USDA Behavior, Motivation & Nutrition Study | NCT00838409

Studies
USDA Behavior, Motivation & Nutrition Study

NCT00838409

Sponsor

USDA, Western Human Nutrition Research Center

Status

Completed

Last Update Posted

Sep 14, 2011Estimated

Enrollment

40Actual

Phase

Not provided

Conditions

Body Weight

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2008

Primary Completion Date

Jun 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

Feb 4, 2009

First Submission Date that Met QC Criteria

Feb 5, 2009

First Posted Date

Feb 6, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 13, 2011

Last Update Posted Date

Sep 14, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study will be a cross-sectional study. The primary aim of this study is to compare the relationship between neurological function, metabolic measures and health-related behaviors between normal weight and overweight/obese perimenopausal women.

Detailed Description

To examine physiological and behavioral factors that may help determine health in perimenopausal middle age women. Neuroendocrine function will be measured by broad assessment of hypothalamic-pituitary-adrenal (HPA) activity. We will also assess metabolic profiles and behavioral and emotional function. We plan to determine correlations between these measures and nutritional state. Other measures may include insulin, glucose, leptin, IGF-1, triglycerides, free fatty acids, and ghrelin and eating attitudes and physical reactivity.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

40Actual

Label	Type	Description	Intervention Names
1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Correlation between metabolic measures and health-related behaviors in normal weight and overweight/obese perimenopausal women.		3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Body Mass index 18-39.9 kg/m2
Peri-menopausal status by self-report

Exclusion Criteria:

Pregnant
Plan to become pregnant
Breastfeeding in the last 6 months
Multiple sclerosis, amyotrophic lateral sclerosis, Parkinson's disease
Menopause confirmed
Unable to refrain from smoking for five hours (self-report)
Unable to refrain from consuming alcohol for two days (self-report)
Weight change > 10 lbs in the preceding 6 months
Chronic corticosteroid use
Oral corticosteroids used more than twice in the last 12 months
Hormonal contraceptives
Antipsychotic, anti-anxiety and anti-depressant medications
Beta adrenergic blockers
Sibutramine, orlistat, phentermine, phendimetrazine, topiramate, zonisamide
Immunosuppressants
Amphetamines and other stimulants
Severe food allergies or intolerances to foods
Insulin Dependent Diabetes Mellitus

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

42 Years

Maximum Age

52 Years

Standard Ages

Adult

Study Population

Community sample

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kevin Laugero, PhD	USDA, ARS, Western Human Nutrition Research Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
USDA, ARS, Western Human Nutrition Research Center		Davis	California	95616	United States

Label	URL
USDA, ARS, WHNRC	View source

Condition Browse Module

MeSH Terms

ID	Term
D001835	Body Weight

Ancestor Terms

ID	Term
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided