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临床试验/NCT01674296
NCT01674296已完成不适用

Seasonality of Stress, Diet, and Physical Activity in Mid-Life Women

USDA Grand Forks Human Nutrition Research Center1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2012年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
52
试验地点
1
主要终点
Change in body fat

研究概览

简要总结

The purpose of this study is to develop a better understanding of factors affecting American's energy balance related behaviors - in this case, food intake and activity. In the present study we will describe the relative contributions of individual psychology and physiology (including metabolism, mood, and sleep habits) and external (season, stressors) contributions to changes in adiposity over a year in free-living individuals.

This study will illuminate season's role in changes in energy balance related behaviors and body weight and composition. Ultimately, this information will be used to identify factors affecting food consumption and individual activity during seasonal periods to help to segment interventions for obesity prevention in mid-life women.

详细描述

This is a longitudinal, observational study of mid-life women spanning one year.There will be frequent monitoring of food consumption, individual activity and individual- level factors thought to influence food consumption and activity such as dietary restraint, subjective stress, sleep quality and duration, and physiological stress as measured by allostatic load.

Specific aims:

  1. To identify seasonal changes in %BF of mid-life women.

Participant's percentage of body fat will fluctuate, and will be highest at the end of the winter season and lowest at the end of the summer season. 2. To describe predictors of seasonal changes in %BF.

There will be no intervention other than frequent monitoring of food consumption, individual activity and individual- level factors thought to influence food consumption and activity such as dietary restraint, subjective stress, sleep quality and duration, and physiological stress as measured by allostatic load. The volunteers will be asked to complete a 7-day activity and energy expenditure monitoring period (along with body composition assessment, questionnaires regarding individual factors thought to affect food consumption and activity, blood draw and urine collection to measure allostatic load) in each of the four seasons over a 12-month period; between monitoring periods they will come to the GFHNRC for measurement of weight, skin carotenoids for assessment of fruit and vegetable intake, and to provide a morning urine sample monthly (8 times), and receive emails reminding them to log on to a secure server and complete a 24-hr recall 3 times a month (36 times during the year).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
40 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Ambulatory women aged 40-60 years
  • Weight stable (±10 lbs) for at least 6 months prior to the start of the study
  • Body mass index (BMI) between 18-35 kg/m2
  • Access to high-speed internet
  • Willing to comply with study requirements

排除标准

  • BMI >35 or < 18
  • Current smoker or tobacco or nicotine use
  • Age <40.0 or >60 years
  • Health conditions (cardiovascular, pulmonary, orthopedic, asthma) that would limit participation in physical activity
  • Medications that would influence appetite, weight gain or weight loss.
  • Intentional changes in diet or large increases in physical activity for the purpose of weight loss during the study. Typical weight maintenance behaviors are not an exclusion criterion.
  • Pregnant, lactating, or planning pregnancy.
  • Travel plans that do not permit full participation.
  • Inability to walk without assistance. The capability to walk upright is fundamental because accelerometry measures the duration and intensity of horizontal physical activities.
  • Inability to give consent.

结局指标

主要结局

Change in body fat

时间窗: Season 1, season 2, season 3, season 4

Body fat location and amount will be assess by dual-energy X-ray absorptiometry

次要结局

未报告次要终点

研究者

发起方
USDA Grand Forks Human Nutrition Research Center
申办方类型
Fed
责任方
Sponsor

研究点 (1)

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