Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate intervention group | Experimental | This arm will receive the intervention immediately following baseline data collection. |
|
| Delayed intervention group | Experimental | This arm will receive the intervention one year following the immediate intervention group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Steven Barnett, MD | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester; National Center for Deaf Health Research | Rochester | New York | 14642 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19407810 | Background | 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. | |
| 36890106 |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Delayed Intervention Group | This arm received the Group 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Error | kilograms | Baseline and 6 months |
|
During the entire course of the study
No adverse events occurred.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Steven Barnett | University of Rochester | steven_barnett@urmc.rochester.edu |
Not provided
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Became Deaf age 3 or younger | Number | participants |
|
| OG001 | 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. |
|
|
| 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). | Posted | Mean | Standard Error | DRA score | Baseline and 6 months |
|
|
|
| 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). | Posted | Mean | Standard Error | moderate PAA score | Baseline and 6 months |
|
|
|
| 0 |
| 48 |
| 0 |
| 48 |
| 0 |
| 48 |
| EG001 | 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. | 0 | 56 | 0 | 56 | 0 | 56 |
Not provided
Not provided
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |