Effect of a Technology-Based Intervention on Weight Change Post-Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- To examine the effect of applying a minimal contact technology-based intervention (TECH) at 1-year post-bariatric surgery on weight change compared to Standard Care over the subsequent 6 months.
研究概览
简要总结
The primary aim of this study is to examine the effect of applying a minimal contact technology-based intervention (TECH) at 1-year post-bariatric surgery on weight change compared to Standard Care. Forty participants at 1-year post bariatric surgery will be randomized to TECH or Standard Care for a period of 6 months (12 to 18 months post-surgery). Analyses will be conducted to compare these interventions for differences in body weight, body composition, fitness, physical activity, engagement, psychosocial measures, and intervention cost and cost-effectiveness of each approach. TECH will consist of a wearable monitor that provides feedback on energy expenditure and physical activity, electronic tracking of dietary intake, and integration of an electronic scale to provide comprehensive feedback to the participant on all components of weight management. TECH participants will receive a monthly telephone call from the intervention staff to provide guidance on their weight management efforts.
详细描述
This randomized controlled trial will examine the effect of a minimal contact technology-based system in comparison to standard care on body weight in adults 1 year post-bariatric surgery. This 6 month intervention will be conducted at the University of Pittsburgh, Physical Activity and Weight Management Research Center. Eligible participants who obtain physician's consent will undergo baseline assessments. Assessments will be described in further detail below.
Eligible participants who complete all baseline assessment procedures will be randomized to one of two intervention groups: The minimal contact technology-based intervention using the Jawbone UP3 System combined with a monthly intervention telephone call (TECH), or Standard Care.
Standard Care serves as the no treatment control in this project. Participants in this group will receive the typical care from their surgeon following bariatric surgery. No additional interventions will be given to participants randomized to this group.
TECH Intervention: TECH is the experimental group in this project. A minimal-contact technology-based intervention for weight management will be given to this group in addition to the standard or typical care received from their surgeon following bariatric surgery. The following information outlines the protocol for this intervention group.
Dietary Component: Dietary recommendations will be based on the subjects' baseline body weight, with calorie and fat intake goals ranging from 1200-2100 kcal/day and 20-30% of daily calories respectively. The calorie goals are based on intake recommendations that have been shown to result in successful short-term weight loss with fat intake goals consistent with the USDA Dietary Guidelines. To facilitate adoption and maintenance of these dietary intake goals, participants will be provided with meal plans and sample recipes. In addition, participants will be taught how to read food labels and will be provided with The Calorie King Calorie, Fat, and Carbohydrate Counter to facilitate self-monitoring of calorie and fat intake. Intervention lessons will be sent to the participants via email and will also include information related to behavior strategies for achieving the desired calorie and fat intake goals.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between the ages of 18-60 years.
- •1-year post-bariatric surgery.
- •Able to walk at 3 miles per hour during a cardiorespiratory fitness test.
排除标准
- •Reports not having access to a computer, access to the Internet, email, or the availability to download software onto a computer.
- •Reports not having a smart phone device that is compatible with the Jawbone UP3 System that will be examined in this study.
- •Has a physical limitation that would prevent engaging in physical activity.
- •Reports being treated for a current medical condition that could affect body weigh (diabetes mellitus, cancer, chronic renal insufficiency, hyperthyroidism, hypothyroidism, chronic liver disease).
- •Reports current congestive failure, angina, uncontrolled arrhythmia, symptoms indicative of increased risk of an acute cardiovascular event, coronary artery bypass grafting or angioplasty, prior myocardial infarction, and conditions requiring anticoagulation therapy (deep vein thrombosis).
- •Has a resting systolic blood pressure ≥ 150 mmHg or resting diastolic blood pressure of ≥100 mmHg or taking medication to control blood pressure that affects heart rate.
- •Reports being treated for a psychological issue (i.e., depression, bipolar disorder, etc).
- •Taking prescription or over-the-counter medications that affect body weight and metabolism.
- •Currently participating in an exercise or weight control study or a current participant in a commercial weight reduction program.
- •Currently being treated for an eating disorder.
- •Currently pregnant, pregnant in the last 6 months, breast feeding in the last 3 months, lactating, to planning on becoming pregnant in the next 6 months.
- •Planning on relocating outside of the greater Pittsburgh area within the next 6 months.
结局指标
主要结局
To examine the effect of applying a minimal contact technology-based intervention (TECH) at 1-year post-bariatric surgery on weight change compared to Standard Care over the subsequent 6 months.
时间窗: 1 year after bariatric surgery - months 12-18 (6 month intervention period)
Body Weight (5 minutes; 0, 3, 6 months): Body weight will be measured to the nearest 0.1 kg on a Tanita WB-110A digital scale (Tanita Corporation; Arlington Heights, IL). Measures will be taken in a light-weight hospital gown with shoes and accessories removed.
次要结局
- To examine the effect of TECH and Standard Care on change in cardiorespiratory fitness.(1 year after bariatric surgery - months 12-18 (6 month intervention period))
- To examine the effect of TECH and Standard Care on change in dietary intake.(1 year after bariatric surgery - months 12-18 (6 month intervention period))
- To examine the effect of TECH and Standard Care on change in exercise barriers.(1 year after bariatric surgery - months 12-18 (6 month intervention period))
- To examine the effect of TECH and Standard Care on change in cognitive restraint and disinhibition with eating behaviors(1 year after bariatric surgery - months 12-18 (6 month intervention period))
- To examine the effect of TECH and Standard Care on change in body image(1 year after bariatric surgery - months 12-18 (6 month intervention period))
- To examine the effect of TECH and Standard Care on change in depression symptoms(1 year after bariatric surgery - months 12-18 (6 month intervention period))
- To examine the effect of TECH and Standard Care on change in eating behavior.(1 year after bariatric surgery - months 12-18 (6 month intervention period))
- To examine the effect of TECH and Standard Care on change in physical activity self-efficacy.(1 year after bariatric surgery - months 12-18 (6 month intervention period))
- To examine the effect of TECH and Standard Care on change in health perception.(1 year after bariatric surgery - months 12-18 (6 month intervention period))
- To examine the effect of TECH and Standard Care on change in physical activity (Paffenbarger)(1 year after bariatric surgery - months 12-18 (6 month intervention period))
- To examine the effect of TECH and Standard Care on change in physical activity (GPAQ)(1 year after bariatric surgery - months 12-18 (6 month intervention period))
- To examine the effect of TECH and Standard Care on change in physical activity (objective monitor)(1 year after bariatric surgery - months 12-18 (6 month intervention period))
- To examine satisfaction related to technology usage for weight management(1 year after bariatric surgery - months 12-18 (6 month intervention period) - collected at 6 months)
- To examine the effect of TECH and Standard Care on change in body composition.(1 year after bariatric surgery - months 12-18 (6 month intervention period))
- To examine the effect of TECH and Standard Care on change in sedentary behavior.(1 year after bariatric surgery - months 12-18 (6 month intervention period))
- To conduct analyses to examine the cost and cost effectiveness of TECH and Standard Care interventions.(1 year after bariatric surgery - months 12-18 (6 month intervention period))
- To examine the effect of TECH and Standard Care on change in weight loss and diet expectations and barriers(1 year after bariatric surgery - months 12-18 (6 month intervention period))