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临床试验/NCT05956574
NCT05956574招募中不适用

Healthy Living: Incorporating Lifestyle Interventions to Encourage a Reduction in Body Weight.

Augusta University2 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2025年4月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
125
试验地点
2
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

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Madison Kindred

Assistant Professor

Augusta University

研究点 (2)

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