Deaf Weight Wise 2.0: Clinical Trial of a Healthy Lifestyle Intervention With Deaf Adults Ages 21 to 70
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Change in BMI (Body Mass Index)
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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-
- •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.
排除标准
- •Exclusion criteria include: subjects without medical clearance who had 1) a cardiovascular disease event in the past six months, 2) or heart condition, chest pain, dizziness, or other reason not to participate in physical activity, 3) or weight loss surgery in the past two years, or 4) are pregnant. Participants with these conditions (as determined by the PAR-Q Physical Activity Readiness-Questionnaire and other questions administered during the initial study screening visit) must obtain medical clearance from their primary healthcare clinician (or maternity care clinician for pregnancy) to be eligible. Those who are unable or unwilling to provide written, informed consent, and inability to see and interact with computer-based questionnaires and educational interventions will be excluded.
研究组 & 干预措施
Delayed Videophone Intervention
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.
干预措施: Deaf Weight Wise 2.0 (Behavioral)
Immediate Group Intervention
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.
干预措施: Deaf Weight Wise 2.0 (Behavioral)
Immediate Videophone Intervention
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.
干预措施: Deaf Weight Wise 2.0 (Behavioral)
Delayed Group Intervention
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.
干预措施: Deaf Weight Wise 2.0 (Behavioral)
结局指标
主要结局
Change in BMI (Body Mass Index)
时间窗: 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
时间窗: 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).
Change in Body Weight (kg)
时间窗: 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).
次要结局
未报告次要终点
研究者
Steve Barnett
Director, Rochester Prevention Research Center
University of Rochester