Seasonal Patterns of Stress, Diet and Physical Activity - Life in All Seasons (LENAS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Lisa Jahns, USDA Grand Forks Human Nutrition Research Center
ClinicalTrials.gov Identifier:
NCT01674296
First received: August 23, 2012
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

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.


Condition
Obesity
Stress
Feeding Behavior
Physical Activity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Seasonality of Stress, Diet, and Physical Activity in Mid-Life Women

Resource links provided by NLM:


Further study details as provided by USDA Grand Forks Human Nutrition Research Center:

Primary Outcome Measures:
  • Change in body fat [ Time Frame: Season 1, season 2, season 3, season 4 ] [ Designated as safety issue: No ]
    Body fat location and amount will be assess by dual-energy X-ray absorptiometry


Biospecimen Retention:   Samples With DNA

Serum, Plasma, Buffy Coat, Urine, Saliva


Estimated Enrollment: 54
Study Start Date: June 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group 1 (2012-2013)
Monitoring of Dietary Intake, Physical Activity and Stress
Group 2 (2013-2014)
Monitoring of Dietary Intake, Physical Activity and Stress

Detailed Description:

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).

The ASA-24 will be administered to assess nutritional intake; Actigraph GT3X+, Actitrainer, and QStarz GPS logger will be used to assess physical activity. Physiological stress will be assessed using the allostatic load index.

  Eligibility

Ages Eligible for Study:   40 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Middle-aged females

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • BMI >35 or < 18
  • Current smoker or tobacco or nicotine use
  • Male sex
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01674296

Locations
United States, North Dakota
Grand Forks Human Nutrition Research Center
Grand Forks, North Dakota, United States, 58201
Sponsors and Collaborators
USDA Grand Forks Human Nutrition Research Center
Investigators
Principal Investigator: Lisa Jahns, PhD, RD USDA-ARS-GFHNRC
  More Information

No publications provided

Responsible Party: Lisa Jahns, PhD, RD, USDA Grand Forks Human Nutrition Research Center
ClinicalTrials.gov Identifier: NCT01674296     History of Changes
Other Study ID Numbers: GFHNRC018
Study First Received: August 23, 2012
Last Updated: July 7, 2014
Health Authority: United States: Federal Government

Keywords provided by USDA Grand Forks Human Nutrition Research Center:
Body Weight/physiology*
Diet*/statistics & numerical data
Diet*/trends
Exercise/physiology*
Female
Humans
Longitudinal Studies
Middle Aged
Obesity/epidemiology*
Seasons*
Time Factors

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 08, 2014