Improving Weight Loss Maintenance Through Alternative Schedules of Treatment

Obesity Clinical Trial

— ImWeL  

Official title:

Improving Weight Loss Maintenance Through Alternative Schedules of Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02487121
• Other study ID #: K23DK081607
• Status: Completed
• Phase: N/A
• First received: June 26, 2015
• Last updated: June 29, 2015
• Start date: April 2010
• Est. completion date: March 2015

Study information

• Verified date: June 2015
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Behavioral:
• variable interval schedule
12 group-based extended care treatment sessions scheduled in 3, 4-week periods over a 12-month period
• self-directed treatment
provision of treatment materials with instruction to work through materials at participant's own pace

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	body weight (kg)	change in body weight (kg) between randomization and month-12 follow-up	12 months	No