ObesityLENASNCT01674296
Seasonal Patterns of Stress, Diet and Physical Activity - Life in All Seasons (LENAS)
An observational study of Obesity and Stress, run by USDA Grand Forks Human Nutrition Research Center at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 40 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Stress, Feeding Behavior
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Aug 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Middle-aged females
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Grand Forks Human Nutrition Research Center
Grand Forks, North Dakota, 58201
About this study
Official title: Seasonality of Stress, Diet, and Physical Activity in Mid-Life Women
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.
Read the 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:
- 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.
- 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.
- Conditions
- Obesity, Stress, Feeding Behavior, Physical Activity
- Keywords
- Body Weight/physiology*, Diet*/statistics & numerical data, Diet*/trends, Exercise/physiology*, Female, Humans, Longitudinal Studies, Middle Aged, Obesity/epidemiology*, Seasons*, Time Factors
- Medical subject headings
- Obesity, Feeding Behavior, Motor Activity, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (2012-2013) | Monitoring of Dietary Intake, Physical Activity and Stress | |
| Group 2 (2013-2014) | Monitoring of Dietary Intake, Physical Activity and Stress |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body fat
Body fat location and amount will be assess by dual-energy X-ray absorptiometry
Measured: Season 1, season 2, season 3, season 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2012 (estimated)
- Study startJun 2012
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA Grand Forks Human Nutrition Research Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- James Roemmich, PhD, Principal investigator, USDA-ARS-GFHNRC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01674296
- Sponsor's protocol ID
- GFHNRC018
- Acronym
- LENAS
- Status last verified
- May 2020
- First submitted
- 23 Aug 2012
- Last updated
- 20 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Jahns L, Johnson LK, Conrad Z, Bukowski M, Raatz SK, Jilcott Pitts S, Wang Y, Ermakov IV, Gellermann W. Concurrent validity of skin carotenoid status as a concentration biomarker of vegetable and fruit intake compared to multiple 24-h recalls and plasma carotenoid concentrations across one year: a cohort study. Nutr J. 2019 Nov 21;18(1):78. doi: 10.1186/s12937-019-0500-0.
PubMed 31752882
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seasonality of Stress, Diet, and Physical Activity in Mid-Life Women
- ClinicalTrials.gov ID
- NCT01674296
- Acronym / sponsor ID
- LENAS / GFHNRC018
- Conditions
- Obesity, Stress, Feeding Behavior, Physical Activity
- Keywords
- Body Weight/physiology*, Diet*/statistics & numerical data, Diet*/trends, Exercise/physiology*, Female, Humans, Longitudinal Studies, Middle Aged
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- USDA Grand Forks Human Nutrition Research CenterUS federal agency
- Study start
- Jun 2012 (actual)
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 28 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (2012-2013) | – | –Monitoring of Dietary Intake, Physical Activity and Stress |
| Group 2 (2013-2014) | – | –Monitoring of Dietary Intake, Physical Activity and Stress |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Middle-aged females
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in body fat
Time frame: Season 1, season 2, season 3, season 4
Body fat location and amount will be assess by dual-energy X-ray absorptiometry
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2020.
- Derived from this study: PubMed 31752882Jahns L, Johnson LK, Conrad Z, Bukowski M, Raatz SK, Jilcott Pitts S, Wang Y, Ermakov IV, Gellermann W. Concurrent validity of skin carotenoid status as a concentration biomarker of vegetable and fruit intake compared to multiple 24-h recalls and plasma carotenoid concentrations across one year: a cohort study. Nutr J. 2019 Nov 21;18(1):78. doi: 10.1186/s12937-019-0500-0.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Roemmich, PhD principal investigator
USDA-ARS-GFHNRC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Stress, run by USDA Grand Forks Human Nutrition Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body fat (time frame: Season 1, season 2, season 3, season 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01674296, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2020.