Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00113711
Status:
COMPLETED
Last Update Posted:
2016-05-13
First Post:
2005-06-09
Brief Title:
Promoting Smoking Cessation and Reducing Weight Gain
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:
2005-06
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 test whether a behavioral intervention could indeed achieve the dual goals of promoting smoking cessation and minimizing weight gain
Detailed Description:
BACKGROUND
When the study began in 1995 more females were initiating cigarette smoking and a growing proportion cited fear of gaining weight as a major reason for refusing to even attempt quitting smoking It had not yet been possible however to prevent post- cessation weight gain through dieting or behavioral treatment without undermining abstinence from smoking The investigators proposed that prior interventions had been unsuccessful because a their weight management interventions were too complex b the programs thwarted a need of the patient in nicotine withdrawal to eat hedonically appealing high-carbohydrate snacks and c the programs heightened patients emphasis on weight control at the expense of their emphasis on smoking cessation by asking them to initiate weight control before or simultaneously with quitting smoking
DESIGN NARRATIVE
The investigators collected pilot data on a promising 16-week intervention that they called the LATE WEIGHT PLAN because it emphasized smoking cessation for the first half of treatment and integrated weight management for the last half The weight management module included a pre-packaged meal plan high-carbohydrate low-fat snacks and low-intensity aerobic exercise All patients continued in the weight management phase of treatment regardless of whether they had succeeded in quitting smoking or were preparing to make new quit attempts Based on pilot findings the investigators estimated the point prevalence of smoking cessation for the LATE WEIGHT PLAN group to be 74 at the end of treatment with weight gain less than 5 lb An EARLY WEIGHT PLAN group controlled for the timing of the intervention using the same target quit smoking date and 16 week program but integrating the weight management module into the first 8 weeks of treatment Like others they found that EARLY weight management efforts while they may have prevented weight gain apparently did so at some cost to smoking cessation which they estimated to be 42 at 4 months Finally a CESSATION ONLY group controlled for the presence of a weight management intervention by dealing exclusively with smoking cessation for the entire 16 week program The CESSATION ONLY group had attained the worst outcome in terms of weight control and an intermediate outcome in terms of abstinence at the end of treatment 50 By randomizing 315 female smokers to the three treatments and comparing abstinence and weight gain after 4 months of treatment and 6 month follow-up 10 months they tested whether a behavioral intervention could indeed achieve the dual goals of promoting smoking cessation and minimizing weight gain
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
When the study began in 1995 more females were initiating cigarette smoking and a growing proportion cited fear of gaining weight as a major reason for refusing to even attempt quitting smoking It had not yet been possible however to prevent post- cessation weight gain through dieting or behavioral treatment without undermining abstinence from smoking The investigators proposed that prior interventions had been unsuccessful because a their weight management interventions were too complex b the programs thwarted a need of the patient in nicotine withdrawal to eat hedonically appealing high-carbohydrate snacks and c the programs heightened patients emphasis on weight control at the expense of their emphasis on smoking cessation by asking them to initiate weight control before or simultaneously with quitting smoking
DESIGN NARRATIVE
The investigators collected pilot data on a promising 16-week intervention that they called the LATE WEIGHT PLAN because it emphasized smoking cessation for the first half of treatment and integrated weight management for the last half The weight management module included a pre-packaged meal plan high-carbohydrate low-fat snacks and low-intensity aerobic exercise All patients continued in the weight management phase of treatment regardless of whether they had succeeded in quitting smoking or were preparing to make new quit attempts Based on pilot findings the investigators estimated the point prevalence of smoking cessation for the LATE WEIGHT PLAN group to be 74 at the end of treatment with weight gain less than 5 lb An EARLY WEIGHT PLAN group controlled for the timing of the intervention using the same target quit smoking date and 16 week program but integrating the weight management module into the first 8 weeks of treatment Like others they found that EARLY weight management efforts while they may have prevented weight gain apparently did so at some cost to smoking cessation which they estimated to be 42 at 4 months Finally a CESSATION ONLY group controlled for the presence of a weight management intervention by dealing exclusively with smoking cessation for the entire 16 week program The CESSATION ONLY group had attained the worst outcome in terms of weight control and an intermediate outcome in terms of abstinence at the end of treatment 50 By randomizing 315 female smokers to the three treatments and comparing abstinence and weight gain after 4 months of treatment and 6 month follow-up 10 months they tested whether a behavioral intervention could indeed achieve the dual goals of promoting smoking cessation and minimizing weight gain
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 |
|---|---|---|---|
| R01HL052577 | NIH | None | httpsreporternihgovquickSearchR01HL052577 |