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Consequences and Correlates of Weight Fluctuations
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Study NCT00005745   Information provided by National Heart, Lung, and Blood Institute (NHLBI)
First Received: May 25, 2000   Last Updated: June 23, 2005   History of Changes

May 25, 2000
June 23, 2005
January 1998
 
 
 
Complete list of historical versions of study NCT00005745 on ClinicalTrials.gov Archive Site
 
 
 
Consequences and Correlates of Weight Fluctuations
 

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.

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.

 
Observational
Natural History
  • Cardiovascular Diseases
  • Diabetes Mellitus
  • Heart Diseases
  • Hypertension
 
 
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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
December 2002
 

No eligibility criteria

Female
 
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00005745
 
5006
National Heart, Lung, and Blood Institute (NHLBI)
 
Investigator: Alison Field Brigham and Women's Hospital
National Heart, Lung, and Blood Institute (NHLBI)
September 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP