Healthy Living: Incorporating Lifestyle Interventions to Encourage a Reduction in Body Weight.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Total body weight
研究概览
简要总结
The purpose of this study is to determine the effectiveness of a physician led, multi-disciplinary approach to treating obesity that incorporates nutrition (mainly, using genetics to identify appropriate food intake), exercise, and motivational counseling. The investigators plan to recruit overweight/obese (BMI>25) males and females to participate. Participants will be randomized to receive a personalized diet plan, or a standard care diet plan; both groups will participate in the exercise intervention. For a 6-month duration, both groups will be asked to improve their diet according to their dietary plan and participate in moderate-to-vigorous physical activity (gradual increase up to 300 min/week). The investigators intend to evaluate standard outcomes of weight loss, and assess for any predictors of positive outcomes. Following the six-month intervention, participants will complete a 3-month no contact phase. This no contact phase will provide insight into the effects of the study on weight loss maintenance. Our team also plans to address acceptability by providing evaluations to study participants and conducting interviews with a small subset of participants to improve the intervention for the future.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-40 years
- •BMI > 25 kg/m2
- •No cardiopulmonary disease
- •stable on medications for 3 months
- •weight stable (+/-5 pounds) for the past 3 months
- •Not pregnant or trying to get pregnant
- •Owns a smartphone
- •Able to walk unassisted
- •Not on supplemental oxygen
排除标准
- •Under the age of 18 years
- •40 years and older
- •Unable to participate in an exercise program
- •Currently pregnant
研究组 & 干预措施
Nutrigenomix
Participants in this group will be asked to complete an oral swab at baseline. This swab will indicate their dietary needs based on their genetic composition. These personalized dietary needs will be shared with the participant; the participant will be encouraged to follow their dietary plan for the duration of the study. Participants in this group will also gradually increase their physical activity up to 300 min/week at 6 months.
干预措施: Nutrigenomix, personalized dietary plan (Behavioral)
Nutrigenomix
Participants in this group will be asked to complete an oral swab at baseline. This swab will indicate their dietary needs based on their genetic composition. These personalized dietary needs will be shared with the participant; the participant will be encouraged to follow their dietary plan for the duration of the study. Participants in this group will also gradually increase their physical activity up to 300 min/week at 6 months.
干预措施: Physical Activity (Behavioral)
Nutrigenomix
Participants in this group will be asked to complete an oral swab at baseline. This swab will indicate their dietary needs based on their genetic composition. These personalized dietary needs will be shared with the participant; the participant will be encouraged to follow their dietary plan for the duration of the study. Participants in this group will also gradually increase their physical activity up to 300 min/week at 6 months.
干预措施: Behavioral counseling (Behavioral)
Control
Participants in this group will receive a standard care dietary plan. They will also be asked to gradually increase their activity up to 300 min/week by 6 months.
干预措施: Physical Activity (Behavioral)
Control
Participants in this group will receive a standard care dietary plan. They will also be asked to gradually increase their activity up to 300 min/week by 6 months.
干预措施: Behavioral counseling (Behavioral)
Control
Participants in this group will receive a standard care dietary plan. They will also be asked to gradually increase their activity up to 300 min/week by 6 months.
干预措施: Standard Dietary plan (Behavioral)
结局指标
主要结局
Total body weight
时间窗: 6-months
Use of scale to measure total body weight
次要结局
未报告次要终点
研究者
Madison Kindred
Assistant Professor
Augusta University