD_DEVIATION 7.4 | 53.5 years STANDARD_DEVIATION 7.6 | 53.4 years STANDARD_DEVIATION 7.8 |
| Became Deaf age 3 or younger Became Deaf age 3 or younger | 42 participants | 86 participants | 44 participants |
| Became Deaf age 3 or younger Became Deaf age 4 or older, or unknown age | 6 participants | 18 participants | 12 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 3 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 45 Participants | 99 Participants | 54 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 45 Participants | 95 Participants | 50 Participants |
| Region of Enrollment United States | 48 participants | 104 participants | 56 participants |
| Sex: Female, Male Female | 32 Participants | 71 Participants | 39 Participants |
| Sex: Female, Male Male | 16 Participants | 33 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 48 | 0 / 56 |
| other Total, other adverse events | 0 / 48 | 0 / 56 |
| serious Total, serious adverse events | 0 / 48 | 0 / 56 |
Outcome results
Primary
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).
Time frame: Baseline and 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Intervention Group | Change in Dietary Risk Assessment (DRA) Score | -6.3 DRA score | Standard Error 1.2 |
| Delayed Intervention Group | Change in Dietary Risk Assessment (DRA) Score | -3.7 DRA score | Standard Error 1.3 |
Primary
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).
Time frame: Baseline and 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Intervention Group | Change in Physical Activity Assessment (PAA) Score | 1.6 moderate PAA score | Standard Error 0.5 |
| Delayed Intervention Group | Change in Physical Activity Assessment (PAA) Score | 1.0 moderate PAA score | Standard Error 0.5 |
Primary
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.
Time frame: Baseline and 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Intervention Group | Weight Change | -5.33 kilograms | Standard Error 0.88 |
| Delayed Intervention Group | Weight Change | -1.98 kilograms | Standard Error 0.6 |