Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005177
Status:
COMPLETED
Last Update Posted:
2016-05-13
First Post:
2000-05-25
Brief Title:
Reno Diet Heart Study
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:
2000-06
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 study weight maintenance behaviors weight trends and behavioral differences between healthy normal weight and mildly obese adults
Detailed Description:
BACKGROUND
The treatment of obesity has met with limited success and clinically significant weight losses have been difficult to achieve and maintain Screening to determine which patient will benefit most from treatment emphasis on maintenance of weight loss and understanding individual weight trends and goals all have demonstrated significant impact on long-term treatment outcome Stunkard established a new classification of obesity according to severity and predicted outcome to treatment distinguishing mild and moderate overweight from severe forms of obesity Those who were classified as mildly obese were those who were most likely to be successful in traditional forms of treatment A comprehensive study of this mildly obese population and normal weight maintenance behaviors provided important information on which to build future treatment interventions andor effective strategies This would be of particular importance in the prevention of obesity and progressive escalation of the obese state
DESIGN NARRATIVE
Subjects were studied retrospectively by history and prospectively in their natural setting for five years A 2 x 2 x 5 multifactorial design was used where sex males versus females and weight obese versus normal were crossed with five different age groups according to decades 20-29 30-39 40-49 50-59 and 60 or more years respectively A total of 50 25 normal and 25 obese were recruited for each agesex group Dependent variables included weight weight trends fluctuation body composition diet activity or exercise weight maintenance behaviors and adaptive responses general well-being emotional states psychopathology routine blood and urinalyses cardiovascular disease risk profile including lipids blood pressure sodium potassium calcium and phosphorus levels diet smoking alcohol and caffeine use onset of menopause and changes in medical status or medication use Comprehensive assessment was done yearly
The study was renewed in 1992 to extend follow-up and evaluation of the RENO Diet Heart Study and to complete and extend testing of the primary hypotheses The three major hypotheses tested included 1 weight fluctuations affected cardiovascular disease CVD risk factors over and above weight change alone 2 weight changes fluctuations and patterns interacted with nutritional behavioral psychological and medical factors but these factors also affected CVD risk independent of weight and 3 retrospective self-reported weights fluctuations and patterns were predictive of prospective weights and weight fluctuations
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
The treatment of obesity has met with limited success and clinically significant weight losses have been difficult to achieve and maintain Screening to determine which patient will benefit most from treatment emphasis on maintenance of weight loss and understanding individual weight trends and goals all have demonstrated significant impact on long-term treatment outcome Stunkard established a new classification of obesity according to severity and predicted outcome to treatment distinguishing mild and moderate overweight from severe forms of obesity Those who were classified as mildly obese were those who were most likely to be successful in traditional forms of treatment A comprehensive study of this mildly obese population and normal weight maintenance behaviors provided important information on which to build future treatment interventions andor effective strategies This would be of particular importance in the prevention of obesity and progressive escalation of the obese state
DESIGN NARRATIVE
Subjects were studied retrospectively by history and prospectively in their natural setting for five years A 2 x 2 x 5 multifactorial design was used where sex males versus females and weight obese versus normal were crossed with five different age groups according to decades 20-29 30-39 40-49 50-59 and 60 or more years respectively A total of 50 25 normal and 25 obese were recruited for each agesex group Dependent variables included weight weight trends fluctuation body composition diet activity or exercise weight maintenance behaviors and adaptive responses general well-being emotional states psychopathology routine blood and urinalyses cardiovascular disease risk profile including lipids blood pressure sodium potassium calcium and phosphorus levels diet smoking alcohol and caffeine use onset of menopause and changes in medical status or medication use Comprehensive assessment was done yearly
The study was renewed in 1992 to extend follow-up and evaluation of the RENO Diet Heart Study and to complete and extend testing of the primary hypotheses The three major hypotheses tested included 1 weight fluctuations affected cardiovascular disease CVD risk factors over and above weight change alone 2 weight changes fluctuations and patterns interacted with nutritional behavioral psychological and medical factors but these factors also affected CVD risk independent of weight and 3 retrospective self-reported weights fluctuations and patterns were predictive of prospective weights and weight fluctuations
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 |
|---|---|---|---|
| R01HL034589 | NIH | None | httpsreporternihgovquickSearchR01HL034589 |