Improving Weight Loss Maintenance Through Alternative Schedules of Treatment

Study Overview
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Brief Summary
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This project examines the effects of differing schedules of extended care contact following weight loss treatment in order to prevent weight regain following treatment.

Official Title
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Improving Weight Loss Maintenance Through Alternative Schedules of Treatment

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: variable interval schedule
* Behavioral: self-directed treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 21 years-old body mass index (BMI) = 28.0 - 45.0 kg/m2 willing to provide informed consent and accept randomization Exclusion Criteria: BMI >45 kg/m2 Illnesses requiring medical attention and/or conditions for which weight loss and moderate physical activity would be inadvisable: diabetes not under active treatment, myocardial infarction or cerebrovascular accident within the last six months; unstable angina within the past six months; congestive heart failure; cancer requiring treatment in past five years (exception: non-melanoma skin cancer); serious infectious diseases (e.g., self-reported HIV); chronic hepatitis; cirrhosis; chronic malabsorption syndrome; chronic pancreatitis; chronic lung diseases that limit physical activity; orthopedic injuries or conditions that significantly limit physical activity. Conditions or behaviors likely to affect the conduct of the trial: unwilling or unable to give informed consent; unable to read English at the 5th grade level; unwilling to accept random assignment; unwilling or unable to travel to attend intervention (due to distance from clinic, work schedule or other scheduling conflicts); likely to relocate out of the service area in next 18 months.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: variable interval schedule<br>12 group-based extended care treatment sessions scheduled in 3, 4-week periods over a 12-month period | Behavioral: variable interval schedule<br>* 12 group-based extended care treatment sessions scheduled in 3, 4-week periods over a 12-month period<br>|
| Active Comparator: self-directed treatment<br>provision of treatment materials with instruction to work through materials at participant's own pace | Behavioral: self-directed treatment<br>* provision of treatment materials with instruction to work through materials at participant's own pace<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body weight (kg) | change in body weight (kg) between randomization and month-12 follow-up | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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weight loss