Consequences and Correlates of Weight Fluctuations | NCT00005745

Studies
Consequences and Correlates of Weight Fluctuations

NCT00005745

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Status

Completed

Last Update Posted

Mar 16, 2016Estimated

Enrollment

Not provided

Phase

Not provided

Conditions

Cardiovascular Diseases
Diabetes Mellitus
Heart Diseases
Hypertension

Interventions

Not provided

Countries

Not provided

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

ID	Type	Description	Link
R29HL057871	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Sep 2004

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

Jan 1998

Primary Completion Date

Not provided

Completion Date

Dec 2002Actual

First Submitted Date

May 25, 2000

First Submission Date that Met QC Criteria

May 25, 2000

First Posted Date

May 26, 2000Estimated

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

Mar 15, 2016

Last Update Posted Date

Mar 16, 2016Estimated

Description Module

Brief Summary

To quantify the association between multiple intentional weight losses (i.e., weight fluctuations) and the development of hypertension and diabetes mellitus among 50,790 female nurses participating in the ongoing Nurses' Health Study II. In addition to assessing the consequences of weight fluctuations, their correlates and course were identified.

Detailed Description

BACKGROUND:

In the United States, approximately one third of adult women are trying to lose weight. Most weight losses are not sustained and in fact may be followed by gains of at least as much weight as was intentionally lost. It is unclear whether there are adverse outcomes associated with multiple intentional weight losses.

DESIGN NARRATIVE:

The prospective study addressed the impact of weight fluctuation on development of hypertension (HPT) and diabetes (DM) by following women who significantly fluctuated in weight compared to those who generally maintained a stable weight. The subject source was all participants between 1989 and 1993 in the Nurses Health Study II (NHS) who did not experience a full term pregnancy between 1989 and 1993 and who were free of HPT, DM and cancer in 1993. A random sample of each of two weight fluctuation classifications, >20 lbs. (3 or more times) and 10-19 lbs. (3 or more times) was identified. A control group of non-fluctuators was matched by age and body mass index strata. Baseline data consisted of information obtained from the 1993 NHS II follow-up along with supplemental questionnaires sent to study participants to elicit specific information on past and present weight gain/loss and intentionality of weight fluctuation. Prospective data came from follow-up questionnaires in 1995, 1997, and 1999. Hypertension and DM ascertainment were obtained from self-report in the questionnaire. This ascertainment method appeared quite adequate based on validity studies carried out on subsamples of this cohort.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

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

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Eligibility Module

Eligibility Criteria

No eligibility criteria

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

100 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Alison Field	Brigham and Women's Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11477495	Background	Field AE, Wing RR, Manson JE, Spiegelman DL, Willett WC. Relationship of a large weight loss to long-term weight change among young and middle-aged US women. Int J Obes Relat Metab Disord. 2001 Aug;25(8):1113-21. doi: 10.1038/sj.ijo.0801643.

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
D002318	Cardiovascular Diseases
D003920	Diabetes Mellitus
D006331	Heart Diseases
D006973	Hypertension