Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005745
Status:
COMPLETED
Last Update Posted:
2016-03-16
First Post:
2000-05-25
Brief Title:
Consequences and Correlates of Weight Fluctuations
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2004-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To quantify the association between multiple intentional weight losses ie weight fluctuations and the development of hypertension and diabetes mellitus among 50790 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 gainloss 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
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 gainloss 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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R29HL057871 | NIH | None | httpsreporternihgovquickSearchR29HL057871 |