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Completed

NCT Number: NCT00575731

Behavioral Strategies for Weight Management

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Weight management strategies

Behavioral

Primary outcomes

  1. Weighing attitudes and behavior

    Time frame: 6 months

  2. Weight fluctuations

    Time frame: 6 months

Secondary outcomes

  1. Psychological outcomes

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • American Heart Association

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
Dec 18, 2007
Registry last updated
May 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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