Clinical trial NCT00575731: Behavioral Strategies for Weight Management
Official title: Behavioral Strategies for Weight Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2007-12-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Although studies demonstrate that people who consistently keep detailed food records are more likely to maintain their weight, few people continue to keep records given the vigilant attention needed. This study will test the efficacy of an alternative approach to record keeping that may be easier for people to sustain and lead to better long-term weight management. We propose that obese adults who attempt to keep their weight within a clearly defined and personalized 'range', e.g., a 5-lb range between 200-205 pounds, will be more likely to continue weighing themselves and remain weight stable because they have learned to self-regulate, i.e., accurately monitor changes in their weight, alert themselves when they've gained too much weight, and 'finetune' their eating and physical activity in response, but with the minimum effort and attention necessary. The primary aim for this randomized trial will examine whether participants in an 8-week 'Fine-Tuning' program are more likely to weigh themselves over the 6-month study than participants in an 8-week traditional 'Record-Keeping' program.

Detailed description: Although studies demonstrate that people who consistently keep detailed food records are more likely to maintain their weight, few people continue to keep records given the vigilant attention needed. This study will test the efficacy of an alternative approach to record keeping that may be easier for people to sustain and lead to better long-term weight management. We propose that obese adults who attempt to keep their weight within a clearly defined and personalized 'range', e.g., a 5-lb range between 200-205 pounds, will be more likely to continue weighing themselves and remain weight stable because they have learned to self-regulate, i.e., accurately monitor changes in their weight, alert themselves when they've gained too much weight, and 'finetune' their eating and physical activity in response, but with the minimum effort and attention necessary. The primary aim for this randomized trial will examine whether participants in an 8-week 'Fine-Tuning' program are more likely to weigh themselves over the 6-month study than participants in an 8-week traditional 'Record-Keeping' program.

Eligibility criteria: Inclusion Criteria:(a)Web screen: Men or women of any ethnic background; age 18 years or older; body mass index (BMI) 25-39; planning to remain in the area for the next six months; not pregnant or not planning to become pregnant within the next six months; has no history of heart disease, including stroke, heart attack, coronary artery bypass surgery, or balloon angioplasty; not currently under medical care for any of the following conditions: cardiovascular problems (stroke, heart attack, chest pain, bypass surgery, etc.); cancer (except skin cancer); diabetes; respiratory problems (chronic asthma, bronchitis, etc.); or psychiatric condition; not currently taking or stable on medications for vascular problems (such as high blood pressure); able to participate in physical activity; does not meet Diagnostic and Statistical Manual criteria for binge eating; does not have a health condition that requires a special diet; not participating in a weight-loss program; not participating in support groups that focus on weight and eating habits; not taking weight-loss medication; not participating in any other research trial; and willing to be randomly assigned to either intervention.

(b)Pre-randomization: Completes all of the following in a timely and thorough manner: baseline clinic visit, baseline questionnaires on the study website, and obtains medical approval for participation (if applicable). Exclusion Criteria:(a)Web screen: Men or women of any ethnic background; age 18 years or older; body mass index (BMI) 25-39; planning to remain in the area for the next six months; not pregnant or not planning to become pregnant within the next six months; has no history of heart disease, including stroke, heart attack, coronary artery bypass surgery, or balloon angioplasty; not currently under medical care for any of the following conditions: cardiovascular problems (stroke, heart attack, chest pain, bypass surgery, etc.); cancer (except skin cancer); diabetes; respiratory problems (chronic asthma, bronchitis, etc.); or psychiatric condition; not currently taking or stable on medications for vascular problems (such as high blood pressure); able to participate in physical activity; does not meet Diagnostic and Statistical Manual criteria for binge eating; does not have a health condition that requires a special diet; not participating in a weight-loss program; not participating in support groups that focus on weight and eating habits; not taking weight-loss medication; not participating in any other research trial; and willing to be randomly assigned to either intervention.

(b)Pre-randomization: Completes all of the following in a timely and thorough manner: baseline clinic visit, baseline questionnaires on the study website, and obtains medical approval for participation (if applicable).

Primary outcomes:
measure: Weighing attitudes and behavior
timeFrame: 6 months
measure: Weight fluctuations
timeFrame: 6 months
Secondary outcomes:
measure: Psychological outcomes
timeFrame: 6 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Michaela Kiernan
role: PRINCIPAL_INVESTIGATOR
References: